Changing of the Guard

July 11, 2017

changingThe various professional organizations representing the IP profession in Israel (LES, AIPPI and IPAA) cosponsored a reception to honour outgoing Commissioner Asa Kling and incoming commissioner Alon Ophir.

The event was held on Sunday in the Israel Yaffe conference center just North of Tel Aviv.

As an IP blogger, I felt obliged to attend and to write about the event. However, it was singularly non-memorable.

About 90 practitioners turned up, including some of the senior members of the profession that rarely patronize IP events. Other senior members were absent. This could, however, be due to vacations and the like.

dinosaurNachman Cohen-Zedek, as the last of the dinosaurs, spoke some words of introduction. I could not tell what he said, and nor could the other participants sitting in my area. The acoustics were poor and most of the speakers forgot to talk into the microphone. Asa used a projector to show a power-point presentation, however, it was out of focus and poorly illuminated, so apart from noting that the talk was illustrated with a steady increase in pink clouds with writing on them, I can’t actually report what he spoke about.

TOMERAs he is wont to do at various events, Dr Zebulum Tomer took the microphone, ostensibly to ask a question but in practice to give a little speech. He clearly believes that his one man crusade against poor pharmaceutical patents is a public service, which it is. However, those developing drugs are also serving a public interest. I don’t think anyone needed reminding that he is not an attorney but an industrialist. He reminds everyone at all events. The lawyers present generally look down on industrialists, and are certainly jealous of his competence in opposing patents which outshone that of anyone present.  The patent attorneys probably were a little jealous, still half wishing we actually made something instead of pushing paper.

Alon OphirThe person compering the event noted that Alon Ophir is the second commissioner named Ophir and that we will have to relate to him as Ophir the Second or some such to avoid confusion. This was a reference to former Commissioner Martin Oppenheimer who Hebracised his name to Michael Ophir. Commissioner Ophir seemed very young. He is a Kippa wearing practitioner which fueled speculation about whether his appointment reflected activism in Bayit Yehudi, the political party that the Minister of Justice represents. The press releases about Commissioner Ophir’s appointment mentioned how impressed the committee was regarding his vision. I was disappointed that he did not explain what his vision was. He noted that obviously outgoing Commisioner Kling did a great job, what does seem to be his focus is in decreasing pendencies and making the patent office ever more efficient. He expressed surprise and disappointment that more Israeli applicants were not first filing in Israel and accelerating examination to get an opinion before having to file abroad and applying the discount when filing PCT applications. He attributed the failure to ‘probably inertia’. Whilst accepting that some practitioners do use time-honoured strategies without consideration of changes, I don’t think this is the whole answer, and hope that the commissioner tries to listen and discuss with the profession instead of assuming that they are all lazy. I had to leave early as I had a ride with another attorney, who on leaving the hall early told me that we would be stuck in traffic. I suggested that perhaps we should go back in and leave later. He thought for a minute and said that he’d prefer to be stuck in traffic. I think this says it all.

With the attraction of introducing a new commissioner and thanking his predecessor, and with July being generally a quiet month, this was an opportunity to hold a stimulating event with the participation of some of the senior practitioners. The organizers chose to invite paid up members instead of reaching out to potential members, and did not consider how to make the event fun or intellectually stimulating. I think this is a shame and a lost opportunity.  It was however, correct and proper that an event happened.

I went on to a Bat Mitzva party. The 12 year-old girl celebrated by completing a tractate of the Talmud. it was the type of event where friends of the parents are Western immigrants with higher degrees and there were a number of patent attorneys present. One noted that his clients filed patent applications in Israel but did not want to speed up examination, and he thought that the changes in recent years whereby one cannot simply suspend examination indefinitely and cannot suspend at all without paying to do so, were commissioner efficiency drives that served no purpose. Readers in the know will not be surprised to learn that the practitioner was ex Fenster & Fenster. This approach, which enabled amending the spec and claims in light of infringers and deferring prosecution and allowance unless a patent was needed, was, though legal, nevertheless an abuse of the system. However, it does emphasize that practitioners are supposed to work the system for the benefit of their clients. Commissioners are supposed to ensure that the system works efficiently and such abuses don’t take place. We are on different sides of the fence.


Chipsico – a Competing Marks Proceeding Where Both Marks were Refused

July 11, 2017

267474On 13 August 2014, the New Dubak Natsha ltd filed Israel trademark application no. 267474 in class 29 for chips (potato crisps). The stylized mark is shown alongside, and reads CHIPSICO Batates Modalaah – (Chipsico Crinkle-Cut Potato Chips).

