Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.
In this abbreviated interview, Senior Editor Tony Hagen talks with Tahir Amin, Dip LP, a former intellectual property attorney who is now co-executive director of I-MAK (The Initiative for Medicines Access and Knowledge), which lobbies to overcome unfair trade practices and make medicines more widely available to patients. He recently testified on AbbVie’s drug patenting and pricing practices before the House Committee on Oversight and Reform.
Amin talked about some of the concerning practices he witnessed during his early career in patenting. He said that patent filers will carefully word patents to allow for multiple ongoing filings. This enables them to build large portfolios of patents that represent legal tangles for biosimilar competitors.
Regarding patents for the reference product adalimumab (Humira), Amin said so many have been filed by AbbVie that it’s too costly and difficult for biosimilar developers to contest them all. This is a failing of the US patent system, he says, because these webs of patents cannot be undone.
He discussed Alvotech’s ongoing attempt to fight AbbVie patents on adalimumab and said he is hopeful that Alvotech will be successful, but he noted that Boehringer Ingelheim previously went to court with AbbVie over adalimumab and eventually settled. This, he said, demonstrates that the patent system is being “weaponized” by originator companies.
Amin described AbbVie as having a “drip feed strategy” in which it files for patents broadly and over time. Originator companies will carefully patent every aspect of biosimilar development they can think of, even if they are no longer using the process that they’re patenting, and this, too, serves as an obstacle to biosimilar competitors.
Additionally, Amin commended Representative Katie Porter (D-California) on her questioning of AbbVie’s CEO, Richard Gonzalez when he testified before the House Committee on Oversight and Reform. According to Porter, AbbVie is not spending as much as it claims on innovation. The company has previously defended the high price of Humira by saying that much of the revenues are reinvested in development of new products to improve the health and lives of Americans.
Originator companies may lose the idealism that leads to new and better products and, instead, simply focus on maximizing their current revenue stream from existing products, Amin said.
Amin talked about the history of the patent system from the 1950s through the 1980s, saying how innovation boomed in the 1950s and then in the 1970s an economic downturn led to a shift in priorities. He said that, today, 11 million patents have been filed and roughly 50% are likely “junk.” That large number of patents is being used as a measure of innovation, which Amin doesn’t think is right.
When asked about his hopes for the Patent and Trademark Office (PTO), Amin said the incoming director should take into account the public interest and effects of drug pricing because the PTO, he said, has never acknowledged the role that patents play in rising drug prices.
Finally, Amin discussed how the COVID-19 pandemic has underscored the patent system problems, because protection of intellectual property and corporate profits has impeded getting the vaccine out to everybody who needs it. However, the public health crisis is causing more people to engage with these issues, and Amin said that this could lead to policy changes that improve the patent system.
Click here to watch the full Deep Dive interview, only on Medical World News®.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.