Novartis – Double Patenting in Israel

July 1, 2015

novartis

The present ruling relates to the issue of identical of overlapping patents and patent applications, and examines the ramifications of double patenting in Israel.

IL 2039732 is a Divisional Application of IL 176831 titled “Compressed Pharmaceutical Tablets or Direct Compression Pharmaceutical Tablets Comprising DRR-IV Inhibitor Containing Particles and Processes for their Preparation”.  During prosecution it received a final rejection and the Applicant, Novartis, appealed this final Examiner’s rejection.

The Examiner considered that the claims of the parent and the divisional application are directed to the same invention. After this issue was first raised, the Applicant amended the claims, but the Examiner considered that the amended claim set (claims 1-23) covered the same invention as claims 23-26 of the parent application. Based on 5293/93 Welcome Foundation vs. Patent Commissioner (1993), the Examiner rejected the claims of the divisional application. A telephone conversation was to no avail. The Examiner issued a final rejection noting that there were substantive issues not addressed, and the Applicant appealed this decision to the Commissioner of Patents claiming that the issue is one of interpretation of the Law.

The Commissioner held a hearing and allowed the Applicant to present a short summary of the comparative law in US, Europe, Australia, Japan, China and India. In this instance, the Examiner did not claim that the divisional had identical claims to the parent application, but that there was some overlap. According to the Commissioner, the issue is one of interpretation of Sections 2, 8 and 9 of the law. These state that an inventor is entitled to a patent, that a patent can only cover one invention and that where two or more applicants file for the same invention, the first to file is awarded the patent. The purpose of divisional applications is to prosecute additional inventions claimed within the same parent application.

In the Welcome case, claims 1-10 related to uses of a pharmaceutical preparation in the treatment of various diseases and claim 15 related to a method of preparation of the active ingredient.  Then Commissioner, the late Michael Ophir ruled a claim for use in preparing a medicament’ and ‘use in the treatment of’ were identical. He did not see that the application related to more than one invention. On appeal, Judge Winograd ruled that one can file and prosecution an application for a material, a second one for the method of fabrication and a third one for uses, provided each application is directed to patentable subject matter and there is no overlap between the cases. There Judge Winograd went on to rule that one application cannot include more than one patentable invention, i.e. one should not award more than one patent for one invention, and this is a corollary of Section 8 that a patent should cover one invention. One can file a plurality of applications for a plurality of related patents provided that each one is directed to a patentable invention and the claims are not identical or overlapping.

In the present case, both the parent IL 176831 and the divisional application IL 203972 have the same title. In IL 203972 there is one independent claim. Claims 23 and 24 of the parent IL 176831 each depend on claim 1, and claims 25 and 26 are dependent on claims 24 and 23 respectively.

The independent claim of IL 203972 is directed to using a powder to form a pill for treating a wide range of ailments. Claims 23-26 of the parent IL 176831 are directed to forming tablets and a corresponding process. The divisional relates to various states that are not in the parent application, but both applications have the same specification. According to the Applicant, the parameters are identical but the parent claims the process whereas the divisional application claims use of the active ingredient to prepare a pharmaceutical.

According to the Examiner, the divisional application claims the use of a formulation for treating a disease, where the formulation is given in claims 23-26 and the diseases treated are listed in claims 1-22. In both cases, the formulation is the same, the particle size is the same and the active ingredients and additives are the same as those given in claims 23-26 of the parent.

Novatis found the Welcome decision poorly claimed and poorly reasoned and could not see why two applications could not claim identical or overlapping inventions. They argued that where applicants are the same, there is no need to relate to identical or significantly overlapping claims, holding that the Israel Patent Law does not prevent multiple patenting. Novartis argued that Section 2 is merely a declarative statement that the applicant may file a patent. It does not have legal ramifications, and certainly does not limit the number of patents that the applicant may file. Section 2 does include the word “one” and it should not be read into the claim such that one patent may be requested for one invention. Support for this interpretation is found by contrast to Section 9 which relates to different applicants with patent applications for the same invention.

