Last week, on Monday, March 7, 2016, Kyle Bass and Erich Spangenberg (Coalition for Affordable Drugs) won two more victories at the Patent Trial and Appeal Board (PTAB). This time Bass and Spangenberg obtained favorable institution decisions in two inter partes review (IPR) petitions filed against the University of Pennsylvania, which challenged patents covering Juxtapid, which it intended to slow cholesterol production so that your body has less cholesterol to remove from the bloodstream.
The innovation at the heart of the patents in question, U.S. Patent No. 7,932,268 and U.S. Patent No. 8,618,135, relates 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.”
To read these institution decisions see IPR2015-01835 and IPR2015-01836. Because the Board did not find it necessary to construe claim terms to reach these institution decisions both decisions are mirror images of one another.
Real Party in Interest
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 so named 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.
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Both the ‘268 patent and the ‘135 patent relied upon an earlier filed provisional patent application for priority, but the petitioner challenged the provisional priority claim because the provisional application did not support the claimed dose ranges or piperidine N-oxide deriviates. The patent owner asserted that one of skill in the art would have been aware of the piperidine N-oxide compound derivatives. The Board was not persuaded, saying that the patent owner failed to explain why the ordinary skilled artisan would realize the invention related to the particular illustrated compound, lomitapide, after reading the provisional. Similarly, the Board was not persuaded that the provisional provided enough information relating to dosage. Therefore, the patent owner was only entitled to an effective filing date of the PCT filing date on March 7, 2005.
Claims from both the ‘268 patent and the ‘135 patent were challenged as being obvious over the combination of Chang and Pink Sheet.
Pink Sheet is a one-page article entitled “Bayer/PPD Implitapide Development Follows Zetia Model as Statin Add-On,” which describes a phase II proof of concept study that uses implitapide as an add-on to statin therapy.
Chang teaches that atherosclerosis can cause coronary heart disease, one of the most common causes of cardiovascular morbidity and mortality. Elevated levels of total and low-density lipoprotein (“LDL”) cholesterol are primary risk factors for atherosclerosis. According to Chang, statins are effective in lowering LDL cholesterol and somewhat effective in lowering triglycerides, but have minimal effect on high-density lipoprotein (“HDL”) cholesterol. Although reducing LDL cholesterol can reduce the risk of coronary heart disease, patients who have significantly reduced their LDL cholesterol levels may still experience clinical event. Thus, inhibitors of MTP are of interest “as a mechanism for reducing not only plasma total and LDL cholesterol, but also plasma very low density lipoprotein (VLDL) cholesterol and triglycerides.”
The IPR petition relied on Pink Sheet for teaching a method of treating a subject suffering from hyperlipidemia or hypercholesterolemia, wherein the MPT inhibitor implitapide is administered in at least three step-wise, increasing doses. The petition argued that the ordinary artisan would have combined Chang with Pink Sheet because Chang teaches that lomitapide is one of three discussed MTP inhibitors (another of which is implitapide, the MTP inhibitor used by Pink Sheet) that are furthest along in clinical trials, with each working in humans and being similarly effective.
The Board determined that the IPR petition sufficiently demonstrated that Chang provided a reason to substitute lomitapide for implitapide as taught by Pink Sheet. The fact that Chang discloses MTP inhibitors other than lomitapide, does not, by itself, make the selection of lomitapide any less obvious.
The patent owner argued that secondary considerations, such as unexpected results, commercial success, and long-felt need, support 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 proceeding the patent owner has simply provided too little evidence to warrant a finding that secondary considerations is sufficient to warrant a finding that there is not a reasonable likelihood that the petition would prevail. Of course, the Board has not yet made a final determination on patentability of any of the challenged claims.
 On March 10, 2016, the Coalition for Affordable Drugs had three more IPR petitions denied. See IPR2015-01797, IPR2015-01799 and IPR2015-01800. These were filed against Insys Pharma, Inc. and challenged U.S. Patent Nos. 8,486,972, 8,835,459, and 8,835,460. More on these petitions to follow.