When a patent application goes abandoned due to a misunderstanding between Attorney and Applicant

August 8, 2018

This case relates to a request to revive an abandoned Application, where the Agent of Record was under the impression that he was instructed to abandon, and thus failed to respond to the office action and to the Notice of Imminent Abandonment and the Notice of Abandonment (which gives a 12 month window to reopen the case as of right). He also failed to report the issuance of these notices to the client. The client denies instructing the Agent to abandon the case.

Israel Patent Application Number 191364 to Pro Natura Gesellschadt for Gresunde Ernahdrung MBH is titled “Agent for Reducing the Usable Calorie Content of Food and for Therapeutic Reduction of Weight in particular in the case of Adiposity (Obesity)”.

The Application was filed on 16 September 2015, and when an Office Action was not responded to, a notice of Imminent Abandonment was sent to the Applicant’s Agent on 2 November 2016, and a Notice of Abandonment was sent on 8 February 2017.

(This wasn’t the first time that this application was considered abandoned due to a lack of response being filed. On 20 August 2015, the case was abandoned, but shortly afterwards, on 16 September 2015, it was reopened by the Chief Examiner under Circular 026/2014 ”Returning Closed or Abandoned Applications to Examination).

On 14 March 2018, i.e. over 12 months after the case was closed a second time, the Applicant petitioned for it to be reopened under Section 164 of the Law.

Applicant’s Claims

Daniel Feigelson, the Agent of Record, claimed that Mr. Virovnik, the Applicant’s representative, only learned that the case had been abandoned in January 2018. The request for reinstatement was submitted two months later because he had to submit affidavits in support of the Application to reinstate the case, together with a detailed response to the Office Action.

Mr Feigelson also claims that in a meeting with Mr. Vorovnik in December 2015, the Applicant requested to delay the Examination in Israel for as long as possible, pending a decision on patentability of the corresponding Application before the European Patent Office. In a phone call of August 2016, Mr. Feigelson understood that he should not do anything to further the allowance of the Israel Application.

The request to revive the case was supported by two Affidavits; one from Mr. Vorovnik and the other from Daniel Feigelson, the legal representative. Mr. Vorovnik’s Affidavit stated that contrary to Daniel Feigelston’s understanding, he never ordered him to let the Israeli Application lapse. Contrary to that stated in Mr. Vorovnik’s Affidavit, Patent Attorney Feigelston stated that he’d understood from the August 2016 conversation, that Mr. Vorovnik was not interested in pursuing allowance of the Israel Application. However, unlike his usual practice, Mr. Faigelston did not document the conversation or send a written notice stating that he would abandon the case as instructed, for Mr. Vorovnik to confirm.

In a hearing on 25 April 2018, Mr. Feigelston clarified that following the conversation of August 2016, he did not update Mr. Vorovnik regarding correspondence from the Israel Patent Office, thus Mr. Vorovnik did not know that the case had become abandoned. At that hearing, the Deputy Commissioner Ms Jacqueline Bracha ordered that Mr. Faigelston obtain a further Affidavit from Mr. Vorovnik expanding on what he did remember from the August 2016 conversation.

In accordance with this order, a further Affidavit from Mr. Vorovnik was submitted on 27 May 2017. However, this Affidavit does not clarify that there was a conversation in August 2018, as Mr. Vorovnik neither confirms nor denies that this conversation took place. It merely states that Mr. Vorovnik does not remember instructing that the case be abandoned. It is noted, however, that in the original Affidavit, Mr. Vorovnik was unequivocal that he did not give such an instruction.

Hearing

Section 21a of the Law defines the time period for requesting reinstatement of an abandoned patent as follows:

Where the Commissioner refuses a patent under Section 21a, he can reconsider the refusal if requested to do so within 12 months.

Section 164a of the Law allows the Commissioner to extend this period on reasonable grounds:

The Commissioner has the discretion, if he sees fit to do so, to extend any deadline of the Patent Office or proceedings before the Commissioner….

Considerations for extending a time period should be based on context and the interests in question. This was clarified by Judge Naor in Appeal 2826/04 Commissioner of Patents vs. Recordati Ireland Ltd, 26 September 2004:

The policy for ruling on the various requests before the Patent Office will change with the context, and depend on the deadline under consideration.