The same day, the Halawani Industrial Company ltd filed two trademark applications for coffee, tea, cocoa, sugar, rice, tapioca, sago, coffee substitute, flour and grain products, bread, wafers, cakes and sweets, honey, treacle, yeast, baking powder, salt, mustard, pepper, vinegar, tomato paste, seasoning mixtures, spices, frozen foods, snacks and crackers. The first application was Israel Trademark No. 267770 CHIPSICO and the second, 267772 was for شيبسيكو, which is Chipsico written in Arabic.

crinkle cutThe trademark department considered the marks as being confusingly similar and the parties failed to reach an agreement, so on 8 May 2016, a competing marks proceeding under Section 29 of the Ordinance was initiated and the parties were invited to present their evidence.

New Dubak Natsha ltd submitted: Read the rest of this entry »


Finnegan Sued for Malpractice

July 9, 2017

In today’s world, patents are often owned by corporations or by groups of corporations. Inventors form companies with investors, or assign shares to investors, and these are considered separate legal entities.

Despite the legal niceties of firms of Attorneys representing companies, in practice Attorneys form connections with real persons who are sometimes the inventor, sometimes the head of R&D and sometimes the CEO or CTO. Often the patent attorney is not fully informed of the corporate structure. Structure itself is a misnomer. It implies something with a plan and a logic. Typically with solid foundations.

When receiving instructions from an inventor, receiving payment from a company and having a POA with another company, it is possible for the attorney to act in accordance with instructions from someone who is not the legal owner of an asset, and to find him or herself with a conflict of interest. Sometimes these are legal niceties that are over-looked. Sometimes they blow up.

Michael Kildavaeld conceived of a razor utility knife with a graphite pencil blade.  The “marking blade” invention marks surfaces with far greater precision than a standard carpenter’s pencil.

In October 2012, Kildavaeld met Robert Cumings, who allegedly had extensive experience in the marketing and manufacturing of tools.  That same month, Cumings introduced Kildavaeld to Harry Billado, who allegedly had experience in patent prosecution, licensing of patents, and bringing inventions to market. Together they formed a Delaware company called  “Contractor Trusted LLC”. In March 2013, Contractor Trusted LLC hired Finnegan Henderson to obtain patent protection on the marking blade invention.  Attached to the complaint is an engagement agreement between Finnegan Henderson and “Contractor Trusted, LLC c/o Mr. Michael Kildavaeld.”

The complaint alleges that Contractor Trusted LLC, marketing as Accutrax LLC began marketing its product to Stanley Black and Decker.  According to the complaint, in October 2014, while Stanley was negotiating with “the LLC” for a master purchase agreement, Kildavaeld individually contacted Stanley and tried to negotiate his own exclusive relationship with Stanley that eliminated Accutrax LLC from the picture.

According to the complaint, Stanley decided to back out of the deal rather than get caught in between the two sides who were in the midst of a patent ownership dispute. On December 23, 2014, the USPTO issued Patent No. 8,915,662.  No assignee was identified on the face of the ’662 Patent.

According to the complaint, the “patent for the Marking Blade” was issued “to Kildavaeld.”  Stanley Black and Decker withdrew from negotiations due to a dispute over who owned the patent.

“Contractor Trusted LLC” (Accutrax) has sued Finnegan for what it considers was acting in favour of the inventor and adverse to its interest, alleging claims against Finnegan for legal malpractice (count 1), breach of fiduciary duty (count 2), breach of contract (count 3), and aiding and abetting the commission of torts and breach of fiduciary duty (count 4). Accutrax seeks an unspecified amount of monetary damages.

The case is styled Accutrax LLC v. Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Mass. Suffolk County Civil Superior Court, Case No. 1784CV01617.

For more details see here.


Reviving an Inflatable Refrigerator…

July 6, 2017

renewIsrael Patent Number 190365 to Abraham Klanss titled “Inflatable Refrigerator and Freezer” lapsed due to failure to pay the second renewal. The Application was submitted on 23 March 2008, and so the deadline for paying the second renewal for years 6-10 was 23 March 2014.

When both the deadline for paying the renewal and the six month grace period passed, the Application was considered lapsed and a notification to that effect published in the November 2014 Israel Patent Office Journal.

From the Affidavit submitted with a request to reinstate the Application it transpired that Applicant had transferred the issue to Advocate Dror Matityahu, but the address of record in the Israel Patent Office was that of Patent Attorney Yoram Tzavyon.

From correspondence between Advocate Dror Matityahu and Patent Attorney Yoram Tzavyon it appears that the Advocate had paid the fee, despite the previous arrangement being that Tzavyon would handle the renewal.

The Applicant received no updates from his lawyer. In January 2017, after trying in vain to contact the lawyer, the Applicant received a status update from the Israel Patent Office and learned that the patent had lapsed.  The first attempt at reinstatement was submitted on paper in April. The current regulations require such requests to be submitted electronically and this happened the following month.

