On April 28, Google published a policy statement on the need for specific patent reforms. The statement was published by Google’s General Counsel, Halimah DeLaine Prado, and titled, Reforming the patent system to support American innovation. The statement is a notable read given that it issued from one of the largest Big Tech companies. The statement identifies four concrete areas where patent reform is purportedly required. Behind its prescriptions lingers its agenda—namely, that patents should have no value at all.
Read MoreTrillium Therapeutics is a clinical stage immune-oncology company that focuses on cancer treatments, and in particular, treatments that inhibit CD47. Trillium is among a group of drug candidates exploring CD47 targeting agents that are attracting investment from Big Pharma. Pfizer recently announced a $25M investment in Trillium. In conjunction with developing its own two CD47-inhibitor candidates, Trillium is also building out its patent portfolio. On February 2, 2021, two additional U.S. patents issued to Trillium, including U.S. Patent Nos. 10,906,954 and 10,907,209. Will Trillium’s patents offer protection against brand competitors or eventual biosimilars?
Read MoreOn June 4, the Federal Circuit issued a precedential decision holding that § 285 under the Patent Statute is inapplicable for awarding attorneys’ fees to the prevailing party in a proceeding for inter partes review. The case is Amneal Pharmaceuticals, LLC v. Almirall, LLC, Case No. 2020-1106 (Fed. Cir. Jun. 4, 2020). While the Court’s decision dispenses rather cleanly with the possibility of collecting fees for prevailing in an IPR, the Court nonetheless left open the door to collecting fees if the IPR is intimately tied to a pending parallel district court case. How much does that matter?
Read MoreIn a precedential decision that issued on May 19, ESIP Series 2, LLC v. Puzhen Life USA, LLC, the Federal Circuit confirmed that the Supreme Court’s recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest. recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest.
Read MoreThe PTAB’s decision in Apple, Inc. v. Fintiv, Inc., Case No. IPR2020-00019 (Paper No. 11) has been designated precedential as of May 5, 2020. The decision outlines the factors that the PTAB will consider when determining whether petitions should be denied under § 314(a) based upon a parallel district court litigation in which the same invalidity arguments have been raised. The case implicates the balance between patent owners and patent challengers, and who carries the heavier load.
Read MoreThe United States Supreme Court has issued its ruling in Thryv, Inc. v. Click-To-Call Technologies, LP. The case is either surprising or unsurprising given your palette for the changing nature of patent rights. But one thing is certain—the stripping of appellate review for institution decisions deprives litigants of valuable jurisprudence that would otherwise make the IPR process more predictable and more efficient.
Read MoreWe previously blogged about Teva’s ($TEVA) petition for post-grant review (PGR) of Corcept Therapeutics’ ($CORT) ‘214 patent. Since then, on November 20, 2019, the PTAB granted institution of Teva’s petition. The proceeding will now be litigated for another year before a final decision. On a recent earnings call, Corcept stated that it believes the standard for institution is “pretty low,” and not necessarily dispositive that Teva will prevail. Now that we have the institution decision, what can we glean from it, and how likely is that Corcept’s patent survives?
Read MoreThe American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other. The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc. The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.
Read MoreThe saga over Corcept Therapeutics’s ($CORT) patent battles against prospective generics for Korlym® is approaching another stage. We previously discussed Teva’s ($TEVA) petition for post-grant review (PGR) of the ‘214 patent. Corcept has filed its preliminary response to Teva’s PGR, and the PTAB is scheduled to decide whether or not to institute the PGR by about November 23, 2019. The ‘214 patent is potentially the strong patent Corcept is currently wielding against generics, since it arguably does read upon Korlym®’s label. Now that the papers are in, what are the odds Teva’s PGR is instituted?
Read MoreIn a recent district court decision from the District of Delaware, the court granted a preliminary injunction, and ordered the defendant to pull the accused products, even though, a few months earlier, a Final Written Decision by the PTAB in an inter partes review proceeding held all asserted claims of the patent-in-suit unpatentable. What was the court’s reasoning? And what are the implications?
Read MoreWe previously blogged about Dr. Reddy’s IPRs filed against MDS patents covering Celgene’s Revlimid®. Those IPRs attracted considerable attention because they were, for better or worse, one of the few data-points within the Revlimid® patent skirmishes we are guaranteed to see before the Bristol transaction closes. The Lotus IPR attacking one of Celgene’s multiple myeloma patent is another datapoint. The PTAB’s decision on whether to institute the IPR is due March 18. How much does Lotus IPR really matter?
