Unipharm Without Representation wins Interim Proceeding in Opposition Against Novartis

February 22, 2018

Background

galvusIsrael  Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION ” the patent application is a national phase of PCT/EP/2005/000400. It relates to a pharmaceutical used in the treatment for diabetes known as Vildagliptin (previously LAF237, trade galvus moleculenames Galvus, Zomelis,) which is an oral anti-hyperglycemic agent (anti-diabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs. Vildagliptin inhibits the inactivation of GLP-1[2][3] and GIP[3] by DPP-4, allowing GLP-1 and GIP to potentiate the secretion of insulin in the beta cells and suppress glucagon release by the alpha cells of the islets of Langerhans in the pancreas.

Unipharm has opposed the patent issuing and in an intermediate proceeding, Unipharm (not represented) submitted a disclosure request for:

  1. the specific testing referred to Appendix E of a the Applicant’s expert witness
  2. All other tests relating to all the formulations that were performed where the particle size distribution was examined.

UnipharmAlternatively, Unipharm requests that the part of the evidence that relates to the evidence submitted in the European Opposition proceeding from Dr Davis’ statement, including Appendix E be struck.

The patent relates to tablets that are made by direct compaction and which include DPP-IV, (s)-1-[(3-hydroxy-1-adamantyl)amino]acetyl-2-cyanopyrrolidin (Vildagliptin) in free radical form or as a salt, wherein at least 80% of the particles compressed into the tablet are in size range of 10 microns to 250 microns.

novartisIn their Statement of Case, Novartis explains that use of direct compression was not obvious to persons of the art wishing to produce vildagliptin formulations, and the distribution and size of the particles affects the character of the tablet in a manner that determines the efficacy of the formulation. The chosen distribution enables tablets to be produced by direct compaction which have high quality, acceptable stability and good physical properties.

With respect to this, Novartis’ expert witness, Dr Davis explains in his expert opinion as follows:

“There is no prior art suggesting that tablets of vildagliptin can be made using direct compression with this size range or any size range. This particle size range and percentage of the active agent is not disclosed in the prior art. It should be noted that the particle size distribution is important to achieving good physical properties in the tablet (e.g. good hardness). Evidence filed in a technical annex for the corresponding European Patent Application No.15199440.7 (available on-line from the EPO at https://register.epo.org/application?documentId=EZQR8ZQ06757DSU&number=EP15199440&lng=en&npl=false),  comparing 88% PSD of 10-250 micron (within the claim) versus 79% PSD of 10-250 micron (outside the claim) shows that the use of a particle size distribution as claimed is important in providing directly compressed tablets with good hardness (Appendix E).”

The Expert witness related to the technical appendixes that were submitted by the Applicant to the European Patent Office which compares tablets that fall within the ambit of claim 1 to those that do not, and this is the basis of the discovery request that Unipharm submitted.

Claims of the Parties

disclosureUnipharm’s opposition to this evidence is that Professor Davis relied on test results from tests that he himself did not conduct, and they express wonderment that Novartis did not produce the drug developers to be cross-examined. In response, the Applicants claim that the disclosure process should be allowed on in cases where it is proven that the documents in question are relative to the proceeding  in general and to the point of contention between the parties, and in this instance the Opposer did not justify his request for disclosure of documents and did not explain how the disclosure would help clarify the question under debate.

grain sizeNovartis further allege that the request for disclosure is wide and general, in that it relates to all testing and formulations made, where particle size was examined. The Applicant further asserts that Dr Davis referred to Appendix E merely to dhow that it was published and not as evidence that the data therein is true(!?)

As to Unipharm’s alternative request, Novartis claims that the Opposer did not base this allegation, and that we are referring to an expert opinion based on data provided to him and his relying on the publication is equivalent to any expert relying on a professional publication such as a paper in a scientific journal or a patent application in a relevant field.

file-wrapperIn response, Unipharm claims that the Applicant’s expert Professor Davis did not merely testify that the document was included in the file wrapper of the European Patent Application, but also reached conclusions in his expert opinion that were based thereon. As far as anything connected to the scope of the disclosure, Unipharm focuses their request and asks to receive the documents relating to the experimentation with the particle distributions and efficacy of formulations made with the specific distributions.

Unipharm claims that the documents will reveal that the tests conducted, if indeed conducted, do not provide sufficient instruction to persons of the art to produce the invention successfully without additional experimentation and thus the patent application should be rejected as not enabled under Section 12 of the Israel Patent Law 1967.

Discussion and Ruling

legal fishing expeditionThere is no doubt that the Commissioner of Patents can request disclosure and access to documents in opposition proceedings. The disclosure is efficient in that it provides documents to the Patent Office that are not covered by Section 18 of the Law (Duty of Disclosure) and which can help clarify if an application is patent worthy. However, disclosure is performed in a manner to prevent the applicant going on an illegal fishing expedition in the applicant’s filing cabinets.

The considerations to be weighed up prior to giving a disclosure order are detailed in Opposition to 60312 Biotechnology General Corp vs. Genentech Inc and in Opposition to 143977 AstraZeneca AB vs. Unipharm ltd, and these are the stage of the opposition reached; the amount of documents and their content; the weight of the claim that the Applicants are attempting to prove with the documents asked disclosure of, their evidential weight, the possibility of the Applicant to obtain the documents themselves, and the burden it will cause the opposing party.

In these rulings it was also determined that disclosure could damage the property rights of the opposing party by forcing revelation of trade-secrets. However, the possibility of such damage being caused does not remove the authority of the patent office to demand such a disclosure., but obliges consideration of the legitimate property rights of the party when applying that authority.

In the opinion of Commissioner Alon Ofir, Novartis is correct that the experimental results will have no effect on the average person of the art’s ability to implement the invention. The answer to this question is found in what is revealed and not in what is not revealed in the patent application.

Nevertheless, Unipharm is correct with regard to everything related to the tests described in Appendix E, since the Applicant himself relied upon this in his statement. In this regard the Commissioner does not accept that this evidence can be considered as external evidence that their Expert Witness relied on. The document was prepared by Novartis themselves, with data they control, and their expert witness relied on it in his Opinion.

tablet-compression-machineThe particle size distribution is claimed by Novartis themselves as being a central element of their invention, and the claims of the Application itself limits the requested patent to one wherein 80% of the particles are in the 10 micron to 250 micron range. The Applicant themselves state in their Statement of Case, that the choice of particle size and distribution is what enables the fabrication of tablets of an acceptable quality by direct compression. Their Expert Witness finds support for this claim in Appendix E which compares tablets having this particle distribution with tablets that do not.

In these circumstances, one should consider the documents as relating to the central question being debated by the parties. Thus the documents relating to Appendix E are ruled relevant and Novartis are required to provide not just those relied upon but other documents summarizing experiments done with the intention of producing Appendix E, even if not included therein.

Novartis is given 30 days to produce an Affidavit of disclosure with the relevant documents describing test results obtained in the experimentation leading to Appendix E, whether or not included in the Appendix, but relating to the hardness of tablets made from different particle distribution.

As an after-note, the Opposer is chastised for using language that does not show respect for the proceedings which was inappropriate.

No costs are awarded.

Ruling on Interim Proceeding regarding disclosure, by Commissioner Ofir Alon, 3 January 2018.

COMMENT

trawlingIn court proceedings in the United States there is wide discovery and the parties effectively go on fishing expeditions with trawlers and haul up everything and then have to wade through the bycatch.  This is not the case in Israel. One can ask for specific documents, but have to justify the request. Thus I have used the term disclosure and not discovery.

self representationIn this instance, Unipharm is not-represented, or to be more accurate Dr Zebulun Tomer is representing himself. No doubt if he runs into trouble he will call on his attorney Adi Levit to represent them. It is unlikely that the inappropriate language lost Unipharm a costs award as since they have not used legal counsel they are not entitled to costs anyway.

We strongly discourage industrialists to represent themselves in Opposition proceedings. The Tomers, however, have so much experience of killing pharma patent applications that there are very few lawyers that have handled so many cases.


Repeated Requests for Reconsideration Smashed

February 22, 2018

smash batmanBack in May 2017 we reported that Talber Pop LTD owns Israel trademark number 240598 “SMASH” for Notebooks, stationery, diaries, binders; gift wrapping paper, paper gift wrapping bows, paper cake decorations, paper party bags, loot bags, cello bags, paper party decorations, paper party hats, paper tables cloths, paper napkins, banner made of paper and/or cardboards; all included in class 16, and Backpacks, sidepacks, back bags, side bags, sport bags, tote bags, book bags, school bags, food bags, pencil cases sold empty, wallets, waist packs, briefcases, bike bags, toiletry cases sold empty, fanny packs, suitcases, umbrellas, umbrella covers; all included in class 18. They also own a second Israel trademark number 241238 for SMASH in class 14 covering watches, chronometers and their parts, and that Smash Enterprises Pty LTD submitted a request to cancel the Talber Pop LTD marks or to allow their marks to be co-registered.

The parties were interested in coexisting, but MS Shoshani Caspi considered it against the public interest in view of the likelihood of confusion. See here.

