Pregabalin - UK

On Oct 13, 2016, The Court of Appeal (UK) has delivered its much-anticipated decision in the dispute concerning Warner-Lambert's second medical use patent for pain indication of pregabalin and skinny labelled generic products. The Court of Appeal has upheld the decision of lower court which held European Patent (UK) No. 0 934 061 invalid in Nov 2015. Court subsequently decided that it would be an abuse of process for Warner-Lambert to amend a claim of the Patent to limit its scope and thereby exclude part of the claim vulnerable to the insufficiency attack.

Ertapenem sodium - USA

On October 7, 2016, Judge Richard Andrews of the U.S. District Court for the District of Delaware issued a decision in Merck’s patent infringement lawsuit against Hospira (a subsidiary of Pfizer) involving Hospira’s ANDA for a generic version of Invanz (ertapenem sodium).

Invanz (ertapenem sodium) is a penem antibacterial indicated for the treatment of certain infections. Invanz is approved in the form of a sterile lyophilized powder for reconstitution with an appropriate diluent for intravenous or intramuscular use. Each vial of Invanz contains ertapenem sodium equivalent to 1 g ertapenem. Each vial also contains sodium bicarbonate and sodium hydroxide as inactive ingredients.

There is one unexpired patent remaining in the Orange Book for Invanz: U.S. Patent No. 5,952,323 (set to expire on May 15, 2017, with pediatric exclusivity until November 15, 2017). The ’323 patent states that ertapenem, when powder-blended with sodium bicarbonate, will produce a stabilized carbamate form of ertapenem upon reconstitution. The stabilized form of ertapenem will convert back into ertapenem over time. The ’323 patent covers the stabilized carbamate form of ertapenem.

Merck also owns U.S. Patent No. 6,486,150 (set to expire on October 27, 2020), which is not listed in the Orange Book. The ’150 patent covers certain processes for manufacturing ertapenem.

Judge Andrews issued his decision in the lawsuit. Judge Andrews issued a decision in favor of Merck with respect to the ’323 patent and rejected Hospira’s challenges to the validity of that patent. Although Judge Andrews agreed with Merck that the ’150 patent covers Hospira’s proposed manufacturing process, he concluded that the ’150 patent is invalid due to obviousness in view of the ’323 patent.

Infliximab - USA

U.S. District Court for the District of Massachusetts granted Celltrion’s “Gilead Motion” for summary judgment of invalidity of U.S. Patent 6,284,471. Celltrion got FDA approval for biosimilar version (Inflectra) of Janssen’s Remicade® (infliximab) product–in April 2016.

The Gilead Motion
As summarized in the court’s September 28, 2016 Memorandum and Order, Celltrion filed a motion for summary judgment of invalidity of the ‘471 patent based on obviousness-type double patenting in view of U.S. Patent 6,790,444. Since the ‘471 patent was granted before the ‘444 patent, the theory of obviousness-type double patenting was based on the Federal Circuit decision n Gilead. In that case, the court held that a patent that issues after but expires before another patent can qualify as a double patenting reference for that other patent.

But the issue was slightly different from Gilead case where both the patents were post-GATT. In this case '471 is pre-GATT (17 or 20 rule) and '444 is post GATT (20 year rule). The court then emphasized the policy concerns behind the doctrine, and found that they would be violated if the ‘471 patent was permitted to extend beyond the term of the ‘444 patent:

Thus, the court determined that the ‘444 patent is citable as an obviousness-type double patenting reference against the ‘471 patent. In view of Celltrion’s concession that the claims were not patentably distinct, the court held that the challenged claims of the ‘471 patent are invalid for obviousness-type double patenting.

Ethinyl estradiol & Drospirenone - Canada

On September 7, 2016, the Federal Court (Canada) found that Apotex and Cobalt infringed three claims of Bayer’s Canadian Letters Patent No. 2,382,426.The Court also found those claims to be valid. The Court reached these conclusions in the context of consolidated patent infringement actions in connection with generic copies of Bayer’s Yasmin and Yaz contraceptive products.

