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Vaccine, Drug Patents on Deck for PTO Director Nominee Vidal

Oct. 29, 2021, 2:41 PM

The Covid-19 pandemic and government concerns over rising drug prices have teed up novel issues for the Biden administration’s nominee for U.S. Patent and Trademark Office director to tackle.

If confirmed by the Senate, Kathi Vidal would assume PTO leadership amid heightened scrutiny of America’s patent system. Intellectual property rights have taken up an outsized role in debates over global vaccine equity and drugmaker strategies to keep lower-cost, competing products off market.

“She’s going in with a mandate from the administration to work with HHS and the FDA on drug pricing issues and overpatenting,” said Matthew Lane, executive director of the Coaltion Against Patent Abuse. “All of these are pretty good signs.”

Vidal, a Winston and Strawn Silicon Valley partner, comes to the PTO from a tech litigation background, having represented the likes of Airbnb Inc. and Microsoft Corp. in patent disputes.

Her work experience in the biopharma space, however, is more limited. Vidal has defended Intuitive Surgical Inc. against allegations that it infringed a rival’s medical device patents and represented Natera Inc. in a dispute involving diagnostic products. But PTO watchers note she comes to the agency with a neutral slate on questions around drug patents currently driving heated debate.

“A compromise ticket is a pretty good sign,” Lane said. “Having someone come in and look at this topic fresh could be a good thing.”

Vidal didn’t immediately respond to a request for comment.

Place of Power

Critics have accused the U.S. patent system of granting drug companies low-quality patents that make it harder for cheaper drugs to enter the market without infringing them.

In the current political climate, the role of PTO director has become “very political,” said Russ Slifer, a former PTO deputy director in the Obama administration. “As polarized as the country has become politically, the competing parties are also polarized when it comes to patents.”

For some Democrats in the drug space, that division translates to “the patent system is hurting mankind because it’s not getting important drugs and benefits to people,” Slifer said. Lobbying from the biopharma industry for stronger patents to protect incentives to innovate, pitted against those who are pushing for lower drug prices, have helped drive this political wedge.

“The public lobbying side"—for instance, openly supporting legislation to reform patent practices that some say keep lower cost copycat medicines off the shelves—is where Vidal’s power lies, Slifer said.

Part of the reason is that “a lot of the things that need to change are statutory in nature,” said Priti Krishtel, co-founder of the Initiative for Medicines, Access, and Knowledge.

Indeed, policy experts say the PTO’s abilities are hampered by the law. Put differently, how the agency and its employees operate is largely governed by how Congress writes patent law.

Right now, “when PTO examiners are examining individual patents, they’re just looking to see if it complies” with the law, she said.

‘Key Voice’

When it comes to the pandemic, Vidal would be expected to provide “a key voice” in ongoing World Trade Organization talks on a global waiver for intellectual property protections on Covid-19 vaccines and treatments, Krishtel said.

The administration in May voiced its support for waiving Covid-19 vaccine protections, though an official approach to that undertaking has yet to be hammered out. Pfizer Inc. and Johnson & Johnson have voiced opposition to the idea of waiving IP rights, as have other drugmakers.

“With its embrace of the IP waiver” and other moves, George Mason University law professor Adam Mossoff said “the Biden administration has made it fairly clear that it is very skeptical about patents and the key role patented innovation serves in our innovation economy.”

Regardless of Vidal’s views on patents in the biopharma space, “she will be taking her marching orders from the administration, and it will be her responsibility to implement the innovation policy of the Biden administration,” Mossoff said.

In Mossoff’s view, “rhetoric-driven narratives” are driving policy fights about patents in the biopharma space, and Vidal could “have a very large impact” on drugmakers’ abilities to invest in and commercialize “cutting edge treatments” due to the discretion afforded the PTO to consider patent validity under existing case law.

Vidal’s influence may prove particularly amplified given the Food and Drug Administration’s request for the PTO to help curb drug prices. FDA acting commissioner Janet Woodcock in September sent a letter asking the agency whether it was considering approaches to limiting drug companies from securing multiple patents on a drug.

Proponents of PTO reforms have noted that rolling back agency changes implemented during the Trump administration could make it easier for generic and biosimilar drug makers to try and get the agency to invalidate problematic patents. They’ve also floated giving patent examiners more time to review applications as a possible change.

Yet how Vidal proceeds will remain to be seen, legal experts say.

“It’s hard to tell at this point in advance what policies she might implement,” Mossoff said. “The degree to which she can give pushback is limited, so it will be ultimately an interesting question as to the degree to which she will implement the administration’s policies or not.”

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Melissa B. Robinson at mrobinson@bloomberglaw.com

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