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Intellectual Property

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US Court Sides With Amneal On ProAir Patents As Teva Vows Appeal

The inhaler patent saga goes on. A US District Court orders Teva to either de-list or correct patents for its inhaler ProAir HFA, but the originator disagrees and gets ready to appeal.

Legal Issues Generic Drugs

Medicines For Europe Highlights Sector Challenges As It Celebrates Milestone Anniversary

At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.

Europe Policy

The Generics Bulletin Podcast: Teva, Sandoz, Sawai and US Orange Book patents

Generics Bulletin’s editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA’s Orange Book.

Strategy Generic Drugs

Key UK Xarelto Patent Knocked Out Again In Boost For Generics Manufacturers

Bayer has been left reeling after the UK Court of Appeal found in favor of generics manufactures and reaffirmed a decision to revoke a key patent shielding its blood-thinner blockbuster Xarelto (rivaroxaban). Challenges to Xarelto’s IP are continuing apace across Europe.

Legal Issues Intellectual Property

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

We take a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

AAM Backs FDA’s Proposal For Skinny-Label Safe Harbors

AAM expressed its support for the FDA’s attempt to protect generics and biosimilar companies and their products with skinny labels that carve out patented indications. Meanwhile, the Senate Committee’s hearing on drug pricing gets mixed opinions.

Intellectual Property Legal Issues

US Eylea Biosimilar Approvals Set Up Competition On Aflibercept

Biocon and Biogen have received simultaneous US approvals for aflibercept biosimilar rivals to Eylea, with both products also receiving interchangeability designations. However, launches may have to wait while IP issues are resolved.

Biosimilars Approvals

Majority Of US Patent Thickets Filed Post-FDA Approval, Study Finds

As different US authorities keep pointing fingers at each other over who is responsible for improper patent listings, a study looks at patent applications that are filed after an FDA approval.

United States Market Access

Ozempic, Inhalers, In The Crosshairs As FTC Goes After Hundreds More ‘Junk Patents’

The US Federal Trade Commission is not resting on its laurels after seeing some success in its initial challenge to what it deems improper or irrelevant US patents that may be strangling cheaper generic competition.

Intellectual Property Legal Issues

ViiV Healthcare And Medicines Patent Pool Celebrate 10-Year HIV Collaboration

On the heels of a decade-long partnership with ViiV Healthcare that has helped 24 million people with HIV, the Medicines Patent Pool introduces a new version of its patent database for essential medicines and COVID-19 vaccines.

Market Access Emerging Markets

Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.

Legal Issues Intellectual Property

What’s Next? Five Things To Look Out For In May

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Generic Drugs Biosimilars

Vanda Comes Up Empty Handed As US Supreme Court Denies Hetlioz Appeal

Vanda looks likely to have to face up to unimpeded US generic competition to its core Hetlioz brand, after a further denial in its litigation against ANDA sponsors Teva and Apotex.

Intellectual Property Legal Issues

US Court Provides Opportunity For Lupin And Zydus To Debut Generic Myrbetriq

Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.

Launches Intellectual Property

Xtandi Pricing and Patents: Alternatives To March-In Urged To Lower Medicare, Medicaid Costs

The timing of the request, with Xtandi’s loss of exclusivity on the horizon, could be explained by the concern that a change in the US presidential administration in 2025 may limit the prospects for near-term relief.

Intellectual Property Reimbursement

Norwich Bruised As Failed US Rifaximin Appeal Bars Approval Until 2029

Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health’s core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label.

Legal Issues Intellectual Property
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