Read MoreLast week, we wrote about milestones to watch for in Celgene’s ($CELG) Revlimid® patent landscape in 2019 that could potentially impact the Bristol Myers ($BMY) transaction. One data-point that investors were anticipating were institution decisions in three petitions for inter partes review (IPRs) filed by Dr. Reddy’s. This week, the PTAB denied institution of all three IPRs. How will those decisions read-through to the overall Revlimid® patent landscape?
Read MoreModerna is currently embroiled in an intellectual-property dispute that may be material to its long-term profits, regardless of which of the products in its pipeline eventually succeed. At least one company, Arbutus Biopharma, has already claimed that Moderna’s tech uses its mRNA delivery technology. Two pending patent disputes may decide whether Arbutus’ patents are a roadblock to Moderna’s revenue.
Read MoreThe PTAB has issued its first post-AIT decision, Unified Patents, Inc. v. Realtime Adaptive Streaming, LLC. In Realtime, the Patent Owner sought to defeat institution by arguing that Unified has run afoul of the AIT decision by failing to identify all RPIs, namely, its members. The PTAB disagreed and instituted Unified’s IPR. (The institution decision was entered in October, but the redacted decision issued on November 27, 2018). How do we square the AIT decision with the Realtime decision? Will third-party filers, such as Unified and RPX, no longer face RPI issues?
Read MoreThe PTAB has denied institution of two IPRs filed by Coherus Biosciences against patents covering Enbrel®’s proteins, the ‘182 and ‘522 patents. The IPRs were not filed by Sandoz, but they will most likely affect Sandoz. Sandoz already has FDA approval to market Erelzi®, which is its biosimilar for Enbrel®. And Sandoz is going to trial against Amgen in April. How do Coherus IPR decisions affect Sandoz's decision to launch at risk? Or to settle with Amgen?
Read MoreThe PTAB has issued its much-anticipated decision on whether Allergan managed to pull off it’s scheme to avoid IPRs of its Restasis® patents by “selling” the patents to the St. Regis Mohawk Tribe. On February 23, 2018, the PTAB denied the Tribe’s motion to terminate the IPRs on the ground based on its tribal sovereign immunity. What were the PTAB’s reasons for denying the Tribe’s motion to terminate the IPRs? And what are the ramifications for similar deals in the future?
Read MoreSandoz was denied institution on two IPRs against Humira® patents owned by AbbVie. As we previously discussed, in late 2017, Sandoz filed eight different IPRs against Humira® patents. Two of those IPRs just failed to reach institution. What are the take-aways, for Sandoz and any other Humira® biosimilars?
Read MoreIn an earlier post, we discussed the pending IPRs filed by Coherus Biosciences against Amgen’s two patents covering its Enbrel® protein (entanercept). Whereas our earlier post summarized Coherus’s argument for why the fusion protein claimed in Amgen’s ‘182 and ‘522 patents should be found obvious by the PTAB, this post will summarize Amgen’s preliminary response.
Read MoreAmgen’s Enbrel® blockbuster faces encroaching biosimilar competition from Sandoz and Coherus Biosciences. Coherus Biosciences has filed petitions for inter partes review against Amgen’s two protein patents covering Enbrel®, the ‘182 patent and the ‘522 patent. The institution decisions are due before the trial: March 15, 2018 for the ‘182 IPR, and March 13, 2018 for the ‘522 IPR. If the IPRs are instituted, that could shift the dynamics, and push the parties to agree on an entry date. What are Coherus's invalidity arguments?
Read MoreAllergan’s PTAB Restasis® fight continues, and a recent email tiff before the PTAB between the St. Regis Mohawk Tribe and Mylan has added a further wrinkle to this case. As we previously blogged, a recent decision by the PTAB (between the University of Minnesota and Ericsson) held that a State’s sovereign immunity against an IPR is waived under the Eleventh Amendment where the State affirmatively asserts the challenged patent in litigation. That decision appeared to potentially doom Allergan’s strategy of passing off its Restasis® patents to the Tribe to defend against the IPRs. A recent email exchange between the Tribe and Mylan (the Petitioner in the pending Restasis® IPRs) at the PTAB suggests the University of Minnesota decision may not, in fact, be the nail in the coffin that Mylan had likely hoped. But it also shows that the Tribe may not be on as sound footing as it is claiming.
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