What You Need To Know About Biden And IP

Law360 (November 8, 2020, 5:22 PM EST) -- President-elect Joe Biden's record on intellectual property is somewhat limited, but he is expected to be vigilant in enforcing U.S. IP rights abroad and active in combating counterfeiters.

Additionally, while the former vice president has previously been criticized for his Big Pharma ties, he appears to be repositioning his stance on how to broaden access to generic drugs and tackle high drug prices.

Biden was named the winner of the U.S. presidential election Saturday with his apparent wins in Pennsylvania and Nevada, but President Donald Trump says he will continue to fight the results in court

Here's a look at what you need to know about Biden and some of his views on IP.

Limited Patent Focus

Biden's appointment to lead the U.S. Patent and Trademark Office will likely set the tone on how a Biden administration approaches patents, rather than the president himself. While the America Invents Act was signed into law while Biden was vice president, he wasn't heavily involved, and he hasn't had much to say on the finer details of patent law.

"In the Obama administration, there was a moment where patent reform captured widespread attention, including within the Obama administration," Mintz Levin Cohn Ferris Glovsky and Popeo PC member Jim Wodarski said. "I would say Joe Biden was never a spokesperson for the administration on that issue."

As vice president, Biden was known for the National Cancer Moonshot initiative in 2016, with the goal of "end[ing] cancer as we know it." That included having the USPTO conduct an accelerated review of cancer immunotherapy-related patent applications without an extra fee, a program that was recently extended to June 2022.

As of Oct. 20, 2020, 167 unique patents had been granted under the program, called Patents 4 Patients, according to the USPTO.

However, University of California, Hastings College of the Law professor Robin Feldman said that program, while well-intentioned, hasn't lived up to Biden's grandiose promise.

"Right now, the patent system is largely encouraging recycling and repurposing [of] existing drugs," Feldman said. "For example, 78% of the drugs associated with new patents are not new drugs coming on the market, they are existing ones. To get the major breakthroughs, we need incentives that focus on whether a new drug (or variant) makes a major contribution to patient care. Small contributions aren't worth the rewards we are lavishing."

Her 78% figure comes from a study she published looking at evergreening — or artificially extending the life of a patent — in drugs on the market from 2005 to 2015.

Protecting U.S. IP

In his platform, Biden promised to "confront foreign efforts to steal American intellectual property" and replace the prior administration's "piecemeal and ineffective approach" with one that's "coordinated and effective."

"China's government and other state-led actors have engaged in an assault on American creativity," his platform states. "From cyberattacks to forced technology transfer to talent acquisition, American ingenuity and taxpayer investments are too often fueling the advances in other nations."

Brian Pomper, an Akin Gump Strauss Hauer & Feld LLP partner who leads the Alliance for Trade Enforcement, said Biden has made it "really clear" that part of the way to enforce IP abroad is through trade enforcement.

Biden will likely approach international trade through the lens of foreign policy, since the latter is what he was more focused on in the Senate, Pomper said. Biden would likely go through traditional diplomatic channels and escalate from there when trying to enforce IP rights in countries like China, as opposed to jumping straight to imposing tariffs like the Trump administration, according to Pomper.

"It's wrong to call it a softer touch," he said. "I just think [the Biden administration] is going to use more traditional means, at least first."

Pomper pointed to U.S. advancements related to biotechnology and 5G as some of the "valuable innovation areas that we lead in" and need to protect.

"We're not going to continue to lead in them if we don't have policies to support them, including a strong patent system at home and strong enforcement on our IP rights abroad," he said.

Crusade Against Piracy

While serving as vice president, Biden was vocal about trying to cut out piracy and counterfeiting. His reputation as vice president was as "the go-to person for the Motion Picture Association on copyright issues," said Knowledge Ecology International President James Love.

Former Sen. Christopher Dodd, D-Conn., who ran the MPAA for much of the Obama administration, told the Los Angeles Times last year that "Joe was our champion inside the White House."

