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News Breaks
April 19, 2014
18:32 EDTTEVASupreme Court denies Teva stay in generic Copaxone case
Teva Pharmaceutical Industries announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808, he denied the company’s application to stay the Federal Circuit's decision due to the potential for the company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis, RRMS, product, Copaxone 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone. Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE patents that expire in May, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition. Any purported generic version of Copaxone would be required to obtain the approval of the FDA prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints in RRMS patients. The company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
News For TEVA From The Last 14 Days
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January 27, 2015
09:10 EDTTEVAGevo announces Supreme Court rules in favor of Gevo
Gevo (GEVO) announced that the U.S. Supreme Court ruled in Gevo's favor and overturned an earlier Federal Circuit Court of Appeals ruling on the interpretation of key patent claims. The result is that Gevo's victory in the Delaware District Court is reinstated, and that the case has been remanded back to the Appeals Court for consideration in light of the new standard of appellate review that was decided in the Teva Pharmaceuticals USA, Inc., v. Sandoz, Inc. case last week. In Teva (TEVA), the Supreme Court ruled that the Appeals Court must apply a more stringent "clear error" standard of review, rather than a "de novo" standard of review. In Gevo's case, the Appeals Court must now apply the "clear error" standard of review and cannot set aside the Delaware District Court's findings of fact in Gevo's favor unless they were clearly erroneous. The Supreme Court's decision effectively reinstates Gevo's victory at the District Court where a final judgment of non-infringement was entered in Gevo's favor following the acknowledgment by Butamax Advanced Biofuels LLC that Gevo does not infringe Butamax's Patent Nos. 7,851,188 and 7,993,889.
January 26, 2015
15:24 EDTTEVATeva confirms U.S. approval of AstraZeneca's Nexium generic
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14:15 EDTTEVATeva unit wins FDA approval for Nexium generic
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January 23, 2015
16:08 EDTTEVATeva volatility elevated, Pfizer approached late last year, Bloomberg says
Teva (TEVA) overall option implied volatility of 25 compares to its 26-week average of 23 according to Track Data, suggesting large price movement into Pfizer (PFE) approach late last year, Bloomberg says.
16:04 EDTTEVATeva rebuffed Pfizer approach late last year, Bloomberg says
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January 21, 2015
08:38 EDTTEVAMomenta announces Supreme Court decision to remand generic Copaxone back to CAFC
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January 20, 2015
14:37 EDTTEVATeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTTEVAMylan says continues to believe '808 patent is 'invalid'
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11:29 EDTTEVATeva says Supreme Court reverses circuit court judgment on Copaxone 20 mg/mL
Teva Pharmaceutical announced the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court’s judgment of invalidity of Teva’s ‘808 patent for COPAXONE 20 mg/mL. The Supreme Court remanded the case to the Federal Circuit for further review in light of the applicable standard the Supreme Court laid out for appellate review of claim construction. A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014, while invalidating the ‘808 patent that is set to expire on September 1, 2015. “We are encouraged by the U.S. Supreme Court’s Decision and look forward to the Federal Circuit’s review. We will continue to explore all available avenues to protect our intellectual property for COPAXONE 20mg/mL,” said Erez Vigodman, President and CEO of Teva. “There is currently no FDA-approved follow-on version of Teva’s COPAXONE. We are encouraged by the FDA’s willingness to date to have dialogue regarding the complexities of COPAXONE 20 mg/mL and the potential limitations and other unknowns of purported follow-on versions,” added Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva.
10:45 EDTTEVATeva spikes, retraces, after win in Copaxone patent case
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10:40 EDTTEVAMomenta Pharma sinks after Supreme Court rules on Copaxone
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10:35 EDTTEVATeva rises after patent ruling upheld by Supreme Court
The Supreme Court upheld a lower court ruling related to generic versions of Teva's Copaxone drug. In the ruling, the court wrote that "When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review." Teva shares are up 1.5% to $58.58 in early trading after the ruling. Reference Link

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