Source: https://newsletter.bpla.org/summer2017-on-sale-bar-to-patent-protection
Timestamp: 2019-04-25 16:32:34+00:00

Document:
END NOTES 1. Helsinn Healthcare S.A. v. TEVA Pharmaceuticals USA, Inc., Nos. 2016-1284, 2016-1787, (Fed. Cir. May 1, 2017). 2. Id. at 3, 23, 24. 3. The four patents are U.S. 7,947,724, U.S. 7,947,725, U.S. 7,960,424, and U.S. 8,598,219. 4. Helsinn at 10. 5. U.S. 5,202,333, now expired, taught use of palonosetron for “prevention and treatment of emesis.” 6. Helsinn at 6. 7. Id. 8. Patent Act of 1952, Ch. 950, 66 Stat. 798 (1952), 35 U.S.C. Section 102(b) stated that, “A person shall be entitled to a patent unless – “… (b) 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 the application for patent in the United States …” (emphasis added). 9. Leahy Smith America Invents Act (AIA), Pub. L. No. 112-20. 125 Stat. 284 (2011) (codified at 35 U.S.C.) [hereinafter AIA]. 10. See, e.g. Manual of Patent Examining Procedure (MPEP) at § 2152 et seq. 11. Helsinn at 4. 12. Id. at 10. 13. Id. at 3. 14. Id. at 21, 23. 15. Id. at 22-23. 16. Id. at 26. 17. Id. 18. Id. at 18. 19. Id. at 27 (“Under Pfaff, there are at least two ways in which an invention can be shown to be ready for patenting: ‘by proof of reduction to practice before the critical date; or by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.”) 20. Id. at 24. 21. Id. at 25. 22. Helsinn at 22. 23. See, e.g. Helsinn at 23, citing RCA Corp. v. Data Gen. Corp., 887 F. 2d 1056, 1060 (Fed. Cir. 1989) overruled in-part on other grounds by Group One Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 1048 (Fed. Cir. 2001). 24. See. e.g. Cong. Rec. – Senate, S1371 (March 8, 2011) (“The current forfeiture doctrines have become traps for unwary inventors and impose extreme results to no real purpose.… The present bill’s new section 102(a) precludes extreme results such as these and eliminates the use of the definition of prior art to pursue varied goals such as encouraging prompt filing or limiting commercialization.”) 25. Id. 26. Cong. Rec. – Senate, S1370. 27. Id. at 42 (“Subsection (b) – Section 102 is amended as follows: (a)(1) A patent shall not issue for a claimed invention if the invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public (A) more than a year before the filing date.…” 28. Helsinn at 23. 29. Cong. Rec. – Senate, S1371 (March 8, 2011). (Emphasis added.) 30. Cong. Rec. – Senate, S1370 (March 8, 2011). 31. Cong. Rec. – Senate, S1496 (March 9, 2011). 32. Pre-AIA jurisprudence is divided as to whether confidential sales or offers of sale by third parties bar an inventor from obtaining patent protection. See, e.g. Chism on Patents, § 6.02.
* Principal at Hamilton, Brook, Smith & Reynolds, P.C., in Concord, MA, and Adjunct Professor at Suffolk University Law School. The author is solely responsible for the views of this article, which do not necessarily represent those of his Firm, or any client or organization.
On April 6, 2001, Helsinn entered into a Supply and Purchase Agreement with MGI Pharma, Inc. (MGI). The Supply and Purchase Agreement, in a partially redacted form that excluded price terms and the 0.25 mg dosage, was filed with the Securities and Exchange Commission (SEC) and, accordingly, became publicly available on April 25, 2001.7 Therefore, the existence of the Agreement was made publicly available more than one year before first-filed provisional patent application (January 30, 2003) to which the four Helsinn patents, including the ‘219 patent, claimed the benefit.
While the court was correct in stating that, “[r]equiring such disclosure as a condition of the on-sale bar would work a foundational change in theory of the statutory on-sale bar,”22 all of the case law cited by the court in Helsinn rejecting any requirement that the details of an invention be disclosed in the terms of a sale predated the AIA.23 Instead, as explained below, that precise “foundational change” recited by the court goes to the heart of the first-to-file system now in place, and was the explicit intent of Congress, at least according to the legislative history of the AIA.
Although the Supply and Purchase Agreement was made publicly available prior to the critical date of the ‘219 Patent, redaction of the 0.25 mg dosage claim element of the ‘219 Patent rendered the publicly-available version non-enabling. If the redacted Supply and Purchase Agreement was prior art under subsection 102(a) of the AIA, then it would be prior art not only to the inventor, but to third parties.32 However, the claimed invention was not enabled by the redacted Supply and Purchase Agreement and, as a consequence, the invention was not publicly available. Therefore, the redacted Supply and Purchase Agreement should not have been considered “prior art” under subsection 102(a) of the AIA. The only document associated with the sale that may have been enabling was the unredacted Supply and Purchase Agreement, which was maintained in secret. To consider this undisclosed document to be “prior art” would constitute a continuation of the forfeiture doctrine by embracing “secret prior art” in violation of the language of 35 U.S.C. §102(a) and the clear intent of Congress.
Elimination of the forfeiture doctrine and “secret prior art” are consistent with establishment of the first-to-file system of the AIA. Public availability and enablement of a claimed invention are hallmarks of “prior art” under the AIA, and are rendered meaningless if a sale, or offer for sale, is publicly available but not enabling, or enabling but not publicly available. The unredacted Supply and Purchase Agreement was not publicly available, and the redacted Supply and Purchase Agreement was not enabling. Neither should have been considered “prior art” under subsection 102(a) of the AIA.
This article originally appeared in IP Extracts® and is reprinted here with permission from Hamilton, Brook, Smith & Reynolds, P. C.

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