During invalidity challenge, Apotex had alleged that the claims in issue were anticipated based on Phase III clinical trials conducted by Bayer in Europe and the United States more than one year before the 426 Patent was filed in Canada. The Court, however, rejected this allegation.

First, the Court acknowledged that there was a theoretical possibility that one of the tablets had made its way to a public person who was skilled in that art. Nonetheless, the Court was not persuaded that access to a tablet would have been sufficient to reverse engineer the invention of the 426 Patent. Specifically, the Court found that certain central aspects of the invention (ie. rapid dissolution and the location of the exposure of the pharmaceutically active ingredient) could not have been discovered without inventive insight.

The Court found that Bayer’s Phase III clinical trial was necessary to evaluate pregnancy prevention in real situations. It thus fell under the experimental use exception. Pharmaceutical companies ought to nonetheless remain vigilant in protecting, through adequate confidentiality agreements and express use restrictions during clinical trials (eg. explicitly specifying drug ingestion and return protocols), their inventions which may be the subject of or accessed through clinical trials. This applies in particular to inventions which could be easily reversed engineered.

Deferasirox - Canada

On Sep 15, 2016, The Federal Court of Appeal (Canada) dismissed an appeal from a decision prohibiting the Minister of Health from issuing a Notice of Compliance to Teva for EXJADE®.

On appeal, the Court of Appeal characterized the sole issue as whether the trial judge had erred in law in its construction of the promise of the relevant patent. Teva acknowledged that the trial judge had correctly identified the principles of law relevant to the utility requirement but erred in the construction of the promise of the patent.

The FCA concluded that the trial judge's construction of the promise of the patent was consistent with differentiation contained in the disclosure and the claims. The Court of Appeal also reiterated that where an allegation of an unfulfilled promise is made, “the patent will be construed in favour of the patentee where it can reasonably be read by the skilled person as excluding this promise”. Thus, the trial judge was correct to differentiate between the compounds and use claims. 

The FCA finally concluded that Teva's allegations of inutility, obviousness and insufficiency were not justified & dismissed the appeal.

Entacapone, Levodopa, and Carbidopa - Australia

On Sep 09, 2016, the Full Court of the Federal Court of Australia delivered judgment [Otsuka Actavis Pty Ltd v Orion Corporation [2016] FCAFC 121] related to infringement/revocation of a patent for a 3-in-1 Parkinson's disease drug, Stalevo (Entacapone, Levodopa, and Carbidopa). 

The Full Court, comprising the bench of Chief Justice Allsop, Justice Nicholas and Justice Yates, unanimously upheld the primary judge's findings that:

1.the licence granted by Orion Corporation (First Respondent) to Novartis Pharma AG (Second Respondent) was an exclusive licence and Novartis Pharma AG therefore had standing to sue Actavis Pty Ltd and Medis Pharma Pty Ltd (Actavis Parties) for patent infringement;

2.the invention the subject of Australian Patent No. 765932 (932 Patent) was, as asserted by Orion and Novartis (Orion Parties), a "new, oral solid fixed dose composition comprising pharmacologically effective amounts of entacapone, levodopa and carbidopa with at least one pharmaceutically effective excipient". The preferable features of bioavailability, stability of the composition and a tablet that could easily be swallowed, which were outlined in the specification and independently claimed in the various claims, were not essential integers of the invention;

3.the relevant claims of the 932 Patent the subject of the appeal were fairly based; and

4.the relevant claims of the 932 Patent the subject of the appeal did not lack definition and were not unclear.

Whilst the Full Court held that claims 17 and 18 (insofar as dependent on claim 17) were not infringed by the Actavis Parties, contrary to the finding made by the primary judge, given the Full Court's view as to the invention the subject of the 932 Patent, the infringement of claims 19, 20, 21 and 22 (insofar as dependent on claims 19-21) was upheld. All of the claims of the 932 Patent asserted by the Orion Parties were held to be valid by the primary judge and this was not disturbed on appeal.