In a ruling concerning extending the 12 month period for reconsideration of a decision to close a file concerning IL 221116 Yaakov Dichtenberg et al. from 7 September 2016, the Deputy Commissioner stated that such requests should consider the interest of the Applicant on one hand, and that of the public interest for certainty on the other.

The relevant considerations are whether reasonable grounds for granting the extension were provided, the size of the delay and the reasons for the delay. See Opposition to IL 110548 Shmuel Sadovsky vs. Hugla Kimberly Marketing ltd, 122 August 2010, and the ruling concerning IL 157563 to Icos Corporation from 21 October 2013.

As to the first consideration, the period of the extension is only a little more than one month over the 12 month period set out in Section 21a, which makes it relatively easy to allow such a short extension.

On the other hand, the case went abandoned due to an apparent misunderstanding between client and attorney that could have been avoided by sending a written summary of the conversation or similar documentation. Furthermore, it was not even properly clarified what instructions the Applicant understood he’d given his attorney during that conversation which he doesn’t remember.

Ms Bracha notes that relying solely on a telephone conversation as grounds for abandoning an application does not seem to her to be reasonable or appropriate behavior. This should be clear since this isn’t even the first case that this application was closed due to not responding to an office action, and consequently one could expect the Agent for Applicant to be more careful.

Furthermore, on discovering that the case had become abandoned, the Applicant could have acted immediately, within the 12 month window under Section 21a. However, she accepts that he preferred to submit a full response to the office action, as was finally submitted.

When weighing up the relatively short delay on one side, and the nature of the mistake on the other, which is far from being reasonable, Ms Bracha applies her discretionary authority under Section 164 to allow the case to be reopened, but on condition that there will be no further extensions whatsoever, for any reason.

Ruling re reopening abandoned application IL 191364, 18 June 2018.

COMMENT

Apart from the stated desirability to confirm instructions of this sort in writing, I would add that even when having received instructions to abandon a case, it is good practice for the Agent of Record to report the Notice of Imminent Abandonment and/or the Notice of Abandonment as a courtesy, since even if there was no misunderstanding and the Applicant does request abandonment, applicants have been known to change their minds.

In cases where a client’s desire to reinstate a mark becomes known to the Agent of Record within 12 months, the request should be made before the 12 month window closes, even if an extension is requested to obtain affidavits and to prepare a response to the outstanding Office Action.  It makes sense to obtain reinstatement as a matter of legal right under the law rather than to attempt to reinstate based on the Commissioner’s discretion. This is particularly the case where there is a contradiction between the testimonies of the Applicant and that of the Agent of Record regarding the chain of events leading to the case becoming abandoned. In this instance, the Deputy Commissioner was amenable. Had she not been, the client could sue the Attorney for malpractice, and his defence would be that he was acting on verbal instruction that he did not bother confirming. Not the best situation to be in.

 


Opposition to IL 190827 to Pfizer – A request to delete paragraphs from Expert Opinion as Widening Front of Attack

August 8, 2018

In evidence submissions, parties can support contentions made in statements of case, but are not allowed to widen their position by introducing new matter. When evidence relating to allegedly new issues is submitted by an Opposer, the Applicant can be expected to oppose the submission. Opposition proceedings are typically characterized by skirmishes regarding the admissibility of evidence, that are discussed in interim rulings. This is one such ruling.

Opposition to IL 190827 to Pfizer

Lyrica

IL 190827 to Pfizer relates to a pharmaceutical composition prescribed for once a day dosage comprising Pregablin and a matrix forming agent of PVP or PVA and CPVP as a swelling agent.

Teva opposed the patent.

This interim ruling relates to a request by Pfizer to remove paragraphs 13-15, 16, 94, 105 and 130 from the Opposer’s Counter-Evidence in Response of Professor Golomb, acting as an expert witness for Teva.

Pfizer claimed that paragraphs 13-15 of the Opposer’s Counter-Evidence in Response stress gelling agents which are not mentioned on the Opposition or in Professor Golomb’s main Opinion. In paragraph 15 of the Opposer’s Counter-Evidence in Response, Professor Golomb alleges that selective reporting on stability, swelling and hardness is arbitrary and they claim that these paragraphs should be struck as they were not submitted in answer to anything in their response.