The parties are in agreement that different applicants cannot be awarded separate patents for the same invention. Novartis holds that the same applicant can be awarded two or more patents for the same invention. The Examiner disagrees. Novartis accepts that there is no economical justification or logic in an applicant having more than one patent, and even sees this behavior as unacceptable. However, so long as there is some difference between the two patents, it is legitimate to award the protection of both patents.

The Commissioner upheld the Examiner’s conclusion and ruled that so long as there is nothing in claim 1 of the divisional that exceeds the scope of the claims of the parent, there is no reason to allow the divisional.

COMMENTS

In the US, the issue of double patenting is dealt with by filing a terminal disclaimer. Although this procedure prevents extending a term of protection (sometimes called ever-greening), it still has negative ramifications. Third-parties such as an alleged infringer may have to show that he is not infringing a number of overlapping patents. Likewise, a competitor may have to show a number of similar patents are invalid or not infringed. This places an unnecessary burden on third parties.

I think that although Novartis is correct that the Law does not explicitly prohibit multiple patents for the same invention, the Commissioner is correct that not to allow it is a reasonable interpretation of the intention and spirit of the law. Because of the large sums of money involved with pharmaceutical patents, this decision may well end up being appealed to the courts. If that happens, we will see how the Israel courts consider double patenting.


Impotent Appellant Has No Standing

July 1, 2015

class action  no standing

This ruling relates to a Class Action filed in bad faith. The court ruled that when Applicant challenges the validity of claims made for a formulation, failure by the Applicant to take the formulation during the minimal period prescribed by the manufacturer, is sufficient to cancel the standing of the Appellant as representing the class in a Class Action.

The Appellant purchased a formulation intended to strengthen the male libido. Prior to the Appellant finishing the prescribed course of treatment detailed in the accompanying literature and as explained by the Supplier’s Helpline, the Appellant filed suit with the District Court claiming that the product is misleading, and requested that the case be considered as a Class Action. However, the District Court refused to see this as a class action since the Appellant had no standing, and therefore could not represent the class.

Supreme Justice Danziger upheld the decision of the lower court without awarding costs to either party, and added that the need to test that the plaintiff behaves equitably is anchored in Section 8(a)4 of the Class Action Law. The ruling of this court does not indicate a general ruling of what is considered equitable behavior as far as Class Actions are concerned. In one case Inequitable behavior occurs when a case is filed due to false motivation, such as an intent to damage a competitor or to “squeeze a compromise”. In other instances, the mere fact that a plaintiff is acting commercially, looking to profit from the Class Action does not, in and of itself, indicate that he is behaving inequitably, however the plaintiff has to behave equitably during the hearing. This is particularly important in cases where the plaintiff wishes to represent a class of consumers and not merely himself and when a lawyer solicits plaintiffs for a Class Action.

In this instance, the District Court has determined, from the evidence before it, that the Appellant:

  • recorded conversations with the service hotline of the vendor
  • did not read the accompanying literature, tried the formulation for too short a period in direct contradiction of the instructions that he received with the formulation
  • contacted a lawyer prior to finishing the course; filed suite 5 days after stopping the treatment
  • via his attorney, submitted advertisements that were not related to his decision to take the treatment

These facts resulted in the District Court concluding that the plaintiff did not have standing in his own right and could therefore not represent the class of men with impotence issues.

The Court concluded that the circumstances indicate that this is a rare case of someone initiating a Class Action inequitably, and contrary to Section 8(a)(4) of the Law. This conclusion is not based on the motive of the plaintiff, for one may be motivated by material gain, but by the inequitable behavior determined by the District Court. Simply not going the full course indicated by the manufacturer is sufficient to make the Appellant not appropriate to represent the class.

Oddly, and perhaps not inappropriately, this case was heard by three male judges, who agreed unanimously with the verdict.

4534/14 Appeal to Supreme Court, Eli Daniel vs. Direct Nature LTD

COMMENT
The Appellant, Eli Daniel, may not have had to pay compensation or costs, but, due to his actions, has entered the Israel legal text-books as having erectile dysfunction. Not the end of the world.

