Category: Pharmaceutical Industry
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Global pharma company Adalvo eying U.S. expansion, says Chief IP Officer
While the B2B pharma company has expanded its European business significantly in the last decade, it is now turning to the U.S. to bring its licensing business, Adalvo’s Toni Santamaria told ip fray at IP Dealmakers earlier this month.
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China Implements Pharmaceutical Test Data Protection Rules: A New Era for Drug Data Protection
China has promulgated the Measures for the Implementation of Pharmaceutical Test Data Protection and the Work Scheme for Pharmaceutical Test Data Protection, which together operationalize for the first time a formal PTDP system in China, granting up to six years of data exclusivity to qualifying chemical and biological drug applicants.
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Pharma giant Takeda ordered to pay over $884 million in damages in Amitiza class action suit: patent litigation settlement was anticompetitive, jury finds
Takeda has said it already plans to “vigorously” appeal the decision, which found its 2014 deal with competitor Par Pharmaceutical to drop its challenge to its AMITIZA patents and delay its generic entry by seven years, anticompetitive.
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Actelion falls foul of disclosure-dedication rule, prosecution estoppel in Federal Circuit challenge to Mylan’s hypertension generic
The Federal Circuit agreed that there was neither literal infringement, nor infringement under the doctrine of equivalents.
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Federal Circuit analysis would create “substantial disincentive” to generic entry, USDOJ tells Supreme Court in Hikma v. Amarin
The key arguments centred on whether it was plausible that Hikma’s marketing amounted to inducement to infringe.
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Merz wins UPC appeal as CoA overturns Paris LD denial and grants PI against Viatris generic in France
The UPC CoA has reversed the Paris LD’s refusal of interim relief and granted Merz a preliminary injunction against Viatris Santé’s fampridine generic in France.
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CureVac sues Moderna in Delaware over Spikevax patents, seeking treble damages but no injunction
CureVac sues Moderna for treble damages but not an injunction over 10 patents related to Spikevax. The case adds to broader post-COVID mRNA patent battles.
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ECJ Advocate General says excipient label is binding for SPC purposes: Halozyme v. Czech IPO
AG Emiliou says a substance in a MA that is called an excipient may not be considered an active ingredient for SPC purposes, which would invalidate grants in eight EU member states.
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Another semaglutide generic enters India as Novo Nordisk patent expires, no injunction issuesÂ
The Delhi High Court has issued a ruling allowing a generic version of semaglutide to be sold without an injunction and indicating a cautious approach to late-stage enforcement, favoring restricted entry over exclusion, by basing it around a contested claim limitation.
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Colombia pushes for compulsory licensing of U.S. pharma company’s patents
Colombia’s Health Minister has revived a previous administration’s investigation into four of U.S. pharma company Gilead’s patents at the core of Hepatitis-C treatment, issuing a public interest declaration to make the licensing of such patents compulsory.