Teva Challenges Gilead Patent Application for HIV Treatment

May 8, 2017

drug cocktailThis ruling relates to a treatment for HIV consisting of a single once-a-day dosage that includes a combination of two or three different active ingredients.

Israel Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. Gilead purchased Triangle so that they would have the capability of producing both  FTC and TDF and in a press release in Bioworld in 2002 which quoted Gilead’s Chairman and CEO, they announced their intention to develop a single dosage formulation that included TDF and FTC, referring to the chemicals by their trade names of Viread and Coviracil. This announcement preceded the priority date and since they announced that they did not anticipate difficulties in formulating the combination, their announcement undermined claims 1 and 12 directed to the combination of TDF and FTC in the standard dosages of Viread and Coviracil. There were additional independent claims for FTC and TDF together with an additional active ingredient – either Reyataz, Kaltera or Sustiva. However, that combination was used in a clinical trial for treating Hepatitis B that was also prior art. This ruling addresses and clarifies the requirements for prior art to be anticipating and what is required to provide an inventive step. It also relates to the issues of claim support, enablement and utility.

History

GileadIsrael Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. On allowance the Application published for opposition purposes and Teva filed an opposition on 26 March 2009 and four months later submitted a detailed statement of case. On 1 February 2010, the Applicant requested permission to correct the application, and on 21 April 2010, Teva requested that the proposed amendments to the claims be refused. There was an intermediate ruling on this by the Commissioner on 22 June 2010, and on 27 June 2010 Teva withdrew their challenge to the amendments and the opposition continued with the amended claim-set. On 8 May 2011, the Opposer submitted an amended statement of case and Gilad submitted their response on 1 January 2012. On 23 September 2012, the Opposer’s evidence was submitted in the form of two affidavits, by Professor Richard Novak and by Professor Joseph Fortunak. On 24 July 2013, Gilad submitted their response in the form of Affidavits by Professor Robert Redfield and Professor G Stahly, and on 10 April 2014 further affidavits were submitted in response to points raised. Read the rest of this entry »


Unipharm Requests Accelerated Examination of Pending Novartis Patent Application

May 7, 2017

novartisIsrael Patent Application No. 249922 is a divisional application of 205208 that was filed on 3 January 2017, and which claims priority from USSN 60/985,668 filed on 6 November 2007. Under Section 16, the filing of the divisional application was published on 29 February 2017.

The ‘922 application relates to “DUAL-ACTING PHARMACEUTICAL COMPOSITIONS BASED ON SUPERSTRUCTURES OF ANGIOTENSIN RECEPTOR ANTAGONIST/BLOCKER (ARB) AND NEUTRAL ENDOPEPTIDASE (NEP) INHIBITOR”.

On 4 January 2017, the Applicant received a Notice Prior to Examination under Section 18 and regulation 36. Examination has not started.

UnipharmUnipharm requested that the examination of the Application be accelerated under Section 19a of the Israel Patent Law. The request was supported by an Affidavit from Mr Zevulun Tomer, Unipharm’s CEO:

I affirm that if IL 249922 to Novartis AG is examined in due course, it will cause a delay in Unipharm’s development of a product that is a high priority. … Making the Examination special will prevent delays and costs and serves the public interest by making drugs more available at lower cost and by opening the market to competition.

EntrestoOn 2 April 2017, Novartis AG opposed the request. Their position was that the request was vague and did not fulfill the conditions of Section 19a(c). Novartis notes that Unipharm did not provide details regarding which drug they intended developing, and if their intent was to develop a generic version of ENTRESTO, Novartis noted that that product was protected by other patents, some of which were pending patent extensions, and so accelerating the examination of ‘922 would not have the allegedly desired consequences.

Novartis also noted that if an Opposition is eventually submitted against IL 205208 under Section 26 of the Israel Patent Law which published for opposition purposes on 31 January 2017, anyway under Commissioner Circulars 035/2017 and 020/2012, no extensions in the Examination of the ‘922 application would be allowed.  The Commissioner noted that on 23 April 2017, the period for submitting an Opposition was still open, so there was no need for him to address this theoretical issue. In response to Novartis’s counter-statement, Unpiharm reiterated their claims.