The circumstances described above are extreme. If Attorney Matityahu did indeed pay the renewal fee, he certainly did not send proof of payment to the patent office so the renewal was not registered in a timely manner. The Applicant for restoration has affirmed that he is unable to make contact with his lawyer so cannot clarify if the renewal was indeed paid as stated.

Section 60 provides for restoration if a request to restore a patent is submitted in a timely manner. The time that had passed since learning of the problem in January and first attempting to reinstate in April was considered by the Deputy Commissioner as being just about timely, it being noted that all the information was available from the database published on Israel Patent Office website, without requiring contacting the secretariat. The Applicant stated that he did not want the patent to become abandoned.

All things considered, despite the doubt, the Applicant can be considered as having fulfilled the requirements of Section 60 and so the Application for reinstatement is published for Opposition purposes provided the missing Renewal is paid.

Decision by Deputy Commissioner Bracha re Reinstatement of Israel Patent IL 19035, 26 January 2017.


Totachi

July 6, 2017

277424Totachi Kougyo Co ltd submitted Israel Trademark Application Number 277424. The Application was in classes 4, 7, 9, 11 and 12 and is shown alongside. The Application is the national phase of an International Trademark under the Madrid Protocol. On 6 December 2016, the mark was allowed and under Section 56vi of the Trademark Ordinance, the International Bureau was notified with details about the deadline for Oppositions.

On 27 March 2017, Total SA filed an Opposition in accordance with Section 24(a) of the Trademark Ordinance 19722 and regulation 35 of the 1940 regulations. Consequently, on 29 March 2017, the International Office was informed, together with the deadline for responding.

The Applicant had two months, until 29 May 2017 to respond to the Opposition. However, until the date of this decision, 18 June 2017, no response was received from the Applicant. On 11 June 2017, the Opposer requested that the Israel Patent and Trademark Office note that the since no timely response was received, the Opposition should be accepted and the mark considered cancelled.

The Adjudicator of Intellectual Property, Ms Shoshani Caspi, accepted this request. Consequently the mark is considered withdrawn and the International Bureau will be duly informed. No costs are awarded.

Decision re Israel Trademark Application 277424 to Totachi Kougyo Co ltd, 18 June 2017


Cancellation of Suprene Mark

July 6, 2017

LSUPRENEIsrael trademark no. 245038 is for the stylized word mark SUPRENE in class 17, for Synthetic rubber; styrenebutadiene rubber; butyl rubber; polyisoprene rubber; polychloroprene rubber; isobutylene-isoprene rubber; ethylene-propylene rubber; ethylene-propylene diene rubber; all included in class 17.The mark is owned by SK Global Chemical Co. ltd, a Korean company.

Dynasol Elastomeros submitted a request to have the SUPRENE mark cancelled.

The request for cancellation was submitted under Section 39a of the Trademark Ordinance 1972. The Statement of Claims and Counterclaims, and evidence were filed, but the parties decided to forgo the hearing, and requested that the adjudicator, Ms Shoshani Caspi, ruled on the basis of the materials on file.

SolpreneThe requester for cancellation, Dynasol Elastomeros, owns Israel trademark no. 242409 for SOLPRENE, registered on 6 May 2013.  SK Global Chemical Co. Ltd tried to oppose that mark, but left it too late by two days so the Opposition was ignored.

Dynasol Elastomeros’ Claims and Evidence

Dynasol Elastomeros claims to be a leading worldwide manufacturer of synthetic rubber that was founded in 1999. Due to their enormous investment made in marketing and promoting their trademarked goods, their competing mark has acquired a distinguishing character and is identified with the goods that are stamped with the mark. Thus the mark has become well-known and identified with Dynasol Elastomeros and their marks.

Dynasol claims that SK Global’s mark should be cancelled since it is confusingly similar in appearance, phonetically and conceptually with their earlier, registered mark.  Since the two marks are used with respect to similar goods and consumers, this could confuse the customers or result in them thinking that there is a commercial connection between the two groups of products.

In summary, Dynasol claims that the mark is unacceptable due to Section 8a as it lacks distinguishing nature; is unacceptable under Section 11(9) as it confusingly similar to Dynasol’s mark and under Section 11(6) as damaging to Dynasol’s reputation; under section 11(5) as selected in bad faith, and against the public order, and under sections 11(13) and 11(14) as being confusingly similar to a well-known mark. To support their allegations, Dynasol submitted an Affidavit by their legal counsel  Mr. Ramon Felipe Estrada Rivero .

SK Global Chemical’s Claims and Evidence

Supremes.pngSK Global Chemical is a Korean manufacturer of oils and petroleum which is the basis of the petrochemical industry, such as ethylene and propylene. They claim to be a leading manufacturer of rubber which is marketed under the SUPRENE mark.

