Patent Docs: Obviousness remains uncertain patentability standard

Codification of the patentability requirement known as “obviousness” was one of the hallmark achievements of the 1952 Patent Act. The statute replaced the court-created standard of “inventiveness” introduced into the law by the Supreme Court in Hotchkiss v. Greenwood (1850), wherein the Court recognized that innovation within the skill of the ordinary worker does not “promote Progress” as required under the Constitution (Art. 1, sec. 8, cl. 8). The genius of the provision (created by Giles Sutherland Rich and P.J. Federico) was that it tethered the subjectivity of the Hotchkiss standard to the more objective consideration of the prior art.

Even this statutory approach is not infallible or exact, something illustrated by two recent decisions: Orexo AB v. Actavis Elizabeth LLC, where the Federal Circuit reversed a district court finding of obviousness in ANDA litigation against the patented drug (Zubsolv, for treating opioid dependence) and Acorda Therapeutics, Inc. v. Roxane Labs., Inc., where the Federal Circuit affirmed a district court finding of obviousness in ANDA litigation (Ampyra®, for treating multiple sclerosis-associated walking disorders). In each case the court considered robust prior art related to the claimed invention, as well as evidence from the “secondary considerations” (or objective indicia) of non-obviousness. These considerations include long-felt but unmet need; failure of others; copying; commercial success; recognition in the art, and unexpected results.

They were set forth by the Supreme Court as a check against hindsight reconstruction of an invention, wherein something that might have been non-obvious at the time the invention was made improperly appears to be obvious when considered by a court (or the Patent Office) assessing non-obviousness of the invention, reflecting a common situation wherein the question “why didn’t I think of that?” is raised upon learning of a new invention.

In Orexo, the patent was directed to a specific formulation of buprenorphine for sublingual administration having beneficial properties, particularly increased bioavailability. The district court was able to find many of the aspects in the claimed formulation to exist in the prior art, and found that any modification of those properties were within the skill in the art to optimize these features. The Federal Circuit reversed, focusing on the distinctions made by the patentee in how these aspects and features were recited in the formulation, as well as the unexpectedly higher bioavailability. The Federal Circuit characterized the District Court's error(s) as using hindsight (i.e., considering the prior art in light of the claimed invention) and relying on the prior art for not excluding Orexo's formulation, as opposed to assessing the extent to which the art provided a reasoned basis for including such formulations.

In Acorda, the invention was a dosing regimen of a known drug, 4-aminopyridine (4-AP), in a way that provided relief to MS-related walking disorders. The claims recited "methods of administering to a patient with multiple sclerosis a sustained-release 4-AP formulation (1) in a 10 mg dose twice daily, (2) at that stable dose for the entire treatment period of at least two weeks, (3) maintaining 4-AP serum levels of 15–35 ng/ml, (4) with walking improved." The extensive evidence showed that there were several failed attempts to use this drug for the claimed purpose, by both the original innovator (Elan) and another sophisticated pharmaceutical company. In this case the extensive prior art (albeit comprising just as extensive failure) was enough to convince the district court and the Federal Circuit that the claimed invention was obvious. The appellate panel found the salient limitations (set forth above numbered 1-4) were recited in the prior art. The court further rejected the relevance of the evidence of the patentee’s success in the face of others’ failure based on the existence of an earlier patent that broadly claimed therapeutic formulations of 4-aminopyridine, which the court held would have blocked any competitors from achieving the obvious regimen claimed by patentee.

These different outcomes illustrate the uncertainty that is always present in patent claims, and the capacity for investment to fail to garner a commercially reasonable (and investment-supporting) return. They suggest that public policy regarding innovator drug products need regulatory exclusivities outside mere patent protection in order to provide necessary incentive for further pharmaceutical innovation.

Codification of the patentability requirement known as “obviousness” was one of the hallmark achievements of the 1952 Patent Act. The statute replaced the court-created standard of “inventiveness” introduced into the law by the Supreme Court in Hotchkiss v. Greenwood (1850), wherein the Court recognized that innovation within the skill of the ordinary worker does not “promote Progress” as required under the Constitution (Art. 1, sec. 8, cl. 8). The genius of the provision (created by Giles Sutherland Rich and P.J. Federico) was that it tethered the subjectivity of the Hotchkiss standard to the more objective consideration of the prior art.

Even this statutory approach is not infallible or exact, something illustrated by two recent decisions: Orexo AB v. Actavis Elizabeth LLC, where the Federal Circuit reversed a district court finding of obviousness in ANDA litigation against the patented drug (Zubsolv^®, for treating opioid dependence) and Acorda Therapeutics, Inc. v. Roxane Labs., Inc., where the Federal Circuit affirmed a district court finding of obviousness in ANDA litigation (Ampyra®, for treating multiple sclerosis-associated walking disorders). In each case the court considered robust prior art related to the claimed invention, as well as evidence from the “secondary considerations” (or objective indicia) of non-obviousness. These considerations include long-felt but unmet need; failure of others; copying; commercial success; recognition in the art, and unexpected results.

They were set forth by the Supreme Court as a check against hindsight reconstruction of an invention, wherein something that might have been non-obvious at the time the invention was made improperly appears to be obvious when considered by a court (or the Patent Office) assessing non-obviousness of the invention, reflecting a common situation wherein the question “why didn’t I think of that?” is raised upon learning of a new invention.

In Orexo, the patent was directed to a specific formulation of buprenorphine for sublingual administration having beneficial properties, particularly increased bioavailability. The district court was able to find many of the aspects in the claimed formulation to exist in the prior art, and found that any modification of those properties were within the skill in the art to optimize these features. The Federal Circuit reversed, focusing on the distinctions made by the patentee in how these aspects and features were recited in the formulation, as well as the unexpectedly higher bioavailability. The Federal Circuit characterized the District Court's error(s) as using hindsight (i.e., considering the prior art in light of the claimed invention) and relying on the prior art for not excluding Orexo's formulation, as opposed to assessing the extent to which the art provided a reasoned basis for including such formulations.

In Acorda, the invention was a dosing regimen of a known drug, 4-aminopyridine (4-AP), in a way that provided relief to MS-related walking disorders. The claims recited "methods of administering to a patient with multiple sclerosis a sustained-release 4-AP formulation (1) in a 10 mg dose twice daily, (2) at that stable dose for the entire treatment period of at least two weeks, (3) maintaining 4-AP serum levels of 15–35 ng/ml, (4) with walking improved." The extensive evidence showed that there were several failed attempts to use this drug for the claimed purpose, by both the original innovator (Elan) and another sophisticated pharmaceutical company. In this case the extensive prior art (albeit comprising just as extensive failure) was enough to convince the district court and the Federal Circuit that the claimed invention was obvious. The appellate panel found the salient limitations (set forth above numbered 1-4) were recited in the prior art. The court further rejected the relevance of the evidence of the patentee’s success in the face of others’ failure based on the existence of an earlier patent that broadly claimed therapeutic formulations of 4-aminopyridine, which the court held would have blocked any competitors from achieving the obvious regimen claimed by patentee.

These different outcomes illustrate the uncertainty that is always present in patent claims, and the capacity for investment to fail to garner a commercially reasonable (and investment-supporting) return. They suggest that public policy regarding innovator drug products need regulatory exclusivities outside mere patent protection in order to provide necessary incentive for further pharmaceutical innovation.

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Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.