Suspending a Patent Opposition Pending Examination of Divisional Application

August 12, 2018

janssen pharma.jpgApplication for patent IL 253468 to Janssen Pharmaceuticals is a divisional application of IL 206448, filed under Section 24 of the Law. The parent application is being opposed by TEVA.

TEVA has asked that the Opposition against the parent application be frozen for 18 months from when the Opposition was submitted, in accordance with Circular 020/2012 which regulates oppositions to allowed patents where there is a pending divisional application.

The Opposer claims that there is an overlap between the invention claimed in the parent and that claimed in the divisional.  Thus it is reasonable to assume that if an Opposition is filed against the Divisional application, similar factual and legal issues will arise, and the expert witnesses will likely be identical. Consequently, freezing the opposition to the parent application until the examination of the divisional application is completed will contribute to the efficiency of both the current proceeding and the expected future proceeding.

TEVA further claims that if the current opposition is not frozen, the Applicant will obtain an advantage since he can manipulate the prosecution process of the divisional application in response to issues revealed in the Opposition process of the parent.

The Applicant does not consider it appropriate to freeze the procedure. Nevertheless, they agree that conclusions reached in the Opposition to the allowed parent application will apply to the divisional application if the Opposer should file an opposition against it. The Applicant considers that this agreement makes freezing the Opposition unnecessary, since if an opposition is filed against the divisional, the findings of the present opposition will apply to it, and this makes the process efficient.

Discussion

The Commissioner thinks that on the grounds of efficiency, the request to freeze the Opposition proceedings should be accepted. As explained in the ruling concerning the Opposition to IL 195030 Teva Pharmaceuticals ltd vs. Boehringer Ingelheim International GMBH, 28 January 2002, paragraph 3 of the ruling:

The authority of the courts to delay a proceeding whilst a different proceeding occurs, raises similar issues that are not contentious. These issues are authority to do so, and discretion, which are applied to ensure efficiency of the proceeding, efficiency of the legal system, saving time and resources, preventing conflicting decisions from issuing, convenience for the parties, fast resolution, balance of convenience and the like. These are true, not only when the parties in the two proceedings are identical, but also when there are different parties but similar issues, similar legal considerations, and the interests to be considered are identical.

In this instance, the parties concur that there is a similarity between the inventions in question. In this case, if an opposition would eventually be filed against the divisional application, it is indeed likely that the similar issues will be raised, similar witnesses will be required to testify and the prior art will be the same in the two proceedings.

The Applicant’s consent that findings in the parent opposition be applied to the divisional, does not adequately address these issues. From a practical perspective, it is unreasonable to make a determination concerning the parent opposition before an opposition is filed in the divisional.

Such a situation would create a state of affairs wherein it is necessary to manage two proceedings with similar witnesses and experts, and similar issues will be considered, or that either the opposition in the divisional case be suspended until the issues are determined in the parent case, or the opposition in the parent case be suspended until the issues are determined in the divisional case or the cases are combined.

Furthermore, even if even various determinations are made in the parent case, it will be appreciated that the parent and the divisional will not have identical claims, and so uncertainty will arise as to whether conclusions from the parent case can be applied to the divisional, and what is the decision in similar but not identical matters to those raised in the parent case.

The commissioner rejects the Opposer’s claim that freezing the opposition is essential to prevent the applicant from applying lessons from the Opposition to the prosecution of the divisional application. Whilst there is some truth in this, it is insufficient, in and of itself, to justify freezing an opposition proceeding. It will be remembered that the Opposer can oppose the divisional application and in that framework, issues relating to the patentability of the divisional application will be considered.

In light of the above, the Commissioner rules that the Opposition proceeding to the parent application be suspended for 18 months from when it was filed, i.e. until 29 September 2019.

The Secretariat of the Patent Office will ensure that the Examiner of the divisional application is aware that there is an opposition against the parent case, and that the divisional application should ,therefore, be examined in accordance with Circular 020/2012.

No costs are awarded at this stage.

Interim ruling regarding suspension of an Opposition to a parent application pending examination of a divisional application, in re IL 206448 to Jenssen, opposed by Teva, ruling by Commsioner Ofer Alon, 19 June 2018.


Amending the Statement of Case to Hone Arguments

August 8, 2018

This interim ruling addresses the issue of amending the Statement of Case in Opposition proceedings before the Israel Patent Office.

IL 209734 to G Patel titled “A monitoring system based on etching of metals” was allowed and published for Opposition purposes.

