Who Took Away The Better Half? Lipitor Patent Battle V

The ‘995 patent With regard to the ‘995 patent, claim construction dispute arises regarding claim 6 to cover the salt atorvastatin calcium. According to Ranbaxy, claim 6 cannot construed to cover the salt because claim depends on claim 2 and claim 2 narrows the subject-matter of claim 1 from atorvastatin acid or atorvastatin lactone, or pharmaceutically acceptable salts thereof. Ranbaxy argued that because claim 2 does not encompass salts, dependent claim 6 cannot cover the salt atorvastatin calcium. Ranbaxy specifically contended that a reading of claim 6 to include the salt would render the patent invalid under section 112, paragraph 4. In response, Pfizer contended that Ranbaxy’s claim construction is erroneous, because Ranbaxy incorrectly assumes that claim 6 must incorporate all of the limitation of claim 2. The Court finds the language of claim 6 to be unambiguous to cover the salt, atorvastatin calcium and concluded that Court’s construction is consistent with the express language of the claim and the understanding of the claim language to one skilled in the art. The Court, however, recognizes that the Court’s claim construction conflicts with the requirements for dependent claims set forth in Section 112, paragraph 4 but concluded that this statutory provision provides no basis to invalidate a claim. Based on above claim construction, the Court concluded that the Ranbaxy literally infringes claim 6 of the ‘995 patent. Patent Term Extension During trial Ranbaxy argued that the patent term extension granted for the ‘893 patent is invalid because (1) the ‘893 patent does not claim atorvastatin calcium; and (2) Pfizer voliated the duty of disclosure by knowingly withholding from the Director representations made by Warner-Lambert regarding the ‘893 patent during the prosecution of the ‘995 patent and its European Counterparts. Based on the Court’s claim construction of the ‘893 patent, the Court concluded that Ranbaxy’s first argument provides no basis for invalidating the patent term extension of the ‘893 patent. With regard to Ranbaxy’s second argument, the Court concluded that information related to prosecution of the ‘995 patent and foreign counterparts of the ‘893 patent are irrelevant to a determination of the scope of the claims of the ‘893 patent and this concluded that Ranbaxy has not established that the alleged withheld information is material such that it was required to be disclosed during the application process for the patent term extension. Accordingly, the Court concluded that Ranbaxy has not established that the patent term extension of the ‘893 patent is invalid. To be continued... Who Took Away The Better Half? Lipitor Patent Battle Who Took Away The Better Half? Lipitor Patent Battle II Who Took Away The Better Half? Lipitor Patent Battle III Who Took Away The Better Half? Lipitor Patent Battle IV