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Intellectual Property

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Samsung Bioepis Quiet On Launch Date After EU Soliris Biosimilar Approval

Samsung Bioepis responded to Generics Bulletin enquiries following its EU-wide approval for a biosimilar to AstraZeneca’s Soliris.

Biosimilars Approvals

Medicines For Europe Highlights Industry Agenda

Ahead of its annual meeting in Malta in mid-June, European off-patent industry association Medicines for Europe has set out the hot topics for generics and biosimilars stakeholders that delegates will be looking to discuss.

Europe Legislation

Stelara Settlement Gives Amgen US Ustekinumab Entry Date

A settlement reached in US patent litigation over Janssen’s Stelara will allow Amgen to launch its ABP 654 ustekinumab biosimilar no later than 1 January 2025. It remains to be seen whether other ustekinumab developers will follow suit.

Biosimilars Deals

US Court Shoots Down Norwich In ‘Unprecedented’ Xifaxan ‘Skinny Label’ Claim

Coming down heavily on Norwich Pharmaceuticals, a US district court has denied the US-based generics firm’s bid for relief post-judgment in a case involving the “hotly disputed” issue of skinny label ANDA products.

Legal Issues Intellectual Property

Industry Impact Weighed As US Supreme Court Refuses Skinny-Label Review

Teva has been denied in its attempt to convince the US Supreme Court to re-examine long-running litigation with GSK over skinny-label carve-outs of generic indications. However, the generics firm has vowed to fight on as the case is returned to the district court level, while the wider off-patent industry weighs the impact of the latest decision.

Legal Issues Intellectual Property

IP Divisions In Indian Courts: Will Pharma See Expediated Adjudication?

A second court in India establishes an intellectual property division to consider IPR matters and notifies rules following the dissolution of the Intellectual Property Appellate Board in 2021. Legal experts outline what that may mean for the efficiency and quality of IPR adjudications.

Intellectual Property India

Norwich Loses US Vyvanse Appeal – But Patents Run Course In August

US-based Norwich Pharmaceuticals has lost its bid to move several months early on US competition to Takeda’s Vyvanse ADHD blockbuster.

Legal Issues Intellectual Property

Sandoz Faces US Denosumab Lawsuit Ahead Of Key 2025 Patent Expiry

Months after announcing that its GP2411 biosimilar denosumab candidate was accepted for filing by the FDA, Sandoz has been sued for alleged patent infringement by originator Amgen.

Biosimilars Legal Issues

European Proposals Outline Compulsory Licensing And SPC Changes

A fresh EU patent package launched by the European Commission proposes an EU-wide compulsory licensing mechanism in times of crisis, as well as a unitary SPC for medicines, centralized SPC grants and a clearer framework for issuing standard essential patents.

Intellectual Property Legal Issues
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