On October 27, 2016, the 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 Pomalyst® and Revlimid®. Those drugs are prescribed to treat multiple myeloma, which is a form of cancer that effects plasma cells typically found in bone marrow. In 2015, Celgene had sales of $5.8 billion for Revlimid®, and $983 million for Pomalyst. Both drugs are known to cause serious birth defects if taken while pregnant.
The claims of the ’501 Patent disclose a method for ensuring that teratogenic drug prescriptions such as thalidomide are not filled for persons that are pregnant or that are at a high risk of becoming pregnant. The claims require that prescribers, pharmacies, and potential patients register with a database. The database tracks the risk that potential users are pregnant or will become pregnant. Those at high risk become a subpopulation, and the method requires that the subpopulation receive counseling information about the risks attendant to fetal exposure to the drug. Only after determining that the potential patient has received counseling, and is not pregnant, may the pharmacy fill the prescription. The claims of the ’720 Patent disclose a similar method aimed at the same goal. Potential patients must enter their information into a database, and a system tracks a set of predefined risks of the drug. Patients are placed into risk groups with those having a higher likelihood of experiencing the attendant adverse effects being placed into a higher risk group. Only after determining that the risk level is acceptable, the system generates a pharmacy approval code. The pharmacy may then retrieve the code and fill the prescription. As these patents pertain to Pomalyst and Revlimid, the goal is to ensure that no pregnant woman, or woman at unacceptable risk of becoming pregnant, is able to fill a prescription.
On April 23, 2015, Kyle Bass and the Coalition for Affordable Drugs IV LLC filed one petition for inter partes review of all claims of the ’501 Patent, and three petitions for inter partes review of all claims of the ’720 Patent. The Board instituted all four petitions on October 27, 2015. Bass challenged the claims of both patents on obviousness grounds, and the Board held them all unpatentable.
The ’501 Patent
In the first Petition, Bass claimed the ’501 Patent claims were obvious in light of three prior art references that disclose: (1) guidance regarding the clinical use and dispensing of thalidomide (another teratogenic drug); (2) a pregnancy-prevention program for women taking Accutane® (another teratogenic drug); and (3) a registry for pharmacies, prescribers, and users of Clorazil® (another teratogenic drug). (IPR2015-01092, Paper 73 at 13.) The Board held that “a person of ordinary skill in the art would have been led to combine, in the manner claimed, the disclosures . . . to address the problem of limiting thalidomide access to patients likely to suffer serious adverse side effects, including birth defects in a developing fetus.” (Id. at 23–24.) Celgene put on evidence of secondary indicia of nonobviousness including long-felt but unsolved need, industry praise, and unexpected results, but the Board found that evidence unpersuasive, and held all of the challenged claims unpatentable as obvious. (Id. at 28-29, 33.)
The ’720 Patent
Each of the three petitions challenging the claims of the ’720 Patent cited very similar art. The first raised five references. The second had two references in common with the first, and raised 11 additional references. The third dropped one reference from the second, and added one additional reference. The art cited discloses various programs, steps, or methods of limiting the exposure, availability, or access to certain drugs that cause adverse side effects. (See, e.g., IPR2015-01096, Paper No. 73 at 17–20.) In the first petition, the Board analyzed the references and held that “the use of integrated response systems in combination with a controlled distribution drug program is a combination of known elements being used for their known purpose to achieve a predictable result, obtaining patient information through an automated process to aid in assessing risk group assignment for prescribing drugs.” (Id. at 29.) In the second and third petitions, the Board used the same language and held all of the claims obvious. (IPR2015-01102, Paper No. 75 at 32; IPR2015-01103, Paper No. 76 at 32.) Celgene did not argue unexpected results in any of the hearings, and the result of all three petitions was a finding that all of the claims of the ’720 were unpatentable as obvious.
The Orange Book lists 17 other patents as covering Pomalyst® and 26 other patents as covering Revlimid®. Celgene can request a rehearing by panel within 30 days of the final written decision, and must articulate all grounds it feels the Board “misapprehended or overlooked.” 37 C.F.R. § 42.71(d). Alternatively, Celgene may appeal directly to the Federal Circuit, 37 C.F.R. § 319, and must file a notice of appeal within 63 days of the final written decision, 37 C.F.R. § 90.3. It is also noteworthy that the Board issued its final written decision exactly one year after institution of the IPRs, as required by 35 U.S.C. § 316.
As seen in the table below, of the seven inter partes reviews that have gone to final written decision, Bass has successfully invalidated claims in six cases.
We will continue to monitor developments in this area.