Ignorance as a Defense

July 10, 2018

thomas jefferson

Ignorantia juris non excusat – “ignorance of the law excuses not” and ignorantia legis neminem excusat – “ignorance of law excuses no one”.

This legal principle holds that a person who is unaware of a law may not escape liability for violating that law merely because one was unaware of it.

pizzaA commercial Broadcasting Authority sued ‘Pizza Slice’ for broadcasting the 2016 European football matches without obtaining a license for public showing.

The owner of the pizza shop claimed the defense of ignorance under Section 58 of the Israel Copyright Law. Somewhat surprisingly, the court accepted that he wasn’t to know that there were rights in the broadcast that prohibited public exhibition.

 


Opposition to IL 201320 to Pfizer & limits to amending the Statement of Case

July 2, 2018

Patent Application IL 201320 to Pfizer is titled “CRYSTALLINE FORMS OF 6-[2- (METHYLCARBAMOYL) PHENYLSULFANYL]-3- E -[2- (PYRIDIN2- YL] ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS”.

On allowance, it published for Opposition purposes, and Unipharm submitted an Opposition.

Prior to publication following allowance, Applicants have very wide discretionary powers to amend claims or submit new claims, provided the claimed mater is supported from the specification. After publication, in response to Oppositions, or even after grant, the Applicant/Patentee is only allowed to correct obvious typographical errors or to narrow the scope of protection by cancelling claims or by amendments that clearly narrow the scope of protection. Nothing that protects matter previously not within the ambit of the claims can be allowed.

In this instance, during the Opposition proceeding, Pfizer requested a narrowing amendment to the specification to clearly define the term ‘substantially pure’ that appears in claim 2. Commissioner Alon allowed the amendment in a ruling of 5 March 2018, and gave the parties a window to amend their Statements of Case to take the amendment into account.

Unipharm, who had already submitted their evidence, decided not to amend the statement of claims, but Pfizer submitted an amended Statement of Claims that was wide ranging.  This included background to the development of the invention and eleven appendices.

Unipharm then requested that Pfizer’s amendment be struck from the record, arguing that amendments to the claims following amendments to the specification should be based on those amendments to the specification. Pfizer disagrees. They note that the Law does NOT require that amendments to the counter-statement of claims be related to the earlier amendments to the statement of claims at the start of the Opposition proceedings, or that they be based on the amendments to the specification. Furthermore, the interim ruling allowing amendments to the statement of case did not include such limitations.

The Applicant drew a parallel to civil court proceedings, however the Commissioner does not accept this since in civil court proceedings, when the plaintiff amends his Statement of Case, he can expect the defendant to be allowed to amend their Statement of Case, whether in direct response, or to broaden their position, and this is the risk taken when amending the Statement of Case once the proceeding is underway.

In contrast, in Patent Opposition proceedings, it is the Applicant that has a right to amend the specification, not the Opposer. In this instance, it is the Applicant that causes the Statement of Case to need to be amended, and he can therefore expect that the Opposer will also amend his Statement of Case , and will not restrict himself to amendments resulting from the Applicant’s amendment. If the Opposer does amend their Statement of Claims, the Applicant can make their amendments.

So what is the appropriate Law if the Opposer does NOT amend their Statement of Case? The Commissioner reasons that the Applicant can certainly correct their Statement of Case with respect to anything that needs correcting. Whenever the specification is amended, the main points of disagreement often shift. The Opposer deciding not to amend the Statement of Claims does not prevent the Applicant from relating to new issues raised by the amendment to the Specification, and to redirect his allegations to these issues. This serves the procedure and focuses the Statement of Case on the real issues. The Commissioner considers that the term “issues arising from the amendment” should be interpreted broadly, in light of the relevant case-law.

Nevertheless, where the amendment to the Statement of Case is totally disconnected to the amendment to the specification, it becomes a regular amendment to the Statement of Case which should be subject to the regular criteria. The submission should be accompanied with a statement justifying the amendments and explaining why they could not have been included originally, and why they should be allowable. This is necessary to prevent the amendment to the Specification becoming a technical tool for allowing unlimited amendments to the Statement of Case whenever the Specification is amended.

In this instance, the amendment to the Statement of Case was the addition of background relating to the development of the XLI formulation. From Examination of the amended Statement of Claims, the Applicant did not indicate any connection, even minimal, between the amendments to the specification and the amendments to the Statement of Case. Furthermore, the Applicant did not justify why the amendment was required now, and was not part of the original Statement of Case, or why the Statement of Case was not amended earlier.

In these circumstances, the Commissioner considers that the Opposer is correct, and the amendments as submitted should not be allowed. The Applicant is given 15 days to refile an amended Statement of Case whose claims are related to the amendment to the Specification, or to state that they do not wish to file an amended Statement of Case. Alternatively, the Applicant may submit a request to amend the Statement of Claims justifying the amendments submitted.

The deadlines for submitting evidence that were given in the interim ruling of 5 March 2018 are canceled. New deadlines will be given once the Applicant files his Statement of Case.

Costs for this will be considered when ruling costs for the main ruling.

Interim ruling by Commissioner Ophir Alon Concerning Unipharm’s Opposition to IL 201320 to Pfizer


New Patent Commissioner overturns Patent Term Extension decision by Predecessor

June 28, 2018

Manufacturers_Association_of_Israel.pngThe Manufacturers Association of Israel opposed an ex-partes decision to allow a patent term extension for Dexlansoprazole, and New Commissioner Ofer Alon has disallowed the extension accepted by his predecessor.

Background

Dexlansoprazole.pngDexlansoprazole is used for treating gastro-reflux and for treating or preventing digestive ulcers.

IL 145996 to Takeda is a patent for Dexlansoprazole that claims various crystalline forms of the salt, a pharmaceutical preparation including the forms, and methods of treatment or prevention of digestive ulcers.

After Takeda successfully obtained regulatory approval for Dexilant™. (Dexlansoprazole) which is the R enantiomer of Lansoprazole, they applied for a patent term extension, which was refused by the Deputy Chief Examiner on 30 June 2016 on the grounds that the registration of Dexlansoprazole is not the first approved medical usage of the active ingredient in Israel, as the racemic mixture of the same active ingredient (Lansoprazole) is already registered.

