Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., Cipla, Ltd.

Docket Nos. 2014-1634, 2014-1635

November 10, 2015

Brief Summary: DC finding that claims to treatment of a species of irritable bowel syndrome would have been obvious in view of genus method claim in prior art patent, other references, and expert testimony affirmed (e.g., nexus between claims and commercial success not shown).

Summary: Prometheus appealed DJ holding that the asserted claims of US 6,284,770 relating to methods for using alosteron (Lotronex) to treat irritable bowel syndrome (IBS, specifically diarrhea-predominant IBS, or “IBS-D”) obvious over prior art (no unexpected results, commercial success, or long-felt but unmet need) or Prometheus’ US 5,360,800 (double-patenting; also the primary reference relied on for obviousness). During reexamination, the ‘770 claims were amended to limit the method to “exclude[e] those with predominant constipation” and requiring an assess[ment of] whether said diarrhea-predominant female IBS patient has experienced symptoms for at least six months” as well as requiring administration an effective amount to such a patient “wherein said effective amount is dependent on the condition of the patient and is at the discretion of the attendant physician.” The opinion explains that Lotronex was approved and launched for IDS in 2000 and then pulled due to side effects. It was “relaunched in 2002, with a new, more restrictive label, new warnings about side effects, and a risk management program”, and a label “correspond[ing] to the limitations of the ‘770 patent claims.” The opinion also explains that the DC found that limiting the patient population “did not change the risk profile” for the drug and “that the decrease in the number of severe indicents is less likely due to the more restrictive label, and more likely attributable to other changes in how Lotronex is prescribed” (Risk Evaluation and Mitigation Strategies (REMS), “black box” warnings on the label, prior removal from the market). The DC found the ‘770 claims to be a species of the genus method claimed in the ‘800 patent (e.g., 27. A method according to claim 17 for the treatment of irritable bowel syndrome.) The FC panel agreed, noting however that “[i]t is well-settled that a narrow species can be non-obvious and patent eligible despite a patent on its genus” (citing AbbVie, FC 2014 (later claims to “active disease” obvious in view of prior art genus method claims) and Eli Lilly, FC 2003) (“We do not think the district court clearly erred in concluding that the lessons drawn with regard to a class of drugs (5-HT3 antagonists) are applicable to a species (alosteron) within that class…it was common practice at the time of the ‘800 patent to determine whether a patient had suffered symptoms for longer than six months.”) The FC panel was also unpersuaded by Prometheus’ argument that, even though “doctors commonly assess IBS patients for pain…and it would have been obvious to use alosetron to treat pain”, “it would not have been obvious to administer alosetron only to patients suffering from at least moderate pain”. It concluded that “[t]he record contains abundant evidence that there was a limited number of known parameters and it would have been obvious to combine the teachings as to each parameter.” It also agreed with the DC’s comparison of this case to In re Cyclobenzaprine (FC 2012) (in which secondary considerations did not support nonobviousness) and its conclusion “that the ‘770 patent was not responsible for the commercial success of reintroduced Lotronex” (nexus not shown). Thus, the DC finding of obviousness was affirmed without consideration of the double-patenting issue.

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