Celgene Asks PTAB to Reconsider Adverse Final Written Decisions
Written By Tucker N. Terhufen and Tasha M. Francis, Ph.D.
On October 27, 2016, the Patent Trial and Appeal Board (PTAB) issued four final written decisions invalidating claims of U.S. Patent No. 6,045,501 (“the ’501 Patent”) and U.S. Patent No. 6,315,720 (“the ’720 Patent”) covering Celgene’s cancer drugs Pomalyst® and Revlimid®. Those patents covered methods for ensuring that teratogenic drug prescriptions are not filled for persons that are pregnant or at a high risk of becoming pregnant, and were challenged by Kyle Bass and Coalition for Affordable Drugs VI LLC (“CFAD”). The PTAB found that all claims in both patents were unpatentable on obviousness grounds.
Pursuant to 37 C.F.R. § 42.71(d), on November 25, 2016, Celgene filed petitions for rehearing of all four IPRs with the PTAB. According to that section, “a party dissatisfied with a decision may file a single request for rehearing” and must “specifically identify all matters the party believes the Board misapprehended or overlooked.” (Id.) Rather than argue that all of the claims should have been held patentable, the requests narrowly focus on two claims—claim 10 of the ’501 Patent and claim 10 of the ’720 Patent.
The ’501 Patent
Claim 10 of the ’501 Patent adds a step to the pregnancy prevention method of claim one, requiring that patients who are capable of becoming pregnant be provided with a contraceptive device or formulation. In its petition, Celgene argues that the “PTAB misapprehended Petitioner’s argument for claim 10.” (IPR2015-01092, Request for Rehearing at 2.) Celgene argues that CFAD’s expert relied on prior art that disclosed a “contraception referral program” that only provided contraceptive counseling. (Id. at 2-3.) Claim 10 of Celgene’s patent requires the provision of actual contraceptives, rather than simply contraceptive counseling. (Id. at 3.) Because CFAD’s expert did not understand the disclosure of the prior art, the PTAB erroneously relied on his testimony to hold that it was an obvious modification of the prior art to provide actual contraceptives. (Id.) Celgene concludes that the PTAB overlooked its argument that “all of the experts in this case, including CFAD’s expert, agree that ‘counseling’ is not the same things as ‘providing,’” and that “telling the patient to think about getting contraception” is not the same thing as “providing a contraceptive device or formulation.” (Id. at 4.) Thus, Celgene argues that CFAD failed to establish its burden of proof that claim 10 would have been obvious, and requests that the Board vacate its Final Decision with respect to that claim. (Id.)
The ’720 Patent
Claim 1 of the ’720 Patent covers a method for detecting high patient risk of adverse effects to a proposed drug. Claims 7 and 10 of that patent further require that the risk probability include the results of diagnostic, and genetic testing, respectively. All three petitions for rehearing make basically the same argument. Celgene argues that the “PTAB overlooked and/or misapprehended evidence and argument showing that petitions failed to carry its burden on claim 10.” (IPR2015-01096, Request for Rehearing at 2 (identical relevant sections in all three petitions).) Celgene argues that the PTAB “overlooked” its argument that while the references of record disclosed other types of diagnostic tests, they did not disclose genetic testing. (Id.) The PTAB ignored how this “undermines” the expert’s opinion that genetic testing was common. (Id.) Celgene then argues that the PTAB mistakenly placed the burden on Celgene to show that genetic testing was not common, and that the PTAB mistakenly concluded that Celgene “did not dispute that genetic testing was known in the art for obtaining diagnostic information.” (Id. at 3.) Celgene argues that it did dispute this information, and that the burden was on CFAD to prove that genetic testing was common, which it failed to do in light of the cited references lacking any mention of genetic testing. (Id.) Thus, Celgene argues that CFAD’s “evidence does not support its argument that claim 10 would have been obvious,” and requests that the PTAB vacate its Final Decision with respect to claim 10. (Id. at 4.)
Notably, it is extremely rare that the PTAB grants a petition for rehearing. To date during 2016, the PTAB has granted only 3.5% of all petitions for rehearing.