Left and right antiomers in a lattice arrangement.jpg

Racemic Lattice for Shoes

In a response filed on 28 August 2016, the Applicant acknowledged that the racemic mixture Lansoprazole includes the R-enantiomer Dexlansoprazole, but the R-enantiomer cannot be separated from the racemic mixture since the crystals themselves contain both the right and the left enantiomers within the same lattice, creating a new complex that is different from the separate enantiomers.

The Applicant submitted that previously registered Lansoprazole is thus not a racemic mixture but rather a racemic compound and consequently the Dexlansoprazole crystals are substantially different from those of Lansoprazole and should, therefore, be registerable.

The Applicant distinguishes between racemic mixtures and racemic compounds with reference to Mitchell AG, Racemic drugs: Racemic Mixture, Racemic Compound, or Pseudoracemate? J. Pharm Pharmaceut Sci 1(1):8-12, 1998).

Dexasportshoe Lattice Arrangement

Dexasportshoe Crystalline Structure

On 27 October 2016, the Deputy Chief Examiner understood the argument as stressing that the enantiomer is more efficacious than the racemic mixture and rejected the request for the patent term extension citing former Commissioner Meir Noam’s ruling concerning Unipharm’s opposition to IL 90465 to A/S Lundbeck (3 February 2009), which ruled that the higher efficacy of enantiomer with respect to the racemic mixture was patent worthy, but did not provide a new material in the sense required for a basic patent that is eligible for patent term extensions.

On 24 November 2016, the Applicant appealed this decision to the Commissioner of Patents, reiterating the arguments that were rejected. Then Commissioner Asa Kling accepted that the enantiomer was not found in the racemic compound and agreed to a patent term extension of 959 days until 30 January 2023 (see ruling re IL 145996 to Takeda from 12 Feb 2017:

In paragraphs 24 to 26 of his decision, then Commissioner Kling stated:

I have been convinced that Lansoprazole is a compound of the enantiomers and it is not possible to isolate Dexlansoprazole from the racemic compound, in contradistinction to the state of affairs in Unipharm vs. Lundbeck where the racemic mixture could be separated into the enantiomers.

Where the relative efficacy is different, Applicants assertion that Lansoprazole is NOT a racemic mixture but rather that the enantiomers share the crystalline structure, one cannot isolate the R enantiomer.

Opposer’s Argument

On 25 May 2017, the Association of Israeli Industrialists opposed the ex-partes decision to issue a patent term extension, based on Section 64g(a) of the Israel Patent Law 1967 for the following reasons:

  • the registration in the register of medical formulations which was the basis for the patent term extension was not the first registration for the active ingredient, contrary to Section 6d(3) of the Law.
  • The Applicant concealed significant relevant facts from the Patent Office. So the Application for a Patent Term Extension is contaminated with inequitable behaviour and is contrary to Section 64b(1) of the Law.

These claims were supported by an expert opinion from Professor Menachem Kaftori dated 24 May 2017.

The Opposer relies on the Lundbeck ruling (Appeal 223/09 Lundbeck vs. Unipharm ltd from 25 May 2009 which asserted that the various terms for material in Section 64a include enantiomers, and wherever the material is an active ingredient or form of the active ingredient that is found in a prior medical formulation that is listed in the register, it cannot be considered as being a first registration under Section 64d(3) of the Law.

The Opposer further alleged that the applicant had already acknowledged that the active ingredient Dexlanoprazole is included in the racemic Lansoprazole in the pharmacology report for Kapidex in a request to market a formulation including Dexlansoprazole in the US (NDA 22,287) which was appended to the ex-partes submission.

Based on Professor Kaftori’s opinion, the Opposer further alleged that coupling between the different molecules in the crystal were inter-molecular bonds and not intra-molecular bonds, so that on dissolution into water a racemic mixture of the enantiomers results.

DexilantThe active ingredient of Dexilant™ is Dexlanoprazole and not the crystal, and the morphological structure of the crystal has no relevance to the issue of patent term extensions. The racemic compound is no different to a racemic mixture as has as the difference between its components, apart from the crystal structure of the raceme. The inclusivity of the re Lundbeck decision does not relate to the isolation of the material by separating the basic cell of the crystalline structure whilst in a solid state, but to the possibility of any separation.

The Opposer further argues that the efficacy of the enantiomers when considered separately or as part of the racemic mixture is not relevant to the question of whether the application in question relates to the first formulation that allows the material to be used for medical purposes in Israel.

LansopropazoleThe Opposer further claims that the Applicant concealed the fact that the material was previously registered in the Lansoprazole registration, and the experimental evidence used to justify the registration were those using Lansoprazole which the Applicant had asked to be relied upon. Similarly, the Applicant had concealed the fact that Lansoprazole had been defined by themselves as being a racemic mixture and not, as they now claimed, a racemic compound, for example, before the Canadian Federal Court of Appeal.

Applicant’s Argument

Takeda reiterated the arguments submitted in the ex-partes hearing by former Commissioner Kling, his ruling of 12 February 2017, and an Opinion of Professor Avi Bino of 19 September 2017.

Furthermore, Takeda rejected the allegation of inequitable behaviour noting that the racemic material Lansoprazole was disclosed and related to in their submission for a patent term extension, and reiterated that it was a different material.

optically active.jpegFurthermore, in their response of 28 August 2016, they clarified that Lansoprazole is racemic compound that is optically active in a different manner to that of the enantiomer. The XRay diffraction pattern of Dexlansoprazole is different, and it is a different chemical entity. The Applicant further claims that the request for a Patent Term Extension is based on a registered product and not on a material after subsequently undergoing any type of process within the human body [apparently dissolution is intended – MF].

The Applicant alleged that the Opposer did not provide support for the contradiction in Mitchell’s paper, and did not provide scientific textual support, experimental evidence or research to challenge the validity of the evidence submitted by themselves in the ex-partes proceeding.

In the pharmacology submission for Kapidex which includes Dexlansoprazole there was experimental evidence relating to pregnant women which included one test conducted with Dexlansoprazole and one test conducted with Lansoprazole. Thus contrary to Opposer’s assertion Dexlansoprazole was examined, and the testing of Lansoprazole was additional data.

Although the therapeutic results themselves are insufficient to prove that a patent term extension is justified, they do teach that there is a difference between the materials that allows a patent term extension.

raceme.jpgTakeda referred to the definitions of racemic mixture, raceme and racemic compound in the IUPAC gold book which is the definitions used by the International Union of Pure and Applied Chemistry and which they claim accords with Mitchell’s paper.