Pfizer alleged that Paragraph 16 of Teva’s Counter-Evidence in Response raises issues not previously raised: that there is no comparison between the claimed invention and known formulations and no indication of any advantage thereover.
Pfizer requested that paragraph 94 be struck since it makes allegations not found in the original evidence submission. Similarly, paragraphs 105 of the Opposer’s Counter-Evidence in Response relates to Cmin values in the simulation summarized in table 15, and paragraph 130 thereof, are not by way of response and should be struck from the record.
Teva responded that the request to have these paragraphs in their Opposer’s Counter-Evidence in Response cancelled was submitted for improper reasons. Paragraphs 13 and 15 are supported by the patent application itself and do not raise new subject matter. They come in response to paragraph 9 of Dr. Tomber’s opinion. That mentioned in paragraph 15 regarding swelling, stability and harness comes in direct response to Dr. Tomber’s claim that these characteristics are advantageous. The claim that this is an advantage of the claimed invention was first raised in Dr. Tomber’s opinion as expert witness of the Applicant and so the first opportunity for the Opposer to refute this allegation is in their Counter-Evidence in Response.
Teva further submitted that Section 16, when read in context, is a response to Dr. Tomber’s claim that there is an advantage in the claimed formulation of the application. Professor Golomb considers that without comparison to other formulations, one cannot claim the present invention provides an advantage thereover. Similarly that stated in Section 95 of the opinion; that the application does not provide stability data, comes in response to Dr. Tomber’s claims regarding the efficacy of the formulation. The Opposer adds that the application and the Applicant’s claims in the Statement of Case do not relate to any advantage provided by the swelling or the hardness.
Section 105 deals with the Cmin value in table 15 and comes in response to Dr. Tomber’s claim that tablets having a 6 hour release window are not appropriate for once-a-day dosage. Teva claims that when reading this paragraph in the Opposer’s Counter-Evidence in Response together with the previous paragraphs one can only conclude that they come in response to Dr. Tomber’s claim.

As to paragraph 130, the Opposer claims that the expert opinion cited comes in response to the Applicant’s claim that formulation is resistant to the compaction pressure which is based on experimental evidence first submitted by Dr. Tomber.

The Applicant considers that the Opposer’s Counter-Evidence in Response was not a fair response to their counter statement of case and the Opposer allegations that Dr. Tomber’s statements went further than required to respond to the Opposition, whereas the Applicant claims that Professor Golomb simply expanded on statements made in the original Opposition, that could have been made in the original opposition.

Discussion

The parties are in no disagreement regarding the Law, but only in how it should be applied in this instance. Consequently, the relevant case law regarding the application of Regulation 62 is only summarized briefly.

This regulation orders that evidence in response must fulfill one of the following conditions: They should relate to the issues that are specifically denied by the Applicant in their counter-evidence, or are raised for the first time in their counter-evidence. In the response to the Applicant’s evidence, the Opposer may not submit evidence that should have been part of their main submission of evidence (See Opposition to IL 178141 Unipharm vs. Bristol Myers Squibb Company, 12 January 2015 following the ruling of the then Deputy Commissioner in the opposition to IL 127833 Teva vs. Abbott, 12 February 2007 (Oppositions to IL 177724 and 205606, request to delete sections from the Opposer’s Counter-Evidence in Response DSM IP Assets B.V. vs. Refine Technology LLC, 16 March 2015).  

The Deputy Commissioner, Ms Jacqueline Bracha considers that, on examining the paragraphs in question, Pfizer’s request to have them struck from Teva’s Counter-Evidence in Response should be rejected.

In Paragraphs 13 and 14 of the Opposer’s Counter-Evidence in Response, Professor Golomb relates to Dr. Tomber’s examples. Most of the criticism is directed to Dr. Tomber not relating to the fact that the examples include additional ingredients that are not claimed, and which could affect the release of the active ingredients.

In paragraph 15 of the Opposer’s Counter-Evidence in Response, Professor Golomb alleges that there is nothing in Dr. Tomber’s Opinion to explain why examples 24, 25 and 40 of the Application were chosen to show stability, swelling and hardness of the formulations claimed. Professor Golomb further claims that the Opinion does not relate to the other components of the examples, apart from those that are likely to affect the hardness and swelling of the tablets. The additional components are defined in the specification as gelling agents. From this, Professor Golomb deduces that the chosen examples do not exemplify formulations that only include the elements of claim 1.

