Drugmakers Play The Patent Game To Lock In Prices, Block Competitors

(George Frey/Bloomberg via Getty Images)
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. is for a fast-dissolving wafer containing buprenorphine, a generic drug that has been around . 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.
鈥淚t鈥檚 hard not to have that reaction of, like 鈥 these vultures,鈥 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 鈥渢herefore no money has been made from this technology.鈥
鈥淭he invention behind the buprenorphine patent in question was developed more than a dozen years ago,鈥 he wrote. 鈥淚f a product is developed under this patent, it will not be commercialized for profit.鈥
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 鈥渆vergreening鈥 or 鈥減roduct-hopping.鈥
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聽聽by patenting a tweaked version of the drug and calling it Nexium. When Abbott Laboratories faced multiple generic lawsuits over its big moneymaker聽, 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鈥檚 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 鈥減atent thickets,鈥 claiming multiple patents for a single drug to build protection from competitors. AbbVie鈥檚 rheumatoid arthritis drug Humira has gained聽, for example.
The U.S. Patent and Trademark Office awards patents when an innovation meets the minimum threshold of being new and聽. 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.
鈥淚s there a better way? Maybe, but that鈥檚 not what we鈥檙e doing,鈥 Acri said.
The controversial patent that Sackler and five co-inventors obtained is widely known as a 鈥渃ontinuation patent.鈥 (The original patent application for the wafer聽聽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 鈥 an oral medicine similar to what Rhodes has patented. Indivior鈥檚 comes in a lime flavor.
Indivior鈥檚 film, which federal regulators approved in 2010, dominates the market with a 54 percent average market share, according to the company鈥檚 most recent financial report. And the company has聽, 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聽.
For opioid historian Herzberg, the patent battles between companies like Rhodes and Indivior are 鈥渁bsolute madness.鈥
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 鈥渘ot how you want drug policy getting made.鈥
Attempts to change the patent system have intensified over the past decade as prices of prescription drugs聽.
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鈥檚 鈥渋nter partes review鈥 process and overturned 43 percent of the patents they challenged, according to聽.
Critics of the administrative process, including the pharmaceutical industry trade group PhRMA, said it creates 鈥渟ignificant business uncertainty for biopharmaceutical companies.鈥 Often companies have to defend their products twice 鈥 both in the courts as well as before the PTAB, said Nicole Longo, PhRMA鈥檚 director of public affairs.
Drug giant Allergan聽聽to overcome the PTAB鈥檚 review process by arguing that the patent couldn鈥檛 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聽聽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.
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