CASRIP Newsletter - Summer 2008, Volume 15, Issue 2
Chipping Away at the Infringer’s “Obvious” Advantage in Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc.
by Barna De
Prior to KSR International Co. v. Teleflex Inc.,2 courts had endorsed a rigid application of the “teaching, suggestion, motivation” (TSM) test to see if a patent claim was obvious.3 In the post-KSR era, courts must use a flexible, “common sense” approach to obviousness.4 Post-KSR cases indicate the “common sense” approach shifts the obviousness scale in favor of the accused infringer.5 While most post-KSR Federal Circuit cases offer obviousness defenses to the accused infringer, Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc. chips away at this “obvious” advantage by offering non-obviousness defenses to the inventor.
II. Procedural History
Ortho-McNeil holds an approved New Drug Application for topiramate, a compound with anti-convulsant properties.6 Mylan filed an Abbreviated New Drug Application for the compound.7 In response, Ortho-McNeil filed an infringement suit against Mylan in the District Court of New Jersey.8 The district court ruled in favor of Ortho-McNeil on claim construction, inequitable conduct, obviousness, and enablement.9 Mylan appealed these holdings.10
In particular, the district court emphasized two points in support of its non-obviousness ruling. First, for a claim to be obvious, “the obviousness inquiry must be independent of the motivations of the inventor.”11 Second, under the pre-KSR TSM test, “the problem faced by the inventor can only be a starting point for the analysis,” and therefore obvious, “if it is a problem that would have been known to one of ordinary skill in the art at the time the invention was made.”12 Mylan appealed this rigorous application of the pre-KSR TSM test.
III. Procedural History
The Federal Circuit asserted two points to support the district court’s non-obviousness ruling and its application of the TSM test as non-rigid. First, KSR posited “a situation with a finite, and in the context of the art, small or easily traversed, number of options” to one of ordinary skill in the art.13 This situation could support an inference of obviousness. In this case, however, an Ortho-McNeil scientist discovered topiramate as an intermediate during a synthesis for new anti-diabetic drugs.14 A person of ordinary skill in the art would unlikely begin the synthesis with the same starting compound used by this scientist.15 Nor would he or she likely select the exact route that produced topiramate as an intermediate or test the intermediate for properties unrelated to the purpose for the development as this scientist did.16 As such, topiramate did not present a “finite number of options easily traversed to show obviousness.”17
Second, the Federal Circuit asserted that KSR rejected a rigid application of the TSM test because such a rigid “reliance on written prior art or patent references” would “unduly confine the use of the knowledge and creativity within the grasp of an ordinary skilled artisan.”18 In this manner, Ortho-McNeil demonstrates that a flexible TSM test is “the primary guarantor against a non-statutory hindsight analysis.”19 In this case, Mylan’s expert “simply retraced the path of the inventor with hindsight, discounted the number and complexity of the alternatives, and concluded that the invention was obvious.”20 In doing so, this expert incorrectly discounted “the inventor’s insights, willingness to confront and overcome obstacles” at the time of invention.21
IV. Impact on the Pharmaceutical Industry
Four of five post-KSR Federal Circuit opinions have resulted in obviousness rulings.22 These cases suggest that KSR has shifted “the obviousness analysis in favor of the accused infringer.”23 Through its ruling, Ortho-McNeil chips away at this advantage by offering non-obviousness defenses for the inventor.
In particular, Ortho-McNeil presents three separate non-obviousness defenses. They are as follows.
a. A person having ordinary skill in the art is unlikely to select a certain starting compound for the purpose of his or her experiment.
b. A person having ordinary skill in the art is unlikely to select the exact route that leads to the formation of the intermediate compound.
c. Upon creating the intermediate compound, a person having ordinary skill in the art, who does not know about the potential utility of the intermediate compound, stops at the intermediate to test it for properties unrelated to the experiment’s purpose.
While these non-obviousness defenses for the inventor do not equal the multiple obviousness defenses for the alleged infringer, they address concerns in the pharmaceutical industry about adequate patent protection and offer a blueprint for other non-obviousness defenses.
In light of post-KSR rulings mostly favoring the accused infringer, the pharmaceutical industry has criticized the post-KSR TSM test as inadequately protecting its patents against hindsight analysis.24 In response, Ortho-McNeil chips away at the accused infringer’s “obvious” advantage and offers non-obviousness defenses to the inventor.
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