Finally, Takeda submits that the Commissioner is not able to sit in judgment and rule on a ‘kind of appeal’ of his own decision, or that of his predecessor.

Discussion and Ruling

For sake of clarity, the Commissioner notes that the term raceme relates to racemic mixtures of S and R molecules in equal amounts, or to racemic compounds where there is a repeating arrangement of the two enantiomers in different proportions within a crystal,

The legal authority of the Commissioner to rule on the Opposition

legalCommissioner Alon dismisses the allegation that he cannot hear this case. Section 64f of the Law allows anybody to oppose patent term extensions or their duration. Under section 64g, ANY reason that the Commissioner should not grant a patent term extension is a valid reason for opposing the extension. The right of the Opposer is independent of whether the extension was the result of an ex-partes ruling or otherwise.

The logic is clear. In the ex-partes hearing, one side presents THEIR arguments, evidence and documentation supporting the issuance of the PTE. The opposition is an adversarial proceeding whose purpose is to allow third parties to challenge the granting of the PTE, Once an Opposition is filed, the Commissioner is obliged to consider the issues raised and to reconsider the determination that a PTE is justified in light of the claims and evidence of the parties.

Registration of Lansoprazole allowed usage of Dexlansoprazole

Section 64d of the Law sets out the conditions for obtaining a Patent Term Extension. Inter alia, it states that one can only obtain an extension for a material listed in the pharmaceutical register, and only if that registration is the first registration of the material for medical use.

It does not appear that there is any dispute between the parties regarding the following facts:

  • The crystal of the Lansoprazole raceme is a racemic compound, which is difference from the enantiomer of Dexlansoprazole (Cross-examination of Professor Kaftori page 12 lines 12-18).
  • When the raceme Lansoprazole is in a crystalline form, one cannot separate the enantiomers into Dexlansoprazole and Levolansoprazole.
  • One can separate a solution of Lansoprazole into its enantiomers by known and established procedures for separating enantiomers. (Opinion of Professor Bino, paragraphs 13-14).
  • When Lansoprazole is separated into its enantiomers one obtains the R-enantiomer Dexlansoprazole and the S enantiomer Levolansoprazole.

As to the possibility of separating the enantiomers. Under cross-examination, Opposer’s expert Professor Bino agreed:

Attorney Tal Band:  Take, let’s repeat this, take a crystal of Lansoprazole, dissolve it in water and what do you get? I suppose you will allow me…

Professor Avi Bino: With pleasure

Adv. Band: You will obtain a solution that includes the R-enantiomer

Prof Bino: the R-enantiomer and the S enantiomer

Adv. Band: and the S enantiomer, which is the active ingredient if we now know that the active ingredient is the R enantiomer? It is the R enantiomer, right?  

Prof Bino: the R-enantiomer in solution

Adv. Band: the R enantiomer I solution is the active ingredient?

Prof Bino: Correct.

Protocol of 9 January 2018, page 53 lines 17-26.

In a different stage of the cross-examination, 9 January 2018, page 46 line 6:

Attorney Tal Band:  It can, that means to say, it can dissolve into the solution…

Professor Avi Bino: Yes

Adv. Band: And this change from crystalline to solution is not a chemical change but a physical one, correct?

Prof Bino: True.

Adv. Band: Good. So in the two states the chemical compound maintains its identity, correct?

Prof Bino: Correct.

See also paragraph 60 of the Applicant’s claims from 19 September 2017 and paragraphs 9-15 of Professor Bino’s Opinion.

right hand.pngThus there is no argument that the R-enantiomer included in Dexilant™ is the same R-enantiomer included in Lansoprazole.

In the Lundbeck ruling, the District Court ruled that registration of a raceme would be considered the first registration for the enantiomers.

The Applicant considers that the Lundbeck case is different since there one could separate the enantiomers as the patent covered a racemic mixture. However, in the present instance, one cannot separate the enantiomers whilst solid, but have to dissolve them in water first, and only then can the enantiomers be separated.

To clarify the point, the Applicant submitted the following schematic illustration on 28 August 2016 to the Deputy Chief Examiner:

Lansopropazole imageThe Applicant claims that the law relates to the active ingredient of the medical formulation, which is crystalline and so should be considered in this form.

lefty.jpgIn re Lundbeck, a mixture was considered, and the unit cell of r-enantiomer structure is found in the mixture (right side) and in the enantiomer (center top), whereas in the present case, (illustrated on the left), there is no r-enantiomer unit cell so one has to dissolve the crystal and then separate and recrystallize to obtain the separate enantiomers in crystalline form.

Applicant claims that the Law relates to the active ingredient of the medical formulation. The medical formulation includes the crystalline structure, and so it should be [examined for patent term extension purposes] in this manner.

The Examiner considers that the fact that one cannot separate the R and L enantiomers whilst crystalline is irrelevant. In paragraph 17 of the District Court ruling in re Lundbeck the court differentiates between inter- molecule bonds and intra-molecular bonds.

Even if we were to accept the Applicant’s claim that the Lansoprazole is a racemic molecule, there are no intra-molecular bonds, but only bonds connecting the molecules to each other, and each enantiomer molecule maintains its identity within the crystal. The attractive forces between the S and R molecules creates the crystal by inter molecular bonds (see paragraph 18 of Professor Kaftori’s opinion and Professor Bino’s remarks on page 48 lines 6-12 of the protocol. As Commissioner Alon clarifies below, it is incorrect to consider the material at the crystalline layer, and so the R-enantiomer is NOT to be considered a new material as far as Patent Term Extensions are concerned.

If one were to consider the crystalline form of the pharmaceutical formulation as being a new material as far as Patent Term Extensions are concerned, the consequence would be that one could dissolve Lansoprazole and consider the solution as being a pharmaceutical formulation, the solution contains both enantiomers in solution would be considered as a different formulation and thus subject to a Patent Term Extension, and it is difficult to accept this result.

Furthermore, the definition of material in Section 64a of the Law is:

“Material” – the active ingredient of the medical formulation or its salt, ester, hydrate or other crystalline structures of the same component.

