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Intellectual Property

FTC’s Latest Effort To Dispute Improper Patent Listings Barely Made A Dent

Trump’s FTC has carried on two legacies – trying to eliminate improper drug patent listings and making minimal impact on such efforts.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Novartis Upbeat Even With Entresto Expiry Looming

Swiss major confident that new oncology drugs will fill revenue gap.

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

The Politics Of Divisionals: How European Patentees Are Still Gaming The System

At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.

‘Prescription Drugs Are Not Golf Balls’ – Opinions Clash On Patents During FTC/DOJ Listening Session

Pro-innovator voices argued that the number of patents asserted in the pharma industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

IGBA Asks G7 To Consider Access Issues

The International Generic and Biosimilar medicines Association has set out three priority areas that it says should be considered by G7 leaders at the current summit in Alberta, Canada, as part of efforts towards ensuring access to health.

Trump’s FTC Continues The Mission Of Eliminating Orange Book’s Improper Patent Listings

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.

Pharma Left Hanging After US/UK Trade Pact

An ‘historic economic prosperity deal’ does not include the sector.

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.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an audio interview.