Freshpoint Quality Assurance Inc. opposed the patent, and after the Applicant submitted their counter statement, Freshpoint requested permission to amend their statement of case.  They justified this request on the basis of the Applicant adding new details. They further argued that some of the amendments were necessary due to admissions of the Applicant in the counter-statement of case, and some were required to focus issues after the specification was twice amended following submission of the Opposition.

The Applicant considers that allowing Freshpoint to amend their statement of case would allow them to improve their position, and this would be financially difficult for him, as a private individual.  Patel further alleged that the amendment did not result from the additional details that he submitted, which should be considered as part of the proceeding and could be addressed in the evidence stage.

The Opposer related to the case-law and alleged that amendments to the Statement-of-case should be generously and liberally allowed.

In general, the Application relates to a system of control based on etching away metal of a two layer system, to provide an indication of time, temperature, humidity and so on.

The Application is a national phase entry into Israel of a PCT application that claims priority from a number of US provisional applications submitted between 3 June 2008 and 2 May 2009. The Israel application was allowed on published for opposition purposes on 31 May 2016 and the opposition was submitted on 30 August 2016.

After the Opposer submitted their statement of case, the Applicant requested permission to amend the specification. The parties agreed that the amendments should follow Regulation 102vi of the Patent Regulations 1968.

Following this agreement, the Opposer submitted an amended statement of case and the applicant again requested to amend the specification, but this time only amended the dependent claims. The Opposer considered that this amendment was not sufficiently justified and contravened Regulation 95 and should be struck. In a ruling of 28 September 2017, the Deputy Commissioner Ms Jacqueline Bracha rejected the request for the amendment to be canceled and when the Opposer stated that they would not be amending their statement-of-case, she ordered the Applicant to file his counter-statement. The second amendment followed the procedure set out in Regulation 102vi of the regulations.

One the Applicant submitted his statement of case, the Opposer requested that additional details regarding the denial in paragraph 25 of the Applicant’s statement of case. These paragraph related to the Applicant’s response to the  Opposer’s contention that the phrase “destructible barrier layer” that appears in the claims is not supported in the priority applications. The Applicant responded, but the Opposer requested interim costs, and that a schedule be set for submission of the evidence. In an interim ruling of 10 April 2018,  costs were awarded and a date for the Opposer to submit their evidence was set.

Instead of submitting their evidence, the Opposer has requested to amend their statement of case.

Discussion

The guiding principle for amending the statement of case before the Patent Office is that unless there are reasons to refuse the request, amending the statement of Case will be allowed, so long as it focuses the discussion on the issues that the parties disagree on. The reasons for not allowing amendments to the Statement of Case are also given:

This court has the authority to allow amendments to the Statement of Case in cases that the amendments relate to the issues that are really disputed by the parties, and where there is no reason NOT to allow the amendment. Such reasons (for not allowing amendments) include inequitable behavior on behalf of the party requesting the amendment, adversely affecting the rights of the opposing party in a manner that cannot be compensated for by a cost ruling, and tardiness in requesting the amendment (see the Request to cancel patent no. IL 154398 (request to correct the statement of case and evidence) Logo Engineering Development ltd vs. State of Israel, 29 April 2012. Furthermore, when exercising the authority, the court should consider the stage that the proceeding has reached, since the Opposition proceeding itself is a barrier to the Applicant obtaining the patent.

(Opposition to Patent 187923 (request to amend the statement of case) Pimi Aggro Clinic ltd vs. Xeda International, 19 May 2013).

In contradistinction to most of the cases  where amendments to the Statement of Case have been requested, here the Opposer does not wish to rely on additional publications that were missed in the search for prior art prior to filing the original statement of case.

As the Opposer claims, in this instance, the amendments are by way of honing the claims. The Deputy Commissioner, Ms  Jacqueline Bracha does not consider that these sharpening of arguments are necessary at this stage of the proceedings, since the honing and polishing of arguments that are not new arguments, may be done at the evidence stage.

Furthermore, the Deputy Commissioner accepts the Applicant’s arguments that many of the requested amendments are actually a “Response”, as they relate to the Applicant’s statement of case. This is evidenced by the many references in the amended Statement of Case of the Opposer to the Applicant’s Statement of Case. The Statement of Response that the Opposer is entitled to submit under Regulation 61 of the Civil Procedure Regulations 1984 is not the Statement of case that the Opposer is allowed to submit in an Opposition before the Commissioner of Patents. Furthermore, it is clear that there is no place for these amendments, since if the amendment to the Statement of Case is authorized, the  Applicant will have the right to File an Amended Statement of Case in response and previously submitted statement of case will no longer represent the points of contention.