Section 19a(c) provides the situations where a third-party can request acceleration of a pending application to another:

(c) A person other than the applicant, and who is not associated with the applicant or works on his behalf, may submit to the Commissioner a detailed request along with an affidavit supporting the facts, for an accelerated examination of an application that was published under section 16A, if one of the following occurs: (1) There is an established concern that the examination of the application of the patent according to the set order may cause the applicant of an accelerated examination application, who works in the field of the invention, a delay in the development or in the production of a product or a process claimed in the patent application under this subsection. (2) Time elapsed since the submission of the request is unreasonably long under section 15 or from the day the request entered the national stage under section 48D, and taking into consideration any significantly lengthy time since the lapsed date up to the beginning of the examination of other application of the same type. (3) Public interest; (4) Extenuating circumstances which provide justification.

As established re Israel Patent Application 221842 J. L. Glatt Lift ltd, 14 June 2016: 

 The possibility of accelerating examination under Section 19a is an exception to the general rule regarding examination that is given in Section 9 and regulation 34:

Applying the exception is likely to damage the principle of the first to file is to be awarded the patent and is likely to damage the general quality of patent examinations. For example, prior art that is not yet examined could be overlooked.

It is clear that accelerating examination under Section 19a is reserved for extreme cases where it is justified to deviate from the normal order. The burden of proof is on the Applicant for  Accelerated Examination who is to detail his request and support it with evidence.

Unipharm’s request and Mr Tomer’s affidavit relate in general to Section 19a(c) but it appears that they intend part (1) which relates to ‘delays in developing or manufacturing a product’ that Unipharm intends to manufacture, and to part (3) that relates to the ‘public good’ that is served by greater accessibility to drugs, reduced costs and competition in the market.

Unipharm claims that under their work program, if a patent issues for the ‘922 application, this will prevent them developing and then manufacturing their product.  Unipharm’s affidavit details the managerial program and preferences. The Commissioner Asa Kling does not see any reason not to accept an Affidavit from a CEO who may be presumed to know the company’s plans. There is no need to cross-examine under Section 163a of the Israel Patent Law 1967, and if it should transpire that Unipharm have lied, this Affidavit could be used against them. Therefore, it seems that Unipharm have provided the appropriate support for their request as required by Section 19a(c)(1) of the Law for accelerated examination.

This is not the case with respect to ‘public interest’ under Section 19a(c)(3) of the Law. As explained in the Glat Lift case, accelerated examination under Section 10 is reserved for extraordinary cases that are important to the State of Israel in general. The Application and Affidavit do not point to such a specific condition. It does not explain how accelerated examination will result in competition that will bring about a drop in prices. As Novartis noted, it doesn’t even explain which market sector will have enhanced access. The Section 19a(c)(3) justification is rejected.

However, due to the Section 19a(c)(1) justification, examination of pending application 249922 will be expedited on payment of the relevant fee. Suspension or extensions will be permitted only in accordance with Section 19(a)(1) of the Law. No costs are awarded.

COMMENT

In this instance, as we are dealing with a divisional application, there is no danger of earlier filed not published art being missed due to the patent being examined out of turn. The Commissioner Circulars 035/2017 and 020/2012 explain Patent Office policy to examine divisional applications of opposed applications as fast as possible. There is a real danger that applicants for pharmaceuticals that are opposed will file continuations and divisionals to keep the patent application alive in an attempt to evergreen. So on balance, it seems that the request is reasonable and the Commissioner was right to grant it. If Novartis are acting in good faith, they should be interested in having their patent application examined as fast as possible. They have not provided a justification for delaying, such as wanting to wait for examination of a corresponding application to be concluded so that they can request allowance under Section 17c or similar.

With a justification under Section 19a(c)(1) it does not matter that the Section 19a(c)(3) request was denied. However, I don’t fully understand the Commissioner’s reasoning. If he considers that one has to be facing a drug shortage within an epidemic, that is one thing. However, I don’t think that one should have to explain how allowing generic competition lowers drug prices for the common good. This is self-evident and true for all drugs, and the underlying logic of free markets and really dates back to Adam Smith’s Wealth of Nations. Still, the Law does seem to require something extraordinary.

We note that Unipharm successfully handled this request themselves, without professional representation. This is not the first time that Unipharm have successfully fought inter-partes proceedings at the Israel Patent Office without using an attorney. Nevertheless, others are strongly advised not to follow their example.


Smash

May 7, 2017

smash3Talber 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.

On 30 December 2017, Smash Enterprises Pty LTD submitted a request to cancel the marks or to allow their marks to be co-registered. On 2 March 2016, Talber Pop responded with their Counter-Statement of Case.

