Articles Posted in Supreme Court Review of Fed. Cir.

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It is rarely in doubt that a drug-maker has the right to bar generic entry into an exclusive market when the drug-maker’s patent is found valid and infringed by a generic applicant, or when such a finding is deemed reasonably likely by the court.

For this reason, it is somewhat surprising that Chief Judge Roberts denied drug-maker Teva’s request to reinstate an injunction against generic entry against its Copaxone® drug product to treat multiple-sclerosis. Notably, all of Teva’s patents-at-issue will expire at least by September 2015. While the length of remaining patent term could have been a factor in the denial of the request, it is difficult to know. The ruling itself is less than 200 words.

The Chief Justice acknowledged that Teva has shown “a fair prospect of success on the merits,” the prong of the analysis that often trips a patentee’s application for injunctive relief. Instead, this relief was denied because the alleged availability of money damages for past patent infringement was found adequate. Thus, the Chief Justice explained, “the extraordinary relief that Teva seeks is unwarranted.”

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In Atlantic Marine Const. Co., Inc. v. U.S. Dist. Court for Western Dist. of Texas, 571 U. S. _ (2013), 2013 WL 6231157 (December 3, 2013), the Supreme Court not only reiterated that a valid forum selection clause must be given controlling weight, with rare exception – when considering a transfer motion under a 1404 analysis – but unamimously held that the analysis in those rare exceptions may give no weight to plaintiff’s choice of forum and may only consider counterveiling public-interest factors. “When parties agree to a forum-selection clause, they waive the right to challenge the preselected forum as inconvenient or less convenient for themselves or their witnesses, or for their pursuit of the litigation. A court accordingly must deem the private-interest factors to weigh entirely in favor of the preselected forum.”

Recognizing the applicability of Atlantic Marine to a forum selection clause in a patent license, yesterday the Supreme Court vacated and remanded a Federal Circuit decision refusing to enforce a forum-selection clause in an EDTX patent suit that, by the agreement, should have been filed in New York. See Broadcom Corporation v. USDC ED TX, et al., case number 12-1475.

Atlantic Marine settles a circuit split in authority. In the Third Circuit, guidelines for the applicability of a forum selection clause were established by Jumara v. State Farm Ins. Co., 55 F.3d 873, 883 (3d Cir.1995). Atlantic Marine, revises Jumara‘s guidance. It appears now that a forum selection clause is entitled to more than the “substantial consideration” – called for by Jumara – in a 1404 transfer analysis. It further appears that one may no longer rely on Jumara’s reasoning that a forum selection clause is but “one facet of the convenience-of-the-parties consideration.” Private-interest factors, as noted above, must now “weigh entirely in favor of the preselected forum.”

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The U.S. Supreme Court’s much anticipated decision in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al., 569 U.S. ___, issued June 13, 2013. In short, the Supreme Court analyzed whether an isolated DNA sequence is patent eligible in light of the fundamental principle that laws of nature, natural phenomena, and abstract ideas are not patentable. The Supreme Court held that mere isolation of an otherwise naturally occuring genetic sequence of DNA is not patent eligible but that a non-naturally occuring DNA sequence may be subject matter eligible for patenting, so long as the other conditions for patenting are met (e.g., novelty, non-obviousness, written description).

While many divergent views are forming on the impact this decision will have on the biotech industry, its impact on patent litigation in Delaware is broadly predictable. In appropriate circumstances, new patent validity challenges can be anticipated against DNA sequence claims asserted in this District and new litigation may flow from the entry of several new competitors expected to offer genentic tests for various diagnostics, some of which will undoubtedly be the subject of a patent controversy within Delaware’s jurisdiction.

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On March 17, 2008, the United States Supreme Court denied PharmaStem’s writ of certiorari in the case of PharmaStem Therapeutics, Inc. v. Viacell, Inc., et al. This case involved various cord blood storage patents and was originally filed in the District of Delaware. A jury originally reached a verdict for PharmaStem and against Viacell Inc., Cyro-Cell Inc., Corcell Inc. and CBR Systems Inc. in an amount of $7,124,333.92; and entered judgment on Viacell’s antitrust counterclaim in favor of PharmaStem and against Viacell. Judge Sleet later overturned the infringement verdict (see a copy of the opinion here). The Federal Circuit opinion affirmed the District Court’s finding of non-infringement but reversed the District Court on the issue of obviousness, finding the patents invalid and entered judgment for the defendants. (See Federal Circuit opinion here.)

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