Patent to Astrazeneca  Successfully Opposed by Teva

April 20, 2017

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

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

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

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


Copaxone patents invalidated by the US Patent Trial and Appeal Board (PTAB)

August 27, 2016
copaxone 2

Following an inter-partes review brought by Mylan against two patents protecting Teva Pharmaceutical Industries’ Copaxone, a drug for treating multiple sclerosis, the US Patent Trial and Appeal Board (PTAB) has invalidated all claims of the ‘250 and ‘413 patents for double-dose 40 mg Copaxone (glatiramer acetate injection) multiple sclerosis treatment. However, on 24 August 2016, TEVA announced that it plans to appeal to the US Court of Appeals for the Federal Circuit.

Erez Vigodman, president and CEO of Teva, said: “We remain confident in the strength of our intellectual property surrounding Copaxone.”

“We are prepared to defend the full suite of our intellectual property through the PTAB and US courts regardless of the time required.”

copaxone 3“We believe patients, physicians and payers will continue to value the efficacy, safety and tolerability of Copaxone and that it will remain a proprietary, global market-leading product for the reduction of relapses in RRMS patients.”

Teva have also announced that the PTAB had declined a request for a post-grant review on an additional Copaxone patent.

Copaxone represents 20% of TEVA’s income and the invalidation sent shares plummeting by 3%.


Patent Opposition Withdrawn But Applicant Not Entitled to Costs

May 9, 2016

piggy bank

Israel Patent 178249 to ASTELLAS PHARMA INC. titled “Pharmaceutical Composition for Use in Solid Formulation Crystalline Solifenacin or Salt Thereof and a Process for its Preparation” was allowed, and on publication, TEVA filed an opposition. Astellas amended the claims three times and eventually Teva withdrew the Opposition. Astellas then filed for costs, claiming that as the Opposition was withdrawn, they had technically won!

The Deputy Commissioner Ms Jacqueline Bracha took a dim view of this, and noted that although she had awarded costs to Teva for their successfully opposing some of the first set of amendments, the Applicant had been allowed to narrow the claim set and make clarifications under Sections 65 and 66 and the resulting claims were significantly different from those originally allowed.

Astellas and Teva were allowed three sides without appendices for their costs requests but although Teva fulfilled this condition, Astellas submitted reams of paper. Furthermore, even with the opposition withdrawn, Ms Bracha had notified Applicant on 21 February 2016 that she intended exercising her authority under Section 34 and to disallow the patent from issuing as it appeared that a case had been made that there was no novelty or at least no inventive step. That as may be, Astellas could not be considered as having won the Opposition, and she saw no reason to award them (or Teva) costs.

 


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.


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.