From discussions with pharmacist clients over the years I understand that the efficiency of all medicines, both classical and alternative (where there are active ingredients, as opposed to homeopathy) work to a greater or lesser extent in different patients due to personal physiology. A class of one is hardly a representative sample to test the efficiency of a treatment. There is a well documented placebo effect and presumably this works in both directions, so a patient lacking belief in a treatment is unlikely to see positive results. I assume that not everyone reacts the same way to aphrodisiacs, and there are large number of foods that are attributed as having both aphrodisiac and libido dampening effects. Apparently, patients taking classical medical treatment for erectile dysfunction still need to feel aroused, and taking the medicine alone has no effect.  I therefore wonder whether the treatment in question works some of the time and for some men. Certainly, there is no indication in this class action that this is not the case.


IL 142809 to Pharmacia Successfully Opposed by Teva Pharmaceuticals

March 18, 2015

R&R          R&R2

IL 142809 to Pharmacia AB was submitted on 25 April 2001 as a national phase entry of PCT/SE/99/02052 “NEW CONTROLLED RELEASE BEAD, A METHOD OF PRODUCING THE SAME AND MULTIPLE UNIT FORMULATION COMPRISING IT”. This published as WO 0027364 on 11 November 1999. The application claims priority from another PCT application filed a year earlier.
On allowance in 2006, the patent published for opposition purposes and on 18 May 2006 Teva filed an Opposition, submitting a detailed statement of case on 18 October 2006. On 12 march 2007 Pharmacia filed a counter-statement. Both sides submitted evidence, held a hearing before then Deputy Commissioner Noah Shalev Shmulovich and then filed their summaries.

As per regulation 202a, the current commissioner, Asa Kling ruled on the opposition based on the material of record.

The application is directed to a bead with controlled release of active ingredients, a method of manufacture and a multi-part formulation that includes the active ingredients. Essentially, the bead comprises a multilayer structure that includes a soluble core covered with non-soluble coatings, and the patent has 23 claims, two of which are independent.

Claim 1 is as follows:

 A controlled release bead comprising:
A core unit of a substantially water-soluble or water-swellable inert material;
A first layer on the core unit of a substantially water-insoluble polymer;
A second layer covering the first layer and containing an active ingredient; and
A third layer of polymer on the second layer effective for controlled release of the active ingredient,
Wherein said first layer is adapted to control water penetration into the core.

Claims 2-7 recite the various lawyers and their formulations and thicknesses. Claim 8 is a Markush claim for various active ingredients. Claims 9and 10 claim different forms of the active ingredient. Claim 10 claims use in vitro. Claims 11-14 claim different materials for the first three coatings. Claim 15 provides dimensions for the core and claims 16 and 17 claim multidose structures.

Claim 18 recites a corresponding method as follows:

 A method of producing a controlled release bead, which method comprises the steps of:
providing a core unit of a substantially water-soluble or water swellable material;
applying a first layer of a substantially water-insoluble polymer to said core;
applying onto said first layer, a second layer comprising an active ingredient and optionally a polymer binder; and
applying onto said second layer, a third polymer layer effective for controlled release of the active ingredient;
Wherein the amount of material in said first is selected to provide a layer thickness that permits control of water penetration into the core.

Claims 19, 21 and 23 claim use of the bead for a treatment for various diseases and claims `19 and 21 claim the active ingredient as tolderene or a salt thereof.