SK Global Chemical has been using the SUPRENE mark since 1991 and it is used in 30 countries, including Israel. The mark is registered in these countries and a large marketing budget has been invested in promoting the mark. Consequently, the SUPRENE mark is identified with SK Global Chemical’s products. Consequently, the SUPRENE mark is well-known in Israel, whereas Dynasol’s SOLPRENE mark is not well known in Israel.

SK Global Chemical claims that there is no confusing similarity between their mark and that of the Applicant since the marks are visually and audibly different. They deny allegations of inequitable behavior in choosing their mark, and accuse Dynasol of choosing their mark in bad faith in an attempt to benefit from the Suprene reputation.

According to SK Global Chemical, since Dynasol are trying to cancel an issued mark, the burden of proof is on them to show that the registration was invalid. Their counter-claims were supported by an affidavit from their president, Mr. Hwa-Youp Cha.

RULING

Are these marks well-known?

Section 39a of the Ordinance states that requests to cancel a mark should be submitted within five years from registration:

 39.—(a) An application under section 38 for the removal of a trade mark from the Register on the ground that it is not eligible for registration under sections 7 to 11 of the Ordinance, or on the ground that the mark creates an unfair competition in respect of the applicant’s rights in Israel, must be made within five years of the issue of the certificate of registration under section 28.

Since the request for cancellation was timely filed, it is necessary to consider it, and so it is necessary to consider if the mark was indeed not fitting to be registered. Trademarks are property rights and cannot be cancelled in a cavalier manner. See for example, Amir Friedman “Trademarks – Legislation, Rulings and Comparative Law (2005) pages 667-670 and BAGATZ 144/85 Klil Non-Ferrous Metal Ltd. Vs Commissioner of Patents, Designs and Trademarks p.d. 42(1) 309-318 (1998):

The burden of proof to show that a mark is registerable is on the Applicant, but in a cancellation proceedings, the burden of proof that a mark is not registerable is on the challenger. The registration of a mark is a prima facie indication that it is registerable and so the burden of proof is on the Challenger to rebut this indication. In all cases where the burden of proof is on one party or another, it switches back and forth in light of the evidence submitted…so a doubt with regarding to validity or otherwise acts in favour of the mark owner.

A mark that is “well-known” under the Law is a mark that is well-known in Israel in relevant circles, and fame abroad is insufficient. See Appeal 9191/03 V&S Vin Spirt Aktiebolag vs. Absolut Shoes Ltd., 19 July 2004. When deciding whether or not a mark is well-known, the following are considered: how well-known the mark is to the relevant population, the scope and longevity of the usage, the investment in promoting the mark over time, the degree that the mark is different from other marks, the degree to which the owners had sole usage of the mark, the investment by owners in registering and enforcing the mark, etc. – Amir Friedman “Trademarks – Legislation, Rulings and Comparative Law (2005) , see also the Opposition to Israel trademark no. 93261 “Pentax” – Pentax SRL vs. Asahi Kogaku Kogyo Kabushiki Kaisha, 3 September 2003.

rubber duckBefore determining the reputation of a mark with the relevant population in Israel, it is necessary to identify the population. From the evidence submitted, the population is not the end-user purchasing off the shelf, but rather industrial entities. This can be learned, inter alia, from Section 9 of the Applicant’s affidavit and from pages 16-26 of the appendix thereof, which details the usage of their rubber, and appendix 3 of the Applicant’s affidavit and their catalogue of products. All these teach that neither the Applicant for cancellation nor the responder are targeting their goods to the end-user, but rather to companies making rubber goods that purchase the raw material from them. It would appear that the end user that purchases rubber gloves, dummies (pacifiers), rubber bands and the like, are interested in the manufacturer of the product and not in the supplier of the raw material.

From the evidence submitted, the Adjudicator is not convinced that either mark is “well-known” in the sense of the Law. In this regard, it will be noted that the parties themselves decided not to hold an oral hearing with cross-examination. However, each party attacked the other’s marks, so the court can only look at the evidence submitted and decide whether a case has been made to support the allegations and to attach evidentiary weight to the evidence.

Mr. Rivero, Dynasol’s legal counsel , testified that the company had spent a fortune in branding and promoting their mark around the world, but no numbers or supporting evidence were given to substantiate this claim. A similar conclusion was reached regarding the claim that the trademarked products had enjoyed tremendous success with the consumers, and that the mark was in use in Israel since 2003 and the products were successful. So the challenger has not reached the burden of evidence for its marks to be considered well-known to the Israeli public.