In this instance, the parties concur that the amended Statement of Case does raise issues not previously raised or widens the claims raised in the following instances:

  • The invention does not deserve priority since the element in claim 1 that is “capable of providing an induction period which is measured by a delay in a visual indication of the destruction of the metal or metal alloy indicator” only appears in this format for the first time in the seventh application from 12 May 2009.
  • The claimed invention is directed to a new property of a known product (chapter 7 of the new Statement of Claims.
  • The invention has no utility (chapter 8 of the new statement of claims.

The claim that the invention is not entitled to an earlier priority date was in the previous Statement of Case, but based on a different reason. The current basis is, according to the Opposer, a result of the Statement of Case in Response by the Applicant, which added new subject matter. The Deputy Commissioner accepts the Applicant’s contention that the Opposer forwent his right to amend his Statement of Case following the second amendment to the specification, and so the request to now amend the Statement of Case is tardy. Furthermore, the element that allegedly is not entitled to the priority date, was already part of the claims when the Statement of Case was first amended, and so the Opposer had an earlier opportunity to challenge it.

As to the claim that the invention lacks utility,  this is based on Fig. 39 of the Application which measures the induction period which was found in the Application prior to the amendment. However, according to the Opposer, were the so called “barrier layer” that is shown in Fig. 3 of the first priority document, which the Applicant relates to in their Response to the request for more details, then that period cannot be measured, and so the invention lacks utility. In other words, from the Applicant referring to Fig. 3, the Opposer concludes both that the Application relates to a new property of a known substance, and that it lacks utility.  From here, it appears that there is a connection between the addition of chapters 7 and 8 to the Statement of Case that relates to the utility of the invention, and the determination of the new property of the known material, and the Applicant’s response to the request for additional information.

 

In light of the above, the Deputy Commissioner accepts the Opposer’s contention that these issues could not have reasonably been submitted earlier.

 

In conclusion, parts 7 and 8 of the Statement of Claims result from the response to the request for more information, do focus the discussion on the contended issues and their submission is allowed.

 

The other requests to amend the Specification are refused. The references to “agreement by the Applicant” in the Statement of Case is really a Statement in Response, and so cannot be considered as amendments to the Statement of Case designed to emphasize the points of dispute between the parties. Amendments that are honing of arguments that relate to prior art previously referenced in the Opposer’s Statement of Case, are not necessary to establish the points of contention, and their place is in the evidence and summations. Amendments due to changes in numbering and deletion of claims can help to understand the Statement of Claims and could be submitted, but it should have been done after the second amendment to the specification. Incorporating them at this stage would require the Applicant to amend his Statement of Case and would result in unnecessary expense.

 

In light of the above

 

The Opposer will submit their Statement of Case amended as per above, i.e. with the addition of chapters  7 and 8 only. The amended Statement of Case will be submitted within 7 days.

 

The Applicant will be allowed to amend his Statement of Case by relating to the new Chapters 7 and 8. It is stressed that further amendments to the Statements of Case will only be allowed with explicit authorization, after submitting a detailed requested to amend the Statement of Case. In light of the limited amendment that the Opposer is allowed to make at this time, the Applicant will have 7 days to file their Amended Statement of Case from the submission of the Opposer’s amended Statement of Case.

Any request for extensions that result from Office pressures, festivals, bank holidays, vacations in Israel or abroad or from the need to the coordinate between the various entities, will not be allowed.

 

Since some of the amendments have been allowed and some have been rejected, no costs are awarded at this stage.
Interim ruling re Request to amend the Opposer’s Statement of Case in Israel Patent Application IL 209734 , by Deputy Commissioner Bracha, 11 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 »


When does the ninety day period for requesting a patent term extension commence?

May 29, 2018

Extension for IL 124123 to Bayer. When does the ninety day period for requesting a patent term extension commence?

In this ruling, the Commissioner accepts that the 90 day period for requesting a patent term extension should be calculated from the date at which the Ministry of Health informs the Applicant of the issuance of the decision to grant a patent term extension, and NOT from the date on the certificate. We now wait for someone to request that all sorts of cases be reopened, and extension fees refunded.

There is a second part to this ruling, in which the Commissioner rules on whether this is indeed the first registration of the drug. For blogging purposes, I am relating to the issues separately.

Kovaltry

The Application for the Extension for IL 124123 to Bayer was filed on 7 August 2016 and relates to the KOVALTRY formulation in the medical products registry from 8 May 2016, and which contains Recombinant Human Coagulation Factor VIII (no relation).

