Helsinn v. Teva: On-Sale Bar Under America Invents Act Clarified
In an important decision, the United States Court of Appeals for the Federal Circuit has interpreted the scope of the on-sale bar under 35 U.S.C. § 102 of the America Invents Act (AIA). In Helsinn Healthcare v. Teva Pharmaceuticals, the court addressed the issue of whether the AIA changed the meaning of the on-sale bar. The court held that post-AIA, "if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale."
Prior to the enactment of the AIA, 35 U.S.C. § 102 stated that a person shall be entitled to a patent unless "the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States." In other words, if the claimed invention is sold or offered for sale more than one year before a patent application is filed, the patent is invalid. This ground of invalidity is known as the "on-sale bar." However, the AIA altered the language of the patent statute, adding the provision "or otherwise available to the public" which has created confusion as to whether a sale or offer for sale must be public to qualify as invalidating.
In Helsinn v. Teva, the Federal Circuit reviewed its pre-AIA case law and noted that confidential sales were also found, in some instances, to trigger the on-sale bar. The court then concluded that the post-AIA interpretation of the on-sale bar provision does not require that the details of the invention be made public.
In a LIVE Webcast, a panel of thought leaders and practitioners assembled by The Knowledge Group will discuss the significant issues and latest insights on the interpretation of the on-sale bar provision of the America Invents Act in light of the Federal Circuit decision in Helsinn v. Teva. The speakers will also look into how this decision affects judicial treatment of the on-sale bar and patent application practice.
Key topics include:
- On-Sale Bar Interpretation Pre- and Post-AIA
- Helsinn Healthcare v. Teva Pharmaceuticals
- The Federal Circuit Decision
- Impact on Patent Practice and Litigation
Nathan Louwagie, Attorney
- Background regarding the on-sale bar before the AIA and the potential changes caused by the AIA.
- The Court’s decision.
- The decisions impact on secret sales.
- Considerations for joint development projects going forward under Helsinn.
Laura Krawczyk, Attorney
Haug Partners LLP
I. Whether the invention was subject to a sale or offer for sale before the critical date
- The Panel analyzed the Purchase and Supply Agreement under the “law of contracts as generally understood” and found that it bears all the hallmarks of a commercial contract for sale. In conducting this analysis, the Court noted that: (1) the absence of the passage of title, (2) the confidential nature of a transaction, and (3) the absence of commercial marketing of the invention all counsel against applying the on-sale bar.
- If these factors were present in the Helsinn case, would the result change?
- If the purchase-supply transaction between Helsinn and MGI was confidential, and not disclosed in any SEC filings, would it still be invalidating?
II. Whether the AIA changed the meaning of the on-sale bar under 35 U.S.C. § 102
- The exact scope of the AIA on-sale bar after Helsinn is unclear.
- Helsinn argued that the AIA changed the law so that the on-sale bar no longer encompassed secret sales and required that the invention be made available to the public to trigger the bar. This argument was based primarily on the legislative history, including floor statements made during the debate regarding the AIA.
- The Federal Circuit found that the floor statements were not typically reliable indicators of Congressional intent. At most, they showed an intent to do away with precedent involving secret uses found to be invalidating under the public use prong.
- The Court stated that the public use issue was not before it and declined the invitation to decide the matter more broadly than necessary.
- The Court ruled that the AIA did not change the statutory meaning of “on-sale” in the circumstances involved in Helsinn.
- The details of the claimed invention do not need to be public for the sale/offer for sale to be invalidating.
- In Helsinn, the Federal Circuit Panel ruled that “after the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale.” Op. at 27 (emphasis added).
- In support of its ruling, the Panel stated: “There are no floor statements suggesting that the sale or offer documents must themselves publicly disclose the details of the claimed invention before the critical date. If Congress intended to work such a sweeping change to our on-sale bar jurisprudence and “wished to repeal . . . [these prior] cases legislatively, it would do so by clear language.” Op. at 26 (emphasis added).
Who Should Attend:
- Patent Attorneys
- Patent Consultants
- Patent Litigators
- Patent Managers
- Patent Owners
- Patent Agents
- Licensing Lawyers
- Outside and In-house Counsel
Nate practices intellectual property law with an emphasis on patent litigation and counseling at Carlson Caspers. He represents U.S. and foreign clients from a broad range of industries, including pharmaceuticals, medical devices and chemicals.
Nate is a registered patent agent with the U.S. Patent and Trademark Office. He served as a legal extern for the Hon. Patrick J. Schiltz of the U.S. District Court for the District of Minnesota. After earning his undergraduate degree in chemistry, Nate served for one year as a paid research intern in Medtronic Inc.’s highly competitive Technical Internship Program. During college, Nate was involved in research projects both at St. John’s University and at Southwest University in Chongqing, China. He is the co-author of an article published in the Journal of Chemical Research related to this research.
For more information, visit https://www.carlsoncaspers.com/our-attorneys/nathan-d-louwagie/.
Nate practices intellectual property law with an emphasis on patent litigation and counseling at Carlson Caspers. He represents U.S. and …
With an expertise in patent litigation, Laura Krawczyk has worked on a variety of cases involving pharmaceutical, consumer product, and electronics clients, giving her a broad range of experience across industries and in an array of technologies. She has extensive experience in all aspects of litigation including discovery, motion practice (comprising case dispositive and post-trial motions), trial and appeal, and draws on her technical background to advise clients through the litigation process.
Ms. Krawczyk has participated in numerous district court trials and appeals. She was part of a team that obtained a favorable, unanimous ruling by the Federal Circuit sitting en banc for the firm’s client, The Medicines Company, which clarified the law regarding the on-sale bar.
With an expertise in patent litigation, Laura Krawczyk has worked on a variety of cases involving pharmaceutical, consumer product, and …
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About Haug Partners LLP
Haug Partners is a full-service, national law firm that provides integrated multidisciplinary legal services for life science and technology companies. Our service offerings include: (i) Antitrust Litigation and Counseling; (ii) Commercial Litigation and Strategic Counseling; (iii) Due Diligence; (iv) FDA Compliance and Counseling; (v) Intellectual Property Enforcement; (vi) Intellectual Property Procurement and Strategy; (vii) International Trade Commission; (viii) Investigations, Compliance, and Risk Mitigation Services; (ix) Licensing and Transactions; and (x) Trademarks and Unfair Competition. With offices in New York, Washington, D.C., and Boston, and through relationships with firms in Germany, China, Japan, and other key international markets, Haug Partners has the resources, technical expertise, legal acumen, and business judgment to consistently deliver optimal outcomes for clients. The firm was founded in 1997 as Frommer Lawrence and Haug and adopted the Haug Partners name in March 2017.