Biden decried copyright violations, counterfeiting and other IP woes in a 2002 report called "Theft of American Intellectual Property: Fighting Crime Abroad and at Home," which he authored while leading the Senate Committee on Foreign Relations.

He later held a roundtable in 2009 on enforcing IP laws tied to privacy, featuring leaders of the time — Commerce Secretary Gary Locke, Attorney General Eric Holder, Homeland Security Secretary Janet Napolitano and FBI Director Robert Mueller — along with media company CEOs, union representatives and legal experts, according to PolitiFact.

"He's been outspoken on piracy issues for a long time, both as vice president and when he was in the Senate, calling piracy a multibillion-dollar problem," said Dechert LLP partner Noah M. Leibowitz.

Biden said in the 2002 report that there needs to be strong federal laws and civil and criminal penalties to fight piracy in the U.S. He also suggested trade negotiations and threats, or negotiations for free trade, could be useful tools to force foreign governments to adequately protect U.S. IP.

"Billions of dollars are being stolen, hundreds of thousands of jobs lost," he wrote. "It is worth the effort to do all we can to stem the tide."

Drug Pricing

Since securing the Democratic nomination, Biden has put forward positions on drug pricing that appear to contrast with a long-standing reputation for being close to Big Pharma. The reputation was gained, for example, by having the Biden Cancer Initiative and the Cancer Moonshot Task Force both headed by Greg Simon, a former Pfizer executive.

KEI's Love, whose organization tries to leverage patent laws to lower drug prices, has been concerned those ties led to Biden's meddling in other countries. For example, in 2014 the vice president wrote to Colombia's president expressing concerns with the country's attempt to make it easier to get biosimilars on the market.

"Biden was the guy that drug companies sent down to tell them not to do that," Love said.

Likewise, the vice president was one of several Democrats who pushed the Indian government not to issue compulsory licenses to get cheaper cancer medications on the market, which it had been considering doing. The New York Times in 2013 had reported that Biden talked to the Indian prime minister about "balancing patent rights and access to medicines."

While Biden has said high drug prices need to be addressed, Mintz's Wodarski said there's nothing in the lawmaker's past to suggest he'd do so by anything along the lines of blocking or voiding patent rights.

"There's nothing that occurred during the Obama administration that would allow for the inference or statement that a Biden administration would support anything like that," Wodarski said. "It's expressly not in his drug pricing platform."

His platform calls for "improving the supply of quality generics," such as by supporting the CREATES Act, a bipartisan bill to get generic drugs on the market faster. More specifically, it allows generic companies to sue when branded companies deny them access to needed samples.

"Generics help reduce health care spending, but brand drug corporations have succeeded in preserving a number of strategies to help them delay the entrance of a generic into the market even after the patent has expired," his platform states. "The Biden plan supports numerous proposals to accelerate the development of safe generics."

Biden has historically voiced support for tackling the prices consumers pay for drugs by increasing access to health insurance, including in a 2016 interview with Tom Brokaw when he was specifically asked about Big Pharma needing to take action.

But it appears Biden may be heading in a new direction with drug pricing, according to Love.

While "Joe historically has been close to the companies, close to Wall Street and close to the publishers," Love said the primaries made it clear that taking these positions hurt his image with younger voters in particular, who were more drawn to progressive candidates like Sen. Bernie Sanders, I-Vt.

Recommendations released by the Biden-Sanders Unity Task Force in July specifically call out Big Pharma and the manipulation of IP. 

"For too long, prescription drug companies have gamed the system to justify their price increases by any means available," the task force said in its recommendations. "Democrats will crack down on anti-competitive efforts to manipulate the patent system or collude on prices. And we will eliminate tax breaks for prescription drug advertisements."

This policy shift has activists hopeful that he's willing to take on Big Pharma more than he has in the past.

"It seems like right now he's not the same guy he was before," Love said.

--Editing by Jack Karp and Emily Kokoll.

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