The Coalition for Affordable Drugs, the entity backed by patent renegades Kyle Bass and Erich Spangenberg, recently won two more victories at the Patent Trial and Appeal Board (PTAB). This time Bass and Spangenberg obtained favorable inter partes review (IPR) institution decisions on two petitions filed against the University of Pennsylvania, which challenged patents covering Juxtapid. Juxtapid is a drug that slows cholesterol production thereby making it easier for the body to remove remaining cholesterol from the bloodstream. To read these institution decisions see IPR2015-01835 and IPR2015-01836. Because the Board did not find it necessary to construe claim terms at the institution stage, both decisions are mirror images of one another.
The patents in question, U.S. Patent No. 7,932,268 and U.S. Patent No. 8,618,135, relate to “the surprising discovery that one may treat an individual who has hyperlipidemia and/or hypercholesterolemia with an MTP inhibitor in a manner that results in the individual not experiencing side-effects normally associated with the inhibitor, or experiencing side-effects to a lesser degree.”
Ultimately, the Board determined that the petitioner demonstrated that the claims challenged were likely invalid because they were obvious. The case will now proceed through the administrative trial. There were, however, several issues that came up in the institution decision that warrant consideration.
Real Party in Interest
The first issue of interest in these institution decisions related to who the real party in interest is. The patent owner claimed that IP Navigation Group, LLC and nXn Partners, LLC, should have been named as real parties in interest because they were named as real parties in interest on previous petitions filed by the Coalition for Affordable Drugs. The Board disagreed, saying simply that there was no evidence provided by the patent owner that either IP Navigation Group or nXn Partners are real parties in interest in this particular proceeding. Thus, a supposition based on previous filings is not enough. Without evidence that IP Navigation Group or nXn Partners should be listed as real parties in interest, the Board was not about to find the petition defective.
Defective Provisional
These IPR institution decisions also remind us of the importance of a high quality and appropriately drafted provisional patent application. Both the ‘268 patent and the ‘135 patent relied upon an earlier filed provisional patent application for priority, but the Coalition for Affordable Drugs challenged the provisional priority claim because the provisional application did not support the claimed dose ranges or piperidine N-oxide deriviates. The Board agreed, saying that the patent owner failed to explain why the ordinarily skilled artisan would realize the invention related to the particular illustrated compound, lomitapide, after reading the provisional. Similarly, the Board found that the provisional did not provide enough information relating to dosage. Thus, the provisional priority date was lost and the remaining priority date related to the effective filing date of the PCT filing date on March 7, 2005.
Secondary Considerations
In order to attempt to establish that the claims will not likely fail as the result of being obvious, the patent owner argued that secondary considerations, such as unexpected results, commercial success, and long-felt need, supported the patentability of the challenged claims. In briefly going through each assertion in rather rapid-fire manner, the Board pointed out that, at this point in the proceedings, the patent owner has simply provided too little evidence to warrant a finding that secondary considerations are sufficient to warrant a finding that there is not a reasonable likelihood that the petition would prevail.
Tags: Erich Spangenberg, Inter Partes Review, IPR, Juxtapid, Kyle Bass, patent, Patent Office, patents, real party in interest, secondary considerations, USPTO
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