So why did the USA decide to put its (our?) patents at risk against Gilead? Moreover, why would the DOJ be willing to risk its existing license relationships for these HIV prevention treatments by attacking a sophisticated patent litigant like Gilead?
Read MoreWe previously blogged about Teva’s ($TEVA) petition for post-grant review (PGR) of Corcept Therapeutics’ ($CORT) ‘214 patent. Since then, on November 20, 2019, the PTAB granted institution of Teva’s petition. The proceeding will now be litigated for another year before a final decision. On a recent earnings call, Corcept stated that it believes the standard for institution is “pretty low,” and not necessarily dispositive that Teva will prevail. Now that we have the institution decision, what can we glean from it, and how likely is that Corcept’s patent survives?
Read MoreAmarin Pharmaceuticals ($AMRN) will be going to trial soon to protect Vascepa® against generic competition. Amarin has asserted 15 claims from six patents against ANDAs filed by Hikma, Dr. Reddy’s and Teva. What are the issues to be addressed at trial?
Read MoreThe American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other. The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc. The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.
Read MoreIntel recently sued Fortress for antitrust violations based upon its alleged monopolistic aggregation of patents. Intel’s allegations mirror those by Capital One against Intellectual Ventures, which were recently rejected by the Federal Circuit. Over the past several years, any patent assertion has had to contend with certain expected defenses: Alice, IPRs, threats of Octane Fitness. Are antitrust counterclaims the next trend?
Read MoreThe Federal Circuit’s current interpretation of a “sale” and “offers to sell” under 35 U.S.C. § 271(a) has permitted vendors that supply components for end products destined for the United States to directly market to and compete for a share of the U.S. market, but simultaneously avoid liability for patent infringement by offshoring all manufacture and delivery of their products. We recently published an article in Law360 discussing how downstream customers from these vendors are likely to bear the brunt of defending more patent suits given that traditional recourse to the customer suit exception or severance under Rule 21 may not be availing. Follow this link to the article.
Read MoreWe previously blogged about an ongoing patent fight between Moderna Therapeutics ($MRNA) and Arbutus Biopharma ($ABUS). That fight could implicate whether Moderna’s pipeline depends upon technology that is patented by Arbutus. Moderna has sought to invalidate three patents owned by Arbutus, and has so far met with mixed success. Who is winning this fight?
Read MoreExelixis ($EXEL) recently received a Paragraph IV certification against its drug, Cabometyx, which is indicated for kidney cancer and as a second-line treatment for liver cancer. The certification was sent by MSN Pharmaceuticals. A lawsuit is likely to be filed by Exelixis against MSN within 45 days of the Paragraph IV certification. How well-positioned is Exelixis to fight this generic challenge?
Read MoreA veritable patent storm has developed between two purveyors of robotic vacuum cleaners, iRobot ($IRBT) and SharkNinja. In September 2019, SharkNinja launched the Shark IQ Robot, which iRobot claims is a knock-off of its highly-innovative Roomba® “i” and “s” Series products. By October 15, 2019, the parties had each filed their own lawsuits, and iRobot has asked a Court to immediately enjoin the Shark® IQ Robot from the market in advance of the critical holiday shopping season. What can we make of these cases?
Read MoreThe saga over Corcept Therapeutics’s ($CORT) patent battles against prospective generics for Korlym® is approaching another stage. We previously discussed Teva’s ($TEVA) petition for post-grant review (PGR) of the ‘214 patent. Corcept has filed its preliminary response to Teva’s PGR, and the PTAB is scheduled to decide whether or not to institute the PGR by about November 23, 2019. The ‘214 patent is potentially the strong patent Corcept is currently wielding against generics, since it arguably does read upon Korlym®’s label. Now that the papers are in, what are the odds Teva’s PGR is instituted?
Read More10x Genomics ($TXG) launched its IPO on September 12, trading up as much as 49% on its debut. While the market is rewarding the company’s prospects, its lingering patent fight with Bio-Rad Laboratories ($BIO) continues. Bio-Rad and 10x have been locked in a patent battle over technology allegedly covering most of 10x’s products. The case, which has been pending since 2015, is now heading to appeal. 10x suffered a fairly significant loss at the jury trial, after which the court ordered an injunction against essentially all of 10x’s products. Earlier this year, 10x launched a redesigned product to circumvent, Next GEM, to circumvent the injunction. Yet, on the eve of 10x’s IPO, Bio-Rad hit 10x with another patent suit, now directly targeting 10x’s Next GEM product. Can Bio-Rad’s patents stop 10x’s trajectory?