The Deputy Chief Examiner sent an Office Action on 13 September 2017 in which she raised the following objections:

  • The Application does not fulfill Section 64xv(a) of the Patent Law 1967 since it was received 9 days after the formulation was registered in the pharmaceutical registry.
  • The Application does not fulfill section 64d(3) of the Patent Law 1967, since it is not the first registration of Recombinant Human Coagulation Factor VIII in the pharmaceutical register.

The Applicant was also required to provide additional details regarding extension orders in the US and in recognized European countries.

On 11 December 2017, the Applicant responded to the Office Action. Following the Request for Patent term extension being rejected on 3 December 2017, the Applicant challenged the grounds for rejection. In their response, they submitted a detailed list of allegations on 7 February 2018 and a summary on 20 February 2018. The Applicant also attended a hearing on 25 February 2018. After the hearing on 1 March 2018 the Applicant submitted a completion of their case.

Bayer raised two main claims. The first was the way of calculating the timing of the request for the extension conducted by the Deputy Senior Examiner in accordance with Section 64xv(a) of the Law. The second related to the previous registration of bioactive ingredients for medical purposes in accordance with Section 64iv(3) of the Law.

Timeline for Submitting the Request for Patent Term Extension

When the Application was submitted on 7 August 2017, the Application wrote that “This Application based on the Kovaltry formulation that was registered on 8 May 2016, and so the Application is submitted within 90 days of registration.”

Ms Assem Mehta Deputy President, Head of the Department of Patents and Licenses, and Assistant to the Secretary, affirmed in an Affidavit supporting the request for patent term extension, dated 22 August 2016, noted in Section 4 of the Affidavit, that the medical device was registered on 8 May 2017.

However, from the Office Action, the Registration Date that appears on the Certificate of Registration is indeed 8 May 2017, but the request for the Patent Term Extension was only filed on 7 August 2017 which is 91 days from the registration date. Based on this data, the Deputy Chief Examiner ruled that the request does not conform to Section 64xv(a) of the Law which requires that:

Section 64xv(a)A request for a patent term extension should be submitted in the appropriate manner, after paying the fee, and not more than 90 days from registration in the Pharmaceutical Registry.

In the response to the Office Action from 11 December 2017, the Applicant claimed that although 8 May 2017 is the date at which the registration for marketing Kovaltry appears in the register, the Authorization only issued on 10 May 2017, and this was the date at which the Manager of the Register for Pharmaceutical Formulations informed the Patentees of the Approval. The Applicant appended a further Affidavit dated 14 January 2017, from Mr Gal Friedman, the Head of Regulation of Bayer Israel, which markets the Applicant’s products in Israel. In the Affidavit, Gal Friedman asserted that regulatory approval was only received on 10 May 2017. An email notification from the Head of Registration of Pharmaceutical Formulations, Dr Einbinder was appended. The email address was given as the formal electronic mailing address of Bayer Israel.

The Applicant claims that from their attempts to clarify the matter, that in the past, the date on the certificate was the only date available for calculating the 91 day period. However, nowadays, one can use the date of informing the Applicant as the starting period of the 90 days.

The Applicant claims that neither the Patent Law nor the Pharmacists Ordinance 1981 define the registration date that appears on the registration certificate. They thus allege that there is no basis to explaining that the 90 day period stated with this date is the correct date for calculating the 90 day period for requesting a patent term extension from a the Deputy Commissioner ruled, rather than the date at which the Applicant was informed (i.e. 10 May 2017).

The Applicant went on to claim that time periods for calculating things that depend on the Authority are generally to be calculated from when the citizen is made aware of the action of the Authority or when the notice is sent.

The Applicant wishes to draw a parallel to the C-471/14 Seattle Genetics from 6 October 2015, where it was ruled that the period for giving marketing approval under the European regulations, is from the day that the Applicant is informed, i.e. the date of notification. The Applicant claims that the basis for this determination is that the marketing approval does NOT enter into effect from the day that the decision is taken, but rather from the date that the Applicant is informed of the decision. Consequently, certificates of registration have two dates and the Applicant believes that one should prefer the later of the two, which fulfills the intention of the legislation, which is to provide a sufficient window for Applicants who have a basic patent, to request a patent term extension – something that they cannot do before knowing that a marketing approval has issued.

The Applicant alleges that this position is supported by the District Court ruling in 32321-10-16 Bristol Myers Squibb Holdings Ireland vs. Commissioner of Patents and Trademarks 26 December 2017, where Section 64x(2) of the Law was interpreted to mean that the period of marketing approval commences with the informing of the decision to the Applicant and not with the date that the Approval was made. The Applicant considers that this should apply to Section 64xv(a) of the Law as well.

The Applicant also considers that the explanation of the Law made by the Deputy Chief Examiner could result in many cases where the patent term extension period was determined by the date appearing on the certificate and the number of days would need to be recalculated.

