CJEU refuses UK High Court’s request for preliminary ruling on SPC applications based on third-party MAs, on account of referred question being “hypothetical” (C-239/19 Eli Lilly v Genentech)
On 5 September 2019, the Ninth Chamber of the CJEU refused a request for referral in relation to the interpretation of Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (‘SPC Regulation‘). In its order, the CJEU held that this request for a preliminary ruling was manifestly inadmissible a under Article 52(3) of the Rules of Procedure of the Court of Justice, as the question referred was hypothetical for the purposes of the dispute in the main proceedings…
Article 3(a) just keeps on giving: AG Opinion in SPC referrals C-650/17 and C-114/18
The Advocate General (AG) has issued his opinion in SPC Referrals C-650/17 (Royalty Pharma) and C‑114/18 (Sandoz). Both referrals seek clarification over whether an SPC may be granted to a specific, individualized, embodiment of the product claimed by the basic patent. The referrals particularly relate to the correct interpretation of Article 3(a) of the SPC Regulation (Regulation (EC) No. 469/2009). Article 3(a) states that an SPC shall be granted for a product “protected by a basic patent in force”. C-650/17 asks how Article 3(a) should be applied to functional claims, and C‑114/18 asks how Article 3(a) should be applied to claims specifying a Markush formula. In his opinion, the AG is clear that Article 3(a) should be interpreted for these types of claims according to the test provided in the CJEU decision C-121/17 (Teva)….
CJEU preliminary ruling judgment in C-688/17 (Bayer) provides interpretation on Art. 9 (7) of the Directive 48/2004/EC (Enforcement Directive) based on a referral from the Hungarian court
On September 12, 2019 the Court of Justice laid down its decision in C-688/17 (Bayer) in a preliminary ruling proceeding coming from the Metropolitan Court, Budapest, about the interpretation of Art. 9 (7) of the Enforcement Directive, particularly regarding the term “appropriate compensation” that is due to defendants in the event a preliminary injunction is subsequently lifted.
In the decision the CJEU ruled that the term “appropriate compensation” is a sui generis notion of EU law and shall be interpreted in a uniform manner throughout the EU. Also the court highlighted that the subsequent revocation of the patent in suit does not as such render the earlier granted preliminary injunction unfounded.…
Vectura wins additional $10m patent damages against GSK
A district court has upped Vectura’s award of $89.7 million in damages by $10m, after a jury trial earlier this year found that GlaxoSmithKline (GSK) has willfully infringed one of its patents. In a press release on Friday, September 13, Vectura announced that the US District Court for the District of Delaware had granted its motion for a 3% royalty rate on all future US sales of the infringing products until Vectura’s patent expires in 2021. It was also granted royalties on previous sales of the products from January 1, 2019 to May 16, 2019.…
Allergan, Lupin Must Face Payer Class in Loestrin Antitrust Suit
A group of pension and benefit funds won class action status Sept. 17 in a lawsuit accusing Allergan PLC, Lupin Ltd. and their affiliates of divvying up the birth control market, but a District of Rhode Island judge rejected a parallel bid by consumers. The multidistrict suit also targets several formerly independent companies owned by Allergan. It concerns patent infringement settlements that Warner Chilcott Co., now an Allergan subsidiary, reached with other drugmakers looking to roll out generic versions of its contraceptive pill Loestrin 24 FE…
Cabaret Biotech Files Lawsuit Against Gilead Over Yescarta Drug
Closely held Cabaret Biotech said it had filed a preemptive lawsuit against Gilead Sciences Inc. and its Kite unit “to end a needless dispute about patent royalties” over the cancer treatment Yescarta (axicabtagene ciloleucel). Gilead, which exclusively licenses a patent from Cabaret for Yescarta in the field of oncology, has protested its royalty payment obligations since October 2018, according to complaint filed Monday in federal court in Wilmington, Delaware. Cabaret is seeking a judgment that the patent isn’t invalid and that but for the license agreement, Yescarta infringes the patent, complaint says…
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