In these examples, Professor Golomb relates to things mentioned in Dr. Tomber’s opinion. However, this is not a new issue first raised in the Response Opinion. In fact, a similar statement to that of paragraph 15 of the Response Opinion is found in paragraph 81-83 of Professor Golomb’s first opinion where he explains why, in his opinion, none of the Examples of the patent match that claimed. The difference is the switching of the words “additional assistive materials” in the first Opinion, with the phrase “gelling agents” in the second opinion. Professor Golomb also explains in paragraph 15 of the Opinion that the additional materials are defined as “gelling agents” in the patent application itself.

From that stated, it is clear that paragraphs 13-15 of the Response Opinion do not raise any new issue but rather come in response to that said previously, and so the request to delete these paragraphs is rejected.

In paragraph 16 of the Response Opinion, Professor Golomb relates to the claim in Dr. Tomber’s Opinion, that the claimed invention is advantageous in terms of stability, swelling and hardness of the tablets as compared to those formulated by the standard methods for obtaining delayed release in the stomach that is described in example 29. In the Opinion of the expert, the comparative data provided is insufficient to prove this advantage. The Applicant claims that Dr. Tomber did not make this claim and so this response comes to reject a claim not made.

Examination of Dr. Tomber’s Opinion shows that in part 9.4 of his Opinion, the expert relates to example 29 of the Application as a comparative example. Dr. Tomber explains that the release of the active ingredient in example 29 after 12 hours is 65%, compared to 80% for formulations of the invention, and so some of the active ingredient in the formulation of example 29 is wasted. It appears that paragraph 16 of the Opinion is an attempt to respond to this contention of Dr. Tomber and is thus a response to an issue raised by the Applicant. To the extent that the Applicant considers that Dr. Tomber’s opinion was not properly understood by the Opposer, they can relate to the alleged misunderstanding in cross-examination. In light of this, the request to delete paragraph 16 is rejected.

Paragraph 94 of the Opinion in Response by Professor Golomb raised the issue that Examples 15-23 which look at Lactam formation over time does not indicate the efficiency of the claimed formulation. In this paragraph, Professor Golomb responds to Dr. Tomber’s claim that was raised in paragraph 30 of his opinion, that “the results demonstrate the efficacy of the claimed invention.” Dr. Tomber continues that the examples show the efficacy of the invention under various conditions. In Paragraph 95, Professor Golomb adds that the Application lacks stability data for Example 29 which also does not include all the elements of the invention. According to Professor Golomb, without stability data, Example 29 cannot be used for comparative purposes as Dr. Tomber had suggested in Section 9.4 of his Opinion. The Deputy Commissioner does not think that Paragraph 95 goes beyond the issues under discussion, since it specifically relates to Dr. Tomber’s Opinion which related to Professor Golomb’s original Opinion. In light of this, the request to cancel section 95 is refused.

In paragraph 104 of the Expert Opinion in Response, Professor Golomb summarizes that stated in paragraph 32 of Dr. Tomber’s opinion regarding adapting the formulation for once-a-day dosage, with reference to the release duration and the amount of active ingredient in the blood over the period of release by the tablet. In paragraph 105, Professor Golomb explains why he disagrees with that stated by Dr. Tomber in Paragraph 32 of his opinion, and supports this with reference to publications cited in his original Opinion. This is sufficient to show that Paragraph 105 of the Response Opinion relates to matters raised by the Applicant and is in accordance with Regulation 62 of the Patent Regulations.

In paragraph 104 of the Expert Opinion in Response, Professor Golomb summarizes that stated in paragraph 32 of Dr. Tomber’s opinion regarding adapting the formulation for once-a-day dosage, with reference to the release duration and the amount of active ingredient in the blood over the period of release by the tablet. In paragraph 105, Professor Golomb explains why he disagrees with that stated by Dr. Tomber in Paragraph 32 of his opinion, and supports this with reference to publications cited in his original Opinion. This is sufficient to show that Paragraph 105 of the Response Opinion relates to matters raised by the Applicant and is in accordance with Regulation 62 of the Patent Regulations.