Ms Shoshani related to the request, but first detailed the conditions for reconsideration.  The correct way to attack a judicial ruling is by Appealing to a higher court, and not by way of reconsideration. See Appeal 5012/01 Jacobovitz vs. Lerner 11 July 2001 where the following is stated:

Parties that argue and return over again to the court cannot expect an advantage. If the party considers that there was a mistake in the ruling, they should timely file an appeal.

Nevertheless, the case-law allows reconsideration in two instances: where there has been a significant change in circumstances that justifies reconsideration, and where there was a technical error in the ruling. See Appeal 7869/17 E.R.M. Properties vs.Daniel Ohr, 23 November 2017 where Judge Minz of the Supreme Court ruled that:

The rulings of this court recognize two circumstances where a ruling can be reconsidered in a reconsideration, other than interim injunctions which are explicitly legislated in regulation 368 of the Civil Procedure Regulations. The first instance is where there has been a significant change of circumstances, and the second case is where the court made a serious and clear technical error – see Appeal 1474/11 Strauss Marketing vs. Orman, paragraph 13, 14 July 2011; 3604/02 OKO vs Shemi p.d. 56(4) 505, 508 (2002), and Tami bin Nun and Tal Habakin “Civil Appears p. 427 edition 3, 2012.

Over the years there has been a worry that parties would make improper use of the opportunity of interim procedures to request reconsideration (see for example, 8420/96 Margaliyot vs. Mishkan Bank HaPoalim for Mortgages LTD (31 July 1997). So it was established that courts can simply throw out such requests on the grounds of improper use of the court proceedings, particularly where the party requests reconsideration over and over. That written in 5168/01 Reuveni vs. Ben Harush 28 Oct 2001 is relevant here:

RepeatFiling repeat requests that are minor improvements of the original request puts an unreasonable burden on the courts. Requesting reconsideration as a routine event is burdensome, and prevents the court providing a service for all its users.

In re Jakobovitz, then registrar of the Supreme Court Boaz Okan noted that:

The creative multiplication of proceedings, notices, reconsiderations and the like, are symptomatic of loose and unravelling systems (Appeal 502/00 Airport Authority vs. Epkon. There is no place to create cross-species rulings that damage the finality of the Court’s decision and may cause the legal proceedings to drag on forever., by misusing the civil procedures and wasting legal resources.

On 30 December 2015, Smash Enterprises Pty LTD requested to cancel the Talber Pop LTD’s marks for SMASH in classes 16 and 18.

The request for cancellation followed Smash Enterprises Pty LTDs attempt to register SMASH as a trademark in class 21 that was refused under Section 11(9).

Smash Enterprises Pty LTDs  application no 274301 is for Containers for household or kitchen use; household or kitchen utensils; containers for beverages; containers for food; heat insulated containers for beverages; heat retaining containers for food and drink; insulated containers; lunch boxes; isothermic bags; bottles including water bottles (containers); beverage coolers (containers); drinking containers; portable coolers; ice containers; ice packs; plastic containers (household utensils); lids for household or kitchen containers; tableware, including plates, dishes, drinking glasses, bowls, cups, saucers, mugs and jugs, all being of plastic materials; cooking utensils for use with domestic barbecues; storage boxes, baskets and containers for household use; household rubbish containers (bins); glassware for domestic use; ceramic tableware; baking trays; storage jars; cooler bags; thermally insulated bags for food and drink. In class 21.

Talber Pop LTD’s mark 24059 is for Watches of all kinds; chronometers and part thereof and accessories; all included in class 14, for Notebooks, stationery, diaries, binders; gift wrapping paper, paper gift wrapping bows, paper cake decorations, paper party bags, loot bags, cello bags, paper party decorations, paper party hats, paper tables cloths, paper napkins, banner made of paper and/or cardboards; all included in class 16, and for Backpacks, sidepacks, back bags, side bags, sport bags, tote bags, book bags, school bags, food bags, pencil cases sold empty, wallets, waist packs, briefcases, bike bags, toiletry cases sold empty, fanny packs, suitcases, umbrellas, umbrella covers; all included in class 18.

coexistOn 26 January 2017, the parties jointly requested coexistence following a mediation proceeding connected to a civil complaint filed by Smash Enterprises Pty LTD against Talber Pop LTD (Civil Complaint 65168-12-16). The request for coexistence under Section 30 was submitted with a copy of the agreement between the parties.

On 26 April 2017, Ms Shoshani Caspi explained in detail why she considered coexistence to be inappropriate as follows:

Thus the Arbitrator Ms Shoshani Caspi finds herself considering two identical marks for the word SMASH for two different entities that cover inter alia the same goods which creates a strong risk of confusion.

As part of their joint submission. the parties should have provided a detailed explanation why TM 274301 in class 21 should be registerable together with TM 240598 in class 18. This wasn’t done, and the parties have provided no explanation as to how to avoid confusion. The request for coexistence is refused. The parties have until 1 June 2017 to inform whether they wish to conduct a cancellation proceeding.

On 16 October 2017 a first request for reconsideration of the decision of 26 April  was received.  In that framework, the party who had requested cancellation noted that they were abandoning the 274302 and 274158 marks for SMASH in classes 18 and 16, despite the fact that the coexistence agreement didn’t relate to those marks. Additionally, the mark owner noted that they were prepared to strike the term ‘food boxes’ from the list of goods of Israel TM 240598.

On the same day, the Adjudicator Ms Shoshani Caspi again rejected the coexistence agreement stating:

There is before me a request for reconsideration of coexistence of the marks based on the agreement reached by the parties, following my rejecting this possibility in my ruling of 24 April 2017. The parties chose to ignore the significant obstacles that prevent coexistence that were stated in paragraphs 18, 21 and 24 of my previous decision. So the petition is rejected.

On 22 October 2017, the parties again requested reconsideration for a second time, restating their positions and claiming that their agreement does not leave room for confusion between the marks. On 25 October 2017, a detained ruling was issued that again rejected the coexistence stating:

I have not found that an error occurred in my ruling of 26 April 2016 (or indeed of that of 16 October 2017). The parties return and make exactly the same claims a third time. Consequently I do not find that there has been a change in circumstances from those under which the original decision and the appeals were given that justifies further reconsideration. Although unnecessary to do so, I note, again, that we are talking about an attempt to register exactly the same mark for goods having a similar commercial nature, without the appropriate and fitting difference between them. Consequently, the petition[ for coexistence]  is rejected a third time.

nagOn 11 January 2018, the parties submitted a third request for reconsideration of the 25 October 2017 ruling, raising the same arguments. Additionally this time the mark owner requested to remove the term “cases (files) of..”

The Deputy Commissioner does NOT consider this amendment as being a “Significant change in circumstances or a technical error that warrants reconsideration of the ruling of 26 April 2017.

The third request for reconsideration is rejected. The Adjudicator is not happy with attempts to negotiate with the court of the Israel Patent and Trademark Office by unsupported requests for reconsideration. She considers these requests adds to the workload of the patent office staff and requires detailed responses and is inappropriate. She considers it would be appropriate to rule costs against the parties to be paid into the public fund but will refrain from doing so this time.

Ms Shoshani Caspi’s problem is that sports bags and school bags may be in different categories from food storage bags and flasks but the requested mark is for words and school bags and sports bags do sometimes have pockets for food, so she considers that different suppliers cannot use the same word mark for these goods, despite registering in different classes (19 and 21). Indeed, in absence of evidence to the contrary, the goods can be considered as complimentary  goods in the same broad category that are often used together, such that the reasonably consumer will assume a common source. See the HRA Laboratoire Pharma vs. Fr Shapira Eyal ltd ruling of 28 December 2017:

With respect to complimentary goods, one has to consider if there is a tight relationship between them, that one is required or significant to the other, or that the consumer is likely to consider that the provision of the goods is the responsibility of the same supplier.

The parties have still not provided any evidence that undermines the Adjudicator’s conclusions regarding a commercial link between the goods, and have only made unsupported statements to the effect that the food packaging supplied by the requester for cancellation is not sold in the same stores as the bags of the mark owner.

Thus, as determined more than once in this proceeding, the certain similarity between the goods listed in issued mark no. 240598 in section 18 and those in application 274301 in class 21, and the identical nature of the two marks (both word marks for SMASH), leaves a high likelihood of similarity which may result in consumer confusion.

As to the obligation undertaken in the coexistence agreement by the mark owners not to use a stylize graphic rendering of SMASH, this was discussed in the 26 April 2017 ruling, and can simply be recited: “it is difficult to ignore the situation where the patent and trademark registrar allows the parties to make use of the word in any style they see fit, merely because of a narrow contractual agreement between the parties, and the trademark register does not faithfully match the trade situation.”

The parties repetitively made shallow claims that the District Court endorsed the coexistence agreement and gave it the status of a court ruling. Examination of the agreement, sections 3 and 4 thereof, indicate that the mark owner obliged himself not to object to the registration of the word “SMASH” by the requester for cancellation in classes 16 and 18, and the requester for cancellation obligated himself to cancel the requests for cancellation.  It is assumed that the learned legal representatives (Eitan Mehulal for Smash Enterprises and Eyal Plum for Talber Pop) did not intend to accidentally claim that this can be interpreted as the court endorsing the right for the Smash Enterprises mark to be registered, since it is known that the Commissioner of Patents and Trademarks has the sole authority to register marks under Section 17(a) of the Ordinance. Thus one has to assume that the court endorsement of the coexistent agreement only obliges the parties themselves.

