The Leahy-Smith America Invents Act was enacted into law on September 16, 2011 and applies to patents filed on or after March 16, 2013.
The America Invents Act was designed to reduce the cost of patent litigation, to resolve major validity issues in an expert tribunal, and to put an end to repetitive challenges.
The America Invents Act was the product of a six-year congressional effort to simplify and internationalize U.S. patent law.
The motivation for pursuing such an ambitious set of reforms to the patent law in a single bill arose from a set of sweeping recommendations from the National Research Council of the National Academies of Science. These recommendations were made in a 2004 report that was the product of the NRC’s four-year study of the patent system.
The NRC recommended eliminating a fundamental aspect of the U.S. patent law that had been in effect since at least the Patent Act of 1836. It proposed to eliminate from U.S. patent law the ability for an inventor to rely on a date of invention to establish whether or not an invention was novel (and thus patentable) over “prior art.”
The NRC urged that the United States return to a patent law principle found in the 1793 Patent Act. Under the 1793 Patent Act, only the filing date of a patent application was relevant to assessing that an invention was not already “known or used,” such that the invention could be considered “novel” and a valid patent could be secured on the inventor’s application for patent. The NRC recommended returning to this principle such that the date of invention would have no continuing relevance in determining patentability.
A corollary to the adoption of this principle arises in the circumstance where different inventors assert that they each independently made the same discovery. In such a circumstance, because invention dates would be disregarded, the first inventor to file for a patent, even if not the first inventor to make the invention, would alone have the right to patent the invention.
In effect, the NRC recommended that the United States abandon what is commonly referred to as the first-to-invent principle for determining patentability (and the inventor’s right to a patent otherwise) and adopt instead a first-inventor-to-file principle. Doing so is one of the seminal changes to U.S. patent law Congress accomplished through the America Invents Act.
Changes to the Patent Law
Congress Internationalized Patentability Law, Including By Adopting The First-Inventor-To-File Principle, In Order To Simplify § 102 And Limit It To Novelty And Prior Art Provisions.
At the time the America Invents Act was enacted in 2011, the first-inventor-to-file principle was observed by every country in the world except the United States. In addition, in every other country of the world, “prior art” was determined by a pair of straightforward considerations.
In the first-inventor-to-file patent systems outside the United States, prior art consists of essentially two elements: (1) subject matter publicly disclosed before the inventor’s patent filing and (2) disclosures made in earlier domestic patent filings, but only if such earlier patent filings eventually become public (i.e., either when such other applications for patent publish or issue as patents). Congress enacted the first-in-ventor-to-file principle through the America Invents Act in part because of the opportunity it presented to incorporate into U.S. patent law some of the relative simplicity typically present in foreign patent systems.
To maximize the prospects for delivering on this objective, Congress needed to make a fresh start with the patent statute, repealing the statute’s core provisions addressing patentability, 35 U.S.C. §§ 102-103. These sections had been respectively titled “Conditions for patentability; novelty and loss of right to patent” and “Conditions for patentability; non-obvious subject matter. ” Congress enacted entirely new §§ 102-103 to replace them.
New § 102 now bears the truncated title “Conditions for patentability; novelty.” The comparison of this truncated title to the title of the repealed statute indicates that Congress had repealed, and not replaced, each of the “loss of right to patent” provisions that had formerly been part of § 102.
By jettisoning the “loss of right to patent” from new § 102, the remaining patentability law under new § 102 is now confined – as its truncated title indicates – solely to the question of novelty in light of the prior art. This title-to-title comparison alone dictates that the courts should reject any construction of the new statute that would carry over any “loss of right to patent” provision from the § 102 repealed to the new § 102.
The repealed § 102 from the 1952 Patent Act had contained seven separate subsections providing a collection of individual “prior art” and “loss of right to patent” provisions. With the repeal of the “loss of right to patent” provisions and the ability to simplify the law on “prior art” under the first-inventor-to-file principle, the America Invents Act was able to distill new § 102’s conditions for patentability into a single subsection that set out all the subject matter that could now qualify as “prior art” and bar a patent for lack of novelty. This subsection is new § 102(a).
New § 102(a) is titled simply, “Novelty; prior art,” indicating that any subject matter that could qualify as “prior art” is now to be found in this single new subsection of the patent statute. Such § 102(a) “prior art” now represents the exclusive basis on which new § 102 imposes a “condition for patentability.”
This reference to “prior art” in new § 102(a)’s title is significant for another reason. The appearance of the term “prior art” in § 102(a)’s title and elsewhere in new § 102 was the first time that the term “prior art” had appeared in § 102 itself. Prior to the America Invents Act, the only patentability-related section of the patent statute in which the term “prior art” had appeared was in § 103.
