Opinion ID: 211331
Heading Depth: 1
Heading Rank: 1

Heading: facts

Text: The ’618 patent and the ’743 reissue patent disclose and claim mixtures of low molecular weight herapin (“LMWH”) used to prevent blood clots. During prosecution of the application leading to the ’618 patent and the ’743 reissue patent, Aventis compared the half-life of a product allegedly covered by the ’618 patent (Example 6 of the ’618 patent or “Debrie LMWH”) at a 40 mg dose to the half-life of a prior art product (“EP 40,144 LMWH” or “Mardiguian LMWH”) at a 60 mg dose. Aventis made these comparisons to the Patent and Trademark Office (“PTO”) in the patent application, in several office action responses, and in two declarations by a French scientist named Dr. Andre Uzan to show an unexpected and significantly better half-life of Debrie LMWH when compared to EP 40,144 LMWH. Aventis did not, however, expressly disclose the dosages at which the half-life comparisons were made, and specifically, that the EP 40,144 LMWH data was for a 60 mg dose. The ’618 patent and the ’743 reissue patent purportedly cover drug compositions called Lovenox® that are approved by the Food and Drug Administration (“FDA”). Amphastar and Teva filed Abbreviated New Drug Applications (“ANDAs”) with the FDA 05-1513 2 to obtain approval to market generic versions of Lovenox®. In response, Aventis, the owners of the ’618 patent and the ’743 reissue patent, filed a patent infringement suit against Amphastar and Teva in the United States District Court for the Central District of California. The district court granted a motion for summary judgment of unenforceability due to inequitable conduct submitted by Amphastar. Without holding a hearing, the court concluded that Aventis’s repeated representations of patentability based on the purported improved half-life of Debrie LMWH were material. The court faulted Aventis for comparing data based on different doses to show an improved half-life, when a comparison of available data using the same doses actually showed that there was little if any difference between the half-lives of the prior art and the purported invention. The court rejected Aventis’s argument that Dr. Uzan’s first declaration can reasonably be interpreted as meaning that the disclosed half-life data was based on different dosages, calling the argument “specious.” Regarding intent, the court rejected Aventis’s argument that the use of the 40 mg Debrie LMWH data, as opposed to the 60 mg Debrie LMWH data, was reasonable. The court stated that the question is not whether use of the 40 mg data was reasonable, but whether there was an omission of material fact, particularly in light of the fact that the same study showed that the 60 mg Debrie LMWH data and the 60 mg EP 40,144 LMWH data was much closer than the 40 mg Debrie LMWH data and the 60 mg EP 40,144 LMWH data. Based on these circumstances, the court found that the facts support a strong inference of intent. The court then weighed materiality and intent. It found weighty uncontroverted evidence sufficient to establish materiality and intent to 05-1513 3 deceive, and further stated that Aventis submitted just a scintilla of evidence in opposition. It therefore granted summary judgment of unenforceability due to inequitable conduct.1 Aventis timely appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(1).