By Sarah Jane
Tribble OCTOBER 2, 2018
David
Herzberg was alarmed when he heard that Richard Sackler, former chairman of
opioid giant Purdue Pharma, was listed as an inventor on a new patent for an
opioid addiction treatment.
Patent
No. 9861628 is for a
fast-dissolving wafer containing buprenorphine, a generic drug that has been
around since the 1970s.
Herzberg, a historian who focuses on the opioid epidemic and the history of
prescription drugs, said he fears the patent could keep prices high and make it
more difficult for poor addicts to get treatment.
“It’s
hard not to have that reaction of, like … these vultures,” said Herzberg, an
associate professor at the University at Buffalo.
James
Doyle, vice president and general counsel of Rhodes Pharmaceuticals, the Purdue
subsidiary that holds the patent, said in an email statement that the company
does not have a developed or approved product and “therefore no money has been
made from this technology.”
“The
invention behind the buprenorphine patent in question was developed more than a
dozen years ago,” he wrote. “If a product is developed under this patent, it
will not be commercialized for profit.”
Yet,
the patenting of a small change in how an existing drug is made or taken by
patients is part of a tried-and-true pharmaceutical industry strategy of
enveloping products with a series of protective patents.
Drug
companies typically have less than 10 years of exclusive rights once a drug
hits the marketplace. They can extend their monopolies by layering in secondary
patents, using tactics critics call “evergreening” or “product-hopping.”
Lisa Larrimore
Ouellette, a patent law expert at Stanford University, said the pharmaceutical
industry gets a greater financial return from its patent strategy than that of
any other industry.
AztraZeneca
in 2001 famously fended off generic versions of its blockbuster heartburn
medicine Prilosec by patenting a tweaked version
of the drug and calling it Nexium. When Abbott Laboratories faced multiple
generic lawsuits over its big moneymaker Tricor, a decades-old cholesterol drug, it
lowered the dosage and changed it from a tablet to a capsule to win a new
patent.
And
Forest Laboratories stopped selling its Alzheimer’s disease drug Namenda in
2014 after reformulating and patenting Namenda XR to be taken once a day
instead of twice.
Another
common strategy is to create what Food and Drug Administration Commissioner
Scott Gottlieb calls “patent thickets,” claiming multiple patents for a single
drug to build protection from competitors. AbbVie’s rheumatoid arthritis drug
Humira has gained more than 100 patents, for example.
The
U.S. Patent and Trademark Office awards patents when an innovation meets the
minimum threshold of being new and non-obvious.
Secondary patents are routinely granted to established drugs when an
improvement is made, such as making it a once-a-day pill instead of twice a
day, said Kristina Acri, an economist and international intellectual property
expert at the Fraser Institute and Colorado College.
“Is
there a better way? Maybe, but that’s not what we’re doing,” Acri said.
The
controversial patent that Sackler and five co-inventors obtained is widely
known as a “continuation patent.” (The original patent application for the
wafer was filed in August 2007.)
Continuation
patents do not necessarily extend the patent life of a drug, but they can have
other uses. In 2016, Rhodes filed a lawsuit against Indivior alleging patent
infringement.
Indivior,
formerly part of Reckitt Benckiser, sells a film version of the popular addiction
treatment drug Suboxone that is placed under the tongue — an oral medicine
similar to what Rhodes has patented. Indivior’s comes in a lime flavor.
Indivior’s
film, which federal regulators approved in 2010, dominates the market with a 54
percent average market share, according to the company’s most recent financial
report. And the company has vigorously fought rivals, including filing
lawsuits against firms such as Teva Pharmaceutical Industries, which sought
approval to manufacture generic versions. Indivior declined to comment.
The
Rhodes Pharmaceuticals version would be a wafer that melts quickly in the
mouth. The inventors list potential flavors including mint, raspberry,
licorice, orange and caramel, according to the patent.
For
opioid historian Herzberg, the patent battles between companies like Rhodes and
Indivior are “absolute madness.”
Decisions
on what is available on the market to treat addicts should be based on what is
the best way to treat the people who have the problem, he said.
Patent
battles, Herzberg said, are “not how you want drug policy getting made.”
Attempts
to change the patent system have intensified over the past decade as prices of
prescription drugs continue to climb.
In
2011, President Barack Obama signed the America Invents Act, which included the
creation of the Patent Trial and Appeal Board. The PTAB is an alternative to
using the cumbersome U.S. court system to challenge weak patents. Generic drug
manufacturers have used the board’s “inter partes review” process and
overturned 43 percent of the patents they challenged, according to recent
research.
Critics
of the administrative process, including the pharmaceutical industry trade
group PhRMA, said it creates “significant business uncertainty for
biopharmaceutical companies.” Often companies have to defend their products
twice — both in the courts as well as before the PTAB, said Nicole Longo,
PhRMA’s director of public affairs.
Drug
giant Allergan attempted to overcome the PTAB’s review
process by arguing that the patent couldn’t be challenged at the review board
because they sold the patent to the St. Regis Mohawk Tribe, which had sovereign
immunity. A federal appeals court ruled this summer that Allergan could not
shield its patents from the PTAB review this way.
This
year, several members of Congress proposed bills that would unwind or limit
changes made by the America Invents Act, though nothing is likely to happen
before the midterm elections. The STRONGER Patents Act, introduced in both the
House and Senate, would weaken the PTAB board by aligning its claims standards
with what has been established by court rulings.
KHN’s coverage of prescription drug development, costs and
pricing is supported in part by the Laura and John Arnold Foundation.
Sarah
Jane Tribble: sjtribble@kff.org,
@SJTribble
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