Grounds for Opposition
The opposition was based on lack of inventive step (obviousness) under section 5 of the Israel Patent Law 1967. In addition, Teva claimed that some of the claims lack utility contrary to Section 3, that some of the claims lack support from the specification in contravention to Section 13 and the Application is laconic and contravenes Section 12.
Pharmacia argued that claiming that the specification was laconic was an inadmissible widening of the Statement of Case, but the Commissioner, Asa Kling felt that the alleged inadequacy of the specification was inherent in the Statement of Case and that Pharmacia related to the issue so he considered it admissible.
As to inventive step, the Commissioner explained that if at the time of filing, the claimed invention was a simple extrapolation that could be considered as a simple development within the field and allowing a patent for it would prevent progress, it would be incorrect to allow a patent.
The Commissioner noted that both sides accepted that beads allowing controlled release of active ingredients that comprised a miscible or non-miscible core, a sealcoat, layers of active ingredients and additional layers were known at the filing date. The sealcoat serves to protect the active ingredient from reaction with the core and may be water impervious or slightly pervious. In the present invention such water penetration was controlled but in the prior art it was less controlled.

Not that kind of seal coat

Not that kind of seal coat

The present invention differs from the prior art in two ways: (i) the sealcoat is miscible in the prior art but is immiscible in the present invention, and (ii) the seal coat of the present invention is rather thicker than usual, but the thickness is not mentioned in the claim-set.

Teva argued that since the core in this case is impervious the sealcoat is superfluous and non-functional and there is no effective difference from the core of the present invention and that of the prior art.

Teva argued that in the priority document this was stated explicitly:

“Each bead comprises (i) a core unit of a water-soluble, water-swellable or water-insoluble inert material (having a size of about 0.05 to 2 about 2 mm), such as e.g. a sucrose sphere; (ii) a first layer on the core of a substantially water-insoluble (often hydrophilic) polymer (this layer may be omitted in the case of an insoluble core, such as e.g. of silicon dioxide), (iii) a second layer of a water-soluble polymer having an active ingredient dissolved or dispersed therein, and (iv) a third polymer layer effective for controlled release of the active ingredient (e.g. a water-insoluble polymer in combination with a water-soluble polymer)”. (WO0012069 page 6 line 33 to page 7 line 6). This point was also clear from US 6,770,295 to the same applicants.

The Applicant countered that the opposer’s explanation of the phrase “control water penetration into the core” was a misrepresentation and the correct explanation is found on page 2 lines 23-25 of the Application and only rates to beads wherein the water penetration to the core is impeded in a controlled manner and excludes beads where the core is protected by an impervious layer. The Applicant argued that the claim of lack of inventive step was based on this wrong interpretation.  In contradistinction to immiscible cores of the prior art in the present invention the core is miscible and is protected by a partial barrier sealcoat which allows controlled release.
The applicant could not explain the working of the sealcoat and how it inhibited release of the active ingredient but argued that the phenomenon exists and this is sufficient for both enablement and inventive step.
It seems therefore, that the key question is whether an immiscible core or a miscible core protected by an immiscible coating are equivalent or if a miscible core protected by an immiscible coating can be considered inventive over an immiscible core. Citing 345/87 Hughes Aircraft vs. State of Israel, it is accepted that a mere scintilla of invention is sufficient, and the question is whether this exists in the present case.

Utility
Teva argued that the utility was not demonstrated in contravention of Section 3 which allows patents for inventions that are new, useful, industrially applicable and non-obvious.
In oppositions, the onus is on the applicant to show utility. Citing 665/84 Sanofi vs, Unipharm the commissioner stated that the application as field has to provide a basis for utility and, if challenged, the Applicant has to prove utility during opposition proceedings. IN enforcement and cancellation proceedings the burden of proof switches and the challenger has to show a lack of utility. Consequently, the Commissioner ruled that without proof of usefulness a patent should not be granted.

According to the Specification, there are three advantages:

  • The claimed bead prevents the soluble core from serving as a reservoir of the active ingredient and extending the controlled release period
  • It reduces the likelihood of the core material releasing active ingredients and reduces the atmospheric pressure (specific vapour pressure?) and prevents the core from swelling
  • It reduces the initial phase during which there is no release of the active ingredient or only minimal release

According to the applicant these advantages transcend specific active ingredients.

The Opposer argued that these advantages are claimed for the specific active ingredient and for other non-specified active ingredients without any rationale or evidence.