The references to “prior art” in new § 102 were part of an effort by Congress to more clearly tie together new §§ 102 and 103 and to better align and more clearly link – and ultimately simplify – the “conditions for patentability” set out under these sections. Indeed, to fully understand and interpret new § 102’s provisions, it is essential to understand the ties Congress constructed between these two new sections.
In this regard, repealed § 103 had provided an obviousness bar to patenting that applied “though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made.” The America Invents Act enacted a new § 103that instead barred a patent for a claimed invention “notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention.”
Comparing the italicized before-and-after text above, Congress made four significant changes that operate to clarify and unify the relationship between new § 102 and new § 103:
First, Congress made the word “disclosed” in new § 103 the generic term for indicating when an activity can result in the creation of “prior art” under new § 102(a) – or bear on obviousness under new § 103. While repealed § 103 used the alternative “disclosed or described” to reference when § 102 would operate to bar an invention for lack of novelty, under the America Invents Act, it is a disclosure that is necessary to create “prior art.” Picking up on this simplified terminology, new § 102 now uses the words “disclosed” or “disclosure” no less than 18 times, while repealed § 102 did not make even a single use of either word.
Second, consistent with the first-inventor-to-file principle, new § 103 no longer permits the inventor to resort to a date of invention to assess non-obviousness. That assessment is now made with reference to the date of the inventor’s patent filing. Because of the importance of patent filing dates, new § 103 utilizes the term “effective filing date,” which is a term that the America Invents Act added as a new definition now found in new 35 U.S.C. § 100(i). This same terminology is now used extensively in new § 102 – in a total of six places.
Third, new § 103 adopts a second new definition, enacted as part of the America Invents Act, to provide greater precision in interpreting the new statute. This new definition appears in 35 U.S.C. § 100(j) and defines the term “claimed invention.” As used in both new § 102 and § 103, a “claimed invention” refers to “the subject matter defined by a claim in a patent or an application for a patent.” The term “claimed invention” now appears a total of 16 times in new § 102.
Fourth, although the term “prior art” from repealed § 103 appears again in new § 103, the context in which the term appears in the new law is different, i.e., the term appears in the context of a first-inventor-to-file statute in which “prior art” is now referenced explicitly in new § 102(a). Given this new context, the same word from the repealed statute now has a quite different meaning, consistent with the first-inventor- to-file statute in which the “loss of right to patent” provisions of the repealed law have not been reenacted.
As for the “prior art” provisions themselves, under new § 102(a) of the America Invents Act, the types of disclosures that now can bar patent claims are set out in two new paragraphs. First, § 102(a)(1), addresses publicly disclosed subject matter as prior art. Second, § 102(a)(2), establishes when disclosures from U.S. patent filings of other inventors can constitute prior art.
Parsing new § 102(a)(1), this paragraph operates to novelty-bar a patent claim based on “prior art” from any of three categories: if “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.”
The third of these three categories can be restated more fully by incorporating the definition from new § 100(j). As so restated, new § 102(a)(1) can impose a novelty bar to patenting when the subject matter defined by the claim has been in public use, on sale, or otherwise available to the public.
Congress Replaced “Known,” A Word Used To Define Prior Art In Patent Acts Since 1790, With “Available To The Public” To Provide A More Apt and Internationalized “Prior Art” Standard.
The phrase “known or used,” up until the America Invents Act was enacted in 2011, had been used to define prior art in every U.S. patent statute since 1790. In contrast, the phrase “available to the public,” now found in § 102(a)(1), had never before appeared in the provisions of the U.S. patent statute setting out “conditions for patentability.”
That said, the term “available to the public” had been judicially recognized at the Federal Circuit as a synonym for the term “known,” as used in repealed § 102(a) in the phrase “known or used.” Further, “available to the public” is a recognized term of art used in patent laws outside the United States to characterize subject matter that can qualify as “prior art.”
Outside the United States, the term “available to the public” has long been interpreted to preclude subject matter that remains confidential or otherwise secret from constituting prior art and being used to invalidate a patent. Based on its use outside the United States – as well as its meaning as interpreted by the courts in the United States – it is an alternative (and fully descriptive) way of requiring that subject matter must be publicly disclosed to constitute prior art.
By 2011, Congress determined that the time had come to reformulate the statutory text to address the ongoing inaptness – or at least incompleteness – of this phrase “known or used” in setting out the actual limitation on subject matter qualifying as prior art. At the same time, in rewriting § 102 in 2011, Congress was faced with the challenge of reducing the redundancy in two of § 102’s subsections (repealed §§ 102(a) and 102(b)) that separately provided that subject matter “patented” or “described in a printed publication” could constitute prior art.
