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Fried Frank Harris Shriver & Jacobson LLP | USA | 6 Sep 2023
A New Era: DOJ Announces Structural Relief for Criminal Violations of the Antitrust Laws
On August 21, 2023, DOJ announced that Teva Pharmaceuticals USA, Inc. (“Teva”) and Glenmark Pharmaceuticals Inc., USA (“Glenmark”) have entered into…
Cozen O'Connor | USA | 4 Aug 2023
Supreme Court Confirms: Subjective Beliefs of Falsity are Fair Game in FCA Lawsuits
On June 1, 2023, the Supreme Court unanimously held in two consolidated landmark cases, U.S. ex rel. Proctor v. Safeway Inc. and U.S. ex rel. Schutte…
Smart & Biggar | Canada | 31 May 2023
Health Canada opens consultation on proposed application of definition of Canadian reference product based on dormant status
A generic drug manufacturer can file an abbreviated new drug submission based on a comparison to a Canadian reference product. Health Canada recently opened for consultation a proposed application of the definition of "Canadian reference product" under C.08.001.1(b) of the Food and Drug Regulations.
S Horowitz & Co | European Union, Israel, United Kingdom | 23 May 2023
Novartis' PI Motion re Gilenya® Denied: Generic Entry Does Not Necessarily Cause "Catastrophic Damages" to the Brand
In a recent decision, the Israeli Supreme Court upheld a decision of the Tel Aviv District Court, which denied a motion for preliminary injunction…
BCB | Mexico | 22 May 2023
Current situation concerning regulation of industrial property and technological innovation in Mexican animal health industry
The Linkage Gazette publicises patents relating to inventions that may be used in allopathic drugs. To date, there are no examples of drugs for veterinary use listed in the Linkage Gazette, despite fully meeting the criteria of an allopathic drug. With the existence of this huge gap in the Mexican legislation, the holders of patent rights for allopathic medicaments for veterinary use are......
Covington & Burling LLP | European Union | 2 May 2023
EU Pharma Legislation Review Series: Bolar Exemption under Patent Rights
The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity…
K&S Partners | India | 26 Apr 2023
Court rejects Bristol-Myers Squibb's injunction request in relation to its Apixaban patent
In a recent case, Bristol-Myers Squibb (BMS) sought a permanent injunction against Zee Laboratories (Zee Labs) for infringing BMS's patent covering the anticoagulant drug Apixaban. BMS alleged that Zee Labs was manufacturing generic Apixaban and selling it on third-party e-commerce websites and social media platforms. The court noted that BMS's patent had already expired, however, and that......
Westerberg & Partners Advokatbyrå AB | Sweden | 24 Apr 2023
When can a preliminary injunction be granted ex parte?
This case discussed in this article examines the conditions under which a preliminary injunction can be granted ex parte. While the Patent and Market Court of Appeal ultimately found that those conditions were not met in the case at hand, the ruling poses interesting questions on the traditionally restrictive Swedish view on ex parte preliminary relief in patent cases. The case shows that a......
Lee and Li Attorneys at Law | Taiwan | 24 Apr 2023
Court rules in favour of pharmaceutical companies that market category two new drugs
When the Patent Linkage Registration System was first launched, accounts were set up specifically for the marketing authorisation holders of category two new drugs to submit their patent information. The Food and Drug Administration (TFDA) subsequently decided to delete such accounts. The Taipei High Administrative Court recently overturned the TFDA's decisions in a judgment that will have a......
Grau & Angulo | Spain | 17 Apr 2023
Barcelona Court of Appeal revokes preliminary injunctions that had temporarily prevented marketing of fingolimod generics
The Barcelona Court of Appeal recently revoked the preliminary injunctions that Barcelona Commercial Court No. 10 had granted at the request of Novartis against Viatris, Teva and Reddy. The injunctions had temporarily prevented these companies from marketing generic fingolimod drugs. The Court concluded that the defendants had committed no acts of unfair competition and that their actions......