In Section 130 of the Response Opinion, Professor Golomb claims that the Application emphasizes the wear data and hardness of the formulation as ways to optimize the release rate of the active ingredient, but he disagrees that the evidence supports this contention. Here again, the Deputy Commissioner accepts the Opposer’s argument that this paragraph comes in response to Dr. Tomber’s statement in paragraph 26 of his Opinion, that CPVP manufacturing provides a significant advantage. In fact, Dr. Tomber dedicated a number of paragraphs to the stability of the tablets, and so the Deputy Commissioner does not consider that Paragraph 130 goes beyond Regulation 62 of the Patent Regulations.

In Section 130 of the Response Opinion, Professor Golomb claims that the Application emphasizes the wear data and hardness of the formulation as ways to optimize the release rate of the active ingredient, but he disagrees that the evidence supports this contention. Here again, the Deputy Commissioner accepts the Opposer’s argument that this paragraph comes in response to Dr. Tomber’s statement in paragraph 26 of his Opinion, that CPVP manufacturing provides a significant advantage. In fact, Dr. Tomber dedicated a number of paragraphs to the stability of the tablets, and so the Deputy Commissioner does not consider that Paragraph 130 goes beyond Regulation 62 of the Patent Regulations.

In light of this, the request to cancel the various paragraphs is refused.

Since the parties informed the Patent Office a few days ago that they are negotiating a way to end this Opposition procedure, no costs are awarded at this time.

Interim ruling re admissibility of various paragraphs in a Response by Opposer to Applicant’s Opinion concerning IL 190827 to Pfizer, opposed by Teva, ruling by Deputy Commissioner Jacqueline Bracha,  6 June 2018.     


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.


Can Non-Israelis be Subpoenaed to testify in Opposition Proceedings?

June 10, 2018

novartis

Israel Patent Application No. 176831 to Novartis is titled “COMPRESSED PHARMACEUTICAL TABLETS OR DIRECT COMPRESSION PHARMACEUTICAL TABLETS COMPRISING DPP-IV INHIBITOR CONTAINING PARTICLES AND PROCESSES FOR THEIR PREPARATION”. It is the national phase entry of PCT/EP2005/000400.

Unipharm

On allowance, Unipharm filed an Opposition to the patent application being granted.  Within the Opposition proceeding, Unipharm, who for this case, have dispensed with the services of Adv. Adi Levit, their legal counsel and have been handling the Opposition unaided by attorneys, have requested that the Israel Patent Office subpoena  John Hutchinson and Mr Kowalski, workers at Novartis to give testimony.

This request follows an earlier request to reveal documentation regarding testing that was appended to the Expert Witness testimony of Professor Davies, Novartis’ expert witness, which was ordered in an earlier interim ruling of 3 January 2018.

Discovery

In response to the discovery request, Novartis submitted an Affidavit with various appended papers. In light of this, Unipharm now alleges that the Affidavit implies that Novartis has not revealed all documents it should have. Unipharm further indicates that the explanation proffered by Hutchinson, who is signed on the Affidavit, “appears to be odd”. Therefore, Unipharm wish to Subpoena him to cross-examine him on this.

lab bookUnipharm further claims that a document titled “Certificate of Authenticity” was included with respect to the laboratory notebook, parts of which were included in the appendices attached to the affidavit. According to Unipharm, Mr Kowalski, who was one of the named inventors, is signed on this document. Consequently, Unipharm requested to cross-examine him as well.

Novartis requests that Unipharm’s request be rejected. They claim that the Commissioner does not have the authority to subpoena witnesses not within the judicial territory of the State of Israel, who are not direct parties in a proceeding. Novartis also notes that Mr Hutchinson’s signature on the Affidavit accompanying the discovery documents was done in the framework of his employment as a patent attorney in the Legal Department of Novartis. Novartis claims that ALL information regarding the management of the proceeding is subject to legal confidentiality and may also be considered as being a trade-secret.

As to Mr Kowalski, he never signed an Affidavit of Evidence in the process and is not a party to it. Similarly Novartis claims that Unipharm has not stated why they need to cross-examine that inventor who was one of three named inventors.

Discussion

The witnesses that the Opposer wished to interrogate are beyond the territorial jurisdiction of Israel and are not parties in the case. Thus the Applicant is correct that Section 163b of the Patent Law 1967 that Unipharm referred to is not a legal basis for their being subpoenaed. The references that Unipharm related to in their request, dealt with witnesses that gave Affidavits or expert witness testimony, and thus could be subpoenaed for cross-examination purposes.