DISCUSSION AND RULING

The issue in question is the correct explanation of the term “Day of Registration of the Medical Formulation” as mentioned in Section 64xv(a) of the Law.

In legislating that the Applicant should submit their request for a patent term extension within 90 days from registration in the Pharmacist’s Register, the legislators attempted to achieve two purposes:

  1. To give the Applicant sufficient time to prepare their application
  2. To allow the public to know with certainty whether a patent term extension was being sought for a particular product, thereby providing market certainty.

Section 64xv(a) has been amended. In the earlier version under the third amendment to the Law, the period for applying for a patent term extension was 60 days from registration of the formulation under the Pharmacist Regulations (formulations) 1986.

In the seventh amendment from 2006, 3 January 2006, Book of Laws 2048, page 195-197, the Section was amended to extend this period to 90 days. The Pharmacist’s Regulations were similarly amended and now state “from the day of recordal under the Pharmacist’s Ordinance. In the 11th amendment the Authority of the Commissioner to extend the period was taken away, so the period is non-extendible (Amendment 11, 2014, Law book 2430, 27 January 2014, pages 274, 278.

From the Applicant’s claims it transpires that there are four periods that could be considered the period of registration from which the 90 days are calculated:

  1. That given as the date of registration
  2. The day that the approval is printed on the certificate
  3. The date when the Pharmaceutical Division informs the owners of the registration – the sending date. and
  4. The date of knowledge – the day on which the owners of the registration receive notification of the registration.

The date of registration is that appearing on the certificate from which the ninety day period has traditionally been calculated when calculating the deadline for requesting a patent term extension (considering the certificate as it stands today).

The date of printing is presumably the date when the Ministry of Health produces the certificate. This is the date on page 3 of the Kovaltry certificate which states printed on 10 May 2017.

The claims and evidence before me do not support the contention that the date of printing of the certificate is necessarily the date on which the Ministry of Health informed the Applicant that their request for registration was successful. Indeed, one can assume that the date of printing will actually change each time that the same document is sent to the printer and so the same certificate could exist with different printing dates. Consequently, the Commissioner does not think that this date can be relied upon as the date for registration with regard to the correct explanation of Section 64xv(a) of the Law.

As to the period of sending or the period of becoming aware, the Commissioner accepts the Applicant’s allegation that calculating the deadline from the Official Date is problematic where the Applicant only becomes aware of the date retroactively, since it is difficult to require someone to take an action within a time period from an event occurring that he does not know about.

The issuance of a marketing authorization is an administrative action as defined in Section 3 of the Law of Interpretation:

An administrative action is an order or an appointment, notice, license, approval and the like, that is given in writing under Law and is not a legislative action.

In his book Administrative Authority, Y Zamir states that (Zamir, Administrative Authority Vol. 2 Second Edition, 201 on page 1320):

Common sense tells us that there are things where not being informed of an administrative decision that adversely affects a person’s rights, should not be in effect at all, or in certain circumstances, if the person was not informed of the decision. For example, let’s consider that an Administrative Authority cancels the work permit of a person but does not inform him of this, is it conceivable that the person will be tried under criminal law for running a business without a license? If an Authority applies a tax and does not tell him, can he be held liable for not paying that tax? Where a Law states that a person is allowed to Appeal or to critique an administrative ruling in some other way within a specific period from that decision issuing, and the person is not informed, should he be prohibited from criticizing the ruling? In summary, it appears that the present situation requires a legislative solution or case-law, that relates to publication of civil rulings. The underlining is by Commissioner.

Logic obliges that giving notification to someone regarding an administrative action relating to him cannot be applied without the person being aware of the administrative action. This is also stated in regulation 4 of the Patent Regulations 1968:

The calculation of the time period for doing an action the Law or regulations require or allow, following actions of the Commissioner or subsequent thereto, should enter into effect from the date when the requirement is given to the postal service and addressed to the client or agent-of-record at the official address, or sent by electronic mail, as per Regulation 16(b). This period starts with the sending of the electronic mail, unless it is established to the Commissioner’s satisfaction, that the message was not delivered.

True, in this instance, we are NOT talking about an action that the Patentee is required to take following an action of the Commissioner of Patents, but due to the action of a different Authority, the Ministry of Health, however the underlying logic is appropriate. It is noted that where the Pharmacists’ Regulations themselves give a time period for an action, the time period is from when the action of the Authority is made known to the person concerned, see, for example, Regulation 9(3) of the Pharmaceutical Ordinance:

 (b) If the director considers that the registration of the formulation in the register should not be renewed, he should inform the registered owner before the registration lapses, the notification should be by registered mail to the official address of the registered owner.  

