“Patent Thickets” on Biologics and What Could Be Done To Chop Them Down to Size

The Biologics Price Competition and Innovation Act lays out a process by which patents on original biologics can be litigated and biosimilars of these drugs can come to market. In practice, though, the process has been exploited by makers of the original biologics, delaying the time between FDA authorization of a biosimilar and its commercialization, Rachel Moodie and Bernard Chao argue in a new paper.

Moodie is vice president, head of legal and intellectual property, biosimilars at Fresenius Kabi, and a student at the University of Denver Sturm College of Law. Chao is a professor at the University of Denver Sturm College of Law and co-director of the school’s Intellectual Property and Technology Law Program.

Their paper, titled “Biological Patent Thickets and Delayed Access to Biosimilars, An American Problem,” was published on SSRN, a preprint service.

Companies that hold the rights to the original biologic cheat the system by churning out “duplicative” patents that do not represent innovationsbut merely digress on previously patented innovations, write Moodie and Chao. Therefore, seven or eight innovations for a single drug can be expanded into duplicative patent “families” for each of the innovations.

The United States allows duplicative patents as long as they terminate on the same date as the original patent covering the innovation. Originator companies deliberately seek out duplicative patents because they cost very little to obtain and are very expensive for biosimilar companies to litigate, according to Moodie and Chao.

“While duplicative patents may cost as little as $25,000 to obtain, on average it costs $774,000 to challenge that patent,” they wrote. Such expense may force biosimilar companies to settle out of court with innovator companies rather than run up a huge legal bill fighting duplicative patents.

AbbVie is a company that has honed the art of filing duplicative patents, according to Moodie and Chao. In the United States, the company filed 18 patents for secondary indications for Humira (adalimumab), whereas in the European Union the company was able to file just one, the authors wrote.

The company received an even longer string of patents for product formulation: 21 versus two in the European Union.

One problem is that in the United States Patent and Trade Office (USPTO) a single official might have sole authority for approving a patent application, whereas in other developed countries a recommendation for approval might have to go before a full committee.

“The USPTO granted 73 Humira patents covering only 14 inventions. As such, 59 of the Humira patents are non-patentably distinct,” the authors wrote.

They offered several potential policy solutions that could make the system work better, because at present patent thickets add 34 months, on average, to the time needed to bring a biosimilar to market.

At the USPTO, “there could be a team of quality control experienced examiners…that approve any notice of allowance before it is sent to the patent filer,” the authors wrote.

Or simply, any duplicative patent claims could be written into the original patent, so that only one patent in a “family” needs to be addressed in a courtroom.

They also recommended a domino system whereby courtroom elimination of one duplicative patent would invalidate others in the same category.

Finally, duplicative patents are possible because not enough description of the innovation is provided in the original patent. The authors suggest forcing the originator companies to thoroughly describe their invention in the original patent.