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.

Australia, Case Law, Litigation, Patents, Pharma, Pharmaceutical patent, Plausibility, Sufficiency of disclosure, Validity

, (Clayton Utz)/

Two recent decisions in the UK and Australia in the long-running pregabalin litigations demonstrate the different approaches in these jurisdictions to determine if a patent specification has sufficiently disclosed an invention.  Readers will recall that the judgments concerned Warner-Lambert’s Swiss-style claims for the use of the compound pregabalin (marketed as Lyrica) in the treatment of…

Netherlands, Pharma, Pharmaceutical patent

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In the Netherlands, Minister for Health Care Bruno Bruins clashed with Novartis last month about lutetium-octreotaat, after the Swiss pharma company had fivefolded the price of this cancer drug, an ‘orphan medicine’ for patients with neuroendocrine tumors. It is the latest of a series of controversies about medicine pricing. Kluwer IP Law discussed the case…

European Union, Generics, Legislation, Pharma, SPC

, (Vossius & Partner)/

The introduction of an SPC “manufacturing waiver” in the European Union, aimed at boosting the competitiveness of EU-based generics and biosimilar industry, gains momentum as the current EU legislative period draws to a close. Under the EU’s legislative procedure, the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal…

Case Law, CJEU, European Union, Pharma, SPC, Switzerland

, , (Vossius & Partner)/

Regardless of whether someone intends to enforce their own supplementary protection certificate (SPC) or finds themself at the receiving end of an SPC infringement action, the question which grounds of invalidity justify the revocation of an SPC may become highly relevant. This question is all the more intriguing in light of the CJEU’s corresponding case…

Case Law, CJEU, European Union, Pharma, SPC

, (Vossius & Partner)/

A quarter-century after supplementary protection certificates (SPCs) were introduced in the European Union, there are still a number of unresolved questions as to which types of products are, in principle, eligible for SPC protection. One further important piece in this puzzle will be provided by the CJEU’s forthcoming decision in the pending referral Abraxis Bioscience…

Case Law, European Union, France, Germany, Pharma, SPC, United Kingdom

, (Vossius & Partner)/

Why would anyone want to have their own supplementary protection certificate (SPC) revoked? – The answer is, quite simply, Article 3(c). Under Article 3(c) of Regulation (EC) 469/2009 on SPCs for medicinal products (and, likewise, under Article 3(1)(c) of Regulation (EC) 1610/96 on SPCs for plant protection products), an SPC shall be granted only if…

Brexit, Netherlands, Pharma, Unitary Patent, United Kingdom, UPC

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(Corrected) The American Food Drug Administration (FDA) will follow the European Medicines Agency from London to Amsterdam because of the Brexit. That is clear from a report on the website of the FDA, describing its international activities. “Since the first foreign office opened in Beijing in November of 2008, FDA’s international presence has grown to…

Case Law, Generics, Netherlands, Pharma, SPC, United Kingdom

(Hoffmann Eitle)/

The District Court of the Hague granted a provisional injunction against Sandoz’ generic darunavir product. As it was already offered in the G-standard, price erosion was an imminent danger for which a provisional injunction was warranted, and the SPC appeared to be valid having been held so in the parallell procedure before the UK court….

Biologics, European Union, Generics, Legislation, Pharma, SPC

, (Vossius & Partner)/

A consolidation and modernization of Europe’s intellectual property framework, featuring a “recalibration” of patent and SPC protection and possibly the creation of a unitary SPC title – those were the ambitious aims set out in the European Union’s single market strategy adopted in 2015. This was followed by a comprehensive evaluation of the legal aspects…

EPC, European Union, Pharma, SPC, UPC

(Clifford Chance)/ /7 Comments

In its judgment of 25 July 2018 (Case C-121/17 Teva v. Gilead), the CJEU had its latest say on the interpretation of article 3 (a) of Regulation (EC) 469/2009 concerning the Supplemental Protection Certificates for medicinal products (the “SPC Regulation”). In particular, it concluded that article 3 (a): “[…] must be interpreted as meaning that…