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Patents

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.

Accord And Sandoz Remain Frustrated As Dutch Xtandi Patent Is Latest To Hold Firm

In a further setback for generics manufacturers, the District Court of The Hague has upheld the validity of a key Xtandi (enzalutamide) patent and its Dutch supplementary protection certificate, rejecting Sandoz and Accord’s challenge based on lack of inventive step.

Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.

Patent Settlements Are ‘Critically Necessary’ As AAM Calculates $423bn Savings Since 2013

The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.

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.

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.

AI In Drug Discovery: The Patent Implications

A Q&A with DeAnn Smith, partner and co-chair of the Patent Trial and Appeal Board Proceedings Practice Group at law firm Foley Hoag.

Micro Labs Agrees To 15-Year Freeze On US Bempedoic Acid Rival

Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.