As we are dealing with the authority of the Israel Patent and Trademark Office, it should be noted that Section 30a allows and does not obligate the commissioner to allow coexistence of identical or confusingly similar marks. Furthermore, in the court ruling 48837-03-14 Biosensors Europe SA  vs the Patent Office 22 February 2015 it was stated that “the burden of proof that there is no confusing similarity is on the companies interested in parallel usage, to show that they have been using the mark in parallel for many years and it has not caused the public to be confused”. For more discussion, see here and here. As stated above, in this instance the parties have not met this burden.

not a rubber stampThus it is ruled that the parties legal representatives (Eitan Mehulal for Smash Enterprises and Eyal Plum for Talber Pop) failed to submit appropriate evidence to support their request for coexistence under Section 30a of the Ordinance, and merely supported their request with the in personam coexistence agreement. The Commissioner of Patents and Trademarks is NOT a rubber-stamp that endorses agreements between warring parties and though allowed to, is not obliged to consider them. The main obligation of the Commissioner is to maintain the integrity of the trademark register and this includes ensuring that there is no likelihood of misleading the public. This forum has established many times that a request for coexistence by the parties does not exert much influence on deciding whether or not to allow such coexistence under section 30a, and is at best an indication that coexistence may be possible that has to be considered with all the considerations, see Supreme Court ruling 1611/07 Micha Danziger cs. Shmuel Mor, 23 August 2012. 

On 3 January 2018, the Adjudicator gave the parties 14 days to submit their evidence, i.e., until 17 January 2018, or the cancellation proceeding would be closed.  The parties have failed to provide such evidence and have also failed to request an extension. The Adjudicator has not ignored the request from the parties to provide guidance for how to restrict the lists of goods to allow coexistence, but she is not clear why this is necessary in light of all the decisions referenced, and does not intend to provide such guidance.

Conclusion – since the Requester for Cancellation has not provided evidence to support his case as asked to, and since no request for extensions of time were submitted, the cancellation proceedings against Israel Trademarks 240598 and 241238 are closed. The Requester for Cancellation is not prevented from filing a new trademark cancellation request if it will be conducted in accordance with the timeframe.

Israel Trademarks 240598 and 241238 “SMASH”, Decision to reject Cancellation Request by Ms Yaara Shoshani Caspi,  18 January 2018.   

 

 


A ballsy trademark ruling

January 30, 2018

SodKGaA & Henkel AG filed a series of Israel trademark applications (Nos.  258658, 258797, 258798 and 259500 as shown alongside.258658

The marks cover Bleaching preparations and other substances for laundry use, rinsing agents for laundry and tableware, stain removing preparations; cleaning, polishing, scouring and abrasive preparations, chemical agents for cleaning metal, enameled sheet metal, wood, cork, porcelain, ceramic, glass, plastic, leather and textiles; spot remover; soaps not for personal use, perfumery, essential oils in class 3, “Disinfectants and deodorants other than for humans and animals”. In class 5, and Sponges, brushes, cleaning cloths, cleaning purposes, hand-operated cleaning appliances, devices for dispensing sanitary cleaning and fragrance products, partially with the addition of disinfectant, included in class 21.

The Israel Trademark Department refused to register the marks on the grounds that they lacked inherent distinctiveness as indication of source, since they were the shape of the products themselves. The marks were also refused under Section 8(b) of the Ordinance 1972, as not having acquired distinctiveness through use.

The Applicant claimed that the marks are registerable since they serve in practice as a trademark, have acquired distinctiveness through use, and the choice of shape is not a result of real aesthetic or practical considerations. The Applicant requested a hearing, and submitted the following evidence:

  • An opinion by Mr Oshik Roshnik, marketing consultant, who held a public survey regarding how well known the marks were. Mr Roshnik attended the hearing and the survey and his conclusions are detailed below.
  • An affidavit from Ms Danielle Rabinowitz who is the product manager for Henkel Sod ltd, which is fully owned by the Applicant. Her testimony affirmed the sales in Israel and abroad and the investment in advertising and promotional activity. Ms Rabinowitz also attended at the hearing.
  • An Affidavit of Ms Cecile Leroi the International Marketing Manager of the Applicant, who testified regarding sales.

A large quantity of marketing material was appended to the affidavits.

sod balls.jpg

From the evidence it appears that the products are sold in Israel in blister packs that have transparent fronts. The mark Sod appears clearly on the packaging, which is the brand for these and other products of the Applicant in Israel. The Sod mark is recognized as being a leading brand in Israel.

juggling four balls

The Applicant claimed that since January 2014 they have invested 15 million shekels in advertising and marketing in various telecommunication channels, including point-of-sale. As a result of this intense marketing, some 6 million units have been sold, which is 30% of the market. These statistics support the Applicant’s contention that the marks have acquired distinctiveness.

The Applicant’s legal counsel emphasized that the marks were registered in a number of countries, including the EUIPO. The Applicant is also prepared for the mark to be registered under Section 16.

Discussion

toffiffee

The tests for validity of a trademark registration for the shape of an article was given in the Supreme Court ruling 11487/03 August Storck KG vs. Alfa Inuit Food Products LTD, of 23 March 2003. These tests are summarized in Circular 033/2016 Trademarks: Emphasis on Examining trademarks from 15 December 2016 as follows:

  1. The requested shape has to serve as a trademark in practice
  2. The requested shape cannot be significantly aesthetic or practical.
  3. The shape has acquired distinctiveness through use

This topic has been widely discussed in the case-law and literature in Israel and abroad. The tests have been largely adopted due to comparative law, and so we can use foreign rulings to aid us in coming to a conclusion.

Nevertheless, the Deputy Commissioner does not consider that the applied for mark fulfils the Supreme Court’s criteria.

The Mark Does Not Serve As a Trademark in Practice

The question asked in this context is whether the public and the applicant see the shape of the mark separately from other marks that are applied to the product to indicate the source, thereby serving as trademarks. As clarified in Berkeley “Kerly’s Law of Trade Marks and Trade Names“, 15th ed. (2011) p. 197, from a UK decision regarding the registerability of the shape of a container:

The relevant question is not whether the container would be recognised on being seen a second time, that is to say, whether it is of memorable appearance, but whether by itself its appearance would convey trade mark significance to the average customer.”

The things are stated regarding containers, but this is also true regarding the shape of the products themselves, since these are not generally considered as being trademarks by the public, and the packaging includes the well known word mark Sod as a trademark indicating the source of the goods. It is true that sometimes a single object will have more than one trademark on it, each being independently registerable. However, in such cases it is difficult for the manufacturer to demonstrate that the public afford each element weight as a trademark: See J. Thomas McCarthey in McCarthey on Trademarks and Unfair Competition (2011), pages 7-12:

“When a label or advertisement contains a cluttered morass of claimed marks in many words, slogans and designs, no one of these things is likely to make a significant trademark impression on customers. If a given designation is a trademark, that should be immediately evident to the ordinary buyer. If it takes extended analysis and legalistic argument to attempt to prove that a designation has been used in a trademark sense, then it has not.”

kitkatThe need for the public and the manufacturer to rely on the shape of the product as an indication of the source of the product is required for it to be registerable has been discussed recently in the UK decision [2017] EWCA Civ 358 Société des Produits Nestlé SA  v. Cadbury UK Ltd. (Kit Kat). In this ruling, the court affirmed the ruling of two lower courts that the shape of the KitKat snack bar is not registerable. In that case, the issue of the burden of proof for registering a product shape was referred to the CJEU:

The judge thought that the answer to this question was not clear and depended upon what was meant by “use of the mark as a trade mark”. As he put it: does it require the applicant to show that, as a result of the use of the mark, consumers rely on the mark as a trade mark, or is it sufficient that consumers recognise the mark and associate it with the applicant’s goods?”

The UK court considered that the European Court’s position was that the public have to rely on the product shape as a source of origin, and not merely to recognize the product shape:

“Accordingly, I agree with the judge that it is legitimate for a tribunal, when assessing whether the applicant has proved that a significant proportion of the relevant class of persons perceives the relevant goods or services as originating from a particular undertaking because of the sign in question, to consider whether such person would rely upon the sign as denoting the origin of the goods or services if it were used on its own. Further, if in any case it is shown that consumers have come to rely upon the mark as an indication of origin then this will establish that the mark has acquired distinctiveness”

Deputy Commissioner Jacqueline Bracha does not consider that the survey and publicity material in the present case proves the Applicant’s contention.

In all cases, the word mark Sod clearly appears in the publicity material, and the advertisements all include the word Sod a large number of times. So it does not appear that the applicant is relying on the visual appearance of the product to indicate the origin thereof.

The extent in which the shape of the package is capable of serving as a trademark depends on the degree that they are different from that typical in the field. See for example, Israel Trademark Application No. 174402 Diageo North America, Inc. from 13 April 2011. The Applicant notes that they chose the mark to distinguish themselves from their competitors. The Applicant submitted a lot of material that shows that cleaning materials intended to be hung in the toilet bowl come in different shapes, however all of these include a hook and a perforated plastic case so that they can serve their function of hanging over the rim and allowing water to reach the cleaning material on flushing. The product in question is not sufficiently distinctive that it is recognized by the public as being a trademark. From the material submitted and from a personal search of the Internet it appears that such products come in various shapes and sizes including five flowers, three crescents three rectangles and so one. Most of the products are coloured and two colours are combined in a single product… Many are sold in transparent packages that have the manufacturer’s logo on the upper part.

