Interpreting the AIA’s “Otherwise Available to the Public”

The enactment of the Leahy-Smith America Invents Act (“AIA”), which President Obama signed into law on September 16, 2011, marked the most significant change to United States patent law since the Patent Act of 1952. While it is undisputed that the AIA’s enactment produces some dramatic changes to the patent system, there has been a great deal of debate over which elements of the previous regime the AIA leaves undisturbed and intact. A prime example of this is the debate over the extent to which the AIA changes certain “conditions for patentability.”

Prior to the AIA’s enactment, 35 U.S.C. §102(b) listed some of the “conditions” that an inventor must satisfy in order to obtain a patent. In relevant part, this portion of the statute stated:

“a person shall be entitled to a patent unless the invention was patented or described in a printed publication…or in public use, or on sale in this country…”

35 U.S.C. §102(b) (hereafter the “pre-AIA” conditions).  The basic purpose of these conditions is to prevent an inventor from deriving commercial benefit from her invention for any extended period of time before filing for a patent. Decades of judicial interpretation have informed the meaning of these conditions. For example, the court has interpreted “public use” to include situations where the use is limited to a single individual and concealed from public view.[1] Likewise, the “on sale” bar has been held to apply whenever an invention that is ready for patenting is merely subject to an offer for commercial sale.[2]

In §102(a)(1), the AIA preserved some of the pre-AIA language while making a few key alterations and additions. In relevant part, the current statute provides:

“a person shall be entitled to a patent unless the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”

35 U.S.C. §102(a)(1) (emphasis added). A key difference between this statutory language and the pre-AIA conditions is the addition of the residual phrase “otherwise available to the public.” Two principal arguments have been presented regarding the meaning of this provision. First, the United States Patent and Trademark Office (PTO) has argued that Congress intended for this residual phrase to modify each of the preceding phrases, thereby requiring that a prior public use or sale must make the invention available to the public in some meaningful way in order to function as a bar to patentability.[3] On the other hand, many academics have argued that Congress did not intend to upset decades of judicial precedent, but rather intended to provide an additional catch-all condition that captures means of public disclosure not envisioned in 1952.[4]

The U.S. Court of Appeals for the Federal Circuit will have its first opportunity to weigh in on this debate in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. This case began when Helsinn filed suit against Teva alleging infringement of Helsinn’s patent for palonosetron—a compound effective in treating chemotherapy-induced nausea and vomiting (CINV). Of note is the fact that more than one year before filing for its patent, Helsinn subjected its invention to an exclusive marketing and licensing agreement with pharmaceutical company MGI. At trial, Teva asserted non-infringement by arguing, among other things, that Helsinn’s patent was invalid because Helsinn’s contract with MGI triggered the “on sale” bar.  Helsinn countered by arguing that the agreement with MGI did not trigger the on sale bar, because under AIA a sale must make the invention available to the public to qualify as “on sale”. The District Court ruled in favor of Helsinn on this issue and accepted the argument that the AIA changes the law such that the “on sale” bar now requires the sale to have made the invention available to the public.

At oral argument, the Federal Circuit panel seemed unpersuaded by Teva’s argument that the “last antecedent” canon, which instructs that “to the public” modifies only “otherwise available,” should apply to resolve this case in their favor.[5]  The panel was similarly unimpressed by Helsinn’s argument that the legislative history strongly supports the notion that “otherwise available” applies to all of the preceding phrases in the series.[6] The panel did, however, appear to at least take under consideration Teva’s argument that “otherwise available to the public” creates an entirely new category meant to include means of disclosure that did not exist in 1952—such as Twitter and other social media.[7] Of course, the panel’s apparent receptiveness to certain arguments reveals little about how the appeal will ultimately be decided. We will have to stay tuned to find out if the Federal Circuit will agree with Helssin and the PTO and hold that the AIA has effectively upended decades of judicial precedent defining the meaning of the conditions for patentability.

 

[1] Egbert v. Lippmann, 104 U.S. 333 (1881).

[2] Pfaff v. Wells Electronics, 525 U.S. 55, (1998).

[3] USPTO Examination Guidelines for Implementing the First-Inventor-to-File Provisions of the Leahy-Smith America Invents Act, 78 Fed. Reg. 11059, 11062 (Feb. 14 2013).

[4] Brief of Amici Curiae 42 Intellectual Property Professors in Support of Appellant, Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., No.16-1284, (Fed. Cir. argued Oct. 04, 2016).

[5] Oral Argument at 08:35, Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., No.16-1284, (Fed. Cir. argued Oct. 04, 2016), http://cafc.uscourts.gov/oral-argument-recordings/search/audio.html.

[6] Id. at 10:30.

[7] Id. at 12:00.

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