THE REFILL: Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW

  • This week, Axios reported that Humira, a medicine that is prescribed to millions of people around the world, “continues to generate more U.S. revenue than any other drug, due to AbbVie extending U.S. patents and consequently retaining higher U.S. prices.”  
  • WHAT YOU NEED TO KNOW: While Humira is notably one of the most profitable drugs in history, it is particularly expensive here in the United States because it faces no competition from biosimilar alternatives, even though, absent patent abuse, a safe, low-cost version of Humira could have been available to American patients as early as 2016 and has been available to patients in the EU since 2018.  AbbVie, the drug company that makes Humira, has marketed the drug since 2002 and holds over 130 patents in the United States, blocking competition for up to 39 years.
    • “Global sales of Humira, the blockbuster drug that treats autoimmune diseases like arthritis and psoriasis, hit $19.9 billion in 2018, an 8.2% increase from 2017, AbbVie reported Friday. AbbVie has collected more than $115 billion in global Humira sales since 2010, 58% of which has come from the U.S.” 
  • It was recently reported out of Law360 that Sandoz Inc. requested the Federal Circuit reconsider their panel ruling that upholds two patents for Enbrel, a popular biologic owned by the drug company Amgen, and warned that this could open the door for future patent abuses as Enbrel has benefited from 31 years of “unprecedented” exclusivity. 
    • “The panel majority wrongly found that Amgen unit Immunex Corp. doesn’t hold enough power over the patents it licenses from Hoffmann-La Roche Inc. to be considered an owner, which meant the patents can’t be invalidated for obviousness-type double patenting, Sandoz said in a petition for rehearing en banc Friday. In doing so, the panel created a ‘roadmap’ for getting out of such double-patenting claims, the petition states.”

WHAT YOU SHOULD BE READING:

Law360: How Orange Book Listings Affect Patent Density, Exclusivity
Omar Robles, Emily Rothkin & Daniel Yu

  • The Humira decision in the U.S. District Court for the Northern District of Illinois turned the spotlight on the issue of patent thickets and the potential effect of those thickets on competition. While many in our industry are contemplating how this will shape the future, we analyze historical data to uncover recent trends in patent density and the foreseeable impact on exclusivity in small-molecule drugs.

ABC News: For Company Behind Coronavirus Drug, Sharp Questions Over Pricing, Potentially Cheaper Option
Lucien Bruggeman

  • In a letter to Gilead executives and federal health officials last week, government watchdog group Public Citizen encouraged the company to investigate whether another of its patented antivirals, called GS-441524, could serve as a viable and less expensive substitute to remdesivir, even though it may make the company less money. The health research experts at Public Citizen, joined in signing the letter by two cancer medicine experts at University of Texas’s MD Anderson Cancer Center, argue that the cheaper drug “is very similar in chemical structure and activity to remdesivir” — and may even “offer significant advantages over remdesivir.”

Center For Biosimilars: Christine Simmon And The Fight For Patent Reform
Skylar Jeremias

  • With multiple issues preventing biosimilar-induced price reduction, Christine Simmon, JD, is working to remove legal hurdles and foster patent transparency for biosimilar manufacturers. Simmon is senior vice president of policy and strategic alliances for the trade association Association for Accessible Medicines (AAM). She is also executive director of the Biosimilars Council a division of the AAM, which represents many large drug manufacturers. Many of the 17 biosimilars currently marketed in the United States have had to face ruthless legal disputes with reference product manufacturers that fought to keep biosimilar competitors off the market for as long as possible.

JD Supra: USPTO Launches Patent Licensing Platform To Promote Covid-19 Technology Development
Roshni Ghosh & Michael Glynn

  • The U.S. Patent and Trademark Office has launched a new web-based intellectual property marketplace, Patents 4 Partnerships, that provides a platform for patent owners to list patents and published patent applications available for licensing in the field of COVID-19 technologies. According to a USPTO press release, the P4P platform aims to “facilitate the voluntary licensing and commercialization of innovations in a variety of key technologies” related to the “prevention, treatment, and diagnosis of COVID-19.”

Times Of San Diego: Opinion: Californians Struggling During COVID Need Access To Inexpensive Biosimilar Drugs
Mihir Parikh

  • As we continue to confront the significant problem of rising health costs, all stakeholders — including California policymakers, health plans and consumers — should ensure that improved access to new and more affordable biosimilar medications are part of the solution. Biosimilars are lower cost treatments that are nearly identical to already approved biologic drugs. Biologic treatments are derived from living organisms such as bacteria or living cells and are often used to treat chronic and rare diseases, including cancer, arthritis, or heart disease. Biosimilars are like generic versions of approved biologic medicines and have significant potential to reduce California prescription drug costs.

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