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7 January 2021AmericasMuireann Bolger

Generics petition Supreme Court to save PTAB patent trials

Generic drug makers are trying to persuade the US Supreme Court to retain an administrative process for challenging patents, in the latest bid to discredit the controversial decision handed down in Arthrex v Smith & Nephew.

In March, justices at the Supreme Court will review the US Court of Appeals for the Federal Circuit ruling in November 2019 that held that Patent Trial and Appeal Board (PTAB) judges were unconstitutionally appointed.

According to the ruling, judges are “principal officers” under the US constitution and, as such, should be appointed by the US President, subject to confirmation by the Senate. In its remedy, the Federal Circuit granted the US Patent and Trademark Office director the power to remove the administrative patent judges from office.

But industry groups representing Apotex, Dr. Reddy’s Laboratories and others oppose this development, fearing that it may lead to the scrapping of tribunal patent validity trials or expose them to political influence. The US government has also argued that the Federal Circuit underestimated the power of the USPTO director and had gone too far in its remedy.

In an amicus  brief filed in December, the Association for Accessible Medicines (AAM), an advocacy group comprising generic producers, stated that its members depend on fair and prompt adjudication of patent claims that seek to block their efforts to bring lower-cost drug options to patients.

“The inter partes review process is thus essential to the work of AAM’s members and to the patients who depend on generic and biosimilar medicines,” said the association.

Generic drug makers facing suits in federal court for patent infringement frequently turn to the PTAB to invalidate the disputed IP. While the suit is ongoing, the US Food and Drug Administration is prevented from approving the generic for 30 months.

However, if the district court stalls the case for the conclusion of inter partes reviews at the PTAB, the 30-month period could potentially elapse while the lawsuit is still pending. This can then allow the generic to bring their product to market.

In its brief, the AAM argued: “When it adopted the current IPR system in 2011, Congress recognised that patent examiners—labouring under an intense workload—frequently issue patents that are invalid.”

The process of inter partes reviews, the association added, allowed for the fixing of those mistakes without forcing competitors to undertake lengthy, expensive litigation to defeat patents that never should have been granted in the first place.

The Coalition Against Patent Abuse (CAPA), which includes AAM, healthcare providers, and patient advocacy organisations as members, also filed an amicus  brief last month

“Congress structured the board to conduct inter partes reviews impartially based on the law, largely free of political pressures from powerful lobbies such as the pharmaceutical industry,” CAPA said in the brief.

In its conclusion, the coalition warned the Supreme Court should ensure the viability of post-grant patent proceedings to enable a competitive pharmaceutical market and protect legal proceedings from unnecessary political influence.

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