A party that wishes to subpoena a citizen or foreign resident to testify must do so under the International Inter-State Legal Assistance Law 1998. See Appeal 3810/06 Dori and Zacovsky Building and Investments Ltd vs. Shamai Goldstein, paragraph 17, 24 September 2007.

Section 47 of the Legal Assistance Law states:

The Authority is allowed to request from another country, that testimony be collected, including that physical evidence be transferred for display in Israel, if the court allows that the evidence is required to hold the trial in Israel; regarding this law, and where the case is pending, the term court refers to the tribunal that is hearing the case.

From the wording of this Section, it transpires that the court will open a proceeding to summon foreign witnesses to a hearing only if it is convinced that their testimony is necessary to conduct the proceeding. In this instance, the Commissioner considers that there is significant doubt as to whether the presence of the witnesses for cross-examination purposes is really required.

Unipharm has requested to cross-examination Mr Kowalski regarding an Affidavit for discovery that he is signed on. The purpose of the discovery process is to enable the main proceeding to be handled efficiently; legal proceedings with face-up cards where each party knows what documents the other parties hold to prevent surprises at the hearing. By this means, unexpected delays are prevented, allowing the court to reveal the truth. Appeal 4235/05 Bank Mizrachi United vs. Ronit Peletz, 14 August 2015.

Opposite the principle of discovery, there are other interests such as efficiency of the court proceeding, defense of the legitimate interests of the party revealing documents, and preventing damage to the interests of third parties – See Appeal 2534/02 Yehuda Shimshon vs. Bank HaPoalim ltd. p.d. 56(5) 193. So the case-law has ruled more than once that it will not allow cross-examination of affidavits of this kind, if they are properly presented (see Appeal 2376/13 Rami Levy Shikma Marketing Ltd vs. Moshe Dagan 8 July 2014, and Zusman Civil Procedures 7th Edition, page 436.

This general rule has two exceptions: The first is that where reading of the Affidavit alone or with reference to its citations, that the Affidavit is defective, the court can order the party revealing documents to file a further Affidavit. Second, where the issue of confidentiality is used, the court can examine the document and decide if this claim is reasonable (see for example, Appeal 240/73 Baruch Vilker vs. Dov Tishler, 205, 2 December 1971 and Appeal 6823/05 Abraham Roimi vs. Bank Leumi of Israel, 12 January 2016.

In this instance, Unipharm did not append an Affidavit, detail or justify why they considered that the current case is one of these exceptions. Thus the Commissioner cannot rule that this is the case, and so the request is rejected.

As to the evidence of Mr Kowalski, Unipharm did not claim that there was any connection between the documents appended to the Affidavit of the Discovery and to the experiments that were appended to Novartis’ evidence, which was the basis of the original discovery request. Note, Mr Kowalski’s signature is only on the Certificate of Authenticity taken from the lab-book that was appended to some pages therefrom that were submitted in the discovery documents. In these circumstances, it is not clear what value Mr Kowalski’s testimony has, even were he to be subpoenaed.

In light of this, the Commissioner does not consider that the requirements of Section 47 of the Law of Legal Assistance are fulfilled with regard to Mr Hutchinson or Mr Kowalski.

The Request is refused. Unipharm will cover Novartis’ costs and their legal expenses to the tune of 2000 Shekels + VAT. These costs will be paid within 30 days.

Interim Ruling in Opposition to IL 175831 Ofer Alon, 30 April 2018.

Comment

It is possible that Mr Tomer has indeed bitten off more than he can chew by handling legal issues procedural issues such as requesting subpoenaing witnesses without legal counsel. However, the costs ruled against him are trivial when considering the issue in question. The Unipharm’s Expert Witness cannot testify to things that he does not know such as what else was in the lab-book, and in Opposition proceedings there is no assumption of validity of the patent. Thus it would be premature to write this request off as a strategic or even a tactical error.


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 »


IPR or AIPPI???

February 27, 2018

conferencesI was contacted by a trainee patent attorney who wishes to attend one of the forthcoming IP conferences in Israel but is not sure which one is better value for money.  The firm where she works are prepared to recognize her attendance as a day of work rather than a vacation, but are not prepared to pay for her participation.

ipr-logoThe 6th Annual Best Practices in Intellectual Property is hosted by the IPR and will take place on March 12th and 13th 2018.

