On March 30, 2020, the Honorable Miranda M. Du from the United States District Court for the District of Nevada ruled against Amarin and invalidated the company’s patents covering Vascepta® as being obvious. In doing so, Judge Du opened the door for Hikma and Dr. Reddy’s to launch generic versions of Vascepta®. In her ruling, however, Judge Du misconstrued the law of obviousness, in particular how secondary considerations are evaluated, and created an opportunity for Amarin to prevail on appeal. Here we will examine the law of secondary considerations and how it was misapplied.
In analyzing whether Amarin’s patents were obviousness, Judge Du held that the generics established a prima facie case of obviousness. In doing so, Judge Du held that a combination of prior art, namely Lovaza and Mori, rendered the claims obvious. A finding of obviousness, however, can still be overcome by focusing on the context for the inventive product rather than on the technical features of the invention. These arguments, which include i) unexpected benefits; (ii) satisfaction of long-felt need; (iii) skepticism; (iv) praise; and (v) commercial success are often referred to as “secondary considerations.” Generally speaking, showing any one of these could negate a finding of obviousness.
In her review, Judge Du analyzed each of the secondary considerations and found that while long-felt need and commercial success weighed in favor of Amarin, the other factors weighed against it. At that point, Judge Du conducted a “weighing of the secondary considerations” and ultimately found that despite two factors (long-felt need and commercial success) supporting a finding on nonobviousness, those factors were outweighed by the secondary considerations which favored the generics.
This is an unusual application of the law of secondary considerations and therefore a potential weakness in the Court’s holding that Amarin can exploit on appeal. The Court essentially weighed the secondary considerations against each other but the law of secondary considerations suggests they should be reviewed differently.
An analysis of Section 103 obviousness stems from the Supreme Court case of Graham v. John Deere, 383 U.S. 1 (1966). Under Graham, Courts look at several factors when determining obviousness, including (1) the scope and content of the prior art, (2) the level of ordinary skill in the art, (3) the differences between the claimed invention and the prior art, and (4) objective evidence of nonobviousness. Of the four Graham factors, the issue of secondary considerations often creates confusion as many practitioners wonder how significant a role they play in an obviousness analysis. According to the Federal Circuit, however, secondary considerations are intended to play a role equal to or greater than the other Graham factors in an obviousness analysis:
“It is jurisprudentially inappropriate to disregard any relevant evidence on any issue in any case, patent cases included. Thus evidence rising out of the so-called ‘secondary considerations’ must always when present be considered en route to a determination of obviousness…Indeed, evidence of secondary considerations may often be the most probative and cogent evidence in the record. It may often establish that an invention appearing to have been obvious in light of the prior art was not. It is to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art (emphasis added).” In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1076 (Fed. Cir. 2012).
Based on this line of reasoning, secondary considerations should be weighed against the other three Graham factors, not against each other. Moreover, when weighed against the other three Graham factors, the secondary considerations should be given more weight.
In fact, there are many instances where a secondary consideration, such as long-felt need, can overcome an obviousness challenge. In Eli Lilly & Co. v. Zenith Goldline Pharm., 471 F.3d 1369 (Fed. Cir. 2006), for example, the Federal Circuit affirmed the lower courts holding that a strong showing of secondary considerations, including information illustrating the long felt need to develop a safer and more effective antipsychotic medication olanzapine (Zyprexa®), was sufficient to overcome an obviousness challenge over a structurally similar compound, clozapine. In that case, testimony established that beginning at least 15 years prior to the discovery of olanzapine, a significant number of investigators were working to develop a safer and more effective antipsychotic drug because “[t]he medical need for better antipsychotic drugs in terms of increased efficacy and fewer unwanted effects is great.” In particular, it was established during trial that there was a need to find a replacement for clozapine due to the significant side effects experienced by patients, including movement disorders, bone marrow suppression and seizures.
Moreover, even from the perspective of a patent prosecutor, most times we rely on only one or two secondary considerations when trying to overcome an obviousness rejection and thus we cannot and do not provide evidence of the others. This is due, in part, to the fact that the invention may not have yet generated information on certain secondary considerations. Commercial success and praise by others, for instance, may not apply to inventions that have not yet been commercialized. For these types of inventions, only long-felt need, failure of others, unexpected results, and skepticism of experts may be available.
Moreover, there is not a certain number of secondary considerations that must be presented. It is up to the patent applicant or patentholder to provide the USPTO or court, respectively, with the secondary considerations that he feels are applicable and they should be reviewed on a case-by-case basis. In the Amarin case, Judge Du found that two secondary considerations weighed against invalidating the patents, and that by itself should have been sufficient to defeat the generics’ invalidity challenge.
Now, this is not to say that any showing of secondary considerations should automatically overcome an obviousness challenge. If the prima facie case of obviousness is very strong, then a showing of secondary considerations may not be enough. In Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007), for instance, Court found that a strong case of obviousness could not be overcome by a showing that amlodipine besylate had allegedly unexpectedly superior results when compared to amlodipine maleate.
While a strong showing of obviousness may outweigh a showing of secondary considerations, requiring the patentholder to present and defend every possible secondary consideration and then weighing them against one another is incorrect.
As Amarin prepares its case for appeal, Amarin should gather caselaw holding that the Judge’s manner of weighing the secondary considerations against each other was inappropriate. Moreover, Amarin will likely show that the District Court’s application of the law was not a harmless application of the law, especially since weighing the secondary considerations against each other appears to have directly impacted the outcome of this case. If the Federal Circuit agrees that the application of the law of secondary considerations was erroneous, it is likely that the case will be remanded back to the District Court to correct its analysis and the dispute over Vascepta® may continue for another couple of year.
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