Evidence
The evidence from each side consisted of expert opinions. Teva produced an expert opinion from Professor Golomb, and Pharmacia releid on expert opinions from Professor Wilson and from a Professor Walther who attempted to reproduce the experiments described in the application.
Professor Walther conducted a number of experiments to demonstrate that claimed in the first example for different active biological compounds. These, together with raw data were appended to Professor Walther’s affidavit at the Commissioner’s request.
There were differences between the raw data and the final conclusions with regard to what active species showed the desired effects and whether a heat treatment affected the results. The Commissioner felt that the discrepancies required explanation.
The Applicant claimed that Tolterodine exhibited the desired behavior, as did Reboxetine and cona, theopheylline and Carbamazepine. This was held sufficient to show that the behavior was a general phenomenon.
The tests related to a core with three coatings whereas the specification proposed a fourth optional coating. This, together with other discrepancies were considered to show light on the utility.
The thick initial layer did show slow release of the Tolterodine in a manner that was close to linear.
In the Application, after three hours some 70% of the active ingredient ws released, but in Dr Walther’s corroborative experiments, after this time lapse, only 43% of the active ingredient had been released.
When comparing Professor Walther’s results with the experiments in the specification it appears that the applicant had problems repeating their own experiments. The problem seems to be that Professor Walther simplified the experimental design and still could not achieve meaningful results. He was able to show that a thicker coating impeded release of the active ingredient but not in a qualifiable and repeatable manner.
As far as Tolterodine, the preferred active ingredient was concerned, Professor Walther was unable to show a correlation between thickness and the rate of release and was unable to repeat the examples in the Application. The Commissioner considered the lack of repeatability an reproducibility as undermining the claimed utility and barring the issuance of a patent.
Adequacy of the Specification
Section 12 requires that the specification be adequate to allow persons of the art to implement the invention. The rationale for granting a patent is in exchange for teaching something useful and failure to teach something sufficiently to allow the teaching to be repeated is considered as invalidating the application: “The sufficiency of a specification is a question of fact and necessarily depends upon the nature of the invention and attributes of the skilled person.” ( Hollister [1993] R.P.C. 7 para. 10-14). In this instance, the purpose of the patent as specified in the priority document was to enable the controlled release of the active ingredient at a predetermined rate over the shelf life of the product.
“An important aspect of all controlled release dosage forms relates to the need for consistent drug release between dose units prepared in the same and/or in different production batches, and throughout the shelf-life of the finished product.”

The surelease polymer specified in the specification and used by Professor Walther in his experiments was supposed to provide repeatable and reproducible results:

“In one embodiment, the invention provides a commercial-scale process for manufacture of controlled-release dosage units. The process comprises co-formulating tolterodine or a tolterodine-related compound as an active drug and a pharmaceutically acceptable polymer-based release-controlling component. … more preferably substantially all of the polymer-based release-controlling component used in the process has an age, at time of dosage unit manufacture, which varies by not more than about 180 days, preferably not more than about 120 days, and more preferably not more than about 90 days.”

Professor Walther was unable to show this control. Under cross-examination he stated that:

“So what we know is that Surelease has lot to lot variability. So one batch of Surelease may perform slightly different from another batch of Surelease. That is an effect that the suppliers do know and understand and that is something that, as part of any formulation development, you would establish how robust a product is towards variability and providing sufficient specifications then on it.”

The problem is that this variable is not described in the specification, rendering the claimed invention not enabled.
The Commissioner ruled that the claimed invention does not have demonstrable superiority, lacked sufficient disclosure and enablement and that no inventive step was shown. Consequently the application was refused.