The mark has not attained distinguishing character through use

There is a connection between the question of whether a mark serves as a trademark in practice and whether it has acquired distinctiveness. The Applicant has to demonstrate that through sales, etc., there is public awareness of the mark.

First and foremost, the Applicant has to show that the goods have a reputation, meaning that the public identifies the goods with the applicant or at least with a specific source, even if not identifying the applicant by name.
….
Continuous significant usage is not what is important, but rather the type of use:  if it is a use that identifies the product with the Applicant, see Appeal 18/86 Israel Venetian Glass Factory vs. Les Verries de Saint Gobain p.d. 45(3) 224, 238.

To prove a relationship between the product and supplier, the Applicant submitted Mr Roshinak’s survey. The questions were directed to respondents who admitted to being the purchasers of domestic hygiene goods for their homes. The respondents were first asked if they were familiar with the products for which the trademarks were sought (specifically the product having Israel TM Application No. 258658). It is noted that the respondents were not asked if they had purchased the product and so those who had seen the advertisements also responded positively and some 67% were familiar with the product. Mr Roshnak explained at the hearing that this is significant. In this regard, it is noted that the publicity campaign was conducted close to the survey and may well have affected the results. See Complaint 31706-01-12 Dan Design Center ltd vs. B.R.A.P. Projects ltd 19 June 2012.

survey3.JPGThose respondents  that responded positively to the first question were asked if the product was known in Israel. The Deputy Commissioner considers this is less relevant since it surveys what the respondents thought and not how well known the product was. In the next stage, the respondents were asked if they were familiar with other products of the same manufacturer and 65% were unaware of any other products or were not sure in their response.

The Deputy Commissioner considers this the most significant part of the survey. The purpose of a trademark is to link a product with other products of the same supplier. See Seligsohn Trademark Law and Similar Law 1973 page 1. If this connection does not exist, the shape of the mark does not serve as a trademark in practice.

In this instance, the majority of the public does not consider the product as associated with a particular supplier and this is clear from the fact that they did not know if the supplier sold other goods. In other words, the public surveyed were unaware of the source of the goods and did not connect the balls with other products marketed under the Sod mark. Since the Applicant acknowledges that Sod is a well known mark associated with a wide range of hygiene products, had they associated the product with Sod, they would have made a connection and mentioned other products.

The Applicant claimed that the acquired distinctiveness exists where the public associate a product with some supplier and not necessarily with a supplier by name. This is true. The principle was established in Appeal 18/86 Israel Venetian Glass Factory vs. Les Verries de Saint Gobain p.d. 45(3) 224, 238. However, in this instance, it is claimed that Sod is a ‘quality brand’ and so it is not reasonable to claim that the majority of the public do not know the brand. Furthermore, from the response to this question, it appears that the majority of the respondents do not relate the product with ANY supplier and for this reason cannot answer whether the supplier supplies additional products.

survey.jpgIn the final survey, the respondents were asked who manufactures or markets the product. This was a multiple choice question with the options Henke, Sod, some other supplier SPECIFY and do not know/not sure. This is a closed-ended leading question similar to that discussed in Opposition 112645 Mei Zach (Clear Water) Shlomo Zach vs. Teneh Industries 1991 ltd from 12 July 2007. Two of the four answers were correct. The others required the respondents to admit to not knowing or to suggest an alternative themselves. It is hardly surprising, therefore, that most respondents answered correctly. Furthermore, the respondents who answered correctly were not even required to remember the manufacturer/supplier’s name themselves….

leading questionMr Rohnak was asked about this during the hearing and responded that respondents are not ashamed to answer that they do not know, and so their choosing a correct answer is significant and indicates knowledge. Mr Roshnak did not think that wording the question differently and giving names of other manufacturers of hygiene products would have led to a different result. This response is speculative and is beyond his competence since it does not relate to making surveys and drawing results but rather to anticipating responses to questions not asked. The fact that most respondents elected “Sod” and not “Do not know” certainly raises the suspicion that the respondents answered that way as the question led them to do so, or because the way the survey was constructed led them to believe that this was the desired response.

Deputy Commissioner Bracha concludes that the survey does not prove that the public identifies the product with the source. Furthermore, it really indicates a lack of identification with any source.

By way of comparison, in the KitKat ruling, most respondents recognized KitKat as being an image of the snack without the name being suggested to them. Nevertheless, the court held that the manufacture does not rely on this recognition and the shape is not eligible for registration. In this instance, the public could not identify the source without leading questions that posed the correct response.

In evidence of acquired distinctiveness, the Applicant submitted an affidavit of the product manager. It is not denied that the Applicant invested large sums in promoting the product to the result that they captured a significant 30% of the market. However, this does not show that the public identifies the product with the supplier without the Sod mark clearly shown.

In light of the above, having concluded that the mark does not have distinguishing characteristics, it cannot be registered under Section 16 either.

The mark is therefore refused.

Ruling by Ms Jacqueline Bracha re 4 Balls Shape Mark to KGaA & Henkel AG 258658, 258797, 258798 and 259500, 18 December 2018.


Transcendental Meditation

January 11, 2018

meditationThe Maharishi Vedic University Ltd. submitted Israel TM Application No. 249554 for מדיטציה טרנסנדנטלית which is Transcendental Meditation transliterated into Hebrew. The mark was submitted on 21 September 2012 and covers:

Education services relating to health; conducting of courses relating to business management; production of video tapes for corporate use in management educational training; providing training courses on business management; provision of instruction courses in general management; conducting workshops and seminars in personal awareness educational services, namely, providing motivational and educational speakers in the field of self and personal improvement; personal development courses; personal development training; provision of training courses in personal development; meditation training; teaching of meditation practices; all included in class 41.

The mark is a simple word mark without stylistic or graphic elements.

Background

Maharashi

Transcendental Meditation is a technique for avoiding distracting thoughts and promoting a state of relaxed awareness. The Maharishi Mahesh Yogi (1918–2008) derived Transcendental Meditation from the ancient Vedic tradition of India. He brought the technique to the U.S. in the 1960s. The technique is a specific form of silent mantra meditation that is often referred to as TM. Since TM also stands for trademark I considered relating to TMTM for the Transcendental Meditation Trade Mark, TMTMA for the Transcendental Meditation Trade Mark Application, but have decided not to use the abbreviation altogether.

In an Office Action dated 9 February 2015, the trademark examiner ruled that the mark could not be registered as, with respect to the services covered, it lacked a distinguishing character as required by Section 8(a) of the Trademark Ordinance 1972.  The Examiner also considers that the requested mark is not registerable since it is descriptive and directly relates to the type or quality of the services provided which are transcendental meditation exercises and the training of transcendental meditation counselors contrary to Section 10(11).

maharishi book

In the Office Action, the Examiner noted that the organization teaching the Transcendental Meditation is called the International Meditation Association, and that hundreds of schools around the world use the technique. Consequently, one cannot allow the Applicant to monopolize the words making up the mark and thereby prevent other service providers from passing on and teaching the Maharishi’s teachings.

In response to these objections, on 30 December 2015 the Applicant responded by submitting an Affidavit of Adv. Macraman Oleh Oyser who is the general manager of the Maharishi Vedic University Ltd., a teacher of Transcendental Meditation and the head of the Legal Department of the Global Transcendental Meditation Organization, and the worldwide IP manager of the Applicant.

In their response, the Applicant claimed that the mark was not descriptive of the services provided and maximally may be considered as hinting at the services. Similarly, they claimed that the phrase Transcendental Meditation was a combination of words that is identified with the Applicant and only with them, since the combination was coined by the Maharishi who established the Maharishi Vedic University Ltd.

The Applicant further asserted that the Global Transcendental Meditation Organization and all its branches was established by the followers of the Maharishi which the Applicant is associated with and is part of the same organizational structure as the Applicant. To support this assertion, the Applicant referred to exhibition 2 of Adv. Oyser’s Affidavit, where the definition of Transcendental Meditation taken from the Oxford Dictionary Online was reproduced.

In addition, the Applicant claimed that the mark was in use in Israel since 1973 and had acquired distinction by virtue of extensive usage, advertising and marketing in Israel and abroad. The Applicant considers that the mark has become a well known mark that is identified with them alone. Similarly, in the years 2009 to 2014 since the application was filed, the Applicant has earned $874,000 from its activities in Israel. These assertions were supported by Adv. Oyser’s Affidavit.

The Applicant failed to convince the Examiner that the mark was registerable and the Trademark Office rejected the mark on 28 January 2016.

yogic fliers

On 2 May 2016, a hearing was held before the then Commissioner of Patents and Trademarks Asa Kling at the Applicant’s request. During the Hearing, the Applicant’s representative argued that the mark was unique and was a compound mark consisting of the combination of two opposites: meditation which is inward looking, and transcendental which is outward looking into the distance. During the hearing, the Applicant also claimed that the registration was requested to avoid misleading the relevant public interested in studying Transcendental Meditation, noting that the Applicant was one of the bodies authorized to train Transcendental Meditation counselors and this would enable quality control which is an underlying justification of the trademark system.