The request for cancellation followed an attempt by Smash Enterprises Pty LTD to register their Israel Trademark Application 274301. After various extensions were authorized, on 26 January 2017 the parties submitted a joint request for coexistence based on a civil court ruling under which they undertook to differentiate their services and goods.

Smash Enterprises Pty LTD’s mark was in class 21 and covered 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.

Essentially, the two parties are interested in co-registration of Israel TM 274301 to Smash Enterprises together with those registered by Talber Pop LTD. (Smash Enterprises did have a second application in class 18, but seem to have abandoned that, as to allow the same mark for similar goods in the same class is particularly difficult).

The Commissioner can allow co-registration under Section 30a for identical or similar marks for identical or similar goods if the application to do is filed in good faith or if there are extenuating circumstances that allows coexistence.

The wording of Section 30(a) is as follows:

Where it appears to the Registrar that there is honest concurrent use, or where there are other special circumstances which in his opinion justify the registration of identical or similar trade marks for the same goods or description of goods by more than one proprietor, the Registrar may permit such registration subject to such conditions and limitations, if any as he may think fit. (b) A decision of the Registrar under subsection (a) shall be subject to appeal to the Supreme Court. The appeal shall be filled within thirty days from the date of the decision of the Registrar. In the appeal, the Court shall have all the powers conferred upon the Registrar under subsection (a). 

The Applicant for coexistence has to prove that he is acting in good faith. Furthermore, he has to establish that despite the marks being identical or apparently similar to those registered, there is no practical risk that the consumer will confuse between the marks. In this regard, in the 87779/04 Yotvata vs. Tnuva ruling it is stated that:

In rulings [based on Section 30a of the Ordinance] the emphasis will be on the equitable behavior of the parties adopting the mark and on the need to protect the public from similar marks that might create misleading or unfair competition (Friedman p. 431).

See also 48827-03-14 Biosensors Europe SA vs. Commissioner of Patents from 22 February 2015:

The burden of proof that there is no likelihood of confusion falls on the two companies interested in the co-registration, and they have to prove that for many years they used the marks in Israel without the public being confused.

In this regard, the main thread running through the Ordinance is that identical or confusingly similar marks should not be registered if they will mislead the public. Thus in  10959/05 Delta Lingerie S.A.O.F vs Cachan Tea Board, India :7.12.06 :

Confusion and the risk of misleading is the living breath of the Ordinance. This is the main danger that we have to deal with. The various options of Section 11 that list marks that may not be registered reflect different types of confusion, and way to prevent them.

Where marks are more confusingly similar, the level of evidence that is required to show that there is no danger in their both being registered by Commissioner discretion under Section 30a is higher. See for example, the ruling concerning Israel TMs 24886 and 233056 Orbinka Investments LTD vs Now Securites Ohr Yehuda 1989 ltd., 24 July 2015 and 252115, 244719 Gaudi Trade SPA vs. Guess, Inc., 27 July 2016.

Alternatively, the Commissioner has to consider whether there are other special considerations that allow identical or similar marks for identical or similar goods.

In this instance the parties have reached a coexistence agreement following arbitration before Adv. Gai-Ron, and the Arbitrator of IP prefers constructive discussion and compromise rather than judicial ruling that are all or nothing. Nevertheless, the mere fact that the parties are interested in co-existing is insufficient to allow it where the is a likelihood of confusion. The Commissioner has the sole authority and responsibility to ensure that the Israel public are not confused by such marks, and such agreements are no more than an indication that must be weighed up with other considerations before allowing co-existence. See 1611/07 Micha Danziger vs. Shmuel Mor, 23 August 2012: 

The desire of the parties that grow and market Gypsophila is one thing. The registration of confusingly similar marks is something else. Furthermore, and this is the important point – we are not relating to the parties’ consent, but to the balances in the law. The prohibition to register the requested mark is based on the need to protect consumers that were not party to the agreement between appellant and defender, (although such agreements may be indicative as part of a general analysis).

Thus it cannot be disputed that the Commissioner is not obliged to follow agreements between the parties. Nevertheless, in appropriate circumstances and where such agreements are valid, the Commissioner may allow co-existence based on such agreements – see 10105-05-16 Campalock ltd vs Commissioner of Patents, Trademarks and Designs 4/12/16.

In this instance, the parties submitted a two paragraph laconic request for co-existence stating that they had reached an agreement. However it is not enough to negotiate an agreement that serves the interests of the parties. A request to allow two pending applications to coexist or for a new application to be registered alongside an existing one must be justified by a detailed explanation showing why the public will not be confused.