Similarly, Mr. Hwa-Youp Cha’s affidavit is insufficient to persuade that by SK Global Chemical Co. ltd’s mark is respected and well-known by the Israeli consumer. His affidavit was also unsupported by evidence and the adjudicator was not provided with any evidence of investment in promoting and marketing goods under the mark, or of the amount of sales in Israel.

In light of these conclusions, relating to cancellation under sections 11(13 and 11(14) based on the mark being well-known, is moot. Similarly, the challenger’s claim that leaving the registration in place will create unfair competition with their well known mark, contrary to section 11(6) of the Ordinance is also moot.

Is there a likelihood of confusion? The triple test

Section 11(9) states that an applied for mark must not be deceptive, as follows:

  1. The following marks are not capable of registration:

(9)   a mark identical with one belonging to a different proprietor which is already on the register in respect of the same goods or description of goods, or so nearly resembling such a mark as to be calculated to deceive;

Whether or not there is deception is determined using the so-called triple test that is found in the case-law, and is based in the sight and sound of the mark, the type of goods, the clients and marketing channels and other considerations, to which the common sense test has been added. See 261/64 Pro-Pro Biscuits (Kfar Saba) Ltd. vs. Fromein and Sons ltd. p.d. 18(3) 275 (1964), 5454/02 Taam Teva (1988) Tivoli vs. Ambosia Surprise p.d. 57(2) 438, 451-453 (2003) and Appeal 5792/99 Communication and religious Jewish Education Family (1997) Ltd. vs. SBS Publicity, Marketing and sales Promotion Ltd, p.d. 55(3) 933 (2001).

The adjudicator was prepared to accept that there was some similarity between the marks, but did not consider this similarity as deceptive. Comparison between marks has to be done between marks in their entirety. When considering allegations of deceptiveness, one should note that the consumer’s memory is imperfect. See A. H. Seligsohn Trademarks and Related Legislation (1973) p. 81 and 6658/09 Multilock vs. Rav Bareach Industries Ltd. 12 January 2010.

The Sight and Sound strand is the dominant element of the test (see Taam Teva ruling). When the marks are compared visually, it is clear that there are differences between them. In the challenged mark, the S is stylized. The first syllable is different. The challenger’s mark starts with the syllable SOL, whereas the challenged mark starts SU which is pronounced differently. The Adjudicator considers that this results in a different visual appearance as well.

The Adjudicator accepts the mark holder’s assertion that PRENE and ERENE are common suffixes in class 17 and these suffixes are established in science, particularly in chemistry, polymer sciences and rubbers. In their summation, the respondent gave many examples of trademarks that included such suffixes, particularly for rubbers, thermoplastics, plastic, polymer mixtures and the like, many of which ended with PRENE or ERENE and were registerable. The Adjudicator also accepted that the trademark register was in the public domain and reference to it did not require an affidavit (see Appeal 941/05 The Cooperative Association of Vinters of Rishon L’Zion and Zichron Yaakov Wineries Ltd. 17 October 2006). Consequently, the suffixes of challenger and respondent should be given little importance.

Although foreign case-law does not bind the Court of the Israel Patent and Trademark Office, the Adjudicator considers it worthwhile to refer to the Spanish Patent Office ruling concerning the stylized SUPRENE mark in a parallel case between the parties, regarding which it will be noted that Challenger did not appeal that ruling:

“There is sufficient word dissimilarity between them, since the only coincident term in the wording is common in almost all trademarks that cover this kind of products, in consequence it is considered that there is no reasonable risk of association between the trademark applied for and the one previously registered.”   

The Peruvian Patent Office came to a similar conclusion as well.

As to the type of goods, the parties agree that there is a large overlap in that both make rubber products of various types, however in both cases, it is the manufacturers and not the end users that are the customers and thus target group.

tiggerSince the customers are industrial companies, before purchasing large quantities of stock one can assume that they would consider the technical specification, resistance to degradation and other properties including price. These industrial customers have technical knowledge and do not purchase rubber materials without consideration, and one assumes that they would look at the stamped on supplier’s brand names and differentiate between the two competing parties. The Applicant for cancellation noted that products are typically purchased by the tonne and customers visit the factory before making a purchase, and it is only after negotiation that the seller and buyer sign a contract that specifies the supplier and the goods purchased.  In view of the nature of the customers, the likelihood of misleading is negligible.

Other Considerations

From the evidence before her, which was not subjected to cross-examination at the request of the parties, it appears that the parties are both manufacturers of raw rubber materials. The Adjudicator was not impressed that one party has a reputation that the other was attempting to ride on.

The Challenger did not bother to submit evidence of actual misleading. No affidavits of clients that were confused were submitted. The onus is on the challenger to show that misleading occurs, and with activities in 70 countries, if there was confusion, it shouldn’t have been difficult to show it. This does not mean that actual confusion is required to cancel a mark, but were such evidence to be available, one assumes that the challenger would present it.

