[Ip-health] Law 360 - What You Need To Know About Biden And IP

Thiru Balasubramaniam thiru at keionline.org
Mon Nov 9 00:58:23 PST 2020


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What You Need To Know About Biden And IP
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By Dani Kass
<https://www.law360.com/ip/articles/1321697/what-you-need-to-know-about-biden-and-ip?nl_pk=72ba9223-e769-4759-8a4c-1b0647be6308&utm_source=newsletter&utm_medium=email&utm_campaign=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
<https://www.law360.com/articles/1326252/biden-beats-trump-at-the-polls-as-court-battles-continue>
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 <https://www.law360.com/articles/1326548>.

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

Biden's appointment to lead the U.S. Patent and Trademark Office
<https://www.law360.com/agencies/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
<https://www.law360.com/firms/mintz-levin> 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.

<SNIP>


Biden's appointment to lead the U.S. Patent and Trademark Office
<https://www.law360.com/agencies/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
<https://www.law360.com/firms/mintz-levin> 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.

<SNIP>

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
<https://www.law360.com/companies/pfizer-inc> 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 <https://www.law360.com/companies/the-new-york-times-co> 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 <https://www.law360.com/articles/1135996/>, 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.



-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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