US President-elect Joe Biden is pushing forward with his plans for office, but what effect will his presidency have on IP?
Perhaps the best guide to Biden’s stance on IP is his platform website, particularly the “Made in all of America” page.
Biden claims that President Trump has “denied science, under-funded research and development, and implemented policies that encourage more manufacturing to move overseas”, and that Trump’s main manufacturing and innovation strategy is “trickle-down economics that works for corporate executives and Wall Street investors, but not working families”.
As part of his pledge, Biden will make a $300 billion investment in research and development and breakthrough technologies, including electric vehicle technology, 5G, and artificial intelligence (AI).
The page also says Biden will commit to purchasing tens of billions of dollars of clean vehicles and products to support the expansion of clean energy generation capacity, and to future purchases in advanced industries such as telecoms and AI.
These commitments will not only create new, lasting American jobs, said Biden, but protect IP and national security from threats from American adversaries that “have gone unaddressed by Trump”.
While Biden also indicates he will fight back against unfair trade practices and the theft of American IP, other mentions of IP and IP-related policies are sparse.
Mark Whitaker, partner at Morrison & Foerster, expects an increased focus on IP and related legislation.
He says: “With a Biden administration, I anticipate a return to Obama-era activism on IP-related legislation and enforcement. IP during the Trump era, both in the administration and within the judiciary committees of both chambers of Congress, was put on the back burner.
“This leaves an opportunity for the Biden administration to take up a number of legislative reforms.”
In agreement, Robert Stoll, partner at Faegre Drinker Biddle & Reath, believes Biden will be “engaged in IP issues particularly as they relate to trade and the enforcement of US rights against pirates and counterfeiters overseas”.
Stoll previously served as patent commissioner at the US Patent and Trademark Office (USPTO), under former President Barack Obama.
Pharma and drug pricing
Patents and IP issues are never the focus of a presidential election, so it’s always difficult to know exactly what impact a candidate will have on patents after the election, explains Chad Landmon, partner and chair of the IP practice group at Axinn, Veltrop & Harkrider.
However, there are some indications, particularly on the pharma side. “Although former Vice President Biden has historically not been a proponent of circumventing patents, Senator Kamala Harris said during the Democratic presidential primaries that she would ‘snatch their patent’ if drug companies don’t agree to reduce their prices,” adds Landmon.
When making the comment, Vice President-elect Harris was referring to the use of the “march-in” provision of the Bayh-Dole Act, which grants certain rights to the government when public funds are used in developing a drug.
”I anticipate a return to Obama-era activism on IP-related legislation and enforcement.”
Mark Whitaker, Morrison & Foerster
Other Democratic primary contestants, such as Senator Elizabeth Warren, have embraced similar positions. Landmon adds: “Although Biden did not take such a position during the primaries, in a recent interview with a healthcare activist he suggested that he would share COVID-19 vaccine technologies with other countries regardless of patents. At this point, it’s not clear if Biden would do this using ‘march-in’ rights or through some other mechanism.”
On November 9, Biden’s transition team announced the formation of the Transition COVID-19 Advisory Board. Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing US pharmaceutical companies, added that it was committed to working with the new administration and Congress to win the fight against COVID-19.
The spokesperson added: “Our IP system—including patents—promotes competition and is the foundation for new treatments and cures for patients. Without reliable patent protections for inventions, innovators couldn’t risk decades and billions of dollars in R&D for the next medicine or vaccine.
“Patent protections also incentivise innovators to continue improving medicines for patients—whether reducing side-effects or finding new diseases a medicine can treat.”
On his platform website, Biden said his plan will “put a stop to runaway drug prices and the profiteering of the drug industry”.
As part of the plan, the Secretary of Health and Human Services will establish an independent review board to assess the value of new specialty drugs which are launched without competition.
“The board will recommend a reasonable price, based on the average price in other countries (a process called external reference pricing) or, if the drug is entering the US market first, based on an evaluation by the independent board members,” said the page.
Biden also plans to limit to inflation all price increases for brand, biotech and “abusively priced” generic drugs.
His platform also calls for “improving the supply of quality generics” and supports the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019. CREATES would allow generic makers that are unable to obtain the samples necessary to gain Food and Drug Administration approval to file for injunctive relief in federal court.
A new direction?
Under the Obama administration, a series of IP initiatives were undertaken, including the America Invents Act (AIA) and the Defend Trade Secrets Act. Biden was Vice President at the time, but it seems he was not heavily involved in the process.
The AIA has faced its own share of criticism, and the Patent Trial and Appeal Board (which was created by the law) was even infamously branded as a “death squad” for patents by Randall Rader, the former chief judge of the US Court of Appeals for the Federal Circuit.
Biden’s choice for USPTO director is likely to influence how the administration approaches patents.
It’s possible that current USPTO director Andrei Iancu could stay on under Biden, but this seems unlikely. Iancu’s predecessor Michelle Lee said she would stay under the Trump administration but left five months later.
Fact File
- 3: the number of references to ’protecting US intellectual property’ in Joe Biden’s “Made in America” manifesto
- $300 billion: the amount Joe Biden pledges to invest in research and development for “breakthrough technologies”
Lee’s backing from Big Tech and her previous role at Google added to concerns from some that the Obama administration was favouring tech companies in patent challenges, or even being controlled by the technology industry.
At this point, it’s unclear where Biden’s pick for USPTO chief will come from but it seems likely the office will continue Iancu’s efforts to further clarify procedures.
Combating China
“Although President Trump has certainly focused a lot of his energies on China over the past four years, during the 2020 Democratic primaries, Biden argued that Trump was erroneously focusing on trade deficits with China instead of confronting the more significant issue of China’s IP theft,” says Landmon.
He adds: “It’s certainly possible that the Biden administration will focus efforts on combating Chinese attempts to circumvent patent and other IP rights.”
As part of Biden’s commitments, he said he will confront foreign efforts to steal American IP.
“China’s government and other state-led actors have engaged in an assault on American creativity. From cyber attacks to forced technology transfer to talent acquisition, American ingenuity and taxpayer investments are too often fuelling the advances in other nations,” said Biden.
According to the new president, the Trump administration’s “piecemeal and ineffective approach” will be replaced with a coordinated and effective strategy.
Biden also affirmed that he would address state-sponsored cyber espionage against American companies.
According to Biden’s policy page, Trump allowed a landmark 2015 agreement negotiated by the Obama–Biden administration to lapse, “dramatically increasing China’s state-sponsored cyber espionage against US companies”.
Biden plans to set out “clear demands and specific consequences” if China’s government doesn’t cease cyber espionage against US businesses. He will also “develop new sanctions authorities against Chinese firms that steal US technology to cut them off from accessing the US market and financial system”.
Creativity and copyright
Finally, Biden has been a staunch advocate against piracy and counterfeiting. According to JC Taylor, senior director, policy and communications at advocacy organisation CreativeFuture, Biden has a “remarkable track record of standing up for creativity”.
As a senator, Biden co-chaired the Congressional International Anti-Piracy Caucus, spearheading the creation of the annual international piracy watch list.
As Vice President, Biden worked alongside Obama to “empower the US Intellectual Property Enforcement Coordinator to advance our nation’s goals of stopping illegal and damaging IP theft,” said Taylor.
Last month, CreativeFuture sent a letter to the Biden campaign, urging Biden to pursue a series of measures to boost copyright protection and enforcement, including the creation of a small claims court for copyright owners.
Taylor concluded: “We hope that President-elect Biden will maintain his commitment to the Constitutional principles of copyright and free expression, and that it will remain a bedrock element of his domestic and foreign policy.”
Image: Shutterstock.com / Alex Gakos