There seems to be no basis to conclude that there is a likelihood of confusion amongst the Israeli customers. The Adjudicator considers it impossible that one or other manufacturer would inadvertently purchase the products of the wrong supplier.

Similarly the challenger’s claim that the registered mark lacks acquired distinctiveness is rejected, as is the claim that the mark was registered in bad faith to trade on the challenger’s reputation. Where there are specific clauses 11(6) to 11(9) one cannot use 11(5) (public order) as a catch-all to prevent confusion.

In conclusion, the cancellation proceeding against Israel Trademark 2458038 is rejected. The challenger Dynasol Elastomeros is ordered to pay 9000 Shekels costs.

Ruling by Ms Yaara Shoshani Caspi regarding Dynasol Elastomeros attempt to cancel Israel Trademark 2458038 to SK Global Chemical Co., 28 May 2017

 


Teva Abandons Opposition but Application Ruled Invalid Anyway

July 5, 2017

 

AstellasAstella Pharma filed Israel Patent Application No. 178249 titled “Pharmaceutical Composition for use in Solid Formulation Crystalline Solifenacin or Salt Thereof and a Process for its Preparation”. The Application was the national phase of PCT/JP/2005/005377 which was filed on 24 March 2005 and claimed priority from a couple of earlier US provisional applications.

The Application relates to a solid pharmaceutical containing Solifenacin or Solifenacin Succinate that is up to 77% amorphous as determined using NMR.

solef moleculeThe Application was allowed, and on 27 February 2002 Teva Pharmaceuticals submitted an Opposition. On 26 June 2013, Astella requested permission to amend the specification. Teva opposed some of the amendments and in an interim ruling of 19 May 2014 Ms Jacqueline Bracha approved some of the amendments, which were then published for Opposition purposes, and since no oppositions were submitted, were then allowed. This ruling relates to the amended specification.

On 29 July 2015, instead of submitting an amended statement of case, Teva abandoned the Opposition. Nevertheless, on 27 March 2016, in a detailed ruling, Ms Bracha explained to Astella that under the Authority granted by Section 34 of the Law, she was refusing to grant the patent. The ruling was based on two publications that Teva had submitted in the Original statement of case that showed that persons of the art would expect the rate and degree of solubility to increase with increased amorphousness of a tablet. On 22 May 2016 the Applicant requested an oral hearing which was held on 4 January 2017 and this ruling follows that hearing.

Applicant’s Claims

Astella, represented by Gilat Bareket, claimed that in a Section 34 proceeding, the burden of proof is on the Commissioner. The claim that since the Opposition was abandoned and following allowance by the Examiner, there is an assumption of validity. Therefore, the Commissioner has to overcome this rebuttable assumption.

The Applicant claims that the prior art describes a process for fabricating Solifenacin hydrochloride crystals. It did not relate to amorphous Solifenacin or to degradation of the amorphous Solifenacin or to medical formulations comprising Solifenacin Succinate.

The Applicant claims that there is a continuous decrease of the active ingredient due to degradation which they determined to be due to the amorphous Solifenacin that is produced in when preparing the tablets.

The Applicant clarified that restricting the amount of the amorphous Solifenacin to no more than 77% increases the stability and reduces degradation to rates tolerable in Japan. Furthermore, the Applicant found that when the fabrication process is wet granulation they can control the amount of amorphous material by controlling the moisture levels. They also claim that using PEG as a binder also lowers the degradation, however the Deputy Commissioner notes that this was not claimed and is thus not part of the invention.

As stated, the invention is intended to provide a stable formulation with less than 0.4% degradation of Solifenacin Succinate in the total amount.

The discussion related to the following publications:

  • Ahlneck and G. Zografi., The Molecular Basis of Moisture Effects on the Physical and Chemical Stability of Drugs in the Solid State,Int. J. PHARM., vol. 62(2-3) (1990) – “Appendix 10”;
  • Y.Shalaev and G. Zografi., How Does Residual Water Affect the Solid-State Degradation of Drugs in the Amorphous State?, J. PHARM. SCI., vol. 85(11) (1996) –  “Appendix 9”;
  • C. Hancock and G. Zografi., Characteristics and Significance of the Amorphous State in Pharmaceutical Systems, J. PHARM. SCI., vol. 86(1)(1997) – “Appendix 11”.