(b1) If the manager informs that he does not intend renewing the registration, he should extend the registration by no more than six months.

(c) The owner of the registration is allowed to appeal the decision not to renew the registration within six months from receipt of the notification under Regulation (b).

So the patent regulations specifically state that where someone has to respond to an action of the Authority, the period for responding will be calculated from the day of sending or from the day of receipt of the notification if it is proven that the notification did not reach its destination. The pharmaceutical regulations state that the period is calculated from notification.

In the ruling of re Bristol, Judge Magen Altovia related to the “submission approach”.

 It is noted that the serving of papers approach sits well with the administrative law that stresses that the period of serving of papers is more important than the reaching of the administrative decision by the deciding party with respect to setting into practice that allowed.

As Judge Magen Altovia stated in re Bristol, the purpose of the civil law procedures is to fulfill real rights. See Appeal 6708/00 Aharon vs. Aharon p.d. 54(4) 702:

At the end of the day, the civil procedures are there to serve substantive rights, and they are there for a purpose. The wider substantive approach, of which good faith is the wellspring, cannot be accompanied by overly strict civil procedures. The legal culture is not only judged by protected rights, but also sometimes by the ways of approaching situations and the status of those being judged.

Consequently, Commissioner Ofir Alon considers that the 90 day period for requesting a patent term extension be calculated in a similar fashion to other deadlines in the Patent Law, i.e. in accordance with Regulation 4 of the regulations, that the date is to be calculated from when the notification is sent to the applicant / patentee, unless the Applicant can prove that the notice was never received, and in such cases, the period is to be calculated from when the consumer learned about the decision.

The Commissioner does not consider that calculating the period from the day that the Notice was given to the Applicant undermines the second purpose of the legislators; the need for certainty. This interest is not damaged if the date is calculated from the day of sending, since this is usually close to the day that the decision was taken by the Ministry of Health. It should be noted that Section 64 of the Patent Law has to be very carefully interpreted, to reflect the balances intended by the legislators.

In this instance, in the request for registration and in the affidavit, the Applicant noted the date of registration as 8 May 2018, even though Mr Friedman did not note that the notification was first sent to the Applicant on 10 May 2017, which the Commissioner is willing to assume was his intention in light of the Applicant’s claim, and noting the date of the printing appears on the certificate. In light of all of the above, the Commissioner rules that the response was timely filed under Section 64xv(a) of the Law.

COMMENT

This ruling seems to indicate that the Current Commissioner is less formulistic than his predecessors. I was rather taken aback by this ruling since I think that the 90 day period is ample to cover regular postage delays and his deadline should be no different from all the others that are calculated from the date on the certificate.

The Patent Office has very many deadlines triggered by an action they take, including the deadline for responding to Office Actions (typically 3 or 4 months, and extendible), the final deadline for responding to all Office Actions for registering a design (one year from the date of the first office action), the deadline for paying the first renewal (three months from issuance of the patent certificate), the deadline for filing oppositions, the deadline for filing abroad under Paris, etc. ALL of these calculate the deadline from the official date, despite the fact that, in practice, the Applicant will only be aware of the date once he/she receives notification which may be some time later.

The 90 day period is sufficient to cover delays of days in the authority informing the Applicant and the time for the Applicant to inform his client. If it can be shown that there were extraordinary delays involved, then there is due cause to argue that the delays were unavoidable and the Commissioner could reasonably give a discretionary extension. If the Law limits the grounds for discretionary extensions, it does so for good reason. In light of this ruling, ALL the deadlines triggered by Patent Office actions are now suspect.

There is no need for this. The 90 day period is sufficient to cover minor delays and, in this instance, the delay was three days. Sixty days used to be considered enough for filing a request. This period has been extended to ninety days. Ninety days is ample.

The 90 day period should not be extendible. The Law requires unavoidable delays and there was nothing unavoidable in this instance. However, although I think the ruling was horrible, there is a precedent for extending the 90 day period based on errors by agent of record being unavoidable. In XXXX, Reinhold Cohn missed the date due to docketing errors. If Pearl Cohen had claimed that they made a docketing error and calculated the date from receipt of notification, it is difficult to see how the present Commissioner could avoid giving the extension given to Reinhold Cohn. Of course, to do this requires knowledge of the previous decision which requires reading the decisions or following this blog.

Even without this, if the Commissioner simply ruled that the delay was unavoidable, he could simply have granted an extension based on payment of an extension fee. Instead, he has ruled that all deadlines are to be calculated from date of sending, or if not received, from date of notification. We predict that this will open a hornets’ nest.

