Wall Street Journal post questions legal reasoning of PTAB in not instituting Tecfidera IPR
in the decision not to institute an IPR over claims of Biogen's '514 Tecfidera patent:
Jacob S. Sherkow, an associate professor at New York Law School, said he was puzzled by the patent office’s reasoning behind its decision on Tecfidera on Wednesday, which he said contradicted legal precedent.
The patent board, in explaining why it had denied the challenge, said the pilot-study description didn’t prove the drug worked against multiple sclerosis, but was at best a “hope” it would work.
Mr. Sherkow said determining the effectiveness of an invention is outside the patent judges’ authority in evaluating IPR petitions and that for decades pilot studies have been considered permissible evidence in patent challenges. “I am shocked by the reasoning of the decision,” he said.
See Hayman Capital’s Kyle Bass Vows to Continue Drug-Patent Challenges
There are two parts to PTAB's reasoning that are found in the text: --[PTAB] said the pilot-study description didn’t prove the drug worked against multiple sclerosis, but was at best a “hope” it would work. --
The written description in the pilot-plant study DID PROVE that members of the genus esters of fumaric acid did work
to modify the progression of MS, as shown by MRI results involving gadolinium compounds. Thus, the pilot-study was far more than a "hope."
The written description did NOT explicitly mention methyl esters, but merely the genus of the class to which methyl esters belonged.
The big question is whether that deficiency merits denial of the petition for IPR. Does knowledge that a member of a class works to modify MS (as proved by MRI/gadolinium) motivate one of ordinary skill to try class members?
See the IPBiz post
PTAB declines to institute IPR against Biogen's US 8,399,514 related to the MS drug Tecfidera published before the Wall Street Journal article.