FDA head Janet Woodcock raises patent-related concerns to PTO director
While matters of drug pricing may not fall squarely under the FDA’s purview, acting FDA commissioner Janet Woodcock made clear the agency’s concerns around patents and competition, according to a letter sent Friday to the US Patent and Trademark Office.
The letter, addressed to Andrew Hirshfield, under secretary of commerce for intellectual property and director of the US PTO, said the FDA is concerned that some companies are filing so-called “continuation” patent applications, which can allow a filer to pile on follow-on patents on one drug, creating a thicket of patents to block or intimidate the competition. While Woodcock did not mention AbbVie by name, the term patent thicket is often used in association with the company’s dozens of patents covering its blockbuster rheumatoid arthritis drug Humira.
“The existence of multiple patents increases litigation burdens and potentially delays the approval of generics and the launch of generics and biosimilar and interchangeable biological products,” she wrote.
The practice of patenting slight tweaks to a new drug, such as formulation changes, new delivery systems, or patents claiming additional methods of use should also come under scrutiny, wrote Woodcock, who’s likely to depart the FDA’s acting commissioner role in about two months.
She pointed to a study, published in the Journal of Law and the Biosciences in 2018, that found 78% of drugs for which new patents were listed in the Orange Book from 2005-2015 were for existing drugs, not new drugs.
Product hopping was her third concern, and Woodcock pointed to the way that some companies effectively switched one drug’s entire market to a new dosing regimen (e.g. twice daily to once per day) and then cordoned off their monopolies with new patents.
In the case of the Alzheimer’s drug Namenda, Actavis (now owned by Teva Pharmaceuticals) and its subsidiary, Forest Laboratories, were found to have anti-competitively launched an extended-release version of its blockbuster drug and delisted the immediate-release version, effectively blocking any incoming generic competition. The Second Circuit said in its decision, “when a monopolist combines product withdrawal with some other conduct, the overall effect of which is to coerce consumers rather than persuade them on the merits, and to impede competition, its actions are anticompetitive under the Sherman Act.”
Woodcock said product hopping “has the practical effect of forestalling competition notwithstanding the fact that the prior product (for which generic, biosimilar, or interchangeable competition has become available) remains safe and effective.”
As far as what’s expected for FDA and US PTO relations moving forward, Woodcock offered up opportunities for PTO examiners and staffers to learn the ways of the FDA’s databases and other expertise to support their “ability to accurately and fairly grant patent term extensions.”
She also questioned whether patent examiners might need more time to review pharmaceutical patents, due to their complex nature, and she sought further information on the Patent Trial and Appeal Board, especially when it comes to data on post grant reviews and inter partes reviews.
“In particular, we would be interested in data regarding the impact of PGR and IPR proceedings, if any, on Orange Book-listed patents and/or patents covering biological products,” Woodcock wrote.