Commissioner Alon considers that one should read Section 64a as all the forms of the active ingredient being considered the same material. This definition implies that the identity of the material is NOT considered in terms of its form in the formulation. The case-law has ruled that the fact that different enantiomers and crystalline structures have different physical properties does not make them considered as being different materials as far as patent term extensions (PTEs) are concerned – see District Court ruling in re Lundbeck, section 20.

This interpretation sits well with the rationale of the Law as stated in the Patent Term Extension ruling concerning IL 124123 to Bayer Healthcare LLC, 16 April 2018:

With regards to active chemical ingredients, one can claim that the legislator defined enantiomers that, although not structurally identical, can be considered as being the same active ingredient, since the experiments on the active ingredient will shorten the way or help develop drugs based on the same active ingredient. So different salts of the same active ingredient are defined as being the same active ingredient with respect to Section 64D(3) of the Law (it is noted that in other jurisdictions, a different conclusion was reached).

Additionally, there is an explicit connection between the breadth of patent protection under Section 64h(d) of the Law and the interpretation of the term ‘material’. Section 64h(d) states:

  1. d) If the Registrar granted an extension order, then the holder of the basic patent may – during the period in which the extension order is in effect – prevent any person from marketing or from producing in order to market without his permission the medical equipment or the medical preparation that incorporates the material, as far as the material, the process of its production, its use or the medical preparation or the process for its production were claimed in the claims for the basic patent.

Recognizing all forms of the active ingredient as being a new material as far as Patent Term Extensions are concerned would result in Patent Term Extensions being granted, not for all forms but only for the form of the active ingredient in the medical formulation. Commissioner Alon considers that proper policy is to provide wide protection for the party developing a new drug, and recognizing the physical form of the material as being different would result in narrowing the breadth of the patent term extension.

The Applicant argues that from the ruling of former Commissioner Noam regarding the Patent Term Extension for IL 97219 Novartis AG (26 December 2005) one can conclude that two active ingredients acting together could be considered as being a new material that is different from the two ingredients considered separately.

Commissioner Kling does not agree. In re Novartis, Commissioner Noam considered the eligibility for a Patent Term Extension for a formulation including two active ingredients that were previously separately recorded in the pharmaceutical register, and concluded that even were there to be a synergetic effect and not merely an additive effect (aggregation), this is only relevant for the question of patentability but not for the question of eligibility of Patent Term Extension, nothing further is stated.

It appears that Commissioner Kling’s ruling of 12 February 2017 was largely based on the conclusion that one cannot separate the enantiomers of the racemic compound. As shown in the Opposition by the statements of case and evidence, is that the compound can be separated into its enantiomers, and that the form is not significant. In other words, the factual basis for Commissioner Kling’s ruling has been eroded and we can thus change the decision.

In light of above, Commissioner Alon rules that the R enantiomer is found in Lansoprazole and the registration of Lansoprazole is the first registration of the R-enantiomer Dexlansoprazole which is the active ingredient of Dexilant™.

The Allegation of Inequitable Behaviour

The Opposer’s allegation that Takeda’s behavior was inequitable, contrary to Section 64b(1) of the Law, is supported by two props. One is the statement appended to the request for a patent term extension that was written by Miyuki Hora which states that Dexlansoprazole is the first registration that allows the use of the product for medical purposes in Israel, without going into details, which comes later.

In addition, the Oppose claims that the Applicant concealed the fact that the examination of the request for registration in the pharmaceutical formulation register relied on tests performed on Lansoprazole, and that the Applicant itself relates to Lansoprazole as being the racemic mixture in a proceeding before the Federal Court of Appeal in Canada, and regarding the date of the claim that Lansoprazole is a racemic compound.

The Applicant’s response to these claims was that the experiments were clearly indicated in the pharmacology report mentioned above, and Commissioner Kling even related to it in his ruling of 12 February 2017. As to the Canada decision, the Applicant acknowledges that they were inaccurate in their terminology regarding mixtures and compounds, but this was due to the fact that case related to a different issue and not to something relevant to the issue of whether the Lansoprazole raceme is a compound or mixture. The same inaccuracy is found in the FDA regulatory approval in the US.

When considering Miyuki Hora’s affidavit, it is true that it relates to the Lansoprazole raceme:

“… Although racemic Lansoprazole was previously approved for medical use, enantiomerically pure Dexlansoprazole has never been approved …”.

Additionally, it seems that the Applicant themselves muddled up the terms in the definition of the raceme, and sometimes referred to it as a mixture and sometimes as a compound, however the Commissioner does not consider that this is indicative of inequitable behaviour. Furthermore, in light of the above ruling, it is irrelevant whether we refer to the raceme as a mixture or a compound, since the question of whether the molecule were previously registered exists in the raceme, which we have established to be the case.

Conclusion

In light of the above, the Commissioner accepts the Opposition and cancels the patent term extension. The Applicant will pay 15000 Shekels costs and 100,000 Shekels legal fees to the Manufacturers Association of Israel.

Opposition by the Manufacturers Association of Israel  to Patent Term Extension for IL 145996 to Takeda, ruling by Commissioner Ofir Alon, 24 May 2018  

COMMENT

I think this decision is completely correct and is also well written and whilst comprehensively addressing the issues raised, is relatively concise.

Since the racemic compound dissolves into the free molecules, the discovery that the R-enantiomer is active may be inventive, but the clam that this is a new material that warrants a patent term extension is ludicrous in light of the previous cases related to by the Commissioner and linked to above.


ἒḱṭα Trademark Conference in Athens

June 24, 2018
greek guards

Exchanging business cards!

I have been attending INTA for some years now. This year the conference clashed with Shavuot (Pentecost), and so I would have been unavailable on Sunday and Seattle has never been a city of major historical or cultural importance. I was therefore pleased to be invited to attend ECTA, the European Community Trademark Association Conference in Athens which is a city I had never previously visited.

ECTA

The ECTA conference had some 800 registered participants which made it only about a tenth the size of INTA. However, there is a limit to the amount of people one can shake paws with and collect business cards from in a three-day period anyway, and 800 participants seemed more manageable.

