Intellectual Property

Biocon’s ongoing legal battle with Regeneron over US patents shielding Eylea was discussed by the originator at a pair of recent healthcare conferences, with a decision due any day.

Teva potentially was only a matter of days away from hearing a decision in its patent litigation battle over Vivitrol (naltrexone) long-acting injectable, but has instead put pen to paper on a settlement deal.

The Brazilian medicines regulator, ANVISA, is considering whether to allow generic drug labeling to omit indications of the originator product that are still under patent. "Skinny labels" also figure in an ongoing court case involving Boehringer Ingelheim's Ofev (nintedanib).

Sun is looking to reignite Orexo’s legal headaches over its key Zubsolv opioid dependence treatment, following the Indian firm’s defeat in patent-litigation proceedings last month.

Teva has dealt out of US patent-infringement proceedings with Exelixis over the originator’s Cabometyx, picking up a date-certain launch early in the next decade.

Speaking during the firm’s Q2 results call, J&J management has indicated that it does not expect biosimilar competition to Stelara to hit the market until at least 2025.

Johnson & Johnson has reached an agreement with the Stop TB Partnership that will allow generic bedaquiline versions of the firm’s Sirturo brand to be supplied in LMICs where patents remain in effect – but critics say the deal does not go far enough.

Entresto, one of the major small molecule opportunities for ANDA sponsors in the US, has seen a key patent knocked out following a challenge by generics manufacturers.

Another ANDA sponsor has tried and failed to navigate Orexo’s patents for its opioid dependence sublingual tablets, Zubsolv.

Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.

Following a US federal court jury decision, Teva looks to be off the hook after being accused of accepting an illegal reverse payment that allegedly kept branded prices artificially high for Gilead Sciences’ HIV power brands Truvada and Atripla.

A sizeable small-molecule opportunity, Pfizer’s Ibrance, is in the crosshairs for several major ANDA sponsors in the US, with Zydus the latest company to receive a tentative nod from the FDA.

Sandoz and Polpharma’s September 2022 lawsuit over their proposed biosimilar to Biogen’s Tysabri (natalizumab) has moved a step forward in their favor, after a US court denied the originator’s bid to block a pathway to market for their proposed monoclonal antibody while proceedings continue.

The Medicines Patent Pool has facilitated sublicenses with seven manufacturers to distribute generic versions of Shionogi’s oral COVID-19 antiviral ensitrelvir across low- and middle-income countries.

Commission backs purchasers and end payers in appeal of district court dismissal of suits against Forest and six generic manufacturers. It contends the court contravened Supreme Court’s Actavis decision and proffered its own justifications for side deals in patent settlements.

Details of the four firms that have been selected to manufacture generic versions of Novartis’s nilotinib treatment for chronic myeloid leukemia have been revealed by the Medicines Patent Pool.