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.
1. Introduction: Over the last decade, in some of the countries that did not introduce patent protection for pharmaceutical products until 1992, there has been an intense debate which has included, inter alia, the following two questions: (i) whether or not under Articles 70.2 and 27.1 of TRIPS, a patent granted following an application claiming…
Although more than 20 years have passed since the Enlarged Board of Appeal issued its decision G 1/92, there is still little case law which provides guidance on how to establish the structure and properties of a particular medicament in a manner so as to be able to rely on the same as a piece…
Introduction In my previous post of 2 August 2013 I made passing reference to the recent decision of the English Court of Appeal in the Copaxone litigation. This case was an appeal of the decision of Arnold J (previously reported here) where he found Yeda’s patent valid and infringed. With permission of the court, Mylan…
The Paris District Court clarified its interpretation of Article 123 EPC regarding disclaimer allowability and allowed a disclaimer restoring novelty of a patent. Click here for the full text of this case. A summary of this case will be posted on http://www.Kluweriplaw.com .
In our post on 30 October 2012 we referred to forthcoming appeals dealing with how the question of obviousness should be tackled by the English courts. The Court of Appeal has now given its verdict in several judgments. The latest decision in Regeneron v Genentech dealt not only with the question of obviousness but also…
The act of including a generic product into the official Austrian pharmaceutical product index before expiry of the relevant patent/SPC, is considered an act of “putting into circulation” and therefore a patent infringement. By the same token the act of applying for reimbursement by an application to be included into the “Red Box” pursuant to…
The Court of Appeal partially reversed the Brussels Commercial Court’s decision invalidating Lundbeck’s SPC for escitalopram, to the extent that it had immediate effect. A summary of this case will be posted on http://www.KluwerIPCases.com
Regarding the interpretation of “offering for the purpose” (of making, using etc.) in the sense of Article 53(1)(b) Dutch Patent Act, the Supreme Court held that offering has to be construed broadly and is not restricted to offering for sale. The defendant submitted its generic product for listing in G-Standaard, the database for medicinal products…