 

aippi-israelThe Third International Conference on the Economics of Innovation is hosted by the AIPPI on April 30th-May 1st 2018 which may interfere with participation in International Workers’ Day, but I suspect that few IP practitioners in Israel actually march.

(The big international conferences fall over Jewish festivals this year. INTA is in Seattle, USA, but overlaps Shavuot. The AIPPI 2018 World Conference in Cancun, Mexico is over Suckot).

Although I believe that firms taking on trainees should invest in them and both the IPR and AIPPI Israel conferences include sessions that provide excellent training for the bar exams and/or professional development, clearly the cost of such conferences adds up rapidly for large firms if they send all of their staff. I can also appreciate why an IP firm may not want someone not yet qualified appear to represent them, when wandering around a conference and meeting potential clients and associates or actual clients and associates.

apprentice payNevertheless, on the salary of a trainee, particularly one with family commitments, both conferences are costly. A significant number of trainees are new immigrants that are self-not living with their parents. Those unluckily enough to be on a percentage of salary may not earn a minimum wage and I believe their ‘mentors’ should be struck off. But even those earning a reasonable fixed trainee salary may find that laying out 850 Shekels for a day of training lectures, is difficult to justify, despite the high quality lunch and coffee breaks and the possibility to pick up a couple of pieces of swag from exhibitors.

fair priceThis does not mean that either conference is objectively expensive when considering the standard of the program and the costs involved in hosting such events in expensive hotels, the quality of the refreshments and the cost of such programs abroad. However, I can certainly see why someone paying for himself or herself may not be able to justify for both events.

mingling 2Licensed In-House practitioners may well be able to get their companies to pick up the tab for them to attend both conferences, and unless swamped with urgent work, I can see many IP managers preferring to schmooze with colleagues and to attend lectures rather than sitting in their offices.  I suspect the coffee break refreshments and lunches provided also compare well to the canteen food or lunch voucher allowance of most hi-tech companies.

trainingIP boutiques are, of course, able to evaluate the relevance of the training for their different staff members, and will no-doubt consider this when deciding who to send to which conference.

As with all such conferences, some sessions will be highly relevant to one’s day to day work, but perhaps lacking in material one doesn’t already know. Similarly, some sessions will be focused on IP issues that may be completely irrelevant to one’s day to day practice.  In this regard, apart from keynote lectures, both conferences have parallel sessions, and one is advised to carefully select presentations to attend that are at least one of the adjectives selected from the group comprising: relevant, intellectually stimulating and informative.

bpip 2018The Best Practices in Intellectual Property conference hosted by Kim Lindy and the IPR is perhaps mis-named. Apart from one session on trade-secrets, the entire program is dedicated to patents and the conference is very much focused on practical aspects of patent management. The conference is particularly targeted at In-House counsel in industry and has much to interest independent patent attorneys in private practice, partners and attorneys at IP firms. However, it seems to have little of interest to those who earn their living managing trademark or copyright portfolios. Sadly in my opinion, it also does not address design law which is a rapidly changing field in Israel.

jam packedThere will be little at the “Best Practices in Intellectual Property” conference to interest academics. However, the program is jam-packed with relevant sessions for prosecuting patents and managing patent portfolios which is what very many in-house IP managers do, and also is the bread-and-butter work of most patent attorneys in private practice.

variety packThe AIPPI conference titled “The Economics of Innovation” uses the term innovation very widely and is much broader in scope than the “Best Practices in Intellectual Property” conference In that features sessions on trade-secrets, design law, trademarks, Copyright, traditional knowledge, taxation of IP and Internet & Privacy. Many of the sessions look at the issue of overlapping types of protection.

madagascan periwinkle

Madagascan Periwinkle, used to treat Hodgkin’s Disease

One of the AIPPI sessions is titled “Traditional Medicine – the influence of IP on Commercial Use and Economic Aspects”. This is not the first time the topic of traditional knowledge has been covered in Israel. Back in 2011, I helped
Dr Shlomit Yantizky Ravid of ONO Academic College organize a three-day traditional knowledge conference that brought representatives from a large number of developing countries and sympathetic US academics that was sponsored by WIPO.  Dr Irving Treitel, a patent attorney who deals with life science patents, especially pharmaceuticals (who was then working for me at JMB Factor & Co.) responded on behalf of the profession. Prof. Shuba Ghosh was the keynote speaker then, as now. Despite much advertising in the press, only some 30-40 people participated in the conference – virtually all speakers of foreign delegates. Apart from Dr Treitel and myelf, I don’t recall any other IP practitioners attending that free conference. I applaud the AIPPI bringing IP issues to the attention of local practitioners, but I doubt that this session will attract a large attendance despite the prestigious panelists.

