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Patent Law Commentary
Agrizap and Ortho-McNeil: Two Sides of Post-KSR Obviousness
Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., et al.
Posted: 05/16/2008
By: John R. Carr, Esq.
Companies Mentioned: Mylan Laboratories, Inc., Mylan Pharmaceutical, Inc., Ortho-McNeil Pharmaceutical, Inc.
Introduction
In KSR v. Teleflex, 550 U.S. ____, 127 S. Ct. 1727 (2007), the U.S. Supreme Court broadened the applicable test in determining whether an invention is “obvious.” As predicted by patent law pundits, the KSR decision was followed by a number of cases in which infringers defended their actions – and won – by having the patent in question declared invalid for obviousness under this new standard. The Court of Appeals for the Federal Circuit (the CAFC) recently heard and decided two separate cases that addressed the issue of obviousness post-KSR. These cases shed further light on the new standard for determining obviousness. While the results are quite different, the lessons for practitioners are, ultimately, the same.
Detailed Commentary
Background
The patent system is set up so that only novel inventions, not “obvious” ones, may obtain patent protection. More specifically, Section 103 of the Patent Act mandates that an invention cannot be patented if a “person having ordinary skill in the art” would consider the invention obvious. In an effort to elucidate when an invention is obvious, promote consistency and avoid inappropriate hindsight analysis, the Federal Circuit had adopted a standard for determining obviousness often referred to as the “TSM” test – the teaching, suggestion, or motivation test. Under that standard, those challenging a patent as obvious had to show that there was a teaching, suggestion, or motivation somewhere in the relevant art (such as published articles, content of previously issued patents, etc.) that made the invention at issue self-evident or obvious. KSR, 127 S.Ct. at 1739.
Without completely denouncing the TSM test, the KSR court stated that “rigid” application of the TSM test “is incompatible with our precedents.” KSR, 127 S.Ct. at 1741. The Court stated: “Rigid preventative rules that deny factfinders recourse to common sense… are neither necessary under our case law nor consistent with it.” Id. at 1742. Rather than looking to a formal, strict rule, the KSR court said that a broader, more flexible approach was needed, one that took into account factors like the knowledge and creativity of a skilled artisan. The Court wrote: “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id.
Under the KSR test, there is no longer any requirement that the prior art references themselves hint, teach or suggest the motivation for making the claimed combination of references. Instead, a broader net is cast in which the related art and general common knowledge of one of ordinary skill can serve to provide such motivation. More specifically, any need or problem known in the field, or a related field, and addressed by the patent can provide a reason for combining the elements in the manner claimed. Further, common sense can be used to simply show that familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle. On the other hand, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp – that resulting invention is “obvious.”
Since publication of the KSR decision, alleged infringers have been using the new standard as a primary defense in order to invalidate the patent at issue as obvious, and the district courts have grappled with exactly how to apply this new standard in determining whether an invention is obvious.
Agrizap: Obviousness based on the inventor’s own prior art
In Agrizap Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008), the Federal Circuit Court relied upon KSR to reverse the district court’s denial of Woodstream’s motion for judgment as a matter of law. In that motion, Woodstream, the alleged infringer, claimed that Agrizap’s patent was invalid for obviousness.
Agrizap had patented an electronic rodent-killing device that it marketed under the brand name “Rat Zapper.” Agrizap sued Woodstream for both fraudulent misrepresentation and patent infringement. The jury awarded Agrizap damages of $1.2 million for fraudulent misrepresentation and $1.4 million for infringement.
On appeal the Federal Circuit affirmed the fraudulent misrepresentation result, but it overturned the infringement award, finding that the district court had erred in determining that the patent at issue (covering the Rat Zapper) was not obvious. More specifically, the Federal Circuit pointed to a couple of other similar patents, including a patent owned by Agrizap for a product called the “Gopher Zapper,” and found that the “Rat Zapper” was basically just an obvious combination of those other earlier patents.
