Pharma IP in view as new USPTO director Kathi Vidal wins Senate confirmation
The US Patent and Trademark Office (USPTO) has a new Senate-confirmed director who may take a crack at pharma patents, as the spotlight has centered on them throughout the pandemic.
President Biden’s nominee Kathi Vidal, confirmed via voice vote on Tuesday night, will take the reins of USPTO’s 13,000+ employees and its nearly $4 billion budget, after she served as managing partner of Winston & Strawn’s Silicon Valley office, after serving for more than 25 years as an IP litigator in private practice.
In her confirmation hearing, Vidal vowed to take a look at discretionary denials at the Patent Trial and Appeal Board, which in recent years have been used to deny patent challenge requests, hurting generic drugmakers’ chances of bringing competition to market quickly for often expensive brand name drugs.
IP also has remained center stage in discussions over Covid-related vaccine equity, and amid ongoing legal battles involving pharmas and their claims invoking certain payments from profits the vaccines have generated.
For instance, Pfizer’s partner, Canadian biotech Acuitas, sued biotechs Arbutus and Genevant, saying in a court filing two weeks ago that their “claim to rights in— and payment for— Comirnaty is baseless.”
This was in the aftermath of Alnylam suing both Pfizer and Moderna, alleging a breach of their intellectual property rights over LNP lipids used in the two giants’ mRNA Covid-19 vaccines.
Nonprofit I-MAK, short for Initiative for Medicines, Access & Knowledge, expressed support for Vidal’s appointment but said there’s work to do.
“We are looking forward to working with incoming Director Vidal, particularly on advancing reforms to create a patent system that is more equitable, transparent, and inclusive,” the nonprofit’s statement said.
What will make Vidal’s new job more distinct from her predecessors is that the USPTO will be more empowered, at least in part, by a Supreme Court ruling from last year: US vs. Arthrex. The court ruled that the director of the patent office, now confirmed to be Vidal, has the power to overturn decisions made by the Patent Trial and Appeal Board, a tribunal that reviews the validity of issued patents.