No infringement, invalidity or inequitable conduct found after bench trial
Robinson, J. Following a bench trial, the Court finds that plaintiff failed to show infringement and is not persuaded by defendant’s claims of invalidity for obviousness and unenforceability due to inequitable conduct.
This action arises out of the filing of an ANDA to market a generic version of the antibacterial drug PREVACID®. Plaintiff filed this suit alleging infringement of its ‘098 and ‘321 patents, which relate to the active ingredient in PREVACID® -- or lansoprazole. Defendant concedes that its generic drug infringes the ‘098 patent but contests infringement as to the “321 patent. It argues that both patents are invalid and unenforceable. The Court construes five terms, including “a pharmaceutical composition” and “granule.” The central issue is the combination of lansoprazole and magnesium carbonate (an inorganic salt which stops lansoprazole from degrading in the stomach) and whether the distribution is “even” as the claims require. The Court finds that plaintiff’s experts failed to present evidence that the accused molecules have an even, or uniform, distribution in the granule. On validity the Court finds unpersuasive defendant’s arguments that the components of the ‘098 and ‘321 patents were disclosed by prior art in that defendant failed to identify a sufficient suggestion in the art for moving the 2,2,2-trifluoroethoxy group to the pyridine ring. Evidence of secondary considerations, including annual sales of over $1 billion and superior properties compared to omeprazole is found in evidence of non-obviousness. The Court also finds no inequitable conduct. While plaintiff withheld data during prosecution, the materiality of that data was not “high.” In addition, the Court finds no evidence of a high level of intent. Defendant does not dispute that the data plaintiff submitted in its application was correct, only that additional data possibly would have brought the patentability of the claims into question. The Court finds that because plaintiff had not overcome any rejections posed by the examiner based on the data it included in the application, or in reliance on any absence of additional data, plaintiff had made no misrepresentation to the PTO.
Experts referenced in the opinion include Dr. David Bugay, Dr. Stephen R. Byrn, Dr. Drew Hirt, Dr. Christopher Lipinski, Dr. George Lenz, and Dr. Chambliss.
A copy of the full opinion is available here.
