Because No One is Immune to the Law
January 25, 2019 - European Union, Pharma, Regulatory, Intellectual Property

A Structured Guide to Recent Case Law of the Court of Justice of the European Union on Supplementary Protection Certificates in Europe

Fourth Circuit’s Decision Revitalizes First Amendment Challenge to the TCPA

In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be extended for up to five years.

Once a patent has been filed, a corresponding pharmaceutical product often has to undergo time consuming regulatory approval before it can be marketed. Sometimes there are only a few years left on the patent by the time the product is first launched. As a result, the net sales time under the exclusivity conferred by the patent is often not long enough to ensure sufficient research incentives and the possibility of compensation. In the EU, Regulation (EC) No 469/2009 (“SPC Regulation”)addresses this issue by providing the possibility to obtain SPCs for an authorized medicinal product, granting essentially the same rights as the original patent (the “basic patent”) for an additional maximum term of five years. Yet another six months can be added if the requirements of the Regulation (EC) No 1901/2006 and Regulation (EC) No 1902/2006 (“Pediatric Extension Regulation”) are met.

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