On July 6, 2017, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) struck down a key patent on Abbvie’s blockbuster rheumatoid arthritis drug, Humira® (adalimumab). This was the second time in as many months that the PTAB struck down U.S. Patent No. 8,889,135 (“the ‘135 patent) finding it obvious over the prior art. The Final Written Decisions by the PTAB were issued in IPR2016-00408 and IPR2016-00409, both IPRs filed by Boehringer Ingelheim. The ‘135 patent was previously struck down on May 16, 2017 as obvious in IPR2016-00172, an IPR filed by Coherus.
The ‘135 patent is directed to methods of treating rheumatoid arthritis with a human anti-tumor necrosis factor α (TNF) antibody known as Humira®. Specifically, Claim 1 is directed to “A method for treating rheumatoid arthritis in a human subject, comprising administering subcutaneously to a human subject having rheumatoid arthritis a total body dose of 40 mg of a human anti-TNFα antibody once every 13-15 days for a time period sufficient to treat the rheumatoid arthritis….”
The ‘135 patent is important because it covers the dosing and treatment regimen of the drug, which is necessary for any biosimilar drug looking for gain FDA approval.
In each of its Final Written Decisions, the PTAB relied on different combinations of prior art as the basis for finding obviousness. In particular, the PTAB rejected Abbvie’s argument that the commercial success of Humira® supported the nonobviousness of the claimed invention, stating, in part, that Abbvie failed to establish a nexus between the commercial success and the claimed dosing regimen.
On a positive note, Abbvie successfully petitioned the USPTO to extend the term of the ‘135 patent by about 300 days, which means that Humira® could gain nearly one additional year of market exclusivity. To gain this additional time, however, AbbVie would need to successfully appeal the IPR decisions against it.
Other patents covering Humira® have also been under attack. On June 9, 2017, the PTAB has issued Final Written Decisions in IPRs filed by Coherus against two other Humira® patents, U.S. Patent No. 9,017,680 (the ‘680 patent) and U.S. Patent No. 9.073,987 (the ‘987 patent), finding the patent claims obvious over the prior art in IPR2016-00188 and IPR2016-00189, respectfully. The ’680 patent, like the ’135 patent, is directed to methods of treating rheumatoid arthritis with human anti-TNFα antibody, while the ’987 patent is directed to methods of treating rheumatoid arthritis by subcutaneously administering a 40 mg dose of human anti-TNFα antibody once every 13–15 days.
One other Humira® patent, U.S. Patent No. 9,085,619 (the ‘619 patent), which covers the formulation of Abbvie’s antibody, is also under challenge at the PTAB.
The PTAB’s decisions here show the vulnerability that biotech and pharma patents face from IPR challenges. Humira® has been the leading drug on the market since about 2011. It costs approximately $3,100USD a month and generates Abbvie billions of dollars a year in revenue, $16 billion in global sales in 2016 alone. If patents protecting blockbuster drugs like Humira® are susceptible to IPR attack, companies that invest millions into developing these biopharmaceutical products should conduct regular reviews of their high value patent properties and develop strategies for better protecting such properties a post grant challenge.
BioPharma Law Blog posts updates and analyses on IP topics, FDA regulatory issues, emerging legal developments, and other news in the constantly evolving world of biotech, pharma, and medical devices.