Judge Hochberg of the District of New Jersey just issued an opinion finding two patents covering Warner Chilcott’s osteoporosis drug Altevia® (risedronate) invalid for obviousness. Warner Chilcott, LLC v. Teva Pharmaceuticals USA, Inc., 2015 U.S. Dist. LEXIS 26207 (D.N.J. March 4, 2015). This case demonstrates the importance of challenging whether alleged unexpected properties and skepticism have a nexus to the claimed invention. It also illustrates the persuasiveness of evidence of contemporaneous development of the alleged invention.
The Alleged invention. Altevia® addresses the food effect experienced with prior osteoporosis drugs in the class. Specifically, the active ingredient was not absorbed by the body when taken with meals because it was captured by the calcium in food. The patents-in-suit claim the combination of risedronate ETDA, a calcium-blocking agent, wherein the amount of EDTA was above that used in the prior art.
The Court’s Obviousness Analysis. The most interesting aspect of the 68-page opinion is the Court’s analysis of secondary considerations. In particular, the Court rejected the patentee’s evidence of unexpected properties because there was no nexus between the unexpected properties and the claims. Warner Chilcott relied on a clinical trial comparing once-daily Actonel® to once-weekly Altevia® that purported to show that Altevia® performed unexpectedly better than Actonel®. The Court found that there was another explanation for the unexpected results with Altevia®—it was easier to comply with once-weekly dosing of Altevia® than once-daily dosing of Actonel®. Therefore, as Warner Chilcott’s expert admitted, the unexpected improvement could have been due to the dosing frequency—an element known in the prior art—rather than the claimed invention.
The Court similarly rejected Warner Chilcott’s skepticism argument. Warner Chilcott presented evidence that the defendant, before Altevia® had been approved and launched, contemplated using increased amounts of EDTA in combination with risedronate, but ultimately decided not to pursue that approach. Warner Chilcot suggested this showed that the defendant was skeptical about increasing the amount of EDTA. The Court disagreed. There was no evidence that scientists were concerned that the claimed amount of EDTA would not work; rather, the defendant was concerned that additional research would have been required because the increased amount of EDTA would have exceeded the levels provided in the FDA’s Inactive Ingredient Guide.
The Court also relied on evidence of simultaneous invention in support of its obviousness finding. Takeda developed a similar drug product with risedronate and increased levels of disodium EDTA several years before the patents-in-suit. But that wasn’t all. The court further found that Warner Chilcott pressured Takeda to abandon a patent application directed to this technology in order to prevent it from becoming prior art to the patents-in-suit. Although the Court did not find that this questionable conduct amounted to inequitable conduct, it certainly factored into the Court’s obviousness decision.