I did not know what to expect, and arrived at 10 am Wednesday morning for a scheduled meeting with a Korean attorney who had reached out to me, and didn’t realize that for non-committee members, there was absolutely nothing to do other than to collect one’s name tag and conference tote.

greek dominoes.jpg

On reflection, I should have toured the Acropolis with my wife, but instead, with the taxis on strike, I explored the neighborhood and park across the road from the Intercontinental, which was the conference hotel. There were loads of people just sitting at cafes and on benches in the streets and parks. I saw two men playing dominos and a further seven watching. Dominoes has never struck me as a spectator sport. This indicated that Athens was still deep in recession with high unemployment. Nevertheless, even now, after 5 years of negative growth, it ranks among the top countries in the world in terms of GDP. Earnings are low for the EU, but still above those of all the ex-Eastern bloc countries and far ahead of the  developing countries of Africa and Asia. Over the three days of the conference there was a taxi strike and then a metro and tram strike. However, the World Cup football probably did its bit to prevent demonstrations.

Graffiti-alley-web.jpg

The Acropolis dominates the city, and there are many impressive neoclassical buildings from the late 19th century to the early part of the 20th century. However, despite the glorious past, the present is seedy. Pavements are uneven. There are many closed shops, graffiti covered hoardings and walls, piles of rubbish on main pedestrian precincts, and no one seems bothered.

I found Athens a little confusing at first. The signs were a nightmare of algebra, and totally incomprehensible. The language sounded nice, but I didn’t understand a word. One can’t help thinking that a little more effort could be made to cater for tourists.

Wednesday

The weather on Wednesday was humid, but despite the dress-code being described as casual on the programme, I was giving my jacket and tie their annual outing. Once I realized that others were dressed down, I gratefully left these in the hotel and wore trousers and a button down shirt as I do in Israel. In fact, the climate, body language, smell of olive oil and pace were very similar to Israel and I felt comfortable walking around Athens.

brown paper packages

These are a few of my favourite things!

The conference was very well-organized.  People were friendly. Thought had gone into the sessions to try to be a little different. The first session open to the plebs was a workshop titled “Plain Packaging in the Industry”. The issue was legislation targeting cigarette manufacturers and forcing them to use plain boxes, sometimes with graphic images of diseased lungs, babies on respirators and the like. The premise was that trademarks were a form of property and property was a constitutional right. I suspect that those that expressed strong opinions represented the large and lucrative portfolios of Marlboro, British American Tobacco and other cigarette manufacturers. In my experience, intellectual property practitioners are largely intellectual prostitutes, i.e. professionals, willing to work for whoever is willing to pay. I have a friend that used to work for the Welcome Trust who was very opinionated regarding ethical drugs, and anti the generic players. Then she got a job with a generic drug manufacturer and her politics changed completely.  Intellectual property is indeed a kind of property, but less so than, say real estate. One cannot do what one likes with one’s house or shop, and there are zoning requirements and planning permission. If the government wants to build a highway through one’s property, it will. Trademark Law prevents registration of marks that are against the public order. I recently explained to a client that he could register a mark for vodka in the relatively liberal Palestinian Authority of the West Bank, but not in Gaza since class 35 does not exist there. The issue seems to be a classical libertarian versus nanny state argument. True, legislation is creeping in to have salt and fat levels marked on food packaging and it is possible that cannabis will be legalized but there may be packaging rules and limitations on who can buy and in what quantity. Still the discussion was interesting, contemporary and different.

strengths-and-weaknesses-of-family-business-1-638.jpg

After a coffee break there was a second workshop on best practices for small and family law firms.  The panel consisted of various senior partners in small businesses, who discussed the problems of having some partners that were members of the family and some that weren’t, the problems with employing and disciplining family members and whether it was a good idea for the next generation to get some experience in a different practice before joining the family firm. I met up with Udi Gavrieli, who was a partner in Seligsohn Gavrieli and Co. where I had qualified as a patent attorney and after starting a law degree, was informed by his late father that I should not have aspirations to becoming a partner. At that time, Udi was qualifying and when he got his license, his father wanted him to be made partner immediately. Then partner of the firm, and Israel’s most successful patent litigator, Adi Levit, became a named partner of Seligsohn Gavrieli Levit which lasted a very short period, before he branched out on his own.

family-business.jpg

Before joining Seligsohn Gavrieli, I worked for Luzzatto et Luzzatto, a fourth generation IP firm with Italian roots and various intergenerational issues. I later set up my own firm and actively used it to help various family members and old friends who were in professional ruts. I merged my practice with Jeremy M Ben-David & Co.,  a father and son team, so have experienced family practices from different sides.  What the session missed, perhaps, was an academic overview of family businesses, since many of the issues are not particularly related to IP. Instead of anecdote, I would have preferred a more rigorous approach. Still the issue was clearly of relevance to a lot of conference attendees and is something that I have never seen tackled by an IP conference.

LG.png

The third session was an overview of trademark search tools available from EUIPO and WIPO.  The session was practical and comprehensive, if uninspiring. For illustrative purposes, LG’s famous logo was searched for in a graphic trademark database, before and after semantic tweaking. It is clear that artificial intelligence and search engines are getting more sophisticated, but still have where to go.

zappeion.jpg

Participants were then bussed to the Zappeion Hall, a neoclassical cocktail venue built for the 1896 Olympics. A dozen local female students dressed in Greek tunics with long pencil skirts and tight bodices, holding torches greeted us on the stairs and added a certain ambiance. The food seemed varied and plentiful.  There was pre-packaged Kosher food for the 3 or 4 of us who’d requested it that included a spinach in pastry boureki (μπουρέκι) and a Feta cheese in olive oil salad that helped one enter the spirit of things. The main food offering seemed to be a Greek style buffet.

Thursday

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I was staying at the Jason Inn, a hotel in Thissio opposite the two active Greek Synagogues. As it was a New Moon, I went to the morning service which started at 8.30 am and finished at about 10.00 am. The small congregation was mostly pensioners.  As in North African style services, the psalms were chanted aloud, but the intonation was very Greek.

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I missed the Annual General Meeting of ECTA, but suspect I would have found it less interesting. I am very pleased however, that Christ(os) Sozos Theodoulou from Cyprus has been appointed the new president.   (When I congratulated him he noted it was condolence for losing the Eurovision. I am, of course, pleased that Israel won, but would be happier if the song was less embarrassingly awful. That said, appealing to the largely ignored but enormous poultry demographic was a brilliant tactic. It was essentially a repeat of Dana International’s 1998 win, where the anti-Israel/anti-Semitic/BDS anti-vote was split between various member states but Israel capitalized on the largely united LGBQTx vote).