In analyzing the prior art, the only difference between the patent covering the “Gopher Zapper” and the patent covering the “Rat Zapper” was the type of switch used to complete the circuit. However, the type of switch used in the “Rat Zapper” was known in the art and was used in two other existing pest control patents owned by other entities. Accordingly, the Federal Circuit determined it would have been obvious to combine these references and use this switch in the “Rat Zapper”.
Although Agrizap argued that there was no explicit hint or suggestion in the references to make such combination, the Federal Circuit cited the new KSR standard, stating: “[t]his is a textbook case of when the asserted claims involve a combination of familiar elements according to known methods that does no more than yield predictable results.” 520 F.3d at 1344.
Agrizap also tried to overcome obviousness by showing evidence of commercial success, long-felt market need, and Woodstream’s obvious copying, but the Federal Circuit said that was not enough. As stated by the Federal Circuit, “(i)n this case, the objective evidence of nonobviousness simply cannot overcome such a strong prima facie case of obviousness.” Id.
Ortho-McNeil: Upholding a patent with a “flexible TSM” test post-KSR
In Ortho-McNeil v. Mylan Laboratories, 520 F.3d 1358 (Fed. Cir. 2008), the Federal Circuit Court affirmed the district court’s grant of summary judgment in favor of the patent-holder plaintiff, Ortho-McNeil Pharmaceutical. In that case, Ortho-McNeil had a patent on a powerful anticonvulsant drug properly known as topiramate, marketed by Ortho-McNeil as “Topomax.” Defendant Mylan Laboratories sought to market a generic version of Topomax before Ortho-McNeil’s patent expired.
In asserting obviousness as a defense, Mylan argued that a person of ordinary skill in the art faced with finding an anticonvulsant drug would necessarily design an FBPase inhibitor such as topiramate. The Federal Circuit disagreed. Instead, it found that development and creation of topiramate was not an “obvious” solution to the problem.
In drawing this conclusion, the Federal Circuit noted that the obviousness standard of KSR presumes a finite and, in the context of the art, small or easily traversed number of options. In this case, the court was not convinced that given the infinite array of foundational chemical compounds with which to start, one would begin with the same compound selected by the inventor. Moreover, the court further noted that there was no showing that one of ordinary skill in the art would follow the exact route that produced topiramate as an intermediate, because topiramate was originally discovered in the course of developing and anti-diabetic type drug—an ordinary artisan in that field would have had to (at the time of invention without any clue of the potential utility of topiramate) stop at and test it for properties far afield from the purpose surrounding its original development in the first place.
Post-KSR lessons learned
These cases provide some guidance in applying the standard set forth under KSR. In particular, if there is a relatively small subset of means for solving a problem and the inventor has simply used one of those means, then a finding of obviousness is more likely to occur. Further, if an artifact or device is being used for its intended purpose and simply being integrated into a new device or form then a finding of obviousness is more likely to occur. This is exactly what happened in Agrizap. A known switch was being used for its specific benefits/efficacy. Although this switch was being used in a new application, there are a limited number of basic switch designs which would perform efficiently in such an application and it would have been obvious to use that switch.
Conversely, if applying a means for solving a problem will involve significant trial and error (testing) then a finding of obviousness is less likely to occur. Moreover, if a known artifact or device is being used for an entirely new purpose – one previously unknown – then a finding of obviousness is less likely. This is exactly was happened in Ortho-McNeil. A known compound was being used to produce a new drug. Although previously known, the prior use was unrelated and significant testing was required in order to ascertain the benefits of using the compound.
The author, John R. Carr, Esq., is a counsel of Zuber & Taillieu LLP, specializing in patent prosecutions and interferences, and trademark prosecutions, oppositions and cancellations.
Patent Law Summary
Read the related Patent Law summary: Federal Circuit Affirms Validity of Ortho-McNeil’s Patent On Epilepsy Drug Topomax
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