Actually, there is a second issue here, which is whether this was the first publication. On that ground, discussed in the next blog posting, the extension was rejected. The Commissioner could, therefore, have ruled on that case and left the present issue open.


Can a Knowingly Abandoned Patent Application be Reinstated?

May 22, 2018

BioMarin

IL 206845 to BioMarin Pharmaceuticals Inc. was refused under Section 21a of the Israel Patent Law 1967. The patent application was the national phase of a PCT application submitted on 6 January 2009. The national phase entry was submitted on 6 July 2010 and claims priority from US applications filed on 7 January 2008 and 22 April 2008.

On 30 January 2013, the Applicant was sent an Office Action to which the Applicant had four months to respond. No response was forthcoming. Following the extensions available under Circular 005/2011 then in force, on 5 March 2014 the Applicant was informed that the file would be closed if no response was submitted within 30 days. This letter went unanswered and the file was closed on 23 June 2014.

3 years

Three years and three months later, on 15 October 2015, the Applicant requested a retroactive extension to respond to the notice of abandonment.

The request was accompanied by an Affidavit that testified to the developments leading to the case becoming abandoned.

  1. In 2005, Merck Serono purchased all rights to the Kuvan medical product, and to the process for manufacturing the active ingredient claimed in the application.
  2. This transfer of rights was not recorded in the patent register and the Application was filed in the name of Biomarin.
  3. In 2012, Merck Serono decided that it was not interested in the patent issuing in Israel and told Biomarin not to respond to the Office Action.
  4. In 2015, Biomarin repurchased their rights to the invention and in 2016-2017 reviewed the usefulness of getting the patent to issue in Israel.
  5. Following the reconsideration, the present request for extension of time to respond was submitted in October 2017.

change-my-mindThe Applicants argued that their repurchasing of their rights and their reconsideration of the portfolio provides sufficient justification for reconsidering the refusal of the patent. Furthermore, unlike in the US and Europe, there is no legal requirement for abandonment so thus, even if the abandonment was following an intentional decision by Applicants or the predecessor thereof, this does not mean that, following a change of circumstances, this cannot be reconsidered and they are entitled to a further opportunity

mistake EinsteinThe Applicants presented their arguments at a hearing on 14 February 2018, during which they claimed that the Applicants can be considered as having made a mistake that they now wish to rectify. They also claimed that returning the application to examination will not cause damage to third parties. Finally, they argued that in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et  al. (15 June 2016), certainly is no more important than other considerations.

Sections 21 and 21a of the Law set out the normative arrangement for these matters as follows:

21.  If the Applicant did not remove the grounds for the Application not being approved within the timetable set out in the regulations or did not correct the lacunae under Section 20, the Commissioner will refuse to allow the patent.
21a. If the Commissioner refuses the patent under Section 21, he can, at the request of the Applicant, reconsider the refusal provided that the request to do so was submitted within 12 months of the refusal.

reasonable

The period laid out in Section 21a of the law is extendable under Section 164 of the Law at the Commissioner’s discretion. The Commissioner’s discretion is summed up in the phrase “if he sees a reasonable basis for so-doing” which is found in Section 164a. The Commissioner’s considerations will change with circumstances, and as Judge Naor stated in Appeal 826/04 Commissioner of Patents vs. Recordati Ireland Ltd (26 June 2004):

The policy regarding different requests for extending deadlines that are brought before the Commissioner, will change with circumstances and with the nature of the proceedings for which an extension is requested.  

 Similarly, the Commissioner has the authority to make the extension dependent on “conditions that he considers to be correct” as stated in Section 164b of the Law.

In cases such as this, there are two main interests. Firstly, that of the Applicant who wishes to protect his invention and, secondly, that of the public which can benefit from inventions that are not patent-protected and are thus in the public domain. It is noted that this case is the national phase of a PCT application and the application and its status is published under section 16a of the Law.

limited

The Deputy Commissioner Ms Jacqueline Bracha considers that the period given in Section 21a, though long, is limited. This protects the public and brings matters to a close. The period given in the Law is a balance between the competing interests.

To extend the 12 month period after the file closes under Section 164 requires ‘reasonable grounds’, as defined in Opposition to IL 110548 Shmuel Sadovsky vs. Huglat Kimberly Marketing ltd, 12 August 2010. The relevant considerations for ‘reasonable grounds’ are the duration of the extension requested and the existence of a real cause for the delay.

Ms Bracha does not consider that the Applicants’ request can be considered reasonable with respect to the delay incurred or the justification to reopen the file. The request to reopen the file was received 39 months after the case was closed. This is 27 months after the usual deadline which is a long time.

