THE REFILL: Latest Dosage of Rx Patent Abuse
WHAT YOU NEED TO KNOW
- CAPA Stresses Importance Of Next USPTO Director – This week, CAPA Executive Director Matthew Lane penned an op-ed in STAT News highlighting the crucial role that the next U.S. Patent and Trademark Office Director will have on reducing drug costs for millions of American patients, many of which are already struggling financially due to COVID-19.
- “Some of the nation’s largest pharmaceutical companies have unbridled control over drug pricing. They also have enormous incentives to block market entry of lower-cost generic drugs for as long as possible, because generic competition reduces the prices of drugs by 80% on average. In fact, many companies have kept out competition by abusing the U.S. patent system.”
- “Looking ahead, there are several important things the USPTO Director can do to help lower drug prices. For starters, the Director can acknowledge the link between over-patenting and higher drug prices…”
- “It is also imperative that the new Director improve patent quality, which would reduce the ability of companies to build thickets… Further, the Director can support an important process at the USPTO known as inter partes review (IPR)… Finally, the Director could change the culture of the USPTO by ending the practice of thinking of patent applicants as ‘customers’ and instead consider the granting of patents as a balancing of interests between promoting innovation and providing the public access to essential technologies.”
- “As the Biden Administration and Congress continues to address the needs of the country, drug pricing should remain top-of-mind when setting any new policy. Particular care should be given to choosing the next USPTO director as they will have immense power over rules that affect drug prices.”
- CAPA Joins Bloomberg Law To Weigh In On The Current Teva Drug-Label Case As The Federal Circuit Considers Changing The “Skinny Label” Rule. At least five lawsuits have been filed since the Federal Circuit’s decision in GlaxoSmithKline v. Teva was released, which undermined the ‘skinny label’ framework used by generic drug companies and would erode the Hatch-Waxman Act.
- “These lawsuits are emblematic of ‘the biggest danger’ imposed on the generic market from the Federal Circuit’s ruling, threatening to ‘cut off a lot of sources of competition,’ Matthew Lane, executive director of the Coalition Against Patent Abuse, said.”
- CAPA Continues “Spot-On Savings” Mini-Series To Show How The IPR Process Can Generate Savings For Millions Of Patients & The U.S. Healthcare System.
- Part III: IPR & Opioid Addiction – Ending Brand Pharma’s Monopoly on Patents. Here, CAPA looked at how the inter partes review (IPR) proceeding for an opioid addiction treatment known as Suboxone opened the door for generic competition.
- In efforts to maintain its monopoly, the firm devised a scheme to switch Suboxone from a tablet-form to a film that would dissolve under a patient’s tongue, which the company could acquire a patent to delay generic entry.
- In an IPR proceeding, the Patent Trial and Appeal Board found an error in five claims of Indivior’s patent and the Federal Circuit affirmed the decision.
- Today, several generics are approved for sale for the sublingual film, and prices have dropped about 50%.
WHAT YOU SHOULD BE READING:
Washington Examiner: Drugmakers raise the prices of hundreds of prescription medications since January
- The prices of hundreds of prescription drugs have risen since January, placing a heavy burden on middle-class families that struggle to afford the often lifesaving medications… “Since the first of the year, we saw over 800 drugs increase in price by an average of 4.6%, and that’s the largest number we’ve seen since we started tracking this,” said GoodRX research director Tori Marsh.
Fierce Pharma: The Top 10 Drugs Losing U.S. Exclusivity In 2021
- As drugmakers respond to the COVID-19 pandemic by developing vaccines and therapeutics, many of them are losing patent protection on older—and once lucrative—medicines. Each year, many of the pharmaceutical industry’s stalwart products lose their exclusive hold on the market, offering an opportunity for generics makers to seize share with cheaper copycats. This year’s expected losses of U.S. exclusivity include the Roche macular degeneration blockbuster Lucentis, two medicines from AbbVie and a Pfizer cancer drug.
- More than two dozen of the largest pharmaceutical companies are urging President Biden to reject a proposal before the World Trade Organization to temporarily waive patent rights in order to widen access to Covid-19 medical products to mostly low-income countries. In a March 5 letter, the drug makers argue that, contrary to assertions, intellectual property is not a barrier to ensuring that vaccines and therapies become available on a global basis.
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