COMMENT
Active ingredients are released from the surface of solids. This is true for components that leach out and for components that are released when a carrier dissolves.
As particles shrink, the surface area to volume ratio increases and the rate of dissolution increases. Having a non-functioning core surrounded with a coating containing active ingredients is to ensure that the effective surface area remains more or less constant and thus the active ingredients are released at a constant rate.
The above explanation is obvious to anyone with a background of materials science and chemistry.
Drugs are more effective if the dosage is released slowly at a constant and predictable rate.
The present invention seems to be based on the premise that over time the core will absorb the active ingredient and that a coated absorbent core is better than a non-absorbent one.
The application is based on Tolterodine as an active material, but other pharmaceutical compounds may be expected to behave in the same way.
Of course, using the same binder and beads of constant diameter won’t give reproducible results if there are other significant variables. The problem here is that the Applicant’s own attempts to demonstrate the efficacy of the claimed invention failed. In such circumstances, the Commissioner couldn’t really have come to a different conclusion than that the application was deeply flawed as the person of the art selected by the applicant was unable to reproduce the results.

The previous Deputy Commissioner resigned four years ago. Obviously this was only one case of many that the current commissioner and his deputy or adjudicator had to rule on. Nevertheless, it seems to me intolerable that the parties should have to wait for four years for this ruling and one wonders why the previous deputy commissioner couldn’t have left less abruptly, and finished these pending cases.

 


A Request for a Patent Term Extension for IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18” to Merck

February 10, 2015

gardasil

IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18” to Merck Sharp & Dohme Corp. was filed on 13 March 1996, and is due to expire on 13 March 2016.

Back in August 2007 a Request for Patent Term Extension was filed based on the commercially available preparation Gardasil. The pharmaceutical preparation contains four active ingredients: Protein L1, types 6, 11, 16 and 18.

The patent claims the Protein L1 type 18 as a product of genetic engineering. The patent relates to the other types of Protein L1 except for HPV 6 L1 for which no patent applications were submitted anywhere. The protein HPV 16 L1 was not claimed in any patent application filed in Israel. HPV 11 L1 was claimed in IL 117591 and expires on 21 March 2016. However, no applications for patent term extensions were filed for this protein.

The legal question that this decision addresses is whether a patent term extension can be requested for a patent that protects only one active ingredient of a pharmaceutical preparation.

The claims of IL 117459 cover a gene sequence of Protein L1 type 18, a vector including the gene sequence, a cell embodying the vector a process of expressing the gene sequence and a preparation that causes a vaccination to the protein including the gene sequence.

The senior examiner considers that Gardasil includes four proteins and any changes in any of them or preparations of three or less will result in a different medicament. Consequently, she considered that there is an inconsistency between the medicine and the claimed invention, in that not all the active ingredients of the claimed invention are in the basic patent.

The Applicant countered that claim 12 of IL 117459  covers a composition that includes (inter alia) HPV 18 L1 and thus the patent does not limit itself to this substance. Consequently, Applicant claims that IL 117459 is a basic patent as defined in Section 64a of the Israel Patent Law 1967 and as referenced in Section 64d. The Law does not require that a basic patent should include all active ingredients of a commercial product, and only one such active ingredient need be listed. Support for this interpretation was argued based on the wording of 64h(d) which relates to an active ingredient included in a preparation and claimed in the basic patent

The Applicant alleged that interpretations that a basic patent should include all active ingredients of the commercially available preparation is contrary to the underlying logic of the legislation and it is unreasonable to include such a limitation by judicial interpretation.

The senior examiner rejected these arguments and the Applicant requested an oral hearing which was held on 28 October 2014 and the Applicant was granted until 10 December 2014 to submit a summary of his arguments.

Section 64d states:

The Commissioner should not grant a patent term extension unless all the following apply:

  • the composition, process for its preparation and usage thereof, medical preparation including the composition, its process for preparation and medical equipment are claimed in a basic latent that is in force.

Section 64a defines the terms ‘composition, ‘medical preparation’ and ‘basic patent’ as follows:

  • Medical preparation – any form of medical drug that has been processed, including preparations for veterinarian applications and those having nutritional value that are injected intravenously.
  • Composition – the active ingredient or salts, esters, hydrates or crystals of the composition.
  • Basic Patent – a patent protecting any composition, production method, use, medical preparation including the composition, or any medical equipment requiring regulatory approval in Israel.

Based on the court ruling concerning the Appeal to patent term extension for IL 97219 to Novartis (26/12/2005) the term composition means a single active ingredient.

