Studies highlight role of US patent system in limiting competition

Regulatory NewsRegulatory News | 05 August 2022 |  By 

Reforming the patent system for brand-name drugs in the United States could be more effective than changes to nonpatent exclusivities in encouraging generic competition, according to an analysis of patent protections for non-biologic prescription drugs.
“Our findings suggest that in the current market, patent lengths, rather than these other statutory exclusivities, are much more likely to be central considerations in drug manufacturers’ revenue predictions,” Victor L. Van de Wiele, of the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital and Harvard University, and his colleagues wrote in Health Affairs. “The findings also suggest that reducing the Hatch-Waxman or Orphan Drug Act exclusivity periods, as some policymakers have proposed, to facilitate timely generic entry, is unlikely to lead to faster competitive markets and lower drug prices.”
Patents for new drug approvals
In a recent analysis published in the journal Health Affairs, the PORTAL team examined patents for drugs approved by the US Food and Drug Administration (FDA) in 2019 and 2020 to determine what the patents cover, the length of market exclusivity from the initially listed patents and whether the same patent protections were granted in other countries.
Overall, there were 78 small-molecule drugs approved by the agency over the two-year period, 10 of which had no listed patents. The remaining 68 drugs were linked to 322 FDA-listed patents, with a median of four patents per drug, according to the study.
The most common patent claims were for the chemical compound (62% of patents) or method of use (61%), followed by formulation (54%), manufacturing process (10%), and co-formulation (4%). More than half of the patents had claims in more than one category, according to the study. Of the 322 patents, 16% had not been granted any foreign patent equivalents in their simple patent family.
The researchers estimated that the patent-protected market exclusivity period for the drugs was a median of 10.3 years, based on the latest expiration date of the listed patent. At the time of approval, patent exclusivity for drugs was generally greater than non-patent exclusivities offered by the Hatch-Waxman Act (five years for new drugs) and the Orphan Drug Act (seven years for orphan drugs).
The researchers recommended that US lawmakers consider changing the FDA patent listing requirement so that all listed patents cover “clinically meaningful innovations” (RELATED: FDA looks to overhaul Orange Book, seeks input on patent listings, Regulatory Focus 29 May 2020).  
“The [US Patent and Trademark Office] would benefit from creating an expert unit for pharmaceutical patent examination, supported by experts from FDA, and giving patent examiners more time to review pharmaceutical patent applications. It could also conduct simple family searches of uniquely American patents and see if there were abandoned or rejected patent applications in foreign patent offices,” Van de Wiele said in an interview with Regulatory Focus.
But the Pharmaceutical Research and Manufacturers of America (PhRMA) questioned the findings and told Regulatory Focus that the data was cherrypicked and the assertions misleading. “Patents do not prevent competition. And R&D that happens after FDA approval, often including costly and labor-intensive clinical trials, paves the way for important advances in patient care, such as the discovery of new uses for medicines, including in pediatric and rare disease populations,” said PhRMA spokesperson Megan Van Etten.
She noted that patent challenges against brand-name drugs have increased dramatically under Hatch-Waxman.
Study researchers reported funding from the Commonwealth Fund, Arnold Ventures, and a Novo Nordisk Foundation grant. One study author also reported serving as an expert witness against Gilead, related to patents on tenofovir-containing products.
Unapproved Drugs Initiative  
In a separate analysis in the journal CHEST,  PORTAL researchers examined the role of the Unapproved Drugs Initiative (UDI) in providing several years of market exclusivity for vasopressin, leading to a steep increase in the price of the antidiuretic hormone – rising from $4 to $237 over a decade.
The UDI, established by FDA in 2006, sought to address thousands of unapproved drugs that were already on the market when Congress enacted the Food, Drug, and Cosmetic Act in 1938 requiring premarket testing and evaluation of new drugs. Under UDI, manufacturers could seek approval of these unapproved drugs and other unapproved versions would be cleared from the market. That created temporary market exclusivity for that manufacturers while other companies went through the approval process. The US Department of Health and Human Services (HHS) rescinded the guidance document that guided this initiative in late 2020 (RELATED: HHS moves to end FDA’s unapproved drugs initiative, Regulatory Focus 24 November 2020). The program was brought back by HHS in May 2021.
In the case of vasopressin, Par Pharmaceuticals received approval for the drug in 2014 and while other manufacturers were ordered to cease production, the company began accumulating patents for the drug. The company had listed 14 patents as of January 2022, with the latest expiring in 2035. However, Par’s market exclusivity ended in 2021 when a federal court ruled that a generic version would not infringe on the company’s patents and the FDA approved the generic’s abbreviated new drug application.
“The story of vasopressin illustrates one example of the common scenario in which manufacturers delayed generic competition by patenting aspects of their products that do not meaningfully improve patients’ health. Drug companies should be rewarded based on the degree to which their drugs benefit patients over what’s already available,” Liam Bendicksen, of PORTAL and Brigham and Women’s Hospital, told Regulatory Focus.
The researchers suggested that FDA or the US National Institutes of Health should fund evidence reviews or clinical trials to support the simultaneous approval of multiple versions of previously unapproved drugs when the evidence supports the products’ safety and effectiveness.  
Health Affairs study
CHEST study


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