THE EPO grants monopolies that kill people, just like the USPTO. It's like corporate interests rather than science or innovation are the sole priority. What about public interest? Or public welfare/wellbeing?
In a 50+ page majority opinion, the Federal Circuit has affirmed a district court obviousness judgment. Judge Taranto penned the majority opinion and was joined by Judge Dyk. Judge Newman wrote in dissent — arguing in 20+ additional pages that the majority improperly discounted the objective indicia of non-obviousness. On news of the invalidity decision, Acorda’s stock price dropped 25%.
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Remember that broad Elan patent exclusively licensed by Acorda. The majority explains that Acorda’s commercial success and the long-felt need for advances were due to the roadblock set-up by that patent. “The risk of infringement liability for marketing in the US would have provided and independent incentive [for third parties] not to develop the invention of the Acorda patents, even if those inventions were obvious.” (internal quotations eliminated; this holding, the appellate court finds was supported by the trial record). Although the Elan patent was a US patent — and thus did not block research (FDA Research Exemption) nor did it block international sales, the majority explained that those caveats are “not shown to be weighty.” Several Amici filed briefs in support of the patentee — however, the Federal Circuit found that the friendly arguments failed for lack of proffered evidence.
Determining obviousness is always a reconstruction, imperfectly done, of a past that never was. The prior art is consulted and the question asked, would the worker of ordinary skill in the art have been able to achieve the claimed invention with a reasonable expectation of success? Of course, this question is posed against a backdrop of the ordinarily skilled worker not having achieved the invention; that accomplishment was attained by the named inventor. Nevertheless, the Supreme Court since Hotchkiss and the Patent Act since 1952 has recognized that sometimes the answer to the question must be no, if only to ensure that the constitutional mandate that Congress only grant patents that will "promote the progress of . . . the useful arts" be satisfied.
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The lawsuit arose when Roxane and co-Defendants Mylan Pharmaceuticals, Inc., and Teva Pharmaceuticals USA, Inc. each filed an Abbreviated New Drug Application (ANDA) for Acorda's multiple sclerosis drug (Ampyra€®) and sent Paragraph IV letters to Acorda (and co-Plaintiff Alkermes Pharma Ireland Ltd.) asserting that four Orange Book-listed patents (U.S. Patent Nos. 8,007,826; 8,663,685; 8,354,437; and 8,440,703) were invalid. As the Federal Circuit panel stated, there was one additional patent, U.S. Patent No. 5,540,938, owned by Elan Corp. plc and exclusively licensed to Acorda. That patent broadly claimed therapeutic formulations of 4-aminopyridine (4-AP); Acorda's patents were for more narrow formulations having specific characteristics and properties that distinguished (undisputedly, for novelty purposes) these claims from the claims of the '938 patent.
Today the Federal Circuit issued three parallel decisions all stemming from the patent case brought by Asghari-Kamrani. The first two decisions affirm the E.D.Va. judgment-on-the-pleadings. In those cases, the district court held that the patentee (Asghari-Kamrani) failed to state a plausible claim for relief within her complaint. In particular, the court found that all the asserted claims were invalid for lack of eligibility. On appeal, the Federal Circuit AFFIRMED in a R.36 Judgment Without Opinion. [Link].
The third decision is an order of dismissal of a parallel appeal from the PTAB (CBM Review). The PTAB had found all of the claims unpatentable as obvious or anticipated. On appeal, though the Federal Circuit dismissed the appeals as moot — and vacated the USPTO decisions.
Petition for Writ of Certiorari. I explain in the article, that the issue was rather low-level up until 2013 and the explosion of inter partes review (IPR) proceedings and resulting appeals to the Federal Circuit. Because those cases typically involve complex obviousness analysis (as in the case at hand), the shortcut route has been for the court to issue R.36 Judgments Without Opinion in these IPR appeals. The result has been hundreds of R. 36 Judgments of PATO appeals over the past few years.
Although a number of parties have raised the issue with the Federal Circuit, the court has not yet addressed the issue directly (other than by continuing to issue no-opinion-judgments). I will note that the same question is also presented in the pending petition in Leon Stambler v. Mastercard International, Inc., SCT Docket No. 17-1140.
Rob Sterne’s team at Sterne Kessler is representing the patentee-petitioner. Sarah Guske (Baker Botts) represented Cisco in the appeal.