There was a two-part session devoted to the latest IP news and trends and then a session on the status of implementation of the trademark directive (EU) No. 2015/2436 which regulates the interaction of European and local law with respect to trademarks. Attendance of the sessions was high. The subject matter was relevant and contemporary.

The large number of participants were split up into different restaurants and dining halls in the hotel, each named after a different Greek god. A generous buffet was provided, and once again, Kosher food was provided. This time it was chicken with olives – again a Greek inspired choice. Olive oil was provided to pour over the salad.

The afternoon session consisted of a Brexit update presented by Tania Clark of D Young and Co. It is still not clear whether European trademarks will simply be converted into UK marks or whether mark holders will have to pay for the privilege. This seems true about the various other IP issues related to Brexit. Deadlines for various decisions and dates when they would come into effect were presented. One simply does not know for certain what will happen until decisions are made and laws are enacted. Still, the UK market is a significant part of Europe and the issues were clearly relevant to all present.

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We were whisked off to Ble Azure, a sort of archipelago by Piraeus that provided outdoor dining on a long lawn with the Adriatic sea on both sides. The buffet was very Greek. Vegetarians were taken care of with plentiful salads, a massive cauldron of mushroom risotto and various pasta. A Greek singer performed.

Friday

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Parallel sessions were arranged, with a trademark track on how pharmaceutical marks are selected and cleared in different countries, followed by a look at where the profession might be in ten years from now going on in one hall, and a session on industrial design and one on copyright in the adjacent room.

After lunch (similar to Thursday, but a different Kosher meal) there was a mock trial on online infringement, an award presentation for various essays, one winner obviously too pregnant to attend, but linked up by video. The final session was an EU Case-Law update.

I did not stay for the Gala Dinner, but returned to my hotel.

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I did pick up a pair of ear-buds for one of the kids and some lokum –not known as Turkish Delight in Greece as Cyprus is still a contentious issue. However, there was little swag at the conference, just mounds of trademark journals that I suspect are hardly read.

Nike

There was a lot of good, cheap fresh fruit available, but in general Greek shopping prices are not much lower than Israel. I did see some attractively priced sports shoes and Louis Vuton handbags, but suspect these were not the genuine article, and as an IP professional, I try to avoid fake branded goods. That said, I did see a certain poetic license in cheap rip off Nike trainers being available for the locals. One must remember that Nike was a Greek goddess who personifies victory, and the American clothing company sort of ripped off this Greek cultural name.

Shabbat

gostijo-athens-kosher-restaurant-450x300Friday night in the synagogue was again a little different. In fact, the synagogue could best be described as Greek Orthodox, with the cantor wearing a black floor length gown with red silk lined bat-wing sleeves and a black pill-box shaped hat. The first part of the service included well-known verses from the psalms, but was different from the standard rites. It was very pleasant and different. Kabbalat Shabbat, which developed in the 16th Century in Safed, Palestine, then part of the Turkish Empire, had evidently reached this Greek corner of the Turkish Empire, but the tunes were different.  The various tourists and holiday makers made their way to the Chabad Restaurant, now providing Shabbat Hospitality. The rabbi was not present as he’d gone to the Rebbe’s tent, which conjured up a picture of a camping holiday. This was not the intention. It was apparently the Yarzheit, death anniversary of the 7th Lubavitcher Rebbe and he’d gone to the grave. I was pleased to see that the wife left behind manning the fort, and presumably the absent Rabbi-emissary, were both aware and not confused that the Rebbe had indeed passed away – something not admitted in all Chabad circles.

There is a small core of religiously observant Jewish IP practitioners from Israel and elsewhere that tend to meet up in these places, but this time, my Kosher colleagues seem to have flown back to Israel. The food was someone familiar by now, as the restaurant had been providing the Kosher food for the conference, but there was a Shabbat twist to it. Guests were treated to Ouzo, instead of the more familiar whiskey, vodka or Benedictine (which was a favorite tipple of the Rebbe).

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The Torah Scroll used in the Shabbat morning service was mounted on rollers, but seemed to have a cloth interleaving rolled around the spools, perhaps to protect the parchment. The scroll was lifted and showed to the congregation before being read, as is common in Hassidic communities.

The service was notable for the Haftarah – reading from the Prophets, being conducted in Greek to a traditional cantillation. The reading in the vernacular is discussed in the sources, but was not something I’d seen before. There was a lot of memorial prayers for relatives and it was clear that 90% of the Greek community was killed in the Holocaust and the community was still traumatized.

I spent Sunday through Tuesday touring Athens. On Sunday I visited the Acropolis and was delighted to spot a large brownish falcon, probably a lanner, on the cliff below the remains.

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On Monday we visited Aegina and sampled the pistachios. We took a bus trip across the island to the marina, and it all looked vaguely familiar, but wasn’t sure from where. One of the tourist shops which was playing old favorites played an ABBA hit, and it hit me. The film Mama Mia was set in a hotel-tavern on a Greek island, and could have been filmed there (it wasn’t). The Aegean Sea was an incredible blue. I heard a clicking sound coming from a thicket of trees and instantly recognized a pair of Sardinian Warblers, not uncommon in Israel, but clearly very much at home in the Greek Islands.

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On Tuesday we visited the Jewish Museum and the Greek Archeological Museum. This was a little overwhelming. There was just so much of it. Clearly the collection is one of the most important in the world. There were exhibits of presented sculpture, pottery and bronze weapons by place of origin, arranged chronologically and thematically by material type.

I look at conferencing as a holiday from the family. If successful, I manage to recharge my batteries so I can cope with a holiday with the kids over the summer.  Athens is a great venue for a week’s holiday and conference.


Kerem

June 10, 2018

CEREMKerem Natural Foods Industry A. L. ltd applied for Israel Trademark Application Number 266067 for Jellies, jams, dried fruit, coconut oil, , black cumin oil, sesame oil, almond oil and other edible oils; Coconut milk, cream and butter; spreads, soup powders produced by cooking and preparing extracts of meat and vegetables, and soup powders for seasoning; all included in class 29, Date syrup, molasses; Coconut sugar and flour, molasses, honey, date syrup, crisp cakes, crackers, spreads and sauces; sweeteners made of stevia or other plants extraction; coconut flour and coconut flour baked products; all included in class 30 and for Fresh and unprocessed Coconut and other tropic Fruits and its products; all included in class 31.

Kerem is Hebrew for vineyards.