The Burden of Proof

The Applicant alleges that the burden of proof resides with the Commissioner. In Y Kedmi “On Evidence”, 4th Edition 2009, it is stated that the burden of evidence depends on the substantive law:

The determination regarding which side bears the burden of proof depends on two basic principles:

  • “The one seeking redress has the burden of proof” [Baba Kama 46a] and this may be plaintiff or the defendant, depending on circumstances.
  • “Evidence follows the Substantive Law” – both when establishing the basis of the legal claim / defense, and when overcoming presumptions.

burden of proofAs a general rule, the burden of proof that a patent application is registerable is on the Applicant see 665/84 Sanofi ltd. vs Unipharm ltd. p.d. 41(4) 729 and Appeal 645-06-13 Unipharm vs. Lilly Icos, 26 January 2014.

The Opposition is considered as a completion of the Examination, and the allowability is reconsidered. It serves to protect the integrity of the register and the executive examination, see Opposition of IL 136482 Bromium Compounds ltd vs. Albermarle Corporation USA, 7 November 2010:

It appears that the attitude of the court has changed since then. Now the Supreme Court sees the Opposition process as a completion of the executive examination that is designed to ensure the public interest and the integrity of the register.

The public interest that the Opposition proceedings serves is detailed in 2826/04 Commissioner of Patents vs. Recordati Ireland Ltd. p.d. 59(2) 85.

The purpose of the Section 34 proceeding is identical to that of Oppositions, i.e. to maintain the integrity of the register, see the Section 34 ruling concerning IL 156034 Serguei Borisovish Sivolovenko vs. Diamcad NV, 25 January 2015:

The Section 34 proceeding is another hurdle that the Applicant may have to negotiate before receiving a patent. During this proceeding, the Commissioner is allowed to consider all the material before him from the Opposition proceeding, and to decide whether to uphold the Examiner’s decision or to change it. The purpose is no different from that of Examination or Oppositions, and is to protect the integrity of the register and the public interest to not issue patents contrary to Section 3 of the Law. Successful negotiation of the Examination stage does not bestow a right to a patent.

The patentee’s right to a monopoly for the patented invention is in rem. Consequently he has to show that the invention fulfils all the requirements of patentability under the Law. The burden of proof only changes once a patent issues. This was clarified by Commissioner Kling in IL 142896 and IL 179379 Medice Arzneimittel GmbH & Co.KG Alkermes Pharma Ireland Ltd, 4 April 2017.

In a cancellation proceeding, the burden of proof that a patent is invalid is on the Requester for cancellation. For example, this was established in Appeal 8802/06 Unipharm ltd. vs. Smithkline Beecham PLC, 18 May 2011:

Section 37 of the Law completes this idea by establishing that Examination and granting of a patent do not guarantee it has validity. So the issuance of a patent by the Commissioner does not create a non-rebuttable assumption of validity. It merely establishes that the Commissioner considered it issuable. (appeal 47/87 Hasam Systems for Defence of Trustworthiness ltd. vs. Bahari, p.d. 45(5) 194, 201-202 (1991). However, the burden of proof that an issued patent is invalid is on the party claiming invalidity (See Appeal 665/84 Sanofi vs. Unipharm ltd. p.d. 41(4) 729, 736 (1987), Appeal 700/78 Isisco International Company for Solar Energy Systems ltd. vs. Banit, p.d. 34(1) 757, 763 (1979).
Thus, before a patent issues, the burden of proof is on the Applicant.

Validity of Patent Application

On page 2 of the Application, the Applicant notes that solifenacin was known as was its efficacy for treating diseases of the urinary tract, salts of solifenacin and the crystalline state of solifenacin hydrochloride and methods of manufacture.

VesicareSolifenacin Succinate was used in Vesicare, see accompanying flyer which was published in December 2004, before the priority date of the present application. The synthesis of Solifenacin Succinate is also described in the prior art (Appendix 3 of the Opposer’s Statement).

The Applicant claims that during development of the formulation they discovered that there is degradation where the amorphous state is present. The Applicant claims that the prior art was unaware of this phenomenon and thus did not address it.

Appendix 9 page 1137 teaches that exposure of solid pharmaceuticals to high moisture results in degradation:

“It is widely recognized in the pharmaceutical field that exposure of solid drugs (small molecules or proteins) to high relative humidity and the resulting association of water vapor with the solid generally accelerate the rate of chemical degradation.”

Further on it is mentioned that the instability typically occurs in the amorphous part of the formulation:

“…most instabilities observed for drugs occur in solution much more readily than in the solid state; when they do occur over practical time scales in the solid state, it is very likely that the reaction is taking place in the more disordered amorphous regions of the solid. Indeed, it has been shown in a number of cases that under otherwise identical conditions reactivity of a particular substance in the amorphous state is greater than that in the crystalline state.”

Appendix 11 teaches that in cases where the active ingredient is found in an amorphous form, this is likely to accelerate the degradation. However, sometimes, the amorphous form spontaneously crystallizes:

“The high internal energy and specific volume of the amorphous state relative to the crystalline state can lead to enhanced dissolution and bioavailability, but can also create the possibility that during processing or storage the amorphous state may spontaneously convert back to the crystalline state.