In that hearing, the Commissioner requested that the transfer of rights from the Maharishi himself to the Applicant be fully documented and substantiated by the 14 August 2016.

On 14 August 2016 the Applicant submitted supplementary evidence including an affidavit of Neal Peterson who was the manager of the Maharishi Vedic University Ltd. the following is the transfer of rights as detailed in the Affidavit.

Maharishi started to teach meditation in 1954 in Southern India, and on 1 January 1958 he established the Spiritual Regeneration Movement SRM in one of India’s capitals. In time, the Maharishi opened 1000s of SRM centers across India where he taught Transcendental Meditation.

meditation profitAfter conducting travels to disseminate his teachings across Asia, in 1959 the Maharashi taught in New York and London and set up the International Meditation Society whilst in London. As he visited more countries, the Maharashi established more local organizations to spread the teachings and to collect tuition fees.

As stated, the first organizations were established under the names SRM or IMS and subsequently these names were less widely used and the movement became better known as GTMO or the Maharishi Movement.

In the early Sixties, Maharishi opened a program for training teachers of the Meditation method under the name Transcendental Meditation. The program is offered by organizations licensed by the GTMO leadership.

To ensure the exclusive connection between the name Transcendental Meditation and the Maharishi Movement and to ensure quality, prior to being accepted to the Transcendental Meditation Counselor Course, the students are required to sign a number of papers in the presence of the Applicant. These include Non-Disclosure and Non-Compete Agreements.

To explain how the rights were transferred from the GTMO to the Applicant, the Deputy Commissioner Ms Jacqueline Bracha referred to the ruling concerning Israel Trademark Applications 29619 and 253899 to the Maharishi Vedic University Ltd. published on 30 October 2017. In that ruling the mark MAHARISHI in English and Hebrew was considered. There, in an ex partes decision, Ms Bracha ruled that the marks could be registered after the Applicant proved that they were the only party using the name MAHARISHI as a trademark to indicate their services.

RULING

Section 8 of the Ordinance states that the basic condition for trademarks to be registerable is that they have a distinguishing nature, as follows:

Marks Eligible for Registration

8.—(a) No mark is eligible for registration as a trade mark unless it is adapted to distinguish the goods of the proprietor of the mark from those of other persons (a mark so adapted being hereinafter referred to as a “distinctive mark”).

(b) In determining whether a trade mark is distinctive, the Registrar or the Court may, in the case of a trade mark in actual use, take into consideration the extent to which such use has rendered such trade mark in fact distinctive for goods in respect of which it is registered or intended to be registered.

Section 11(10) of the Ordinance describes one of the categories of marks that is not considered as having a distinguishing nature.

(10) a mark consisting of numerals, letters or words which are in common use in trade to distinguish or describe goods or classes of goods or which bear direct reference to their character or quality, unless the mark has a distinctive character within the meaning of section 8(b) or 9;

The evidence appended to the Application indicates that the term Meditation relates to an ancient tradition that is in element of many religions.

“Meditation has been practiced since antiquity as a component of numerous religious traditions.”

In paragraph 13 of Adv. Oyser relates to Transcendental Meditation as Mantra Meditation that indicates holy sounds or the names of God. In Hinduism and Buddhism the practitioner of Mantra Meditation attempts to unify himself with the God.

Similarly, in the same section of definitions, the Applicant explains that the source of Transcendental Meditation is the Guru Dev and that according to Maharishi this is a development of Vedic writings and old books that are adapted for the modern world.

Furthermore, as part of their evidence submitted for registering 29619 and 253899 for the mark MAHARISHI in English and Hebrew, the Applicant submitted an Affidavit by Alexander Oded Kotai who is the Israel Director of the International Meditation Association Israel, of the Maharashi International School and of the Israel Institute of the Science of Creative Intelligence. In the framework of his Affidavit, he also explains what Transcendental Meditation is, and in paragraph 21 states that:

Thus Transcendental Meditation is the name chosen by Maharishi to indicate and mark the meditation technique that he learned from Guru Dev and developed in India in the fifties. Maharishi developed the technique and adapted it for the modern world, and attributed it to his spiritual mentor, Guru Dev. Maharishi explained that the technique is a revelation of the principles found in Vedic writings, which is a collection of religious texts considered the oldest in Hinduism. According to Maharishi the Vedic writings have been misunderstood in the past hundreds of years. Maharishi teaches that Vede is knowledge of the science of awareness and, according to this science, there is an awareness of the formation of the material of the universe.

Atharva-Veda_samhita_page_471_illustration-56a483c15f9b58b7d0d75d06

From this it appears that the basis of Transcendental Meditation is found in the Buddhist religion and Transcendental Meditation is the Maharishi’s interpretation of Vedic literature. Nevertheless, the requested mark does not appear in the ancient Vedic literature. We are dealing with a phrase that the Maharishi coined for the technique he developed.  Adv. Oyser states this explicitly. Neal Peterson states that when he started out in Southern India in 1954, Maharishi called this Transcendental Deep Meditation and shortened this to Transcendental Meditation as the years went by.

This raises the question of whether this is enough for the Applicant to be granted a trademark or whether it should be left open to the public for reasons of public interest.

Section 11(5) of the Trademark Ordinance excludes from registration:

(5) a mark which is or may be injurious to public policy or morality;

In this regard, see paragraph 46 of the Ruling concerning Israel Trademark Applications IL 232770 and 232271 for Lubavitch (English letters) and for Chabad (in Hebrew and English) from 2 May 2016:

The purpose of the Ordinance is not to limit freedom of speech or freedom of religion – Section 11(5) of the Ordinance does not allow registration of marks that adversely affect the public order.

The conclusion that Maharishi (who transferred his rights to the Applicant as described above), coined the term Transcendental Meditation which is the applied-for mark, but this does not give the Applicant the right to register the mark. In this regard one may compare copyright with trademark law as per Neil Wilkof and Shamnad Basheer in their book “Overlapping Intellectual Property Rights”  2012) page 148, which relates to R Griggs Group Ltd and others v. Ross Evans and others ECDR 15,para 20 [2004]:

“…copyright is intended to protect creative skill and labour whereas the function of trademarks is to distinguish the goods or services of one provider from those of another. Trade mark law he said ‘has nothing to do with protecting any creative skill and labour in coming up with a trade mark‘, rather it is meant to prevent potential confusion among members of public.”

The Applicant claims that the purpose of the trademark registration is to protect the public from unregulated teaching of the technique since the technique relates to the mental health of the patient and there is thus a danger that it being applied by someone not qualified will damage the patient’s wellbeing. This is clear from the protocol of the discussion.

Freud

It is noted however, that the list of services for which the trademark is applied for does NOT include mental health, presumably since treatment of mental issues requires an appropriate education and license from the Israel Ministry of Health. It is noted that the services defined as ‘educational services relating to health’ are related to the psychology profession and is regulated by the Law for Psychologists 1977 which defines Psychology as

Working in Psychology is a profession related to diagnosing and quantifying issues and problems of mental health education and behavior of people and the treatment, rehabilitation, consultancy and training related to these issues and problems is generally to be performed by psychologists.

Since it is unreasonable to register the mark, Ms Bracha did not see fit to rule on whether this service should be allowed. It is brought merely to discredit the claim that the mark should be registerable since it relates to mental health and is in the public interest that its counselors are licensed by Maharishi Vedic University Ltd.

Transcendental Meditation is a process that anyone can learn and teach and this does not require the agreement of the inventor or creator of the technique. Consequently, the technique must remain available for anyone to learn and teach. It is not fitting to prevent the public from expounding a meditation technique. Even if there is a contractual arrangement that prevents a person from spreading the technique he has learned, it is not clear that the limitation would be enforced by the relevant legal authorities.

In this regard, the words of then Deputy Commissioner Noach Shalev Shmulovich in paragraphs 29and 30, of the Trademark Ruling concerning Israel Application No. 178707 Ori King vs. Adi Shanan I.P.E.C.

I am not certain that one can protect a method of treatment, even temporarily when those that developed it are teaching and disseminating it, since there is no trade secret here. One cannot register a patent for a method of treatment. Although there may be copyright on educational materials, this does not extend to the technique itself or and the right to provide treatments or to teach others. That as may be, one cannot register a trademark to provide protection for a method of treatment by virtue of the registration.

Furthermore, the claim made before me that the application does not deal with the trademark protecting the method, but only its teaching and dissemination, lacks substance. Where the technique is available to the public its teaching should be available to the public, unless the law provides some limitation, however, the way to provide a monopoly on the technique is not via the trademark register, since registration cannot be used to protect the technique.

Albert_Einstein_Head.jpg

In a similar manner, it appears that if the Hebrew University had tried to register a trademark for “Relativity”, it would be rejected. [MF – The Hebrew University holds the Einstein Archives and owns the name Einstein as a trademark which they license as a source of income.] One also cannot register Transcendental Idealism as a trademark for an institute teaching Kantean Philosophy. Teaching that doctrine also requires some sort of agreement since one cannot say that everyone is capable of understanding this and teaching others.