Aripiprazole - Australia

On Aug 24, 2016, the Full Court of the Federal Court of Australia handed down a decision [Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 2) [2016] FCAFC 111] in which it upheld Justice Yates’ findings that Otsuka’s patent relating to aripiprazole, a drug used in the treatment of schizophrenia, is invalid for want of novelty and inventive step.

The patent that was at stake in this case was AU2005201772, titled “Substituted carbostyril derivatives as 5-HT1A receptor subtype agonists” (“the 722 Patent”). The 772 patent essentially claimed the use of aripiprazole to create a medicament which would be used to treat disorders of the central nervous system which are associated with the 5-HT1A receptor. 

The decision represents a blow for pharmaceutical giants Otsuka (the patentee) and Bristol-Myers Squibb (the Australian licensee of the product). Subject to any application for special leave to appeal to the High Court of Australia, generic pharmaceutical companies could now seek to list on the Pharmaceutical Benefits Scheme and enter the market with a generic aripiprazole product, which will lead to an automatic 16% price cut for aripiprazole.

Mesalamine (Lialda) - USA

On Sept 16, 2016, Circuit Judge Jordan (Delaware) issued a one-page order announcing a decision that favors Zydus. More specifically, the court decided that Shire had failed to prove Zydus’s generic tablets would infringe that patent.

There is only one patent directed to Lialda listed in the Orange Book: U.S. Patent No. 6,773,720 (set to expire June 8, 2020). The ’720 patent covers “controlled-release” oral mesalamine formulations that include (1) an “inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerides, waxes, ceramides, and cholesterol derivatives with melting points below 90° C” and (2) “an outer hydrophilic matrix wherein the inner lipophilic matrix is dispersed” that “consists of” other listed substances. The ’720 patent further requires that mesalamine (3) constitute between 80 and 95% by weight of the total composition and (4) be “dispersed” in both the lipophilic and hydrophilic matrices.

Shire is also pursuing patent infringement litigation against other players like Actavis (now a subsidiary of Teva), Mylan, Osmotica, Amneal, and Lupin.

Citalopram - EU

The European General Court (GC) has issued a judgment on Sep 08, 2016, confirming that "pay for delay" agreements in the pharmaceuticals sector constitute serious infringements of EU competition law. European General Court dismissed Lundbeck’s appeal against the European Commission (“EC”)’s decision to fine it – and a number of generic companies – for delaying market entry of generic versions of Lundbeck’s anti-depressant citalopram product.

The European Commission adopted an infringement decision in June 2013, imposing fines totalling €146 million (including €93.8 million on Lundbeck) for infringement of Article 101 of the Treaty on the Functioning of the European Union (TFEU). Lundbeck and the generic companies appealed the decision and the General Court has upheld the Commission's decision and the fines in full.

This isthe first European Court judgment that confirms the Commission's position that "pay for delay" agreements infringe EU competition law. Further appeals are also pending with the General Court concerning similar types of agreements involving Servier and five generics competitors and delayed generic entry of perindopril (a cardio-vascular medicine), following a Commission decision of 2014.

Tiotropium - Netherlands

By a judgment of Sep 07, 2016, District Court of The Hague (Netherlands) revoked certain claims of the Dutch part of a European patent (EP1379220) held by Boehringer due to a lack of inventive step.

Boehringer is the holder of European patent EP1379220 (“EP 220”) for ‘Inhalation capsules with certain moisture content’, granted on 29 December 2004. Teva initiated the proceedings for annulment of certain claims of EP'220. The District Court in its validity assessment applies the problem/solution approach and states that the closest prior art in the present case is a phase II clinical trial study on a tiotropium formulation contained in capsules for an inhaler.

The District Court concludes that the technical problem is to provide an alternative capsule material for tiotropium to be administered by means of an inhaler and rules that this problem would be solved by the skilled person without inventive step in the light of an article titled “HPMC Capsules – An Alternative to Gelatin”. Thus Teva’s claim for annulment of certain (amended) claims of EP 220 is granted.

EP'220 patent was also litigated in UK, Germany, Norway and court invalidated the claims of said patent in Oct 2015, Jan 2016 and Jun 2016 respectively in those countries.