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China Steps Closer To Offering An SPC System

 
• By Aidan Fry

A recent public consultation raises the prospect of extending patent terms in China by up to five years; greater data protection, as well as patent linkage, are also being mooted.

GreatWall
Generics could soon face an additional barrier to entry in China in the form of supplementary protection certificates • Source: Shutterstock

Supplementary protection certificates (SPCs) have taken a step closer to being implemented in China after the National People’s Congress completed a one-month public consultation period on draft amendments to the Chinese Patent Law. The proposed amendments form part of a broader move towards stronger intellectual property (IP) protection in China that also includes pharmaceutical data exclusivity.

Acting on a State Council resolution, China’s National Medical Products Administration (NMPA) proposed a general framework for patent linkage and...

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Zydus Trastuzumab Suit Dismissed In India For ‘Illusion Of Cause Of Action’

 
• By Dean Rudge

After nearly a decade of procedural delays, a Bombay High Court has finally tossed Zydus Cadila’s pre-emptive complaint against Roche over its Herceptin biosimilar, calling it an “illusion” of a real dispute.

Alchem Fined Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

US Federal Circuit Says It Will Not Rehear Viatris Invega Trinza Infringement Ruling

 
• By Dean Rudge

The US Federal Circuit’s March 2025 decision affirming a lower court’s determination on both induced infringement and non-obviousness concerning a key patent shielding Janssen’s Invega Trinza (paliperidone palmitate) long-acting injectable is set to stand – for now.

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Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 
• By Anju Ghangurde

Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?

Alchem Fined Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

 
• By Dean Rudge

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.