Regenxbio previously sued Sarepta Therapeutics for infringement of U.S. Patent No. 10,526,617 (“the ‘617 patent”). The patent is owned by the University of Pennsylvania and exclusively licensed to Regenxbio. Yet, the district court presiding over the lawsuit recently invalidated the ‘617 patent, thereby effectively ending the suit. Regenxbio has already started the appeal process. What is the likelihood Regenxbio can revive its patent claims against Sarepta’s DMD therapies?
Read MoreBristol Myers Squibb recently announced a deal to buy Karuna Therapeutics for $14 billion. Bristol Myers has touted the deal as accelerating the company’s expansion into neuroscience. Karuna’s lead asset, KarXT, is an antipsychotic that is a combination of two prior drugs, xanomeline and trospium. Analysts have reported that KarXT could surpass $6 billion in annual sales. However, that may depend on whether Karuna has protected KarXT with sufficient intellectual property. Does KarXT have strong enough patent protection to ward off generics for long enough to make Bristol Myers’ gamble pay off?
Read MoreIn late September, Corcept Therapeutics finally went to trial against Teva in the parties’ long-running patent dispute over Teva’s prospective generic for Korlym. The Hatch-Waxman litigation between the two companies has been waging since 2018. Numerous patents have come in and out of the case over that time. Yet, by the time of the trial a few weeks ago, Corcept had narrowed its case down to alleging Teva’s infringement of only two patents: U.S. Patent No. 10,195,214 and 10,842,800. The parties’ post-trial brief have been filed. What do they say?
Read MoreAcadia Pharmaceutical has been litigating to keep out generics for its Parkinson’s Disease drug Nuplazid®. Although Acadia initially sued five separate generics for infringement of multiple patents, all the generics settled-out except one, MSN Pharmaceuticals. And in the case against MSN, only a single patent remains at issue (U.S. Patent No. 7,601,740). MSN recently moved for summary judgment on the ground that the ‘740 patent is invalid for obviousness-type double patenting (ODP). A recent precedential Federal Circuit decision, In Re: Cellect, LLC, addressed the ODP doctrine in detail. How will Cellect affect Acadia’s defense against the last generic holdout for Nuplazid®?
Read MoreMicrospherix has been embroiled in a long-running patent suit against Merck and its spinoff Organon. The suit alleges that Organon’s drug, Nexplanon, is infringing multiple Microspherix patents. Nexplanon is a contraceptive implant that accounts for 10 percent of Organon’s sales. After several years, the suit is finally teeing up for trial in October 2023. Yet, Microspherix has recently tried to short-circuit the trial by asking the court to knock out one of Merck’s primary defenses in the case before trial. Will Microspherix’s ploy work?
Read MoreRecent amendments to the Pandemic and All-Hazards Preparedness and Response Act (PAHPARA) authorize HHS to study alternative economic models for the pharmaceutical business that essentially divorces research and development costs from drug prices by taking away the state-sanctioned monopolies such as exclusivity periods and patents. Should pharma be forced to make money without patents? Or are there fixes to the patent system that could cut down the delay of entry of lower-cost generics?
Read MoreNovartis is currently involved in a multi-district patent litigation campaign to block generic entrants for Entresto®, which is Novartis’ blockbuster heart medication. In the fall of 2022, Novartis went to trial on the validity of one of the asserted patents, U.S. Patent No. 8,101,659(“the ‘659 patent”). On July 7, 2023, the district court invalidated the patent for lack of written description despite rejecting an enablement defense based upon the same evidence. The district court’s decision highlights a clear tension between claim construction and enablement that, if left to stand, could permit pharmaceutical companies to block lower-cost generic medications with patents they did not actually invent. Read the full post at IPWatchddog.
Read MoreNovartis is currently embroiled in a sprawling multi-district patent-litigation campaign to block generic entrants for Entresto®, which is Novartis’ blockbuster heart medication. Numerous generics have filed ANDAs, and Novartis has asserted a variety of patents against them. In the fall of 2022, Novartis went to trial on the validity of one of the patents, U.S. Patent No. 8,101,659 (“the ‘659 patent”). The trial briefs suggest Novartis is asking the court to block lower-cost generic entrants based on a patent that it didn’t really invent. How can this be?
Read MoreTowards the end of last week, we learned of the sad and unfortunate fate of the five passengers aboard the OceanGate Titan submersible. This tragic episode has raised several questions, most of which are beyond the scope of this blog or this post. Yet, what is encompassed within the scope of this blog is that OceanGate had four granted U.S. patents. Is there anything we can learn about this tragic episode from those patents?