 

taxCertainly patent attorneys, whether in-house or in private practice, should be familiar with the different types of protection available to be able to advise or at least refer clients.  Patent Attorneys should also be aware of tax issues, at least broadly, to be able to refer their clients to accountants where appropriate to do so. There are very many large US firms registered in Delaware that conduct R&D in Israel. There are also many firms that are physically based in Israel, but decide to incorporate in the US for political reasons, and these include start-ups as well as larger firms. I have clients that have fairly small staff but are incorporated as an IP holding company that owns the patents, trademarks, copyrights and designs and a separate manufacturing company that licenses the IP assets. The tax issues are not something that a patent attorney deals with, but attorneys-in-law may practice IP and tax law, and in-house legal counsel may deal with IP and taxation.  Apart from understanding how tax issues affect their own income and how various taxes can be legally avoided and what is considered illegal evasion and criminal, I believe that IP professionals not practicing tax law should nevertheless have a general grasp of the tax issues that face their clients to be able to advise them where they should seek guidance from a tax attorney, accountant of tax-consultant.

In summary, both conferences are value for money. People only having the time or budget to attend one should consider which one to go very carefully, and it is worth working out in advance which sessions to attend.


November 8, 2017


LES Israel and IPAA invite you to an event on Wednesday, November 15, 2017, 09:00-
12:30 at ZOA House (אמריקה ציוני בית ,(26 Ibn Gabirol St. (corner of Daniel Frisch St.), Tel
Aviv (The presentations will start at 9:30).
The event will be dedicated to the topic:
Patent Term Extension Peculiarities
Israel and Europe
The topic will be presented by distinguished speakers, as follows:
 Mr. Liad Whatstein (Liad Whatstein, Adv.), Founding Partner of the Israeli law firm Liad
Whatstein & Co.:
Patent Term Extensions under Israeli law – The Eccentricities of The Local System
 Mr. Tjibbe Douma (Tjibbe Douma, Adv.), Senior Associate at the law firm of De Brauw
Blackstone Westbroek NV, The Netherlands; and
Ms. Tessa Malamud-Cohen (Tessa Malamud-Cohen, European and Israeli Patent Attorney),
Director, Patents, Global Intellectual Property of Ferring Pharmaceuticals/Bio-Technology
General (Israel) Ltd.:

SPC Squatting: SPCs Based on Third Party Marketing Authorization
 Mr. Tal Band (Tal Band, Adv.), Head of the IP Practice Group in the Israeli law
firm S. Horowitz & Co.:
Patent Term Extensions in Israel – When is it “Game Over”?

We will allocate some time at the end of the event for discussion and welcome comments
from the audience.
The event is free to LES Israel and IPAA members.
Non-members: NIS 70 charge.

Kindly confirm your participation by return email to les_israel@yahoo.com.

COMMENTS

The speakers are considered distinguished by IPAA and LES. I’ve cut and pasted their notification verbatim. I do not disagree, but merely wish to note, that the adjective is not one I chose. The speaker list is balanced in that Tal represents TEVA who usually are generics opposing patent term extensions (although recently trying to reinvent Copaxone to keep it evergreen). Liad works for the patent developers who try to obtain patent term extensions, and Tessa works in-house in the industry. I do not remember meeting Mr. Tjibbe Douma and suspect with a name like that, I would.

counting-sheepMy extensive practice has not involved patent term extensions since I split with Jeremy Ben-David, whose father, Dr Stanley Davis, drafted the Neurim patents for Circadin, whose UK Patent Term Extension went to the European Court of Justice, see here, here, here, etc, so the event has little interest to me personally, although is clearly important for the pharma crowd. Perhaps we should let sleeping sheep lie.