Roche vs. Natco – Genus vs. Species Patent Dispute over Risdiplam

Spinal Muscular Atrophy (SMA) is a rare genetic disorder that causes progressive muscle weakness and wasting, impacting voluntary muscle movement. India sees 3,000 to 4,000 new SMA cases annually, given its birth rate of 25-27 million per year. Evrysdi (Risdiplam), developed by Roche, is a breakthrough oral therapy for SMA. It was approved in India […]

Sanofi’s recent infringement lawsuits at the Unified Patent Court (UPC) mark a pivotal moment for pharmaceutical patent litigation. Background: Sanofi’s Jevtana (cabazitaxel), used for treating metastatic castration-resistant prostate cancer (mCRPC), has faced competition from generics since its regulatory exclusivity expired in March 2021. Sanofi’s market exclusivity now hinges on its medical use patent (EP 2,493,466), […]

Update: Teva Granted 30-Day Stay on Inhaler Patents’ Orange Book Delisting Last week, a federal judge in New Jersey granted Teva a 30-day stay during a hearing on their request. Amneal, supported by the FTC, has achieved a significant legal victory against Teva by successfully removing Teva’s inhaler patents from the FDA’s Orange Book. Amneal […]

Sandostatin (Octreotide) LAR is used for treating acromegaly, carcinoid tumors, and neuroendocrine tumors, among other conditions. Novartis owned EP 2377519, which expired on November 18, 2023. This patent covered specific processes for preparing octreotide acetate microparticles. In EU-5 countries, Teva and Pharmathen have approvals for generic versions of Sandostatin LAR, but only Teva has launched […]

In a recent decision, the Swedish Patent and Market Court provided critical insights into the interpretation of Article 3(b) and 3(d) of the SPC Regulation. The court opined that: The Marketing Authorization (MA) for Trimbow cannot be considered the first MA for the combination of formoterol fumarate and glycopyrronium bromide (Bevespi Aeosphere) because Trimbow contains […]

In the United Kingdom, multiple generic competitors initiated invalidity lawsuits seeking revocation of Bayer’s key dosing patent protecting Xarelto 10, 15, and 20 mg (EP 1845961, the ‘961 patent; set to expire January 19, 2026) at the UK High Court (UKHC). In late March 2024, the UKHC granted Bayer’s request for a preliminary injunction against […]

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#honor #recognition #gratitude #ipessentia

Thanks, Garima & Sneha for discussing TICAGRELOR, DAPAGLIFLOZIN, CHLORANTRANILIPROLE and SAROGLITAZAR cases at length & sharing the shifting trend.   #Genusspeciespatent #disclosurecoverage #interiminjunction #jurisprudence

Thanks, Bird & Bird, Life Sciences team…….. Mark Hilton & Jane Owen, for sharing the recent shift in Interim injunctions in UK & Australia Aden Chen, for providing insights on the implementation of Patent Linkage in China   #Patentlinkagechina #interiminjunction #Germanlawupdate #patenttermextension