• Jul 30 2019
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  • Category: CAFC Updates

The Coalition for Affordable Drugs (“CFAD”) filed a petition for inter partes review (“IPR”) challenging the validity of all of the claims of Celgene’s U.S. Patent No. 6,045,501 (relating to methods for delivering a drug (like thalidomide ) to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug) and three petitions for IPR challenging the validity of all of the claims of U.S. Patent No. 6,315,720 (relating to methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug). The Patent Trial and Appeal Board (“Board”) determined that all of the claims of the ’501 patent and some claims of the ’720 patent were obvious. With respect to the ’501 patent, Celgene challenges three aspects of the Board’s obviousness determination on appeal: (1) its finding that the prior art satisfies the “computer readable storage medium” limitation; (2) its finding that it would have been obvious to counsel male patients about the risks of teratogenic drugs; and (3) its findings on secondary considerations. However the CAFC rejects each of these challenges.  With respect to the ’720 patent, Celgene challenges but the CAFC rejects two aspects of the Board’s obviousness determination: (1) its finding that there was a motivation to improve the existing distribution methods of potentially hazardous drugs; and (2) its finding that a person of skill in the art would have been motivated to develop the claimed invention. Celgene also argues that the retroactive application of IPRs to patents filed before September 16, 2012, when the relevant provisions of the Leahy-Smith America Invents Act went into effect (“pre-AIA patents”), is an unconstitutional taking. After concluding that this is one of those exceptional circumstances in which the CAFC’s discretion is appropriately exercised to hear Celgene’s constitutional challenge even though it was not raised below, the CAFC decides that IPRs do not differ sufficiently from the PTO reconsideration avenues available when the patents here were issued to constitute a Fifth Amendment taking – – there are differences, but these differences are not sufficiently substantive or significant to constitute a taking. Accordingly, the CAFC affirms.

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