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The Hatch-Waxman Act allows the FDA to permit a generic version of a branded product, which is partially patent protected, to come to market if the generic manufacturer “carves out” the patent-protected indication from its label. The scope of protection from a finding of induced infringement afforded to generic manufacturers by this “skinny label” provision…
28 U.S.C § 1498 (a) (Governmental Use) The United States (U.S.) does not have any provisions for a compulsory license. The closest provision that it does have to the licensing of medicines and vaccines is what is called March-in rights. March-in rights allow the U.S. government to grant licenses to patented inventions provided the development…
The Unified Patent Court will open its doors for cases around mid-2022. That is the expectation of the UPC Preparatory Committee, which has published a time plan for the Provisional Application Period (PAP) and start of the UPC today. According to the plan, the PAP will have to be approximately eight months “to conclude all the work…
In Omni MedSci, Inc. v. Apple Inc., ___ F.4th ___, Nos. 2020-1715, -1716 (Fed. Cir. Aug. 2, 2021), the U.S. Court of Appeals for the Federal Circuit held that the University of Michigan’s technology transfer bylaws did not constitute an automatic assignment of a professor’s patent rights. This decision has important implications for the drafting…
Legal basis The legal basis for compulsory licenses can be found under the Indian Patent Act, 1970 (Indian Patent Act), Chapter XVI, read with Indian Patent Rules, 2003 (Indian Patent Rules). Requirements for obtaining a compulsory license Compulsory licensing under the Indian Patent Act is well codified and is in line with international agreements. The…
The legislation which enables Germany to ratify the Unified Patent Court Agreement has entered into force. It was published in the Federal Law Gazette on Thursday 12 August 2021 and came into force a day later. The development follows the dismissal, last month by the German constitutional court, of two requests for an interim injunction against…
In an Iberian validity dispute pitching a Spanish generics manufacturer against Portugal’s national pharmaceutical champion Bial Portela, the busy and influential Barcelona Commercial Court No. 5 rules on the “problem-solution approach”. In line with other recent decisions, the Court confirms i) that it may depart from the claimant’s choice of closest prior art and ii)…
The German Federal Court of Justice (FCJ) confirmed that for setting the value in dispute of nullity actions on standard essential patents (SEPs) the well-established general rule applies, i.e. in the absence of special circumstances the value is 125% of the value of the infringement action(s) on the same patent (Order of May 11, 2021,…
Although the grounds of the decision under R. 111(2) EPC do not have to deal in detail with all the arguments of the parties, at least the key points of discussion must be addressed. The grounds must respond to the relevant facts, evidence and arguments and contain the logical chain that led to the formation…
Almost ten months after India and South Africa sparked the debate on the protection of intellectual property rights with the TRIPS COVID-19 Waiver (IP/C/W/669), there is still no consensus at the TRIPS Council in favour of any action. Despite the support of numerous other WTO Members, including the United States, the TRIPS COVID-19 Waiver still…
