THE REFILL: Latest Dosage of Rx Patent Abuse
WHAT YOU NEED TO KNOW
- The Coalition Against Patent Abuse’s Executive Director Matthew Lane penned an op-ed in Morning Consult recently on the need to address patent abuse and anti-competitive pricing tactics used by some major pharmaceutical companies. In his op-ed, Mr. Lane dives into the current imbalance between rewarding new drug innovations and competition from low-cost alternatives. The continued manipulation of the U.S. patent system hasn’t helped either, allowing some major drug companies to extend market exclusivity for their drugs, sometimes indefinitely, keeping prices high for millions.
- “While there may be good reason to reward new drugs with high profits, the health care system is running out of money to pay for new innovations due to these anticompetitive games.”
- “Tactics such as patent thicketing are used to exploit legal loopholes within the patent system to extend a drug’s monopoly far beyond what Congress intended. These types of practices subsequently block generic competition and are one of the key factors today in high drug prices.”
- “All the while, American tax dollars and federal funds contribute to research and development of new drugs… yet patient access and savings generated through competition from generics has so far been of little priority in the marketplace.”
- “Thankfully, however, there are solutions to balance competition with innovation. Proceedings conducted by the U.S. Patent and Trade Office’s Patent Trial and Appeal Board known as the inter partes review process are instrumental in cancelling erroneously issued patent claims…”
- “Addressing patent abuse means prices on older drugs will go down so that our government and patients can afford new ones.”Click Here to Read the Full Op-ed in Morning Consult
- ICYMI: CAPA Asks Congress to Address the Supreme Court’s Recent Decision to Preserve the Inter Partes Review Process, Balance Innovation with Patient Cost In the wake of the recent U.S. Supreme Court decision in the United States v. Arthrex Inc. case, CAPA said that it’s critical for Congress to now address this decision and work to protect and strengthen the Inter Partes Review (IPR) within the U.S. Patent & Trademark Office (USPTO), by ensuring that IPR is prompt and focused.
- “It cannot be stressed enough that PTAB’s ability to conduct IPR proceedings is critical to addressing the pressing policy crisis caused by ever-lengthening patent monopolies. Patent thickets have resulted in rising drug prices and limited access to medications that American patients rely on. While the Courts have offered a solution that largely safeguards the IPR process, it is up to Congress to not only preserve, but strengthen IPR in a way that balances innovation and competition,” CAPA Executive Director Matthew Lane stated today.
Last year, CAPA filed an amicus brief with the Court in its review of United States v. Arthrex Inc., outlining its concerns regarding the lower court’s decision to eliminate job protections for PTAB judges who were tasked by Congress to ensure that issued patents meet patentability standards. As CAPA expressed, politicizing PTAB judges opens the door for greater partisan influence in patent decisions. Congress intended for the IPR process to simply be a way for the USPTO to correct mistakes, and allowing such influence opposes that intent.
WHAT YOU SHOULD BE READING:
- The $56,000 annual price for Biogen Inc.’s recently approved Alzheimer’s therapy is drawing increasing criticism ahead of a decision by the U.S. government on reimbursement policies for the medication. The Employers’ Prescription for Affordable Drugs, a coalition of health-care purchasers, said in a letter to congressional leaders on Monday that taxpayers and employers will have to pay billions of dollars for the drug, called Aduhelm, without knowing whether it works.
- The Supreme Court has confirmed that PTAB Judges yield unreviewable authority during inter partes review and therefore acting as Principal Officers under the US Constitution. Therefore the APJs should have been nominated by the President and confirmed by the Senate. BUT, the Court solved the problem in a new way–by making PTAB determinations reviewable by the USPTO Director. This leaves the PTAB system in-place, but will place major insider political pressure on the PTO Director (and current Acting Director).
- The Senate Judiciary Committee’s intellectual property panel will delve this afternoon into patent quality, an issue that’s come into play during the Covid pandemic… Ranking member Thom Tillis (R-N.C.) will push for eliminating a program that diverts fees collected by the U.S. Patent and Trademark Office to often unrelated programs, according to his prepared remarks. He will also advocate for creating a “gold-plated” patent that would involve a more rigorous review process, making it “virtually impossible to challenge” — an idea Barack Obama backed during his 2008 campaign.
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