These partially overlapping subsections used different terminology to reference the categories of subject matter other than that arising from patents and printed publications that could constitute prior art. Repealed § 102(a) used the phrase “known or used by others in this country,” while repealed § 102(b) characterized such subject matter as being “in public use or on sale in this country.”
Congress, in crafting new § 102(a)(1), took the approach of effectively concatenating these two subsections and replacing “known” with the more apt and more internationalized term “available to the public” – positioning the latter phrase as a terminal qualifier to limit the preceding categories of § 102(a)(1) prior art to subject matter publicly disclosed. Thus, this new qualifier – “or otherwise available to the public” – can be understood to define prior art under new § 102(a)(1) as being limited to the types of publicly known subject matter that could have qualified as prior art under repealed § 102(a).
As so limited, this new statute – like repealed § 102(a) before it – vindicates the constitutional function of the patent system to promote progress in useful arts. What is already “known” to the public needs no patent monopoly to encourage its disclosure, but the prospect of exclusive rights under a patent provides a continuing incentive to disclose what the inventor yet holds in confidence and yet remains secret, i.e., has not yet been publicly disclosed.
Thus, it follows from the text of new § 102(a)(1) that both “public use” and “on sale” activities, whether or not such activities are attributableto the inventor, can novelty-bar a patent claim, but only if the actual subject matter defined by the patent claim at issue did not remain confidential or otherwise secret, i.e., had become available to the public.
Congress’s Adoption Of The First-Inventor-To-File Principle Permitted Elimination Of All § 102 “Loss Of Right To Patent” Provisions.
The decision to draft a new patent statute that was devoid of “loss of right to patent” provisions, long part of the patent law, was taken just as seriously by Congress as the companion decision taken in the America Invents Act to abandon a first-to-invent system that had been codified as part of the patent statute since 1836. It was a decision, however, that was made with a compelling justification.
In general, “loss of right to patent” provisions address inventor-attributable activities that can result in a particular inventor forfeiting the right to patent – even if the claims to the invention would otherwise have met the patentability requirements as new and non-obvious over the prior art. Such provisions were found in repealed 35 U.S.C. § 102(c), § 102(d), and § 102(f) and in the “in public use” and “on sale” provisions of repealed § 102(b).
While such forfeitures might be justified policy-wise to preclude an excessive delay in the inventor seeking a patent once an invention had been fully commercialized, this policy justification has limited, if any, importance where the first-inventor-to-file principle applies.
In the first-inventor-to-file world, inventors have an imperative to promptly seek patents on inventions, once made, given the inability to use the date of invention to rescue patentability if the invention in question has been the subject of a pre-filing public disclosure. For this reason, Congress found little justification – whether for policy reasons or otherwise – for reenacting “loss of right to patent” provisions under the America Invents Act.
Moreover, maintaining such provisions, even if a cogent policy justification could have been articulated, would have detracted from congressional efforts to internationalize U.S. patent law by embracing the first-inventor-to-file principle. This would be particularly true of a forfeiture of the right to patent based upon inventor-attributable “on sale” or “public use” activities in which the subject matter defined by the patent claims was not made available to the public. Maintaining a forfeiture of this type could have left the United States alone in the entire world with such a provision in its patent law.
Also, given the focus on inventor-attributable activities, including activities of the inventor’s assignee, such “loss of right to patent” provisions invite discovery of the activities of inventors and their assignees to determine if the patent right has been forfeited. Such provisions in the patent law can greatly compromise the efficiency and effectiveness of yet another seminal change to the U.S. patent law, the new post-grant review procedures enacted as part of the America Invents Act. Congress provided the opportunity for any member of the public to challenge the validity of any newly issued U.S. patent on any ground that could be raised as a defense to the infringement of the patent, but in a proceeding designed with a one-year time limit for reaching a final decision – a limit premised on Congress’s determination that discovery burdens in the old law would be gone in the new.
Thus, not only did new § 102(a)(1) restrict any bar to patenting to activities producing a public disclosure of the subject matter defined by the claim of a patent – through the overarching requirement for such subject matter to be made “publicly known” or “available to the public” – but did so for compelling reasons, i.e., in light of the overall context in which the America Invents Act was conceived and enacted.
Under The America Invents Act, “On Sale” Activities Must Make The Subject Matter Defined By A Claim Available To The Public In Order For § 102(a)(1) To Bar A Patent On The Claim.
