Three Takeaways From Bayer Snub In Indian Bolar Exemption Case

An Indian court has ruled against Bayer in a case concerning certain key aspects of the country’s Bolar provision - the experimental use or early working exception – with respect to the German multinational’s Nexavar and Xarelto. The court held that the meaning of “selling” under the provision cannot be construed to “exclude therefrom selling by way of exporting”.

German multinational Bayer Corp. suffered a setback in India, after the Delhi High Court failed to find merit in its contention on key aspects pertaining to Section 107A of India’s Patents Act - the Bolar Provision – in a case against the Indian firms Natco Pharma Ltd. and Alembic Pharmaceuticals Ltd.

Natco and Alembic have been permitted to export the active ingredients in Nexavar (sorafenib tosylate) and Xarelto (rivaroxaban)

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legal & IP

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.

NIH Funding Cut Left Less Money On R&D Table, Tariffs Would Add To Woes: Aragen’s CEO

 
• By 

Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs

Deal Watch: FTC Keeps Current Merger Guidelines In Place, For Now

 
• By 

Plus deals involving Incyte/Genesis, Merck & Co./Epitopea, Merck Serono/Asceneuron, Tivic Health/Statera and more.

More from Business

Multiple Launches Help Lilly’s Japan Growth

 
• By 

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

AbbVie Pays $335m Up Front To Partner With ADARx On siRNA Therapeutics

 
• By 

ADARx CEO Zhen Li told Scrip the collaborators will advance novel siRNA medicines, but ADARx retains its clinical-stage and many preclinical programs and remains open to more deals.

Bluebird, Private Equity Firms Look To Sweeten Buyout Deal

 

Shareholders are being offered a flat fee of $5 per share as an alternative to $3 plus a contingent value right, which could be a more attractive option if they want cash up front.