In Novartis, then Commissioner Dr Meir Noam (himself a chemist) ruled that the term basic patent in both Section 64a and 64d relates to the first patent that protects an active ingredient and that the term composition is in the singular, implying that one new ingredient is sufficient and that novel combinations of known ingredients cannot be considered as a basic patent.  A preparation that includes one new ingredient that requires regulatory approval may be protected by extending a basic patent. Combinations, aggregations and synergies of known ingredients may be patentable but such patents are not basic patents.

In this instance, the issue is the regulatory approval of a combination of active ingredients, not the basic patent. Gardasil includes four active ingredients. Each one provides a parallel vaccination effect and maintains its pharmaceutical character. The four proteins are separately synthesized by fermentation in recombinant Saccharomyces cerevisiae (a species of yeast) but are combined into one treatment for economical reasons and due to ease of use.

(HPV Type 16 L1 and HPV type 18 L1 are also components of the registered drug Cervarix registered to a third party, and the proteins are each separately active.  However, Cervarix was registered after Gardasil).

Since the drug Gardasil comprises four separately active ingredients that each has an independent effect and do not work as a synergy, the Commissioner accepted that Gardasil could serve as the first regulatory approval of HPV type 18 L1. He found support in the ruling fo Judge Dotan in the Novartis case. He noted that Merck could have requested regulatory approval for the four proteins separately and the discussion would be moot. Finally, citing the Neurim ruling (13281-06-12 based on the ECJ ruling that Melatonin for treating insomnia was not obvious in light of veterinary treatment for causing sheep to rut earlier), it is clear that the purpose of the Law is to provide patent term extensions for new types of treatment, and there was no reason why the Applicant should have had to register each active ingredient separately.

Furthermore, in Appeal 223/07 Lundbeck vs. Unipharm it was ruled that patent term extensions should be analyzed from an IP perspective and not from a pharmaceutical perspective. The Supreme Court upheld this ruling.

Furthermore, in the medical register, Gardasil is listed as including four active ingredients, including HPV 18 L1, and this is, indeed, the first medical registration of this ingredient in Israel.

Consequently, based on the extension awarded in the UK for EP 1359156, the Israel patent was extended 493 days to 19 July 2017.

Ex Partes ruling concerning patent term extensions to IL 117459 “DNA ENCODING HUMAN PAPILLOMAVIRUS TYPE 18” to Merck Sharp & Dohme Corp. by Commissioner Asa Kling, 11 January 2015.

COMMENT

This is a publication of an ex-partes ruling. It is possible that local generic manufacturers such as Teva or Unipharm may challenge this.


On Blood Pressure and Diabetes. Can citations post-dating the effective Filing Date be used as evidence of what was known at the time of filing?

February 10, 2015

 

blood pressure

Israel Patent Application No. 140665 to Novartis relates to preparations including Valsartan and Amlodipine for treating high blood pressure and diabetes. The application is a national phase of PCT/EP/1999/004842 and claims priority from an earlier US patent application.

The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two references that were published after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and espunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicated the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

Comment

Although not allowed to be added to the record, as it could have been submitted earlier, this ruling does seem to indicate that such post priority publications may indeed be used to show what was prior art.


Can post priority-date publications that describe clinical practice be considered prior art?

February 5, 2015

exforce

Israel Patent Application No. 140665 to Novartis tited “Use of Combiantion Compositions comprising Valsartan and Amlodipine n the preparation of medicaments for the treatment and prevention of diabetes related hypertension” relates to preparations including  Valsartan and Amlodipine for treating high blood pressure and diabetes.

The application was a national phase of PCT/EP1999/004842 from 9 July 199 and claims priority from an earlier US patent application.  The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two publications from after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and expunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known.

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicate the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

The Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

In this case, the additional information is not prior art in the public domain, or it would not have been accepted for publication. It post-dates the application and is, therefore, not prior art. The Deputy Commissioner did not consider this material as indicating what was widely known prior to the priority date. The Opposers are trying to use the citations of Lip to show what was known prior to the priority date, and to do this, they should have submitted these citations in their statement of case.