On 28 February 2017, HaKerem – Alcoholic Beverages ltd  opposed the registration. On 8 June 2017, Kerem Natural Foods submitted their counter-statement. HaKerem – Alcoholic Beverages ltd had until 11 August 2017 to submit their evidence, but this deadline was extended twice, to 12 November 2017, but the evidence was not forthcoming and instead HaKerem – Alcoholic Beverages ltd withdrew their opposition.

Kerem Natural Foods Industry then submitted a request for costs of 62,450 Shekels accompanied by an agreement with their attorneys regarding their hourly rate and various receipts evidencing payment in practice.

HaKerem – Alcoholic Beverages objected to the costs requested. They prevailed in the Opposition proceeding and are entitled to costs under section 69 of the Ordinance which states that

In any hearing before him, the Commissioner is entitled to award reasonable costs.

The right of the prevailing party to receive actual costs incurred depends on the amount requested, that it is properly documented, and that it is reasonable, necessary and proportional. See for example, Bagatz 891/05 Tnuva vs. Ministry of Trade and Industry p.d. (1) 600, 615 (30 June 2005). However, the arbitrators are required to consider the case specifics and legal policy, and are not obliged to award full costs – see Appeal 6793/08 Loar ltd. vs. Meshulam Lewinstein Engineering and contractors LTD. 28 June 2009, at paragraph 19.

The case specific considerations do not form a closed list and each case should be considered on its merits. These include the behaviour of the parties. The way the case was handled, the complexity of the case, the time invested in the case, whether the case requires specific expertise, the importance to the parties, whether the case has public interest ramifications, and the like.

As to judicial policy considerations, as previously ruled in Patent cancellation procedures against Israel Patent numbers 179379  and 142896 Alkermes Pharma Ireland Limited Novartis Pharma Services vs. MEDICE Arzneimittel GmbH & Co.KG from 28 March 2018, the patent office has an obligation to serve the greater public interest. In this framework, when addressing cost requests, the patent office has to find the right balance between the encouraging trademark submissions – both to protect property rights in brands and to prevent misleading the public regarding sources of goods, and not to discourage the submission of oppositions against unreasonable trademark applications. Awarding high costs to applicant or opposer could create an obstacle to filing that shifts from this balance.

In the present case, the request for costs did not provide sufficient details to substantiate their claim, and did not explain the basis of the costs, the number of hours spent by their attorneys, etc.  Consequently there is a real difficulty to determine whether the costs requested fulfill the considerations laid out in re Tnuva.

The Adjudicator of Intellectual Property, Ms Yaara Shoshani Caspi does not accept the claim of the enormous amount of work preparing evidence immediately on the filing of the Opposition, prior to the opposing counsel submitting their evidence. The Applicant did not explain why the Opposer should have to bear the burden of the Applicant’s obliging himself to pay global legal fees regardless of the work required, and also to provide a ‘bonus’ if the case is dismissed. The Adjudicator does not find this type of arrangement fulfills the ‘reasonable and necessary expenses’ requirement.

In this instance, the Opposition was abandoned at an early stage, after the filing of the counter-statement of case.  The Applicant did not need to file evidence, there was no hearing and no summations were required. In such a case there is no justification to award costs of 62,450 Shekels as requested. Compare for example, the cost request for Cancellation of Israel Trademark No. 140219 BASF Poyurethanes GmbH vs. Pazker ltd, 12 September 2015.

Conclusion, by way of estimation, costs of 7000 Shekels including VAT are awarded, to be paid within 14 days, or interest will be accrued.


Bayer – Part II – Are Patents for Bio-Similars Elligible for Patent Term Extensions???

June 5, 2018

This is the second part of a ruling concerning Patent Term Extensions (PTEs) for Kovaltry. The first part related to when the ninety day period from registration commences and is discussed here.

This second part of the ruling is a precedential decision that rules whether a patent for a bio-pharmaceutical material such as a protein can be can be considered as being a basic patent if there is a previously registered bio-similar molecule; it being appreciated that the amino acid sequence may be the same, but the spatial structure, activity and efficacy may still be different. In view of its legal and financial significance, the decision is fully translated below. We apologize for any incorrect technology. 

After the request for a patent term extension for Kovaltry was received from Bayer, the Patent Office issued an Office Action as follows:

Paragraph 6 of the Affidavit appended to the letter of 22 August 2017 notes that there is no other formulation that includes Recombination Human Coagulation Factor VIII, fabricated by the defined cell culture and the defined conditions under which KOVATLRY is manufactured. It is possible that the Blood Coagulation factor claimed in the Application is different from the Blood Coagulation Factors that have been registered, but the Active Ingredient of the Recombination Human Coagulation Factor VIII formulation is registered in the registry of pharmaceutical formulations in various formulations mentioned hereinabove.

The other medical formulations mentioned as including Factor VIII were Novoeight, Octanate 1000, Koate and Kogenate.

Kovaltry

On 11 December 2017, the Applicant responded to the Office Action and claimed that the active ingredient, the Recombinant Human Coagulation Factor VIII, is a new material derived from a new genetic engineering process that is protected in the present application, and that Kovaltry is the first formulation that allows its medical usage in Israel, as required for a patent term extension in Section 64D(3) of the Law.

The Applicant explained that Factor VIII is intended for treating Hemophilia A which is characterized by a problem with blood clotting due to a fault in or a lack of Factor VIII. In the new process covered by the Application, the heat shock protein 70 (HSP70) is introduced into the gene of the host cell and additional actions are taken to produce the active ingredient, which creates a new protein Factor VIII, which has a different structure from other proteins that relate to a lack of endogens in the Factor VIII coagulant. The structure of the protein, as applied for in the Application is as follows:

Bayer

The Applicant further explained that the folding structure of the protein is different due to the manufacturing route, and it attracts a lot of sugar groups (glycans), which allow the protein to automatically fold and provides a pharmokinetic advantage to the protein when compared to other formulations. In this regard, the Applicant notes that most properties, such as the glycan group appended, which have been glycosylated, are relevant to the half-life of the protein in the blood.

The Applicant claims that the registration file of the Kovaltry formulation indicates that the Ministry of Health considered the formulation to have a new active ingredient, and so it had to undergo the specific regulatory requirements of the Ministry of Health. The Applicant relies on the Procedure of the Ministry of Health for registering products of this type; Changes and Innovation in Medical Formulations from 1 February 2015, which differentiates between six different categories for registration.