Read MoreThe Federal Circuit recently ruled on a case brought by Intellectual Ventures against Capital One ($COF). The case is Intellectual Ventures I LLC v. Capital One Financial Corp., 2018-1367 (Fed. Cir. Sep. 10, 2019). While the underlying case arose out of IV’s assertion of its patents against Capital One, the appeal focuses on Capital One’s counterclaim that IV was an unlawful monopolist by aggregating a series of patents and asserting them through litigation. Capital One lost the appeal. But the question remains – how much teeth do antitrust counterclaims have against aggregating and enforcing patents through litigation?
Read MoreThe long-running patent dispute between Amgen ($AMGN) and Regeneron($REGN) and Sanofi over their competing PCSK9-inhibitors (Repatha® and Praluent®) has reached another milestone. The case also represents another milestone in the changing landscape for patents covering biologic drugs. The Amgen decision is at least the second district court decision this year that has invalidated biologic antibody patents under the doctrine of enablement. The earlier decision related to MorphoSys patents asserted against Janssen related to Darzalex®. The takeaway is clear: as biologic drugs take up a larger share of the pharmaceutical medications in the U.S., courts are making it harder for drug companies to use overly-broad patents to corner the market on a particular inhibitor.
Read MoreAnother generic has filed an ANDA with the FDA for a license to distribute a generic version of Korlym®. Teva is no longer the only company seeking to sell generic Korlym®, which therefore increases the likelihood that Corcept Therapeutics ($CORT) will face a generic competitor for its main drug at some point in the future.
Read MoreIt’s rare that patents make the mainstream news, and even more rare that one company’s allegation of patent infringement touches—even remotely—on issues of national security. Yet, that appears to be happening with U.S. Senator Marco Rubio’s proposed legislation to block Huawei from seeking relief for infringement of its granted U.S. patents. There isn’t really much precedent for legislating that a certain set of patents are unenforceable. Can this really happen?
Read MoreYes, the PTAB declined to institute 5 out of 6 of Comcast’s IPRs. At the same time, the PTAB did not say there was anything per se wrong with Comcast’s multiple attacks on a single patent, even as it paid lip service to the “potential for abuse of the review process” by filing multiple petitions. For Comcast, therefore, there is not much downside to the PTAB’s decision, especially since the ‘363 patent has already been deemed likely invalid. For Rovi - and other patent owners for that matter - there is little solace in the PTAB determining that 6 IPRs against a single patent is overkill in this particular case. For them, even one IPR can be deadly to their property rights…
Read MoreThe Power Integrations case illustrates that there is growing discontent with the current regime that permits companies to circumvent liability for patent infringement despite considerable and concerted efforts to capture a share of the U.S. market for their products. See article on IPWatchdog.
Read MoreAnd just like that, it’s over. Boehringer Ingelheim has thrown in the towel in its patent fight with AbbVie over Boehringer’s proposed biosimliar for Humira®. Boehringer was a lone hold-out among a long line of proposed biosimilars for AbbVie’s blockbuster. Boehringer’s distinction was that it had raised a unique defense, namely, arguing that AbbVie had built an unfair “patent thicket” around Humira® that was unenforceable. We previously blogged about Boehringer’s “unclean hands” defense here and here and here. Now that Boehringer has settled, what are the larger lessons for future biosimilar patent fights?
Read MoreHigh drug prices remain in the news. A recent precedential decision from the Federal Circuit shows that certain drug prices will stay high if drug companies can simply take a mandate from the FDA, which was not their idea, and file a patent on it, thereby cornering the market on all IP around that mandate. The case is Endo Pharmaceuticals Inc. v. Actavis, LLC, Case No. 2018-1054 (Fed. Cir. May 3, 2019).
Read MoreSenior Judge Joseph F. Bataillon of the District of Delaware issued a comprehensive ruling on the various post-trial motions filed by the parties. As his decision notes, during the pendency of the post-trial motions the Federal Circuit decided to affirm an earlier IPR decision cancelling claims (including the asserted claims) from the ‘183 Patent. Which therefore tasked the Court with deciding whether the invalidation of one of the two patents underlying the jury verdict would impact on the damages award.
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