The question that arises is whether a coined phrase for a philosophical or religious teaching, such as the application in question which combines transcendental and meditation, that arguably can obtain copyright protection, should be protected under trade laws.

anne frank

The beginning of an answer to this question is found in decisions that relate to names of creations. In a decision given by the court of appeal of the OHIM as it was known, and is now known as the EUIPO, relating to a trademark for “Le Journal d’Anne Frank”, inter alia, for books and newspapers, theatre productions, video tapes and fims on electronic media. See Re 2401/2014-4  Anne Frank Fonds (31.08.2015).

The Court of Appeals considered that the mark does not lack a distinguishing nature with regards to the goods and that the public can use the mark to differentiate between goods and services originating with the mark holder and those originating elsewhere. Furthermore, the European tribunal considered that the wide publicity of the mark as the name of the book was insufficient to prevent it being registered.

As noted in the decision regarding the Opposition to Israel Trademark Application No. 247693 for DEMART PRO ARTE B.V and Fundacio Gala-Salvador Dali vs. V.S. Marketing (Israel 2005) ltd. (31 May 2016) it appears that the European ruling does not sit well with the US Law, nor with the Israel Law regarding registering the names of creative works as trademarks. Seligsohn related to this in his magnum opus Trademark Laws and Related Legislation, Shocken 1973, page 7:

“Regarding Goods”… a trademark cannot exist where a symbol relates substantively or technically with trade. The title of a book cannot be a trademark where there is a link between the title and the content of the book such that the title indicates its content and character.

In a similar matter, the US Supreme Court refused to accept a tort of Passing Off or misleading regarding the origins of a product where a television series was based on a book whose copyright had terminated after ruling that passing off under the Lanham Act was not intended to protect original creations and this was different from copyright. See re Dastar v. Twentieth Century Fox Film 539 US at 37 (2003).

Basheer and Wilcoff relate to this on page 155 of their book:

“…in its decision, the Supreme Court went further, holding that the US trademark laws ‘were not designed to protect originality and creativity and that to hold otherwise would be akin to finding that§43(a) [of the Lanham Act] created a species of perpetual patent and copyright, which congress may not do‘”.

Similar to the US Law, in Israel the protection granted by Copyright Law is given for a limited period, whereas trademarks may be renewed indefinitely. Consequently, prior to allowing a trademark to be registered, one has to balance between the rights of the author and the public good. See page 144 of Basheer and Wilcoff:

“Copyright subsists for a finite period, after which the work falls into the public domain where it can be used by anyone without attribution of authorship, whereas trademark rights can endure for as long as the indicia are used and associated with the owner’s offerings- potentially hundreds of years or more.”

As stated in her decision of 30 October 2017 regarding the registration of the name Maharashi in Israel, Ms Bracha noted that the Maharishi Foundation Limited had splintered from the Applicant’s organization and had given up on registering “Maharishi” in Hebrew or English but still taught the Transcendental Meditation discipline in various territories around the world. She did not think that it was correct to limit the teaching to one organization or another by trademark registration.

Furthermore, one cannot ignore the fact that a registration for Transcendental Meditation Programs exists in Israel TM No. 47738 that was submitted on 17 April 1979 by the Applicant. Without relating to whether this mark should have been registered back then, it is noted that the evidence submitted by the Applicant indicates that the International Association for Transcendental Meditation Israel, which is the local representative in Israel, markets and publicizes their services under a stylized mark that includes the registered trademark “Transcendental Meditation Programs”. It seems therefore that the mark cannot be registered in Israel without appropriate regulation.

Israel Trademark Application No. 249554 is thus refused.

Ruling by Ms Bracha re Israel Trademark Application Number 249554 for “Transcendental Meditation”, 20 December 2017.

COMMENT

The former Chief Rabbi of the United Synagogue and Peer of the Realm Dr Jonathan Sacks has a joke that appears in Not in Heaven:

Beatles and Maharishi

When I was a student at university in the late 1960s – the era of student protests, psychedelic drugs, and the Beatles meditating with the Maharishi Mahesh Yogi – a story went the rounds. An American Jewish woman in her sixties travelled to north India to see a celebrated guru. There were huge crowds waiting to see the holy man, but she pushed through, saying that she needed to see him urgently. Eventually, after weaving through the swaying throng, she entered the tent and stood in the presence of the master himself. What she said that day has entered the realm of legend. She said, “Marvin, listen to your mother. Enough already. Come home.” 

 


New Israel Patent Commissioner Makes Purpose Driven Interpretation of Patent Term Extension Legislation to Transfer Protection from One Drug to Another

December 21, 2017

Wyeth submitted a request for a patent term extension for Israel Patent Number 120701 titled “2 – PHENYL – 1 – [4 – (2 – AMINOETHOXY OR PROPOXY) ) – BENZYL] – INDOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM ” The patent issued on 26 December 2005 and the basic 20 year protection period will run out on 18 April 2019.

CONBRIZAOn 17 June 2012 Conbriza was registered in the Israel register of drugs. Conbriza contains bazedoxifene acetate. This was the first Israeli registration of Bazedoxifene for medicinal purposes and so, on 19 October 2015, a patent term extension order issued for Conbriza, until 14 April 2022.

DuaviveOn 16 November 2016, the drug Duavive which contains bazedoxifene acetate together with conjugated estrogens was registered in the Israeli register. The Applicant explained that Duavive is a more modern version of Conbriza which Pfizer (which owns Wyeth) had developed and is marketing in Israel.

The treatments are both for treating the symptoms suffered during menopause, such as the so-called hot flushes.

calculation

On 22 May 2017, the Wyeth informed the patent office that Conbriza was taken off the drug register and Duavive was registered. Wyeth claimed that the change should not affect the patent term extension since both drugs contained bazedoxifene, and that the patent term extension should be calculated from the first of the registrations.

Following this notification, the Applicant was invited to attend a hearing under section 149 before a ruling issued. The Applicant did want to attend such a hearing and on 5 July 2017 the Commissioner Ophir Alon indicated that in the hearing, which was held on 31 July 2017, the Applicant would explain why they felt that the provisions of Section 64(vii)(3) should not apply in this case.

Ruling

Section ii(1) of Chapter D of the Law deals with patent term extensions. Inter alia, Section 64D of the Law states that:

64D. The Registrar shall not grant an extension order, unless the following conditions have been met:

(1) The material, the process for its production or its use, or the medical preparation that incorporates it or the medical equipment was claimed in the basic patent and the basic patent remains in effect;

(2) In respect of a medical preparation—a medical preparation that incorporates the material is registered in the Register of Medical Preparations under regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746—1986 (hereafter: Pharmacists Regulations);

(3) The registration said in paragraph (2) is the first registration that allows the material to be used in Israel for medical purposes;

(4) No extension order was granted previously in respect of the basic patent or in respect of the material.

From here, it is clear that the condition for giving a patent term extension is that there is a registration of a drug that includes the active ingredient and it is the first registration that allows the active ingredient to be prescribed in Israel, which was not previously subject to a patent term extension.

Section 64L states the cases where a patent term extension lapses. In 64L(3) it is stated that:

64L. An extension order shall laps in each of the following instances:

(3) If registration of the medical preparation that incorporates the material was cancelled—on the day on which the registration was cancelled;

Thus the wording of the black letter law seems to be that if the registration including the active ingredient is cancelled, the Patent Term Extension is cancelled as well.

The Applicant’s claim is that in cases where the company that registered the first drug has a number of registrations for different drugs containing the active ingredient, the Legislators did not intend that the protection period would lapse simply because one of these was cancelled. Rather, the legislators intended that only in cases where at some time after the issuance of the extension period, there are no registrations of drugs including the active ingredient in Israel, the extension period would lapse. In such an instance, where there are no drugs on sale in Israel there is no legitimacy in keeping the patent term extension active and so Section 64L(3) applies.

The Applicant claims that since Duavive contains the active ingredient and was registered before the registration of Condiza was cancelled, one or other preparation containing the active ingredient was continuously registered in Israel and so the patent term extension remains in force.

The Purpose of the Patent Term Extension Regime

As known, the term of a patent is 20 years from filing in Israel [or from the PCT filing date – MF] subject to paying extension fees. This period is the accepted balance between the desire to encourage inventors on one hand, and to enable the population to benefit from technological advances on the other.

balance

This balance has a special regime for pharmaceuticals and medical devices that is given by Section B1 of Chapter 4 of the Law. This regime compensates patentees for delays in registration but allows the generic drug industry to prepare for market entry to the benefit of the population as a whole. Where the conditions of the Law are met, it is possible to extend patents for pharmaceuticals and medical devices by up to five years.

This is how things were presented on page 18 of Appeal 8127/15 Israel Association of Industrialists vs. Mercke Sharpe and Dohme Corp, 15 June 2016:

The purpose of the extension period is to compensate the patentee for the period of patent protection that is de facto lost due to the amendment of the patent law. The period of protection in Israel and other countries having patent term extensions takes into account the period that the patentee takes to register the drug which is longer than the period lost by the patentee. However, in the Draft Amendment by the Committee for Constitution, Law and Justice it is stated that the extension is for the period that the patent for the drug is registered but regulatory approval by the Ministry of Health has not yet occurred, and so the extension is identical to this period. Either way, the main purpose is to provide fair compensation to the patentee.

Explaining section 64L(3)

As stated previously, there are two possible interpretations to Section 64L(3) of the Law. In the first explanation the words “registration of the medical preparation that incorporates the material was cancelled” relates only to the first registration, as defined in Section 64D(2), so that when the first registration is cancelled, the patent term extension ends.