… In the first, a material may exist intrinsically in the main amorphous state or it may be purposefully rendered amorphous and we would like to take advantage of its unique physical chemical properties. Under these circumstances we usually want to develop strategies to prevent physical and chemical instability of the amorphous sample. In the second case, we may be dealing with a crystalline material that has been inadvertently rendered amorphous during processing. This type of amorphous character usually exists predominantly at surfaces at levels not easily detected and has the potential to produce unwanted changes in the physical and chemical properties of the system. In this situation we usually want to process the system so that the amorphous portions of the solid are converted back to the most thermodynamically stable crystalline state.”

amorphousThe Application describes attempts by the applicant to prove that there is a connection between the amorphous state and the results of degradation F1 (table 2 on page 38 of the Application.

The Applicant compared the stabilities of samples 1-4 that included 63%, 73%, 715 and 7% amorphous material, with samples 1-3 that contained 92%, 90% and 92% amorphous material. However, the results of table 2 do not show a clear correlation between the amount of amorphous material and the F1 decomposition product. For example, example 1 had 63% amorphous material but only 0.31% F1, whereas example 2 had 73% amorphous material but only 0.29% F1, and in comparative sample 1 with 92% amorphous material  there was 0.48% F1, and in comparative sample 3 with 92% amorphous material  there was 0.4% F1.

Furthermore, as can be seen from table 2, the moisture of the granulate influences the F1 breakdown product, and can at least partially explain the difference between the results of comparison samples 1 and 3. The Applicant claims that there is some correlation between the water content of the granulate and the amount of amorphous material but it is not certain that the amorphous material content influences the amount of F1 degradation product.

japaneseFurthermore, it appears that the 0.4% limit that the Applicant set was based on the Japanese Health Ministry requirements and was not empirically determined. The Applicant admits that the Japanese acceptable limit was 0.5% and 0.4% is preferable. Table 2 shows that even where the amorphous quantity exceeded 77%, less than 0.5% of F1 was obtained.

Even if we assume that the Japanese Ministry of Health limits are desirable, the applicant has not established that there is a problem attaining these limits that the invention overcomes, due to the stability of the salt. The 77% amorphous material limit is also not empirically established. The Applicant was not able to produce Solifenacin Succinate with more than 0.5% F1 degradation product, and there is no linear connection between moisture content and amorphous material content.

Applicant does not deny that amorphous Solifenacin Succinate can spontaneously crystallize (see Appendix 2 and letter of 5 December 2012 and “Analysis of Appeal in European examination file from 17 April 2012 that the Applicant submitted in the corresponding European application. The slight differences in F1 product are even less significant due to this spontaneous crystallization.

There are a few more paragraphs regarding the various compositions and the binder (that wasn’t claimed and then, the Deputy Commissioner states that) from another angle, Appendix 9 teaches that there is a close connection between moisture and the amount of amorphous material present – page 113:

“Generally, for reactions occurring in the amorphous solid state, the rate of reactivity increases with increasing water content, and this can be attributed to the ability of the amorphous solid to absorb water vapor into its bulk structure, forming an amorphous solution. In a few cases it has been reported that a certain amount of water must be present to ensure chemical stability, e.g., lipid peroxidation rates decrease with the addition of small amounts of water; however, a destabilizing effect of absorbed water is more generally the case for the major types of drug degradations, e.g., hydrolysis, oxidation, or deamidation.”

So it seems that average persons of the art at the time in question would conclude that limiting moisture would limit the amorphous material in the formulation and this would, in turn, limit degradation. Consequently, this has no inventive step whatsoever.

CONCLUSION

The invention is wholly lacking in inventive step and so the IL 178249 Application is rejected.

COMMENTS

I am not a pharmacist, but have a fairly strong background in chemistry. It seems to me to be fairly obvious how to control the crystallization rate and extent, and how this will affect solubility. Possibly high school thermodynamics in inadequate, but a basic undergraduate course of chemical thermodynamics is more than adequate to predict this invention, so it seems to me that the Deputy Commissioner was correct to refuse the patent.

Formally, the Opposer is wrong to claim that the onus of proof is on the Commissioner. The case-law considers the Opposition proceeding as part of Examination and does not assume that the Examiner concluding that an invention is patentable establishes a presumption of validity. TEVA’s withdrawal of their Opposition may have been a commercial decision. In practice, although formally Israel requires an inventive step, an Examiner has to show anticipation or obviousness not to grant a patent. TEVA made some of the scientific literature of record, and the Deputy Commissioner was correct to relate to it.

This decision seems to be correct. However Astella, may appeal it to the courts.