As to the submission that the client changing their mind is grounds for opening an intentionally abandoned application, the Deputy Commissioner does not find this convincing. She finds support in Appeal 83/86 Sokol vs. Yismach, p.d. 40(1) 577 cited in the Sadovsky case, where it is stated that:

The discretionary authority to extent deadlines is intended to overcome mishaps and externalities that are beyond the litigant’s control.

One cannot consider a decision not to continue prosecuting as being an external cause, a mishap or an error. Ms Bracha notes that the circumstances described in the Affidavit show that the error we are dealing with is imported from Contract Law and is at best “a mistake in the equity of the deal” which is not grounds for cancelling a contract.

In a similar manner, it has been determined that not paying a renewal of a patent due to a determination that it is not worthwhile to do so is NOT considered as a reasonable ground for reinstatement, and that is where we are dealing with an actual right that the patentee was awarded and not with a pending application as in this case. See Request for Reinstatement of IL 177522 of “Yad Conena Ltd from 9 June 2014:

The circumstances of the case before me do not fulfill the above requirements. A decision was taken not to pay the Renewal fee. The patentee knew that the there was a need to pay the renewal fee as this was not the first time that he had needed to pay it. One can assume that after the case lapsed and was reinstated in 2011, the patentee made inquiries regarding the next renewal. From the Affidavit it transpires that the patentee made an informed decision NOT to pay the fee. In these circumstances one cannot conclude that the fee was not paid in reasonable circumstances that justify reinstatement.  The economic difficulties that the Applicant noted are not considered reasonable grounds for not paying the renewal, particularly where no evidence of the debit was submitted.

As a footnote, Ms Bracha relates to the claim that the request finds support in Appeal 8127/15 Association of Israel Industrialists vs. Merck Sharp & Dohme Corp. et  al. (15 June 2016), that in patent law, fidelity and consistency is no more important than other considerations. Ms Bracha considers that certainty is not all-seeing and that sometimes certainty will be sacrificed for other interests. In  re Association of Israel Industrialists, it was stated:

True, there is validity to the suspicion that certainty may be damaged when a court comes to interpret the Law (Aharon Barak Legal Interpretation, Interpreting Legislation Volume 2 583 (1993). Nevertheless, this is one consideration amongst many that can be used where there is nothing in the wording of the Law or elsewhere to directly contradict this. In this instance, it appears that the legislators did not put the question of certainly regarding when a patent lapses as the main consideration.

In other words, the consideration of certainty is an important consideration but where the wording of the Law or its purpose indicate that the legislators preferred some other consideration, the Court will interpret the Law accordingly.

Ms Bracha does not consider that in this instance the Law or the case-law expounding the Law indicate that the legislators preferred the interest of the Applicant over that of public certainty, She considers that to the extent that there is a legal tradition for interpreting Sections 21a and 164 of the Law, it is one that requires the Applicants to provide a real and reasonable cause for incurring a delay, and this is necessary since there is public reliance on the patent lapsing.

revival-2

The Applicants also requested to learn from what is stated in foreign legislation, that what is not stated in our Law is not a requirement. That is, that whereas other laws explicitly state “unintentional” this implies that there is no such requirement in Israel Law. Whilst it is true that Section 21 does not require abandonment to be unintentional, it does provide a normative timeframe for reinstatement, whereas the US and European law do not.  Any deviation from this period is considered in the mirror of Section 164 which is interpreted in light of the nature of the deadline to be extended and the type of proceeding before the Commissioner. This was detailed above, and will not be repeated. It is sufficient to note that one cannot rely on the inclusion or omission of a word in the Israel Law as the basis for its interpretation whilst ignoring the case-law.

It seems that the circumstances are such that the case was abandoned intentionally and can only be rectified if this was not legal. The request is refused.

IL 206845 to Biomarin: refusal to reinstate application, Deputy Commissioner Ms  Jacqueline Bracha, 17 April 2018.     

COMMENT

In extraordinary circumstances, long-dead applications have been reinstated. See for example IL 194015 to Natapov, Perstnev, Perstnev and Vilacer titled “the Insulating Material”. Here the patent had lapsed three years earlier, but had not published. The record is probably Israel Patent Number 139892 “INNER WORKINGS FOR A WATER TREATMENT UNIT” to Yigal Tsabri  which was revived seven years after it lapsed.

I am frankly surprised by the audacity of the Applicants’ representative for trying to  argue that this knowingly abandoned patent application could be revived more than 12 months after going abandoned and am pleased that the Deputy Commissioner came to the decision that it could not be.