The second explanation, proposed by the Applicant, is that one should understand the words “registration of the medical preparation that incorporates the material was cancelled “ as relating to all drugs that include the active ingredient and not merely the first one to be registered, so that there are no drugs including the active ingredient on the register.

Ofir Alon

The New Commissioner Ophir Alon considers that the interpretation is in line with the rationale of the Law proposed by the Applicant. As stated previously, the intention of the legislator was to compensate the patentee for the period required to register the drug. Section 64D of the law refers to the conditions for granting a patent term extension. The purpose of 64D(2) of the Law is to ensure that the active ingredient has undergone registration, and that of 64D(3) to ensure that that this was the first instance of the active ingredient being registered.

Since these conditions are fulfilled, it does not seem that there is much significance in the first registration specifically, that its cancellation requires cancellation of the patent term extension and cancelling the compensation that the law provides the patentee, whilst the active material remains registered, albeit with other active ingredients.

Registration of more advanced or better drugs that include these active ingredients is desirable.  Such registration is likely to require additional registration by the Ministry of Health. Adopting an interpretation under which the cancellation of the first registration for which the patent term extension period was calculated automatically results in the cancellation of the patent term extension will lead to a situation in which the patentee who has several registrations will have to keep the registration of a drug not being sold in force merely to keep the patent extension in force. This is artificial and not desirable.

However, accepting the second interpretation allows the patentee to cancel or not renew the first registration whilst keeping the patent term extension in place to protect additional drugs subsequently registered. This prevents circumstances where a patent term extension is in place but no drugs are registered for sale in Israel.

In summary, it appears that the correct interpretation of the Law is to compensate the patentee for the period he could not exploit his patent whilst waiting for regulatory approval, which includes protecting the public interest by promoting development of new treatments, and these aims are achieved by the interpretation allowing the extension to stay in force as long as there are drugs that include the active ingredient.

This interpretation serves the purpose of the Law and the public interest as it provides an incentive for the patentee to develop new versions of its drugs, that are more advanced or more efficacious than the original treatment, and allows the cancellation of registrations that are n longer marketed.

The Commissioner is aware that linguistically, the objective pronoun “the medical preparation” apparently relates to the medical preparation mentioned previously. Nevertheless he does not think that a literal reading helps to clarify things in this instance. For example, if we were to take a literalist approach to understanding section 65L(3) we would wonder what the legislator intended by “including the ingredient” at the end of the section, since it is clear that the medical preparation whose registration was the basis of the patent term extension includes the active ingredient, as stated in Section 64D(2):

(2) in respect of a medical preparation—a medical preparation that incorporates the material is registered in the Register of Medical Preparations under regulation 2 of the Pharmacists Regulations (Medical Preparations) 5746—1986 (hereafter: Pharmacists Regulations);

FROM THE GENERAL TO THE SPECIFIC

The cancellation of the Conbriza registration occurred after Duavive was registered, and so in one form or another the active ingredient was continuously registered from when Conbriza was registered until today.

So, by applying a purpose-driven interpretation to Section 64L(3), the registration was never cancelled and from when the patent term extension was issued until today, the medical preparation was under continuous protection.

The medical preparation Duavive includes the bazedoxifene ingredient together with conjugated estrogens. In other words, to create continuity in the registration, the active ingredient has to be identical to the one for which registration was granted. The Patent Term Extension for Israel Patent No. IL 120701 will remain in force subject to the Applicant submitting an Affidavit that the combination of the bazedoxifene ingredient together with the conjugated estrogens does not create a new material. This affidavit must be submitted within 30 days of this ruling.

Ruling concerning the Patent Term Extension for Israel Patent No. IL 120701 for bazedoxifene (Conbriza and Duavive), Ophir Alon, 15 October 2017

COMMENT

This ruling could be a baptism of fire for the new Commissioner.

The main question that the appointment of a new commissioner generates is whether he will favour the drug development industry or the genetic drug industry. The sums of money generated every day of a patent term extension and in supplementary patent protection for variants such as changes in dosage regimes is enormous. In this regard, Israeli companies are involved as both generic players and as drug developers. Despite TEVA being the world’s most successful generic drug provider, It was Teva’s Copaxone falling over the so-called patent cliff that caused the massive drop in share prices and layoffs, rather than lost sales of generics.

Here the Commissioner has taken an analytical approach to the law, trying to understand the rationale rather than the most literal interpretation. This is in line with guidelines penned by Former Chief Justice Aharon Barak who was known for such interpretations, which perhaps less charitably and more formalistically could be described as subverting the Law as legislated to further lofty aims as he saw them. Such creative interpretations coupled with him declaring that Basic Laws were constitutional and reading into them powers that the Knesset never intended, has led to judicial activism that those on the right see as undermining the Knesset as legislator, and those on the left see as saving democracy from the people’s elected representatives.

I remember litigators that represent the drug developing companies saying during Dr Meir Noam’s term as Commissioner, that, until he was replaced, their clients could not get justice. I do not know if this was fair. Dr Noam was a chemist, and generally where he accepted Unipharm’s arguments that an opposed patent application lacked novelty or inventive step, their arguments were persuasive, or at least seemed so to me. Nevertheless, in practice, he did rule in favour of the generic companies, but his rulings held up on Appeal.

At the start of his term in office, the previous Commissioner, Adv. Asa Kling, could not rule on cases where one side was represented by Reinhold Cohn or Gilat Bareket because of a perceived conflict of interest. Centocor Ortho Biotech Inc. received regulatory approval for a pharmaceutical preparation described in IL 154325.

From the affidavits submitted by employees of the agents for applicant (Reinhold Cohn Patent Attorneys) it is clear that, despite the firm being organized and having procedures in place to cover patent term extensions, there was human error. The deadline was missed and this was discovered seven months later.

Section 164 A1 of the patent law states that:

164.—(a) The Registrar may, if he sees reasonable cause for doing so, extend any time prescribed by this Law or by regulations under it for the performance of anything at the Office or before the Registrar, except for…section 64… …unless he is satisfied that the application in Israel was not submitted on time because of circumstances over which the applicant and his representative had no control and which could not be prevented;

The Deputy Commissioner Jacqueline Bracha threw Reinhold Cohn a life-line by ruling that mistakes were unavoidable, thereby allowing a missed deadline for requesting patent term extensions to be retroactively extended despite the Law being unequivocal that the deadline was not extendible. For more details, see here.

The patent term extension legislation has been amended several times, in the third, seventh and eleventh amendments to the Israel Patent Law.

The third amendment was ambiguous and in an ex-partes ruling affecting three patents in what is now known as the Novartis ruling, Then Acting Commissioner Israel Axelrod understood that the amendment was designed to give a real advantage to the drug development companies and they could choose the country to base their patent term extension on.  This was not what the Knesset intended and the amendment was again amended in what was the Seventh Amendment of the Israel Patent Law, to tidy up this and other ambiguities of the original amendment. Israel Axelrod, who was widely expected to be appointed as Commissioner but instead, was side-ways promoted to the Beer Sheva District Court.

In 2006, under intense pressure from the US who put Israel on their special 301 Watch List of countries not properly protecting Intellectual Property, the State of Israel amended their Patent Law again.

Arguably the Commissioner is correct that the purpose of the Law is to strike a balance between the conflicting interests. Arguably, however, as in the Novartis ruling and subsequent amendment, the intention of the legislators remains to provide narrowest possible intention to rules governing patent term extensions, to encourage generic competition, thereby favoring local industry over foreign companies, and providing cheap medicine. We should bear in mind that the legislation was the result of heavy US protectionist pressure, and in the same way that the US government tries to benefit US interests, it is (at least arguably) legitimate that the Israel Law is intended to protect local interests as much as possible.

Teva is not, of course, the only Israel company to bring a drug to market. Neurim managed to patent Circadine which is a treatment for insomnia based on melatonin, and also obtained patent term extensions around the world. In the UK, the patent office refused to grand a patent term extension arguing that the active ingredient was used in a treatment for sheep.  Judge Arnold upheld the patent office’s position, see patent term extensions for Neurim which was appealed to the House of Lords, and Lord Robin Jacobs referred it to the European Court of Justice ECJ in his last ruling on the bench. The ECJ took a similar position to that of the current commissioner, preferring an interpretation that considers the rationale behind the law to a literalist ruling.

The main problem with ex-partes rulings is that arguments of the other side are not heard.  It is not inconceivable that Duavive works and Conbriza didn’t, not because of a new material being developed but because of some symbiotic effect between the bazedoxifene ingredient and the conjugated estrogens. In this instance, Duavive was developed by Wyeth/Pfizer but it is not inconceivable that such a drug could be developed by a third party. If the Conbriza formulation is not on sale and no other drug by the patentee, should Wyeth-Pfizer be entitled to a drug term extension past the main patent lapsing? Another hypothetic question worth considering is that an active ingredient protected by a patent term extension could actually not be so active at all, and could be co-dispensed with a drug that itself is active, but cannot be patented. The combination could be protected by the patent term extension in a scam designed to defraud the public. I am not alleging that this is the case here. I have no ideas what conjugated estrogens do or how they work. I am merely highlighting a slight logical flaw in the Commissioner’s reasoning.