According to the Applicant, when the Israel Ministry of Health relates to the Recombination Human Coagulation Factor VIII as being a new active ingredient as far as registration in the drug register is concerned, one has to apply a similar rationale when considering the drug for a patent term extension in order to fulfill the purpose of the legislation which is the underlining logic of the patent term extension, which is to compensate the patentee for the period when he cannot market the formulation containing the patented product due to regulatory requirements. The Applicant argues that one should differentiate between medical formulations that have active chemical ingredients that are small molecules, and biological formulations that are differentiated by proteins manufactured in different ways. They argue that the different proteins are typically different from each other in both their structure and their physical properties.

From the claims it transpires that the difference results from the way that the protein is manufactured. The applicant explained and supported their explanation with various appendices, the manufacture of a biological pharmaceutical formulation that includes proteins is very difficult due to the size of the protein, the way it folds, the general structure, changes in translating the chain of amino acids to create the protein, the cell culture used to manufacture the proteins, and so on. All changes lead to changes in the protein itself, in its. glycosylation and medical effect.

Due to these differences, the Applicant alleges that Health Ministries around the world have created different regulatory procedures for biological pharmaceutical formulations. They claim that even though there may be several medical formulations for addressing a lack of a particular enogen, such as Factor VIII, due to the issues raised above, they will be different from each other in practice. Furthermore, their active elements which cause blood clotting will be different and have different international classification.

In their response, the Applicant further explained that there are other formulations that treat Hemophilia A, which are fabricated in different ways such as by separating active ingredients from human plasma, formulations obtained by genetic engineering of part or a full gene, formulations that include healed proteins and formulations that include Factor VIII with additional proteins.  The Applicant claims that these formulations are completely different from Kovaltry, despite their purpose being to overcome the endogenic lack of the blood clotting Factor VIII as described above.

The Applicant focused on the differences between the active ingredients of the medical formulations cited by the Examiner and the active ingredient of Kovaltry. As to Kogenate, the Applicant claimed that its active ingredient was different to Factor VIII, even though the sequence of amino acids was the same, since the proteins of the structure are different at the gene level and the protein level. The Applicant appended journal articles that related to the differences between the formulations as an example of improved pharmakinetics.

In light of the above, the Applicant considers that one cannot apply Section 64D(3) of the Law in the same way for biopharmaceuticals when comparing active ingredients with prior art as is done for chemical pharmaceuticals.

In response to these claims, the Deputy Chief Examiner responded in a letter of 31 December 2017, that obtaining the strict regulatory approval required for pharmaceuticals is no indication that a patent term extension is also appropriate. To support this differentiation, the Deputy Chief Examiner referred to 223/09 H. Lundbeck A/S vs. Unipharm ltd et al (22 May 2009).

The letter also notes that the journal papers appended to the response explain that the process for obtaining Factor VIII in the patent in question creates a new protein with a different structure, with glycosylation and different pharmakinetic properties which affect the half-life of the protein in the blood, but do not influence the formulation, and the protein that is the active ingredient of Kovaltry is Factor VIII which exists in Kogenate and other pharmaceutical preparations.

Furthermore, the Deputy Chief Examiner considered that the improved glycosylation or the addition of the HPS70 may affect the folding and could be a new process, but the registration of a medical preparation is given for a formulation and not for the process of manufacture, and differences in the Factor VIII are simply a bi-product of the processing route.

The Deputy Chief Examiner added that though the process of manufacturing the proteins in Kovaltry and Kogenate are different with a difference that expresses itself in yield, better cells and other repeatability differences, the sequence of amino acids is the same, despite the amount of glycans that underwent glycosylation on the proteins So compared to preparations that were registered earlier than Kovaltry, the Deputy Chief Examiner rejected the Applicant’s claims with respect to each of the formulations.

On 7 February 2018, the Applicant submitted a request for a hearing regarding the rejection, and submitted a further statement of claims on 20 February 2018. O 25 February 2018 an ex-partes hearing was held before the Commissioner during which the Applicant reiterated their claims and added the following claims:

Factor VIII is a complex protein and changes in the process result in significant changes to the structure thereof and to the medical affect thereof. Consequently, when comparing twoproteins to ascertain whether or not they are the same material, one has to consider the structure and not merely the sequence of amino acids which is the first stage of characterization, but also the three dimensional form and the intracellular activity.

After the hearing, the Applicant submitted a summary on 1 March 2018 that proposed an appropriate test for considering the novelty of biopharmaceuticals. The proposed test has three levels. Firstly one should consider if the material is a biological medicine. Then one should consider if the protein has a new structure, and finally various tests for determining whether a protein is new or not, such as whether it is a specific protein, whether the regulatory approval was Read the rest of this entry »


Luistone, Bridgestone, what’s the difference?

May 27, 2018

GoldbergA Chinese man and his Jewish friend were walking along one day when the Jewish man whirled and slugged the Chinese man and knocked him down.
“What was that for?” the Chinese man asked.
“That was for Pearl Harbor!” the Jewish man said.
“Pearl Harbor? That was the Japanese. I’m Chinese.”
“Chinese, Japanese, you are all the same!”
“Oh!”

They continued walking and after a while the Chinese man whirled and knocked the Jewish man to the ground.
“What was that for?” the Jewish man asked.
“That was for the Titanic!”
“The Titanic? That was an iceberg.”
“Iceberg, Goldberg, you are all the same.”

Shandong Luistone Wheels Co submitted Israel Trademark Application No. 287968 for LUISTONE in Class 12. The Application was the National Phase of International Trademark (Madrid) Number 1309157.

On 18 October 2018, the International Bureau was informed that the mark was allowed subject to no oppositions being filed.

On 31 January 2018, Bridgestone Corporation opposed the mark under Section 24a of the Trademark Ordinance and regulation 35 of the trademark regulations 1940.

On 6 February, the International Bureau was alerted under Section 56(vi)b of the Ordinance, and provided with the timetable for submitting a response and counter-claims.

Under Regulation 37, the Applicants had two months to submit a counter-statement, and the final deadline was 6 April 2018. No counter-statement or request for an extension were received until 26 April 2018 when Arbitrator of Intellectual Property Ms Yaara Shoshani Caspi ruled that the mark could therefore be considered abandoned and the file closed. No costs were awarded.