Whilst not wishing to rule out using a paper that provides history of what was known earlier, the Deputy Commissioner warns against the danger of a hindsight bias and of reading the authors conclusions into the prior art.

As to the Opposers argument that the Applicant should have submitted an affidavit to support the evidence, Ms Bracha rejected this as the dates are not contested and so an affidavit is unnecessary.

In conclusion, Ms Bracha ruled that Sections 25-26 and 86-88 of the second opinion should be deleted. Legal costs of 5000 Shekels were ruled against the opposers.

COMMENT

In the DSM  vs. Mifalei Migun case, Judge Judith Schitzer of the District Court correctly ruled that one does not have to submit an affidavit with every piece of evidence or statement, so the Deputy Commissioner is correct on this account.

As to the late submission of evidence however, I think that the Opposers can fairly be penalized for not timely submitting these papers by having interim costs awarded against them for not submitting the evidence earlier, but the evidence should be related to substantively if it testifies to what was practiced prior to the patent being filed and not thrown out on procedural grounds. Ultimately the purpose of the Opposition proceeding is to clarify novelty and inventiveness to protect the public interest. If a drug becomes patented and should not be, the public will pay monopoly prices. Sure, the opposers have to answer as to why these papers were submitted late. Maybe the applicant should be given a second chance to respond and compensated for delays, but I disagree with this decision to throw out what could be key evidence.


US Supreme Court Overturns Federal Circuit’s Ruling Regarding Validity of Patent for Teva’s Copaxone

January 21, 2015

copaxone

Copaxone is a blockbuster drug based on the glatiramer acetate copolymer which was patented by Yeda (the Tech Transfer Company of the Weizman Institute) and licensed exclusively to Teva to manufacture.

On Tuesday 20 January 2014 the U.S. Supreme Court reversed an appeals court ruling that invalidated Teva Pharmaceutical Industries patent on the blockbuster multiple-sclerosis drug Copaxone, giving the drug maker a new opportunity to forestall generic competition.

The claims specify a particular molecular weight range but do not specify what method was used to measure the molecular weight. Sandoz argued that this is a fatal flaw and the claims are indefinite under §112. The District Court found for Teva, and was convinced by Teva’s argument that the claim clearly meant the “peak average molecular weight”, and not either of the two alternatives of “number average molecular weight” or “weight average molecular weight”.

On appeal, the Federal Circuit held to the contrary and found the patent invalid for indefiniteness. In reaching this conclusion, the Federal Circuit reviewed de novo all aspects of the District Court’s claim construction, including the District Court’s determination of subsidiary facts. The issue before the Supreme Court was whether that was permissible, or whether the Federal Circuit had impermissibly set aside the District Court’s findings of fact without the requisite finding of clear error on the part of the District Court (in violation of Federal Rule of Civil Procedure 52(a)(6), for what it is worth). The Supreme Court of the USA accepted TEVA’s appeal that found that the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit’s decision was vacated and the case remanded.

The Supreme Court Decision ruling was made by seven judges with two dissenting. Justice Breyer gave the Opinion with Justices Roberts, Scalia, Kennedy, Ginsburg, Sotomayor and Kagan affirming. Justice Thomas filed a dissenting opinion which Justice Alito concurred with. According the majority opinion the Federal Circuit had indeed impermissibly conducted a de novo factual review. So the Federal Circuit’s decision was vacated and the case remanded. In the dissenting view, the opinion was that the Federal Circuit had not overturned findings of fact, but had instead formed a different conclusion of law as to the claim construction. Therefore, there had been no breach of the Federal Rules of Civil Procedure. The case has been referred back to the Federal Circuit Court of Appeals.

COMMENT

The ruling will help TEVA prevent generic competitors from entering the Copaxone market until the patent expires in September. There seems to be a power struggle going on in the US court system with the Supreme Court reprimanding the Federal Circuit for assuming powers that are not rightfully theirs.


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