by Dennis Crouch
Helsinn v. Dr. Reddy’s and Teva, Civ. No. 11-cv-03962 (D.N.J. March 3, 2016) [Helsinn Opinion]
The district court decision in this case is focused on the medical marijuana substitute Aloxi (Palonosetron) by Helsinn and its U.S. Patent Nos. 7,947,725, 7,960,424, 8,598,219. Of these, the district court found that the ‘219 patent is an AIA patent. As is common in the drug industry, Helsinn carried out a number of clinical trials (working with third parties) prior to filing that included selling the du. And, a primary question for the court was whether the invention was “on sale” prior to the invention and/or filing date.
Under pre-AIA rule, the “on sale” bar included prior secret sales and offers-for-sale. See Metallizing Eng’g Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516 (2d Cir. 1946). Although the AIA includes the identical “on sale” language, the rewritten Section 102 also includes the additional catchall “otherwise available to the public.”
As the fist decision interpreting the new statute, the court (Judge Cooper) here held that the “otherwise” language modifies and limits the “on sale” provision — indicating that sales and offers for sale only count as prior art if they are also “available to the public.”
§102(a)(1) requires a public sale or offer for sale of the claimed invention. The new requirement that the on-sale bar apply to public sales comports with the plain language meaning of the amended section, the USPTO’s interpretation of the amendment, the AIA Committee Report, and Congress’s overarching goal to modernize and streamline the United States patent system.
The court’s interpretation here is parallel to that of the USPTO in its examination guidelines. Although not the law, the Patent Office’s statements appear to have influenced the court here. It also falls in-line with what Paul Morgan suggested in his 2011 article. Paul Morgan, The Ambiguity in Section 102(a)(1) of the Leahy-Smith America Invents Act, 2011 Patently-O Patent Law Journal 29. Download Morgan.2011.AIAAmbiguities.
Here, because the patentee’s sales were kept secret (“subject to and performed under confidentiality restrictions”), they could not be considered sales under the new statute.
Teva filed its Federal Circuit appeal in the case on March 7, but the brief is not yet public. I expect that the Federal Circuit opinion will be interesting — especially if the court reaches this issue. (The court might not reach the issue depending upon whether the actions are excluded under the upcoming Medicines Co. v. Hospira en banc decision. In addition, the court did not explain why the patent in question–a continuation from a pre-AIA case–counts as an AIA patent.)
My basic take on the statutory construction issue is that it could legitimately go either way. My hope is that the issue is resolved to remove the uncertainty and the likelihood that a significant number of patents are wrongly issued.