Posts Tagged: "on sale"

n a relatively short, unanimous decision authored by Justice Thomas, the Court begins by explaining that twenty-years ago in Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67 (1998) the Court determined that an invention was on sale within the meaning of pre-AIA § 102 if it was subject to a commercial offer for sale and it was ready for patenting. Moreover, Thomas recognized that prior to passage of the AIA the Federal Circuit had clearly established that a secret sale could invalidate a patent. Therefore, given the settled precedent, Justice Thomas explained that there was a presumption “that when Congress reenacted the same language in the AIA, it adopted the earlier judicial construction of that phrase.” The Court also found the catch all phrase “or otherwise available to the public” was “simply not enough of a change… to conclude that Congress intended to alter the meaning of the reenacted term ‘on sale.’”

On Tuesday, December 4th, oral arguments were held before the U.S. Supreme Court in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA. The nation’s highest court will determine whether a secret sale of an invention, or a sale of a technology under terms that require the invention to remain confidential, triggers the on-sale bar under 35 U.S.C. § 102(a)(1), thereby preventing the invention from being patented. With this question squarely before the Supreme Court, several members of the legal industry who are watching this case offer their views on the major takeaways and the potential consequences of the Supreme Court’s decision, which will issue next year.

On the morning of Tuesday, December 4th, the U.S. Supreme Court held oral arguments in the case of Helsinn Healthcare S.A. v. Teva Pharmaceutical USA (transcript of oral arguments here). This case asks the nation’s highest court to determine whether the sale of a patented invention which required the purchaser to keep the invention confidential (i.e.: a “secret sale”) qualifies as invalidating prior art under the on-sale bar found in 35 U.S.C. § 102(a)(1)… Justice Samuel Alito said that the most serious argument for Jay to deal with was the plain meaning of the new statutory language under the AIA; if “on sale” meant on sale publicly and privately, then the “or otherwise available to the public” language wouldn’t make much sense in the context of the statute.

Despite the April 2011 priority date asserted for the ‘031 design patent, the PTAB found in its institution decision that the ‘031 patent wasn’t entitled to the priority date for the patent application resulting in the ‘838 patent because of a lack of written description support for the design claimed in the ‘031 patent… C&D Zodiac had provided evidence from a slide-show presentation shown at a B/E Aerospace Investor Day event in March 2012 which included slides (see left) depicting the Spacewall technology covered by the ‘031 patent as well as commercial success including an $800 million contract with Boeing signed in 2011.

On June 25th, the the U.S. Supreme Court agreed to hear Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., on appeal from the Federal Circuit. The case will ask the Supreme Court to decide whether an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention under the terms of the Leahy-Smith America Invents Act (AIA). In other words, is a secret sale prior art? To assess some of the reasons why the Supreme Court likely decided to take up Helsinn’s appeal, and some of the arguments we are sure to see again at the merits stage, we explore some of the amicus briefs filed with the Supreme Court encouraging them to take up the case on appeal.

On Monday, June 25, 2018, the United States Supreme Court granted cert. in Helsinn Healthcare S.A., v. Teva Pharmaceuticals USA, Inc. The single question presented by Helsinn in the petition accepted by the Supreme Court read: Whether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.

The Federal Circuit reiterated that the on-sale bar does not exempt commercial agreements between a patentee and its supplier or distributor. It is the commercial character of the transaction that is more relevant than the parties involved when assessing whether there was a commercial offer for sale.

In Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., the Federal Circuit reversed the district court and held that Helsinn’s pre-AIA patent claims, “were subject to an invalidating contract for sale prior to the critical date,” and furthermore, “the AIA did not change the statutory meaning of ‘on sale’ in the circumstances involved here.” The asserted claims of the post-AIA patent were also ready for patenting prior to the critical date… The on-sale bar, before and after the AIA, does not require a finding that the offer or sale disclosed the details or claimed features of the invention, so long as the product embodies those features when sold. An invention is reduced to practice, and ready for patenting, when it is reasonably shown to work for its intended purpose, which for a pharmaceutical product is not contingent upon FDA approval.

Earlier today the United States Court of Appeals for the Federal Circuit issued a major decision interpreting provisions of the America Invents Act (AIA), specifically the AIA on-sale bar provisions. In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit panel of Judges Dyk, Mayer and O’Malley determined: “after the AIA, if the existence of the sale is…

The Federal Circuit, sitting en banc, unanimously reversed the prior panel, holding that MedCo was not barred from seeking its patents due to a commercial sale under § 102(b). The sale of manufacturing services by a contract manufacturer to an inventor to create an embodiment of a patented product for the inventor does not constitute a “commercial sale” of the invention. Further, “stockpiling” a product prior to the bar date is not a “commercialization” that would trigger § 102(b). Instead, the transaction must be one in which the product is “on sale” in the sense that it is commercially marketed.

The district court held that the patent was not invalid because those communications did not constitute an offer for sale that would trigger the on-sale bar. Watson appealed. The Federal Circuit reversed, holding that the communications did constitute an offer to sell. Applying basic tenets of contract law, the Court held that an offer must be complete, such that acceptance creates a binding contract. Merck’s communications were a complete offer because they were solicited and contained prices, terms of payment, and terms of delivery.