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King Pharmaceuticals, Inc v. Sandoz

January 25, 2011


The opinion of the court was delivered by: Garrett E. Brown, Jr., U.S.D.J



This matter comes before the Court on Plaintiffs' renewed motion for judgment as a matter of law or for a new trial. (Doc. No. 357). This patent case was tried to a jury, which returned a verdict that the patent was invalid and Defendants did not infringe that patent. Plaintiffs filed their motion on October 18, 2010, (Doc. No. 357), Defendants filed an opposition on November 19, 2010, (Doc. No. 363), and Plaintiffs filed their reply on December 6, 2010. (Doc. No. 367). The Court has considered these submissions without oral argument pursuant to Federal Rule of Civil Procedure 78. For the reasons stated below, the Court finds that there was sufficient evidence to support the jury's verdict that the patent was invalid because it was obvious and denies Plaintiffs' motion.


This Hatch-Waxman patent litigation began on December 5, 2008, when King filed a complaint alleging that Sandoz filed an Abbreviated New Drug Application ("ANDA") seeking approval to engage in the commercial manufacture, use, sale, or importation of 800mg metaxalone tablets that are allegedly covered by King's patent, U.S. Patent No. 7,122,566 ("the '566 patent"). (Compl. at ¶ 13). On March 30, 2010, Sandoz received FDA approval to market their generic metaxalone product and began an at-risk launch. This Court denied Plaintiffs' motion for a preliminary injunction, (Doc. No. 121), and the case proceeded to trial. The parties tried the case before a jury from September 7, 2010, to September 16, 2010. At the conclusion of the trial, the jury found that all of the asserted claims of the patent were invalid and that Sandoz did not infringe them. (Doc. Nos. 344-45, 349). The Court entered judgment consistent with that verdict. (Doc. No. 346).

A. Facts

The facts, in the light most favorable to Defendants are these:

This patent infringement case involves the '566 patent, which claims a method of treatment for patients using metaxalone. The inventor of the patent, Dr. Richard A. Roberts, testified that he conceived the invention no earlier than July 2005 while taking a shower. (Sept. 7, 2010 Trial Tr. at 85). Claim 1 is representative of the issues of this case, as both parties acknowledge. (Pls.' Br. at 2-3; Def.'s Br. at 5). Claim 1 provides:

1. A method of using metaxalone for treating a patient's condition comprising: providing a patient with metaxalone; and informing the patient or a medical care worker that metaxalone affects the activity of a cytochrome p450 isozyme, and that administration of metaxalone with a substance that affects activity of cytochrome p450 isozyme can affect plasma concentration, safety, efficacy or any combination thereof of metaxalone, the substance, or both. ('566 patent, 64:47-56). Metaxalone is not a new drug; indeed, it has been marketed and used for more than 50 years. (See PTX 1). Consequently, the first step, "providing" the patient with metaxalone is not new; (see Sept. 7, 2010 Trial Tr. at 127), it is the "informing" step that allegedly adds new matter to the art. The informing step involves telling the patient that metaxalone affects cytochrome p450 and that its administration with another substance that affects cytochrome p450 can change the effects or effectiveness of metaxalone or the other substance. ('566 patent, 64:47-56). Thus, the invention focuses on imparting this new information about cytochrome p450.

Prior to Dr. Roberts' invention, quite a bit of knowledge was available about the cytochrome p450 system and metaxalone's metabolism. Plaintiffs' expert Dr. Guengerich testified that as far back as 1966, the person of skill in the art knew that metaxalone was metabolized by oxidation, that most metabolism by oxidation occurs in the liver, and that 85% of liver metabolism uses the cytochrome p450 system. (Sept. 8, 2010 Trial Tr. at 133-136; see also Sept. 7, 2010 Trial Tr. at 85-87). The 2003 Skelaxin drug label also disclosed that metaxalone could impair a patient's ability to function if taken with a CNS depressant or alcohol, which Dr. Guengerich opined may have been due to the p450 system. (Id. at 140-42).

