United States: Insufficient Showing Of Public Availability Of Prior Art And Strong, Unrebutted Evidence Of Commercial Success Defeats IPR Petition

The Patent Trial and Appeal Board (PTAB) has issued a final written decision determining that the Coalition for Affordable Drugs VIII, LLC ("Coalition" or "Petitioner") failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (the "'135 Patent") were obvious.

The '135 Patent, which is owned by the Trustees of the University of Pennsylvania ("UPenn"), is directed to a method of treating a patient suffering from hyperlipidemia and/or hypercholesterolemia by administering compounds that inhibit microsomal triglyceride transport protein (MTP) according to a dosage regimen that minimizes serious side effects.  The '135 Patent teaches that, although several MTP inhibitors were developed by pharmaceutical companies, clinical development of these drugs was discontinued due to significant and serious hepatotoxic side effects observed during clinical trials.  The inventors of the patent discovered that these serious side effects can be significantly reduced by utilizing a dosage regimen that starts with a low dose of the MTP inhibitor, lomitapide, followed by a gradual step-wise increase in dose levels. The PTAB instituted a trial based on the Coalition's arguments that the challenged claims are obvious in view of two combinations of prior art references: (1) the Stein presentation and the Chang reference, and (2) the Pink Sheet and the Chang reference.

First, the PTAB found that the Coalition failed to establish that the challenged claims were unpatentable based on the Stein presentation and the Chang reference because the Coalition did not demonstrate that Stein's presentation constituted a printed publication for prior art purposes. The Coalition did not establish that the Stein presentation, which was presented as a webcast at Analyst Day at PPD, Inc., was publicly available because there is no evidence that: (1) a skilled artisan would have accessed the presentation via webcast or on the PPD website, and (2) the presentation was posted online prior to the priority date of the '135 Patent.

Second, the PTAB found that the Coalition did not prove by a preponderance of the evidence that the challenged claims were obvious in view of the Pink Sheet and the Chang reference because the Coalition did not establish a reasonable expectation of success. Although the Pink Sheet teaches the claimed dosing schedule with an MTP inhibitor (implitapide), the Coalition did not establish that a skilled artisan would have reasonably expected or predicted that lomitapide as taught by the Chang reference could be substituted for implitapide with a reasonable expectation of effectively treating hyperlipidemia or hypercholesterolemia without unacceptable levels of toxicity.    

Finally, the PTAB found that the evidence of secondary considerations in this case supported a finding of nonobviousness. UPenn established that its licensee, Aegerion, received Food & Drug Administration approval for JUXTAPID®, a lomitapide treatment for homozygous familial hypercholesterolemia, which has generated more than $420 million in revenue since its launch in 2013. The Coalition did not challenge the commercial success of the patent, but instead argued that UPenn did not establish a nexus between JUXTAPID® and its commercial success and that the commercial success is not commensurate with the scope of the claims. The PTAB stated that nexus is presumed because JUXTAPID® is the commercial embodiment of the challenged claims, and, in addition, UPenn presented evidence that the JUXTAPID® marketing prominently displays the dosing schedule encompassed by the claims. The PTAB found that the challenged claims are commensurate in scope with the patent owner's evidence of commercial success because, contrary to the Coalition's arguments, the JUXTAPID® website describes the claimed dosing method. Thus, the PTAB found that the unrebutted evidence of commercial success supports the patentability of the challenged claims.

The Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, IPR2015-01835, Paper No. 56 (PTAB Mar. 6, 2017).

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