Intellectual Property

Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Generics Bulletin looks back at a selection of the most significant legal stories from 2022, including a major victory in the UK on the Eliquis blood thinner giant and continued action on generic label carve outs, which has the potential to reverberate through the US industry.

Pfizer’s Ibrance is set to lose exclusivity in the US only by 2027, but the Indian market is buzzing with activity as generics including from top-ranked drug maker Sun Pharma vie for a share of the pie. Competing CDK4/6 inhibitors are already available but can cut-price palbociclib versions alter market dynamics?

In a closely-watched case, the first of two planned in less than 18 months, MSN Laboratories scooped a mixed verdict from a US district court regarding its proposed generic version of Exelixis’ Cabometyx (cabozantinib) tyrosine kinase inhibitor.

Court sets aside order pertaining to patent for Novartis’s Entresto in India, setting the stage for high-octane generic competition that potentially includes frontline domestic companies. If the Swiss firm appeals, market dynamics may be impacted but prices of same-composition second brands of the heart-failure therapy are already headed southwards.

Jazz Pharmaceuticals’ GW Pharma arm has brought a patent infringement suit against more than a dozen proposed ANDA sponsors targeting generic versions of its marijuana-derived Epidiolex (cannabidiol) to treat rare and severe childhood-onset epilepsies.

The US Court of Appeals for the Federal Circuit has comprehensively rejected Genentech’s patent-litigation appeal against Sandoz over the ANDA sponsor’s generic version of its Esbriet treatment for idiopathic pulmonary fibrosis.

Novartis has agreed to pay out $245m to purchasers and retailers to resolve a lawsuit accusing the originator of an unlawful deal with Par that delayed US competition to the Exforge antihypertensive.