The statute contains a terminal qualifier on subject matter that can qualify as prior art that cannot be simply disregarded. It states that: “the subject matter defined by a claim” (which is the new statutory definition for the term “claimed invention” in new § 100(j)) must be “on sale, or otherwise available to the public” for new § 102(a)(1) to bar a patent. As written, this language on its face precludes knowledge not available to the public from barring a patent.
As drafted in 1952, now-repealed § 102(b), which expressly provided that a patent could be barred based on “on sale” activities, served as a dual-purpose statute, at least as interpreted by the courts. As interpreted, it imposed both a “prior art” bar (applying no matter to whom the “on sale” activities were attributable) and a “loss of right to patent” bar (specific to inventor-attributable activities).
The judicial interpretation of the 1952 statute as containing such a dual bar was not expressly precluded in the repealed statute given the open-ended, non-limiting language used in the text of the repealed law. In general terms, repealed § 102(b) simply required the “invention” (not the “claimed invention” defined as “the subject matter defined by a claim”) to be “on sale” (but only if so in the United States) outside the one-year period. In addition, there was no overall qualifier on public availability, i.e., the repealed statute did not specifically limit “on sale” activities where the subject matter defined by a claim was available to the public.
Thus, as drafted and unlike the new § 102(a)(1), repealed § 102(b) could presumably accommodate both a “prior art” construction and an inventor-forfeiture function. And, of course, the 1952 legislative history explained that it did just that – since the 1952 Patent Act did not purport to be modifying the patent law with respect to the statutory conditions for patentability from the patent statute that had come before it.
According to the facts before the Federal Circuit, all that was publicly disclosed from the inventor-attributable “on sale” activities was that the patent owner had agreed “to supply … 0.25 mg … palonosetron products.” However, the subject matter defined by the claims of the patent detailed a very specific formulation of that product to which the patent claims were limited (i.e., “palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base; from 0.005 mg/mL to 1.0 mg/mL EDTA; and from 10 mg/mL to about 80 mg/mL mannitol”).
Had the “on sale” activities undertaken here not been attributable to the inventor, there could be no § 102 patent bar based upon such activities – either before or after the America Invents Act. The sole effect of the America Invents Act on this appeal must be, therefore, to apply this outcome in the case of non-inventor-attributable “on sale” activities equally to inventor-attributable “on sale” activities.
Under the New § 102(b)(1)(B), The Sole Bar To Patenting Under § 102(a)(1) Arises From Publicly Disclosed Subject Matter.
In drafting new 35 U.S.C. § 102(b)(1)(B), Congress excluded as prior art subject matter disclosed by someone other than the inventor,otherwise constituting prior art under § 102(a)(1) to an inventor’s patent, if the “subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor.”
For § 102(b)(1)(B) to operate properly, Congress needed to restrict this special exclusion from prior art to the circumstance where the disclosure by the inventor had triggered the start of the one-year “grace period” set out in § 102(b)(1)(A). This “grace period” is triggered only if the inventor has made a disclosure that would otherwise qualify as prior art under § 102(a)(1). The drafting challenge, therefore, was to identify text to include in § 102(b)(1)(B) that would be co-extensive with § 102(a)(1)-type disclosures by the inventor.
The term “disclosed,” standing along, would not work for this purpose. This term is used in the new statute as a generic term that covers disclosures that could become prior art under both § 102(a)(1) and § 102(a)(2) – and, a patent-filing disclosure of the type described in § 102(a)(2) does not trigger the start of the “grace period.”
Congress solved this drafting challenge using the words publicly disclosed. Because Congress had limited § 102(a)(1) prior art to subject matter publicly disclosed, the use of the term publicly disclosed in § 102(b)(1)(B) removed the possibility that its prior art exclusion would apply, for example, to the situation where the inventor had made a non-public disclosure in a provisional patent application that later was abandoned and had never become public. Thus, publicly disclosed is the perfect synonym for disclosed under § 102(a)(1).
If this public disclosure limitation had not been placed into the statute, an inventor could have filed and abandoned a provisional application years before someone else had independently discovered and published in the same subject matter. Without the word “publicly,” the inventor could assert entitlement to exclude the later publication by someone else as prior art under § 102(b)(1)(B) – even if the prior art disclosure had appeared years after the inventor abandoned the provisional patent filing.
Congress avoided creating such a loophole in the new statute through the publicly disclosed limitation. By requiring the inventor to publicly disclose, thereby creating § 102(a)(1) prior art, and thereby triggering the start of the one-year “grace period,” the inventor would be forced to seek a patent during the one-year period or forfeit the right to patent on the publicly disclosed subject matter altogether.