There is no way to relate to whether the sides behaved equitably since the case should be closed before a hearing is conducted. The parties did not even address this issue in their request. The  marks are identical for the word SMASH and there is certainly a similarity between schoolbags in class 18 and food bags and drink containers in Class 21 since these goods could be sold in the same retail outlets and there is therefore a room for confusion between goods in classes 18 and 21.

The Examiner reached a similar conclusion when she objected to the 2743011 mark under Section 11(9), and mere consent of the owner of a mark cited against a pending mark is insufficient to overcome a Section 11(9) objection.

The agreement does list the steps that the parties have undertaken to take, but this is insufficient. Firstly, the mark owner of the registered marks undertakes not to use a logo similar to that of the Applicant for cancellation, but the logo is not appended. An agreement not to use the same graphic is too narrow since the degree of similarity that is allowed is not related to. The registration would cause the register to be different from that happening in business.

Under the agreement, the side requesting cancellation would have the sole right to use the mark for boxes and containers for storing food and drink and the mark owner would be prohibited from so-doing. However, the mark owner’s registration 240598 (group 18) includes “food bags”. Food bags are essentially food storage bags. There is thus an overlap which creates confusion.

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.

Consequently, 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.

Smash ruling, Ms Shoshani Caspi, 26 April 2017.

Comment

The ruling is solid and both parties were represented. The parties are interested in compromising. The Patent and Trademark Office have to consider the public interest and to prevent confusion, but nevertheless one wonders why the arbitrator did not simply request that the parties relate to a list of issues that their agreement does not address, rather than to refuse the request.

 


Panama Jack

April 23, 2017

Panama JackPanama Jack Inc. submitted a cancellation request against registered Israel TM No. 79826 for a Panama Jack pendant which was registered back in 1994 in group 25 by Grupp Internacional SA.

Section 41(a) of the 1972 Tradeamrk Ordinance states that:

Any interested party may request cancellation of a trademark on the grounds that there was never a good faith intention of using the mark and that the mark was not used in good faith within the three year period prior to the cancellation request being submitted.

Registered trademarks are considered property rights in all respects and should not be undermined without due consideration. The requester for cancellation was to show that the mark was not in use. See 476/82 Orloged.vs. Commissioner of Patents p.d. 39 (2) 148. The burden of evidence then bounces back and forth between the parties, and if the challenger provides prima facie evidence that shows that a mark should not be cancelled, the burden of proof then falls on the mark owner to dispute the evidence brought by the challenger and to supply evidence that there was, in fact, use of the mark. Where there remains a doubt, this works for the benefit of the mark owner, and the mark will not be cancelled. BAGATZ 296/89 Philip Morris vs. Moorgate Tobacco Co Ltd. p.d. 41 (1) 485.

Regulation 70 of the 1940 Trademark Regulations state that:

A request to correct a registration or to cancel a registered mark from the register will detail the facts and the requested correction and will be submitted in two copies; one to the Registrar and the other to the owner of the mark.

In this instance no one denies that the mark owner received a copy of the cancellation request.

Section 71 of the regulations state the case should continue as follows:

With submission of a cancellation request with copy to the registered owner, the matter proceeds in accordance with regulations 37 to 46 (opposition regulations) with the appropriate changes.

The mark owner has two months, i.e. until 30 January 2017 to respond. In this instance, he failed to do so and also failed to request an extension of time. In so doing, Section 71(a)a applies:

If the owner of a mark does not submit a response under Sefction 70 within two months, the Commissioner will give the supplicant two months to state their case.

In this instance, as the mark owner has failed to respond, the Supplicant for cancellation has two months to submit their evidence.

Re 79826 Grupp Internacional vs. Panama Jack, Intermediate Ruling Shoshana Yaara Caspi, 13 March 2017


Trademark Cancellations – Jumping on the band wagon

April 23, 2017

the herbsMichael Noy-Meir owns Israel TM No. 106994 for “Supherbs”. He is represented by Chani Rosenberg and Associates.

Ambrosia Supherb LTD filed a cancellation request and Peretz Gan, represented by Chani Roenberg and Associates wishes to join the case as a third-party. Peretz Gan claims to be a partner with Noy-Meir the mark owner for 20 years and that both of them used the mark over a twelve-year period.

The Cancellation request was submitted on 3 November 2016 and on 27 November 2016, Peretz Gan requested that the mark be assigned to him, based on an agreement from 19 September 2016.

