By: Gabriela Dueñas

Congress, the Food and Drug Administration (“FDA”), and the United States Department of Health and Human Services (“HHS”) are calling on the United States Patent and Trademark Office (“USPTO”) to join the fight in drug pricing abuse.[1]  The FDA acting Commissioner, Janet Woodcock, M.D., and the heads of the Senate Judiciary Intellectual Property Subcommittee, Senators Patrick Leahy and Thom Tillis, sent letters to the USPTO urging the agency to start monitoring patent applications in a stricter manner.[2]

It is likely that these letters originated from two recent events: 1) Biden’s executive order calling on federal agencies to establish policies to promote increased competition in the American economy by lowering prescription drug prices; and 2) the recent ruling in Belcher Pharmaceuticals, LLC v. Hospira.[3]  In Belcher Pharmaceuticals, the United States District Court for the District of Delaware concluded that Belcher Pharmaceuticals’s (“Belcher”) patent was unenforceable due to inequitable conduct on the part of Belcher.[4]  Just two months ago, the Federal Circuit affirmed the district court’s finding that Belcher’s patent application is unenforceable because it told the USPTO that a certain aspect of its invention was novel, but told the FDA otherwise.[5]  The Federal Circuit agreed with the district court in finding Belcher’s statements deceptive.[6]  Biden’s executive order and the Belcher Pharmaceuticals holding prompted Congress, FDA, and HHS to call for the USPTO to further inter-agency collaboration with the FDA to combat abusive prices in the pharmaceutical industry.[7]

However, this is not the first time the federal government has sought to lower drug prices.  Last year, former President Trump signed an order in an attempt to lower Medicare’s prescription drug prices, which included implementing a “most favored nations” pricing scheme.[8]  Under this pricing scheme, Medicare would have been required to tie the cost of certain medicines to the lowest price paid by other countries.[9]  Shortly before its effective date, United States District Judge Catherine Blake for the District of Maryland blocked former President Trump’s order, finding the order violated federal law because the public did not have a chance to comment on the rule before it was signed.[10]  Other prior efforts by government entities have also been unsuccessful, as prescription drug costs continue to be a major public concern.[11]

Although prior attempts have not yielded positive results, there is still hope for those who advocate for fairly priced prescription drugs.  This is the first time that Congress, HHS, and FDA are pushing the USPTO to work together with the FDA to tackle this fight.[12]  This is a huge step forward in combating drug prices from an intellectual property standpoint.  While a collaboration between the USPTO and the FDA will not solve the decades-long issue of drug pricing abuse altogether, it would be a great starting point.  An open line of communication between the USPTO and the FDA would make it easier to identify attempts to game the system and could also pave the way to greater reforms in the pharmaceutical industry.[13]

[1] See Dani Kass, Pressure Mounts On USPTO To Join Drug Pricing Fight, Law 360 (Sept. 20, 2021, 6:01 PM), https://www.law360.com/ip/articles/1422908/pressure-mounts-on-uspto-to-join-drug-pricing-fight?spotlight=1.

[2] See Kevin Dunleavy, To lower prices, Senate leaders, FDA chief urge U.S. patent officials to rethink intellectual property on drugs, Fierce Pharma (Sept. 14, 2021, 9:15 AM), https://www.fiercepharma.com/pharma/to-lower-drug-prices-senate-leaders-fda-urge-u-s-patent-and-trademark-office-to-alter-patent.

[3] See Kass, supra note 1; see also Ian Lopez, Biden Drug Price Pressure on Patent Office Draws Skeptics, Bloomberg Law (Sept. 21, 2021, 5:30 AM), https://news.bloomberglaw.com/ip-law/biden-drug-price-pressure-on-patent-office-draws-skeptics.

[4] Belcher Pharms., LLC v. Hospira, Inc., 11 F.4th 1345, 1346-47 (Fed. Cir. 2021).

[5] See Kass, supra note 1; See also Belcher Pharms., LLC., 11 F.4th at 1351.

[6] See Jonathan Davies, Carol Laherty, & James Whittle, Alert: Inconsistent Positions at FDA and USPTO Render Patent Unenforceable, JD Supra (Sept. 15, 2021), https://www.jdsupra.com/legalnews/alert-inconsistent-positions-at-fda-and-2845449/.

[7] See Kass, supra note 1.

[8] See Tamara Keith, Trump Signs New Executive Order On Prescription Drug Prices, NPR Politics (Sept. 13, 2020, 8:23 PM), https://www.npr.org/2020/09/13/912545090/trump-signs-new-executive-order-on-prescription-drug-prices; See also Allison Inserro, Trump Targets Drug Prices With 2 Orders Using International Pricing, Ending Rebates, AJMC (Nov. 20, 2020), https://www.ajmc.com/view/trump-targets-drug-prices-with-2-orders.

[9] See Keith, supra note 8; See also Eric Sagonowsky, Judge blocks Trump’s ‘most favored nation’ drug pricing rule, Fierce Pharma Politics (Jan. 4, 2021, 9:28 AM), https://www.fiercepharma.com/pharma/fierce-pharma-politics-judge-blocks-trump-s-most-favored-nations-drug-pricing-rule.

[10] See Inserro, supra note 8; See also Brendan Pierson, Federal judge blocks Trump administration drug pricing rule, Reuters (Dec. 23, 2020, 3:23 PM), https://www.reuters.com/article/us-usa-trump-drug-pricing/federal-judge-blocks-trump-administration-drug-pricing-rule-idUSKBN28X2II.

[11] See Juliette Cubanski, Tricia Neuman, & Meredith Freed, What’s the Latest on Medicare Drug Price Negotiations?, KFF (July 23, 2021), https://www.kff.org/medicare/issue-brief/whats-the-latest-on-medicare-drug-price-negotiations/.

[12] See Kass, supra note 1.

[13] See id.