Big Pharma

EU unveils sweeping pharma, biotech, and medical device reforms
23 December 2025   Europe’s life sciences sector is getting a major overhaul. A spate of reforms promises faster approvals, less red tape, and more innovation, reports Marisa Woutersen.

Latest Features

Europe
The High Court’s ruling clarifies aspects of the SPC waiver but leaves unresolved questions relating to export-country rights and confidentiality, say Claire Phipps-Jones and Luke Norton of Bristows.
Americas
Companies that integrate data rights into their IP strategy with a holistic approach will lead in innovation while minimising risk, says Terri Shieh-Newton of Mintz.
Europe
With EU trilogues deadlocked over the package, the future of drug exclusivities and access-linked obligations hangs in the balance. Jackie Mulryne and Paul Ranson of Morgan Lewis pinpoint the flashpoints to watch as negotiators push for a year-end deal.
Big Pharma
Clinical trials create a patent paradox. With EPO case law rapidly reshaping the 'expectation of success' test—most recently T136/24—the line between innovation and obviousness is blurred. Amanda Simons of J A Kemp offers drafting strategies to secure protection for your downstream innovations.
Americas
Parties impacted by exclusion orders need to carefully weigh their options for seeking clarity or rulings on redesigns, explain Daniel Muino and Charles Provine from Morrison Foerster.
Europe
As Big Pharma stalls investment in the UK, the government urgently needs to return to the negotiating table to salvage a key growth area, writes Tim Belcher of EIP.
Americas
In the second of a two-part series, Mercedes Meyer of Banner Witcoff and Brandon Phemester of Novavax delve into the real reasons why medicine costs more in the US.
Americas
In the first of a two-part series, Mercedes Meyer of Banner Witcoff and Brandon Phemester of Novavax explore how legislative, judicial, and executive policies have dramatically altered the risks for drug innovation.
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11 December 2025   Israeli drug maker bows to FTC pressure, removing scores of “improperly listed” patents in boon for generic manufacturers.
9 December 2025   Solicitor General urges the US Supreme Court to hear an appeal in its dispute, arguing that a ruling threatens the future of skinny labelling and the availability of lower-cost generics.
2 December 2025   The move could unlock billions in life sciences collaborations and position the UK to rival the US and China. But turning a famously conservative, patient-safety-first institution into a commercially savvy innovation hub will be no small feat.
27 November 2025   Director Squires rescinds previous guidelines and clarifies that there is no separate, modified inventorship standard for AI-assisted inventions.
26 November 2025   Balancing tight budgets while keeping up with fast-changing biosimilar rules is all in a day’s work for Novartis’s R&D IP team, but how do they stay on top of it all?
21 November 2025   The week exposed fractures in the UK's industry—but also unexpected reasons for optimism. Five themes dominated conversations about the direction of the country's life sciences sector.
20 November 2025   The country’s public health service has replaced its IP framework with a nine-step plan, as the government tries to reposition the UK as a global life sciences leader.
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