On 4 January 2017, Deputy Commissioner Jacqueline Bracha ruled that if the mark survives the cancellation process, it may be assigned, but cannot be assigned whilst under attack.

Ambrosia Supherb LTD object to Peretz Gan being added as a third-party. They claim that there is insufficient evidence that he was rights in the mark as required by Regulation 72 of the 1940 trademark regulations. The Supplicant for Cancellation has also requested that following submission of an Affidavit, a date for a hearing be set.

Regulation 72 states:

Any person other than the registered proprietor who claims to have a benefit in a registered trade mark in respect of which an application has been filed under regulation 70 may apply to the Registrar for permission to allow him to join the proceeding and the Registrar may refuse or grant such permission after hearing the parties concerned and to set the conditions that he shall deem necessary. Before the application is heard in any manner whatsoever, the Registrar may demand that the applicant make an undertaking to pay the same expenses that the Registrar shall award to one of the parties in the circumstances.

The Deputy Commissioner does not see justification to reject the request. Section 72 sets a low bar for adding third parties to cancellation or opposition proceedings. It is adequate for a third-party to declare some interest to be cojoined to the proceeding. The Deputy Commissioner does not consider that the third party has to prove standing and refers to the Patent Office Ruling concerning 216,916 Danny Argon vs. Strauss Culture Factories LTD (11 November 2012):

Where the Third party claims apparent rights to a mark and excluding him from the proceeding would have negative consequences, it seems appropriate to include him in the proceedings as it seems improper to prevent him for stating his case.

A hearing is set for 20 April 2017 at 2 PM and the third-party may submit his supporting affidavit by 6 April 2017.


Patent to Astrazeneca  Successfully Opposed by Teva

April 20, 2017

Rosuvastatin_structure.svgRosuvastatin is a member of the statin class of drugs that is used in combination with exercise, diet, and weight-loss to treat high cholesterol and related conditions, and to prevent cardiovascular disease.

Israel Patent IL 166626 to Astrazeneca is the National Phase of PCT/GB2003/003463 filed in August 2003 and titled ” Process for preparing the calcium salt of rosuvastatin 

The Application was allowed and published for opposition in September 20011 and Teva filed an Opposition. A hearing was held in July 2015, and by June 2016 both sides had finished submitting their summaries and counter summaries.

The patent covers a process for obtaining (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid calcium salt. The application included 27 claims of which the first, independent claim is as follows: Read the rest of this entry »


Cancellation Proceedings Against an Israel Patent for a Modular Support Bracket

April 6, 2017

Figs for ACMoshe Lavi registered Israel Patent No. 157035 titled “MODULAR SUPPORT BRACKET”. A competitor, Zach Oz Air Conditioning LTD and Zach Raz filed to have the patent cancelled on grounds of invalidity. They seem to have botched the attempt, but I think that this ruling is a poor one.

Background

In the past, Lavi has tried enforcing the patent against Zach Oz Air Conditioning LTD. (Back then, around 2004, I was engaged as an expert witness by Counsel of the Defence, Soroker Agmon. In my Expert Opinion, I argued what is known as ‘the Gilette Defense’ stating that the correct interpretation of the claims was much narrower than that which Lavi and his lawyers Pearl Cohen Zedek Latzer Bratz (Pearl-Cohen) was using and Zach Oz’ support bracket was not infringing. Furthermore, if one considered that Zach Oz’ brackets were within the ambit of the claims, the patent would not have issued in the light of the myriad of prior art shelf support brackets.  On the day of the trial, Lavi dropped the charges and Zach Oz agreed not to infringe the patent.

It was not the first time that Pearl-Cohen have tried to assert a patent against a competitor that was not infringing. They tried this in the US on behalf of Source Vagabond against Hydropak. In that instance, the New York District Court fined Pearl-Cohen and the lawyers actively handling the case $187,308.65. That ruling was then Appealed to and upheld by the Federal Circuit Court of Appeals).

Frustrated by repeated bullying by Moshe Lavi and Pearl-Cohen, Zach Oz filed a cancellation proceeding against the Israel patent. Confusingly, their Attorney is called Pearl. It is not Zeev Pearl, but another practitioner.

Pearl-Cohen submitted a rather ambitious attempt to have the case thrown out as Zach Oz had not argued invalidity when accused of infringing, and Pearl-Cohen argued that this was a sort of in absentia estoppel since they could have raised the argument back then, and didn’t. The Commissioner threw that argument out, and allowed the cancellation proceeding to proceed.

The cancellation proceeding has now run its course and the following article Read the rest of this entry »