The 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 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 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 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 MoreCorcept Therapeutics ($CORT) recently filed a new lawsuit against Teva ($TEVA) related to Teva’s proposed generic for Korlym®. The new suit asserts three new patents that were recently listed in the Orange Book. Are the three new patents a game-changer?
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 MoreSince announcing the pending acquisition of Celgene ($CELG) by Bristol Myers ($BMY), investors have focused upon the patent-cases involving Revlimid®. There are multiple cases and petitions for inter partes review (IPRs) at various stages of resolution. The key question among investors is whether there will be any key milestones in those cases--especially during 2019 before the Bristol acquisition closes—that will clarify exactly when any of the pending generics will enter. In this post, we identify three potential milestones to watch for from the Revlimid® patent landscape in 2019.
Read MoreCelgene ($CELG) has announced plans to be acquired by Bristol Meyers Squibb ($BMY). A settlement conference is scheduled in the Hatch-Waxman patent case between Celgene and Dr. Reddy’s on January 10, 2019. Now that Bristol Meyers is at the table, will the parties be able to reach a settlement that couldn’t be reached before?
Read MoreA recent precedential decision from the Federal Circuit sheds important light on how the Court views attorneys fees in patent cases.
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 MoreBoehringer Ingelheim has been one of the lone holdouts in AbbVie’s ($ABBV) campaign to delay biosimilar competition against Humira® until 2023. To date, AbbVie has settled with almost all proposed biosimilars for entry dates in 2023. Is Boehringer going to launch at-risk?
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 MoreMylan’s biosimilar for Herceptin® has FDA approval since December 2017. Several months earlier, in March 2017, Mylan reached a global settlement with Roche and Genentech regarding their patents covering the drug. The terms of the settlement have not been made public, which raises the question – when did Mylan agree to launch?
Read MoreOn August 3, Dr. Reddy’s filed three petitions for inter partes review (IPR) against three patents owned by Celgene and listed in the Orange Book for Revlimid®. Does this indicate that Celgene and Dr. Reddy’s are close to a settlement? If not, what are the take-aways?
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 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 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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