Pharma

Pharma, an abbreviation commonly used for the pharmaceutical industry, discovers, develops, produces and markets drugs or pharmaceutical drugs for use as medication. Pharma depends heavily on patents to protect its inventions worldwide, as well as on Supplementary Protection Certificates (SPCs). Pharmaceutical companies are subject to laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Pharma includes production of generic medicines. Pharma may also refer to (patent) litigation related to pharmaceutical products.

Enforcement, Injunction, Litigation, Patents, Pharma, Pharmaceutical patent, SPC, Switzerland, Validity

(MLL Legal Ltd.)/

In a decision issued this summer, the Swiss Federal Patent Court had the opportunity to comment on the catalogue of grounds for invalidity which can be brought against a Swiss SPC. The Federal Patent Court issued a PI based on Genzyme Corporation’s Swiss SPC for sevelamer, although it was unclear whether the Swiss Institute of…

Case Law, CJEU, Pharma, SPC

, (Vossius & Partner)/

Supplementary protection certificates (SPCs) used to be granted in the European Union only for novel active ingredients, but not for new therapeutic applications of previously authorized active ingredients. While this practice fundamentally changed as a result of the CJEU’s landmark decision Neurim (C-130/11) of 19 July 2012, the scope of this ruling has given rise…

Case Law, Pharma, Pharmaceutical patent, United States of America

(Wolters Kluwer Legal & Regulatory US)/

Concluding that the asserted claims of patents relating to dosing and administration of the drug Copaxone used to treat multiple sclerosis are obvious, the U.S. Court of Appeals the Federal Circuit has affirmed a decision by the federal district court in Delaware invalidating the patents, handing a major victory to generic drug manufacturers. The Federal…

Case Law, Pharma, Pharmaceutical patent, United Kingdom

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The Court of Appeal dismissed an appeal filed by Cubist against the Patents Court decision that one of its patents relating to antibiotic daptomycin was invalid for obviousness. The Court of Appeal was satisfied that the first instance Judge had an ample evidential basis to find the claimed invention obvious, his finding was properly reasoned…

Case Law, Pharma, United Kingdom

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Following the Court of Appeal’s decision that two of Regeneron’s patents were valid and infringed, it refused to grant Kymab permission to appeal to the Supreme Court, but held that the injunction against Kymab should be stayed, subject to certain conditions, whilst Kymab applied directly to the Supreme Court for permission to appeal. The Court…

EPC, EPO, European Union, Germany, Investment, Litigation, Pharma, Pharmaceutical patent, TRIPS, TRIPs Agreement, UPC

(Rospatt Osten Pross )/ /10 Comments

Since the Eli Lilly v. Canada award of 2017, the relevance of international investment law for patents has been known to a wider public. In response to the revocation of two Canadian patents concerning the compounds olanzapine and atomoxetine by Canadian courts, the US pharmaceutical company Eli Lilly initiated arbitral proceedings against Canada on the…

European Union, Pharma, SPC

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The Court of Justice of the European Union (CJEU) has clarified when a product is ‘protected by a basic patent’ within the meaning of article 3(a) of the SPC Regulation. In a long awaited preliminary ruling, the CJEU decided last week that: ‘Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May…

Equivalents, Extent of Protection, Infringement, Litigation, Pharma, Pharmaceutical patent, Scope of protection, United Kingdom

(Bristows)/ /3 Comments

On 12 July 2017, the UK Supreme Court handed down a ruling which caused a shockwave to resound across the UK patent community. For more than a decade, when addressing the issue of the construction and infringement of a patent, every practitioner would have focussed on the question prescribed by Lord Hoffmann in Kirin Amgen:…

Case Law, Ireland, Pharma

(Mccann Fitzgerald)/

The applicant, Teva, sought an order for the revocation of the Irish designation of European Patent No. (IE) 1379220 entitled “Inhalation Capsules” (the “220 Patent”) on the grounds of (i) obviousness, (ii) an “AgrEvo” challenge and (iii) insufficiency.  The Court ruled in Boehringer’s favour by upholding the validity of the 220 Patent and rejecting all…

Pharma, Pharmaceutical patent, Prior use right, Public prior use, United States of America, Validity

, (Kramer Levin)/

As a follow-up to our previous post “The Federal Circuit Has Its Final Say On the “On-Sale” Bar Under the AIA,” the Supreme Court has granted certiorari in the Helsinn v. Teva case, which concerns whether the America Invents Act (“AIA”) changed the longstanding “on-sale bar” rule.  This means that at least four of the nine…