Supreme Court to consider whether Patent Trial and Appeal Board must address all patent claims challenged in an inter partes review petition.
While it's not the headliner inter partes review case before the US Supreme Court, the outcome of SAS Institute v. Matal could impact the way patent challenge proceedings are handled by the patent office and what claims can be litigated in district court.
The court will determine whether final written decisions by the US Patent and Trademark Office's Patent Trial and Appeal must...
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The Trump Administration may differ from the Biden Administration in some areas of health care antitrust enforcement, but experts said some Biden-era priorities may be maintained.
MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.
Newly enacted standard contractual clauses for negotiating clinical trial agreements in Germany appear positive for sponsors compared to the clauses that trial sites were typically requesting in the past, eg, those relating to compensation for the transfer of inventions, according to lawyers.
The agreement to resolve or stay numerous legal and administrative disputes resulted from a recent appeals court decision and the new agency leadership's receptiveness to negotiations, said Vanda, which has filed a barrage of challenges against the FDA in recent years.
MSN Laboratories wins another case against Novartis and will keep approval for its generic version of Entresto. The decision effectively confirms that US FDA can approve ANDA labels that make limited wording changes to carve around patent-protected indications, reinforcing the agency’s flexibility.
EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.
The Immunization Safety Office leveraged a “coordinated network of complementary surveillance systems” to monitor COVID-19 vaccine risks during the pandemic, but its communications faced challenges and were often intertwined with CDC efforts to promote vaccination, NASEM report finds.
