Helsinn Healthcare SA, et al v. Dr. Reddy's Laboratories, Ltd., et al, 3-11-cv-03962 (NJD March 3, 2016, Order) (Cooper, J.)
Monday, March 7, 2016
Press Release and Form 8-K Did Not Make Invention Available to Public as Required by Post-AIA On Sale Bar
Following a bench trial, the court found that plaintiffs' post-AIA chemotherapy drug patents were not invalid under the on-sale bar because plaintiffs' invention was not available to the public. "[Plaintiffs] and [their licensee] entered into a Supply and Purchase Agreement for the sale of [plaintiff's] commercial [drug] product. . . . It is inapposite that at the time of the agreement, the product was uncertain and awaiting FDA approval, because the appendices to [the license and supply agreements] specified the exact dosages and concentrations that were in the pending FDA filings. Indeed, under a pre-AIA analysis, the Court’s analysis would end here with a conclusion that the . . . Agreement constituted a contract for sale, thus satisfying the 'sale' prong of the on-sale bar. However, the post-AIA on-sale bar also requires that the sale or offer for sale make the claimed invention available to the public. [Defendant] asserts that the Form 8-K and [plaintiffs'] press releases made the existence of the agreement available to the public. However, [plaintiffs' licensee's] Form 8-K was redacted and indicated only that [plaintiffs] and [their licensee] had entered into an agreement to purchase [plaintiffs'] product. . . . [Defendant] has failed to show how [the licensee's] Form 8-K or [plaintiffs'] press releases on the [license] Agreement made [plaintiffs'] claimed invention, i.e., its palonosetron formulation, available to the public."