[vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text css=””]In July, the Senate unanimously passed legislation that would limit the number of patents drugmakers can assert for a single product. Touted as a step toward improving the affordability of medications, the legislation has highlighted the debate over the impact of “patent thickets” in drug manufacturing.<\/p>\n
The bipartisan Affordable Prescriptions for Patients Act of 2023 (S.150<\/a>) was introduced by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT). The bill, which Cornyn says<\/a> will prevent drug manufacturers from “gaming the system,” targets anticompetitive behaviors by allowing the Federal Trade Commission to challenge pharmaceutical companies that use multiple patents to extend drug exclusivity.<\/p>\n Stakeholders remain divided on the issue. Some claim that drug manufacturers use complex webs of overlapping patents to stifle competition and inflate drug prices. Others argue that \u201cpatent thickets\u201d are only a political talking point and that patents are essential to product innovation.<\/p>\n What is a patent thicket?<\/strong><\/p>\n There is neither a universally recognized nor a legal definition of \u201cpatent thicket.\u201d The term can be traced to the 1970s when SCM Corporation accused<\/a> Xerox of accumulating numerous patents for plain paper copying machines and stifling competition by making it difficult for other companies to navigate the technology landscape without infringing patents.<\/p>\n Today, the term patent thicket is used in two ways. It can refer to multiple parties owning overlapping patent rights on a single product, resulting in high transaction costs and coordination challenges for competitors. Alternatively and most frequently, it describes and indicts a manufacturer\u2019s strategy of amassing multiple patents related to a single product.<\/p>\n Continuation or \u201cfollow-on\u201d patents are typically granted based on “terminal disclaimers,\u201d which specify that they will expire at the same time as the original patent. However, critics argue<\/a> that a manufacturer\u2019s strategic accumulation of \u201coften meaningless patents\u201d complicates the development of competing products or generic alternatives, effectively extending a patent holder\u2019s monopoly. By contrast, some manufacturers of drugs and biologics contend that referring to patent thickets has become a politically expedient oversimplification of a complex issue. They maintain that multiple patents\u2014which may be specific to different formulations or delivery methods\u2014are part of reasonable periods of exclusivity.<\/p>\n The oft-cited case<\/strong><\/p>\n Critics of patent thickets in the life sciences frequently cite<\/a> the example of Humira, a blockbuster drug used to treat various autoimmune conditions. AbbVie, the pharmaceutical manufacturer behind Humira, has filed<\/a> approximately 247 patent applications on various aspects of the drug, resulting in at least 132 issued patents. This intricate network covers the active ingredient, formulations, manufacturing processes, and methods of use, making it challenging for competitors to introduce biosimilars.<\/p>\n Before the entry of biosimilar competition, AbbVie was involved in numerous legal actions to protect its market position, including filing lawsuits alleging patent infringement by biosimilar manufacturers. In turn, in 2019, a group of welfare-benefit plans that covered Humira for their beneficiaries sued AbbVie in federal court, accusing the company of violating antitrust laws. Their suit was dismissed, and the federal judge who authored the appeals court decision affirming the dismissal asked<\/a>, \u201cBut what\u2019s wrong with having lots of patents?\u201d<\/p>\n These legal skirmishes served to fuel the debate over how to encourage innovation while ensuring competitive markets.<\/p>\n Regulatory action<\/strong><\/p>\n President Biden\u2019s 2021 Executive Order Promoting Competition in the American Economy<\/a> stated that \u201ctoo often, patent and other laws have been misused to inhibit or delay\u2014for years and even decades\u2014competition from generic drugs and biosimilars, denying Americans access to lower- cost drugs.\u201d The order directed the Commissioner of the Food and Drug Administration (FDA) to communicate to the United States Patent and Trademark Office (USPTO) any concerns that the existing patent system could \u201cunjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law.\u201d<\/p>\n Acting FDA Commissioner Janet Woodcock, M.D., subsequently advised<\/a> USPTO of the FDA\u2019s concern that \u201cthe existence of multiple patents increases litigation burdens and potentially delays the approval of generics and the launch of generic and biosimilar and interchangeable biological products.\u201d<\/p>\n In May, the USPTO issued a proposed rule<\/a> that would make it easier for manufacturers of biosimilar or generic drugs to challenge the patents held by brand-name drug makers. The Office noted that it was proposing new requirements to prevent “multiple patents directed to obvious variants of an invention from potentially deterring competition and to promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by one or more terminal disclaimers to another patent having a claim finally held unpatentable or invalid over prior art.\u201d<\/p>\n In a comment letter<\/a> supporting the proposed rule, the Federal Trade Commission stated that it had \u201clong been mindful of the potential anticompetitive effects of patent thickets.” It applauded USPTO’s efforts to address the “harmful exploitation” of the current system.<\/p>\n Objections<\/strong><\/p>\n Some industry representatives and jurists caution that weakening patent protections would reduce incentives for investment in new drug development.<\/p>\n Emily Michiko Morris, a professor at the University of Akron School of Law, argues<\/a> that \u201cthere\u2019s a lot more work that needs to be done before we can actually allege that there are, in fact, patent thickets.\u201d She contends that \u201cyou can\u2019t just look at the numbers of patents. You\u2019ve actually got to show what the effect of those patents is and what the effect of having additional patents actually is on the potential for others to be able to enter the market.\u201d<\/p>\n Hans Sauer, Deputy General Counsel and Vice President for Intellectual Property at the Biotechnology Innovation Organization (BIO), has contended that the term patent thickets has become a verbal \u201cmeme<\/a>\u201d used to oversimplify the conversation about patents in the life sciences and to misrepresent the motives of manufacturers. In 2019 testimony<\/a> before the Senate Subcommittee on Intellectual Property, Sauer argued that invalidating patents or denying applications under overly broad criteria could deter third parties from investing in or licensing the technology, potentially stalling funding for research and development and delaying new cures or treatments for patients.<\/p>\n Moving forward<\/strong><\/p>\n With eight in ten Americans saying<\/a> that prescription drug costs are “unreasonable” and voters on both ends of the political spectrum worried<\/a> about the affordability of healthcare, Democrats and Republicans alike are eager to be seen working to address drug prices. It is not surprising that patent thickets have become a target for policymakers on both sides of the aisle.<\/p>\n The ongoing debate underscores the complexities of balancing innovation and access in the healthcare industry.\u00a0 As the conversation continues, finding common ground will be essential to advancing healthcare policy that benefits all Americans.[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":" [vc_row full_width=”stretch_row” gap=”35″][vc_column][vc_column_text css=””]In July, the Senate unanimously passed legislation that would limit the number of patents drugmakers can assert for a single product. Touted as a step toward improving the affordability of medications, the legislation has highlighted the debate over the impact of “patent thickets” in drug manufacturing. The bipartisan Affordable Prescriptions for Patients […]<\/p>\n","protected":false},"author":19,"featured_media":8463,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","ap4_related_services":"","footnotes":""},"categories":[428],"tags":[],"class_list":["post-8459","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-companies"],"yoast_head":"\n