Further, information was available about the role of cytochrome p450 in drug metabolism, particularly in two guidances issued by the FDA. In 1997 and 1999, the FDA set forth two guidances, one which was an intended to be a complement to the other (collectively "the FDA Guidances"). The Guidances recommend that drug manufacturers incorporate the results of cytochrome p450 testing on their package inserts. (DTX 52 at 13-16). In the "Techniques and Approaches for Studies In Vitro of Drug Metabolism and Drug Interactions," the FDA Guidances also explicitly set forth how to carry out in vitro studies to determine either:

(1) which p450 enzymes the body uses to metabolize a drug, or (2) which p450 enzymes are induced and inhibited by a drug. The Guidances explain that these tests are "exceptionally rapid and straight forward" as well as "inexpensive and readily carried out." (DTX 51 at 6, 7). While these Guidances were primarily directed toward new drug applications, (see DTX 52 at 1), they also provided for testing of drugs already on the market in order to determine drug-drug interactions. *fn1 (DTX 52 at 3, 5, 11; Sept. 15, 2010 Trial Tr. 31-33).

The FDA Guidances teach that when two substances are metabolized by the same cytochrome p450 pathways, "the potential for a drug inhibiting the metabolism is almost always present," and that it may also be present for different pathways. (DTX 51 at 4).

Against this backdrop, Dr. Roberts ordered cytochrome p450 testing on metaxalone. The testing that provided the information disclosed by the invention was not conducted by Dr. Roberts himself, but by In Vitro Technologies ("IVT"), a third-party testing company that routinely performed this type of testing. (See Sept. 8, 2010 Trial Tr. at 146; Sept. 7, 2010 Trial Tr. at 86). Dr. Roberts asked IVT to take metaxalone and conduct tests on its interaction with the predominant p450 enzymes involved in drug metabolism. (Sept. 7, 2010; Trial Tr. at 146-47). IVT prepared the protocols, the written procedures for the studies, and chose the p450 enzymes that were known to be predominantly involved in drug metabolism. (Id. at 146-47, 164-65). Dr. Roberts relied upon IVT's expertise to develop these protocols. (Id. at 164-65).

IVT also performed work to develop a method to detect metaxalone for the studies. (Id. at 160-163). IVT conducted the tests and produced a series of reports about the results because they had the equipment and expertise to run the studies. (Id. at 143-47; Trial Tr. at 116, Sept. 15, 2010 (reading in the June 17, 2010 Dep. Tr. at 277)).

At the time of the invention it was also known in the art that the p450 enzymes that IVT tested for were involved in drug metabolism. The Background section of the '566 patent, which explains the prior art, explains that "Cytochrome p450 isozymes identified as important in active agent metabolism are CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4." ('566 patent, 2:31-33). Dr. Guengerich, an expert for the Plaintiffs, agreed that the isozymes tested by IVT were known to be involved in drug metabolism because of papers published by the Pfizer and Amgen groups. (Trial 152-153, Sept. 8, 2010).


While Plaintiffs do not take issue with the Court's charge to the jury, they nonetheless

argue that the jury could not reasonably have found against them because no reasonable jury could have found that the patent was invalid and no reasonable jury could have found that Sandoz did not infringe the patent. Specifically, Plaintiffs argue that no reasonable jury could have found that the invention of the '566 patent was anticipated by prior art because the alleged anticipating reference does not disclose the "informing step" of its invention. (Pls.' Br. at 7-10). Plaintiffs further argue that no reasonable jury could have found that the '566 patent was obvious because the prior art did not disclose any method of treatment or suggest combining references to perform p450 testing with metaxalone. Plaintiffs also suggest that secondary factors militated against a finding of obviousness. (Pls.' Br. at 10-17). Finally, Plaintiffs argue ...

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