PTAB Analyzes Section 112 Support in Declining to Institute IPR on Galdmerma’s Rosacea Patent

The PTAB recently rejected Dr. Reddy’s Laboratories’ IPR petitions for Galderma’s patent covering its Oracea® (doxycycline) product for the treatment of rosacea.  Galderma’s patent, U.S. Patent No. 8,603,506 (“’506 patent”) is directed to the treatment of rosacea using low dosages of the tetracycline antibiotic doxycycline.

Dr. Reddy’s filed three petitions for IPR against the ’506 patent. Two of the petitions focused on traditional obviousness arguments, whereas the third was based on a challenge to the claimed priority date.

In the first two petitions, Dr. Reddy’s argued that it was known in the prior art that rosacea was caused by inflammation (rather than microbes) and that prior art in the periodontal field established that doxycycline at low levels had anti-inflammatory effects.  The PTAB rejected this position on two grounds.  First, the PTAB found that, as of the filing date, the cause of rosacea was not known and it was unclear whether inflammation was, in fact, a cause of rosacea.  Second, the PTAB found that a person of ordinary skill would not necessarily have believed that the use of doxycycline to treat periodontal disease would inform the use of doxycycline in the treatment of rosacea.  The PTAB thus concluded that there was not a reasonable likelihood that Dr. Reddy’s would prevail in their petitions.

In the third petition, Dr. Reddy’s Dr. Reddy’s claimed that the ’506 patent did not have written description support in its priority applications and, therefore, the claims were invalid based on references dated later than Galderma’s claimed priority date.  Interestingly, the priority applications had the same specification as the ’506 patent itself.  Galderma thus argued that Dr. Reddy’s attack “should be rejected as a thinly-veiled attempt to circumvent 35 U.S.C. § 311(b), which permits inter partes review on a ground that could be raised under section 102 or 103.”  The PTAB did not, however, agree with Galderma and addressed the substance of Dr. Reddy’s claim.  Ultimately, the PTAB found that there was, in fact, written description support for the claims in the ‘506 patent.

Despite the fact that Dr. Reddy’s was unsuccessful in getting institution of this IPR, the decision is still informative.  Based on this ruling, it appears that a petitioner can get the PTAB to consider whether claims are supported by written description by challenging the claimed priority date and relying on later prior art.   This may be a way of bringing a § 112 issue before the PTAB in a procedure that is reserved for § 102 and § 103 challenges.