That as may be, this ruling is a brave but reasonable one. Being ex-partes it cannot be challenged directly, but could be challenged by TEVA, Unipharm or some other generic company launching a Bazedoxifene containing formulation during the extension period.  The Knesset could also decide to amend the Patent Extension Law to rule out this interpretation if they deem fit to do so.


Cost Ruling in Moshe Lavi vs. Zach Oz – A failed attempt to get a poorly written patent canceled.

December 20, 2017

Figs for ACMoshe Lavi owns Israel Patent No. 157035 titled “MODULAR SUPPORT BRACKET” which describes  a support bracket for an air-conditioner unit. He’s tried to enforce it in the past against Zach Oz Airconditioners LTD, and the parties came to an out-of-court settlement.

Lavi then sued again, and Zach Oz countered by applying to have the patent cancelled. This attempt was unsuccessful and a ruling upholding the patent issued on 5 March 2017.

Lavi then applied for costs under Circular MN 80. According to Lavi and his attorneys, Pearl Cohen Zedek Latzer Brats, the costs incurred in fighting the Opposition were a fairly massive 526,750.058 Shekels!? We assume that there is a typo here, and the costs requested were just over half a million Shekels and not just over half a billion shekels, as that would be ridiculous even for Pearl Cohen. It seems that they charge in dollars and not Shekels, and are unaware of the need to round up to the nearest 5 agarot.

Lavi claims that he is entitled to the real costs incurred, which are reasonable, necessarily incurred and proportional in the circumstances. He accuses Zach Oz of acting in bad faith by challenging the validity of the patent. His counsel appended a list of legal counsel’s hours, invoices, and an affidavit by Moshe Lavi.

The Respondents Zach Oz, confusingly represented by an Adv. Pearl (not Zeev, even he is aware that fighting both sides of an opposition proceeding is not acceptable) claimed that the costs were unreasonable and some were unnecessary or disproportional. They also claimed that it was Moshe Lavi who acted inequitably. They note that the case-law states that costs are not meant to be a punishment, and the costs in this case were unreasonable and were incurred due to unnecessary wariness by the patentee. Furthermore, the adjudicator is supposed to take into account the public interest and importance in maintaining the integrity of the patent register. Awarding inflated costs in cases that they lose, would discourage people from challenging the validity of patents and would prevent access to legal recourse.

Ruling

The winning party is entitled to costs incurred in legal proceedings. However, the arbitrator is not obliged to rule actual costs, and is required to consider the specifics of the case and judicial policy. See paragraph 19 of Appeal 6793/08 Loar LTD vs Meshulam Levinsten Engineering and Subcontracting Ltd. 28 June 2009.

In the case-law it was ruled that for the Applicant for actual costs to prove that they are reasonable, proportional and necessary in the specific circumstances. See Bagatz 891/05 Tnuva Cooperative for Marketing Agricultural Produce in Israel Ltd. et al. vs. The Authority for granting Import licenses et al. p.d. 70(1) 600, 615 from 30 June 2005. The limitation of costs to being necessary and proportional is:

To prevent a situation wherein the costs awarded are too great, and will discourage parties from seeking justice, will create inequalities and make court proceedings unnecessarily costly, limiting access to the courts. (Appeal 2617/00 Kinneret Quarries ltd. cs. The Nazareth Ilit, Planning and Building Committee, p.d. 70(1) 600, (2005) paragraph 20.

The amount of work invested in preparing submissions, their legal and technical complexity, the stage reached in the proceedings, the behavior of the parties before the court of the patent office and with regard to opposing party, inequitable behavior of the parties, etc. All these are considerations that should be taken into account when considering “the  specifics of the case”.

In this instance, the patentee did win his case and is entitled to recoup costs, and the losing party does not dispute this. However, in this instance, the patentee is not entitled to the requested costs for reasons detailed below.

Firstly, after consideration of the case and the submissions, none of the parties appear to have acted inequitably. It is not irrelevant that neither party has related to the decisions made in this instance, including the main ruling. This is because there is no evidence of inequitable behavior by the parties. Similarly the affidavits are acceptable. In this regard, it is not reasonable to accept the patentee’s allegation that the challenge to their patent was baseless. The file wrapper shows that the challenger made a reasonable and fair attempt to show that the patent was void, based, inter alia, on prior art.

Furthermore, as to the costs requested, the adjudicator, Ms Shoshani Caspi did not think that they were reasonable, essential or proportional, as required by the Tnuva ruling.

The expert opinion of the expert who attended the hearing, costs of 29,685 Shekels including VAT were incurred. This was considered reasonable. It also appears to have been necessarily incurred. However, the Applicants did not need to use lawyers to prepare the expert opinion’s opinion for him, whilst claiming costs for him preparing his opinion as well. This is a double request for costs and should be eradicated.

In his Affidavit, Mr Lavi claimed that the challenge to his patent caused him to spend $137,901.37 including VAT. This is the 499,065.058 Shekels requested by the Applicant, excluding the expert opinion. The Affidavit explains that this sum includes his legal counsel’s work, couriers, printing, etc., however, no evidence of couriers and printing costs were given, and it appears that these incidentals were included in the invoices from his legal representative. To provide evidence for the legal costs incurred, invoices from PCZL were appended which included the hours spent by attorneys working on the case.

One cannot ignore the fact that the list of work done included demanding extensions, attempts to negotiate an out-of-court settlement, interim proceedings that the opposing party won, an appeal of the refusal to throw the case out, https://blog.ipfactor.co.il/2015/03/08/il-157035-if-one-accused-of-infringing-a-patent-does-not-challenge-its-validity-is-the-accused-estoppeled/

and other costs that are not essential and thus not reasonably chargeable to the other side.

double dipThe attempt to roll these unnecessary costs to the losing side and the double charging for the expert witness are inappropriate to use an understatement, and one assumes that these requests were made inadvertently as they were signed by educated attorneys that are well versed in the relevant legal processes.

Furthermore, after a detailed review of the file, Ms Yaara Shashani Caspi concluded that the case was relatively simple and there were neither particularly complicated legal or factual questions. Consequently, it is difficult to accept that the request for costs of 499,065.058 Shekels [sic] including VAT is reasonable, essential or proportional in the circumstances. It will be noted that as ruled in the Tnuva case (paragraph 19). The real costs that the patentee incurred is only the starting point and not the end point of the costs ruling.

It transpires that the time spent in each round was very large. For example, 65 hours was spent on a request to cancel an expert opinion, and 44 hours on the request for costs, etc. The Applicant did not provide an acceptable justification for these figures.

In light of the above, legal costs will be awarded by estimation, and in addition to the 27,685 Shekels (including VAT) to the expert witness, a further 150,000 Shekels (including VAT) are awarded in legal fees.

The deadline for paying the costs is 30 days, then interest will be incurred.

Legal Costs Ruling by Ms Shoshani Caspi in cancellation proceedings of IL 157035 Moshe Lavie vs. Zach Oz, 25 October 2017.

Comment

The whole case was mishandled by Zach Oz, who could and should have won the original infringement case in court, but decided to accept a poorly worded out-of-court settlement. By any reasonable attempt to construe the claims so that the patent was not anticipated by support brackets for shelves, Zach Oz’ supports were not infringing. In other words, they could have used the Gillette defense.

Ms Shoshani Caspi’s criticism of PCZL overcharging and double dipping is appropriate in this instance. The attempt to have the case thrown out on a creative estoppel based on not having challenged the validity of the patent when sued for infringement was ridiculous. Ironically, this patent is not worth the costs spent on litigating it. This is a clear instance of lose-lose by all concerned except the lawyers.


NOCTUROL

December 20, 2017

NocturolWellesley Pharmaceuticals LLC submitted Israel Trademark Application No. 284926 for NOCTUROL; a Pharmaceutical preparations for reducing frequency of urination in Class 5.

NocturnoUnipharm, a large Israeli generic drug manufacturer and distributor that sells the mild hypnotic Zopiclone as a treatment for insomnia under the brand-name NOCTURNO opposed the mark on 10 September 2017.

On 11 September 2017, the Court of the Israel Patent & Trademark Office gave Wellesley Pharmaceuticals two months to file a counter-statement of case.

The deadline of 11 November 2017 passed without a  a counter-statement of case being filed, and on 20 November 2017, Unipharm requested that their Opposition be accepted and the application refused.

Section 24(v) of the Trademark Ordinance states:

If the Applicant does not submit such a response, it is as if they have abandoned their mark.

The Opposition to Israel Trademark Application No. 284926 is thus accepted.

In general, the prevailing party is entitled to costs. The considerations are the time involved, complexity, work done, equitable behavior, etc. Under her Authority given in Section 69, the Adjudicator, Ms Yaara Shoshani Caspi, ruled costs of 2000 Shekels including VAT.

COMMENT

Notably, the director of Unipharm, Dr Zebulun Tomer (who has more experience in patent oppositions than any mere lawyer or patent attorney) filed the trademark Opposition himself, without involving their legal counsel Adi Levit.

As Unipharm did not use legal counsel, they are not entitled to costs. This is clear from Patent Oppositions where they prevailed in similar circumstances. The cost ruling was given without sides requesting costs and is appealable to the District Court. However, the I would be surprised if Wellesley contests it.