It's no secret that drugmakers will do whatever it takes to defend their products from generics for as long as possible. Now, nine drugmakers are being asked to reconsider their patenting strategies.
In filings with AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Gilead Sciences, Johnson & Johnson, Merck, Pfizer, and Regeneron, activist shareholders at the Interfaith Center on Corporate Responsibility (ICCR) are asking companies to weigh patient access when they're developing patent strategies.
“The cost of medicines has long been a barrier to health,” Lydia Kuykendal of Mercy Investment Services, which led the filings at Amgen and Johnson & Johnson, said in a statement. “Drug makers engaging in excessive patenting prevents generic competition and keeps prices high for the patients in need of these medicines—sometimes a matter of life or death.”
The shareholders asked the nine companies to create and disclose a process that would consider the effects of extended patent protections on patient access.
ICCR highlighted "patent thickets," the term for complex webs of patents covering single products, as the pharma industry's primary method of stretching exclusivity and preventing generics from reaching the market. The investors see the companies’ typical patent practices, which “clearly prioritize” profits over patients, as “fundamentally at odds” with their purported missions, Sr. Judy Byron of the Northwest Coalition for Responsible Investment, said in a statement.
In one example of a lucrative patent thicket, AbbVie notoriously gained more than 100 patents on its megablockbuster Humira. Despite complaints, a court found the strategy legal.
In most of the ICCR filings, companies were called out for specific patents. According to the House Committee on Oversight and Reform’s drug pricing investigation that finished in 2021, which ICCR cited in its proposals, Amgen’s Enbrel has received 39 patents and raised its price over 28 times since its 2003 launch, while Bristol Myers Squibb’s Revlimid has had 109 patents and 40 years of exclusivity.
AbbVie was called out for raising the price of Humira 27 times, not to mention its 130 patents. Secondary patents on Eli Lilly’s Humalog gave the insulin 17 more years of exclusivity and the company has raised its price by 1219% since launch, ICCR pointed out. J&J’s Remicade has over 100 patents, while Merck has filed for 95 secondary patents on Keytruda.
Pfizer’s Lyrica has received 69 patents to extend exclusivity to 32 years and its price has been raised by 155% between 2013 and 2019. Meanwhile, 65% of Regeneron’s patents on Eylea were filed after its 2011 approval, ICCR cited from I-MAK, a health equity advocacy group.
The proposal submitted to Gilead didn’t list specific patents on any drugs, but did note that hepatitis C treatments Sovaldi and Harvoni have been called out by Senator Elizabeth Warren for a thicket of “questionable” patents.
ICCR has been a thorn in pharma's side for several years. The group has petitioned pharma companies over executive pay, COVID-19 pricing strategies and more, but its requests are typically denied.
Meanwhile, the group isn’t the only one concerned about patent thickets. In July, the FDA and the U.S. Patent and Trademark Office (PTO) exchanged letters outlining their concerns about how pharma companies use the patent system.
That collaboration came after President Biden’s 2021 executive order asking the agencies to leverage their experience in promoting “innovation, competition, and the approval and regulation of safe and effective drugs.”