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Intellectual Property

Set Alert for Intellectual Property

Questions Swirl Around US Aflibercept With Biocon Decision Imminent

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.

Biosimilars Intellectual Property

Teva Settles On US Vivitrol Despite Conclusion Of Patent-Litigation Trial

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.

Deals Intellectual Property

Firms Await Brazilian Regulator’s Decision On Allowing ‘Skinny Labels’ For Generics

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).

Intellectual Property Market Access

Sun Is Not Walking Away From US Zubsolv Defeat

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.

Legal Issues Intellectual Property

With Settlement In Hand, Will Teva Outstrip MSN On US Cabometyx?

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.

Legal Issues Intellectual Property

Ustekinumab Rivals Face Exclusion Until 2025

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.

Biosimilars Intellectual Property

J&J Faces Further Criticism Over Bedaquiline Despite Licensing Deal

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.

Deals Intellectual Property

ANDA Sponsors Knock Out Key US Entresto Patent, Mylan Falls To Infringement

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.

Intellectual Property Legal Issues

Sun Pharma Faces Nine-Year Wait After US Zubsolv Ruling

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

Intellectual Property Legal Issues

EC Says ‘Bolar Exemption’ Should Cover Pricing, Reimbursement & HTA Processes

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.

Europe Intellectual Property

Teva, Gilead Swerve $3.6bn Claim Over US Truvada, Atripla Settlement

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.

Legal Issues Intellectual Property

Another US Generic To $3bn Ibrance Passes Muster – When Will They Launch?

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.

Approvals Generic Drugs

Sandoz, Polpharma Overcome US Injunction Bid On Tysabri Biosimilar

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.

Legal Issues Intellectual Property

MPP Facilitates Agreements With Seven Manufacturers For COVID-19 Antiviral

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.

Coronavirus COVID-19 Intellectual Property

FTC Argues Forest Side Deals In Bystolic Pay-For-Delay Case May Be Unjustified Payments

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.

Legal Issues Generic Drugs

MPP Unveils Quartet Of Nilotinib Licensees

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.

Deals Intellectual Property
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