Read MoreAbbVie’s Pharmacyclics recently sued BeiGene for patent infringement. Both companies distribute Bruton’s tyrosine kinase (BTK) inhibitors for treatment of, among other indications, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Pharmacyclics sells Imbruvica® and BeiGene sells Brukinsa®. Will Pharmacyclics prevail, and if so, what will it gain?
Read MoreBy now, we have all read about the recent debacle of an attorney who filed a brief drafted by AI that turned out to have fabricated case citations. The case is a cautionary tale. But it will hardly diminish the threat that AI poses to the legal profession. That threat applies equally to patent lawyers. Will generative AI eventually replace patent lawyers?
Read MoreBad facts make bad law. The case of GlaxoSmithKline’s lawsuit over Teva’s generic Coreg® drug is a case-in-point. I previously blogged about the case here and here. Given that the Supreme Court declined to grant certiorari, we’re now stuck with Federal Circuit precedent holding that a generic can still face liability for induced infringement of a method-of-use patent covering a section viii carved-out indication. What will be the consequences of this?
Read MoreI have blogged about the Amgen v. Sanofi case several times, and the case has been summarized in my prior posts andelsewhere. The case pitted two competing PCSK9-inhibitors against one another, and after several years, resulted in cancelling broad patents covering the new class of antibodies. Whenever there is any case that cancels patents within the pharmaceutical or biotech space, the common knee-jerk retort from some commentators is that the decision will suppress innovation, chill R&D and discourage any investment in life-saving medicine. In this case, the opposite is true.
Read MoreThe Supreme Court has denied the recent bid to fix Alice and Section 101 jurisprudence. In two cases that each petitioned for certiorari, Tropp v. Travel Sentry, Inc. and Interactive Wearables, LLC v. Polar Electric Oy, the Federal Circuit affirmed district court decisions holding the asserted patents directed to ineligible subject matter. The Supreme Court’s denial is particularly acute since the Solicitor General recommended that cert be granted. And it is more painful given that this denial follows another recent instance where the Solicitor General also recommended that the Supreme Court take up Alice. Once again, the patent community mourns another lost chance to clear up the mess that has become Alice. But let’s face it—will the Supreme Court ever save us from Alice? . . . The answer is, probably not.
Read MoreCorcept Therapeutics has been battling for years to halt Teva’s generic for Korlym®. Although Corcept started off with only two patents, it has been adding patents to the Orange Book ever since Teva’s ANDA was filed. By periodically litigating those patents in piecemeal fashion, Corcept has delayed generic Korlym®’s availability to consumers at lower-cost prices. Yet, in a recent order, the court finally called out Corcept’s delay tactics and indicated it would award attorneys’ fees. What happened?
Read MoreOne of the common refrains from the pro-patent drug chorus is that patents are necessary to protect and incentivize expensive research and development by pharmaceutical companies. While that may be true in some cases, there are examples where it is clearly not. One current example includes deuterated analogs for ruxolitinib. One company researched which deuterated analogs among thousands of possibilities might be useful, whereas a different company cornered the market on all deuterated analogs based upon two sentences in patent disclosure years ago. Guess who wins.
Read MoreIn February 2023, United States Senator Elizabeth Warren penned a letter to Kathi Vidal, Director of the USPTO, asking what the Patent Office can do to blunt Merck’s use of patents to stall entry of lower-cost alternatives for Keytruda. Unfortunately for consumers, the answer may be, not that much.
Read MoreSenator Warran recently asked what the Patent Office can do about patent thickets. Yet, the courts are in the unique position of having to contend with scores of patents asserted within a single suit. When a brand pharmaceutical company shows up with 20, 60 or 100 patents in a single suit, those challenges can be exacerbated by orders of magnitude. So, how have courts face this challenge? Regeneron’s pending patent suit against Mylan over its prospective biosimilar for Eyelea® is an interesting example.
Read MoreOn August 26, Moderna issued a press release announcing it will be filing suit against Pfizer and BioNTech for patent infringement. Both Moderna and Pfizer/BioNTech sell Covid-19 vaccines that is based upon mRNA technology. Moderna is accusing Pfizer/BioNTech’s Covid-19 vaccine, Comrinaty®, of infringing Moderna’s patents covering certain features of Moderna’s mRNA technology. (At the time of publishing this post, Moderna’s complaint had not yet been filed. Once the complaint is filed, I will update the post.)
Read MoreDr. Stephen Thaler has done something that few have done in decades – made Philosophy professors suddenly relevant. He filed patent applications around the world that named an artificial-intelligence (AI) device as the inventor. The AI device is named “DABUS,” or Device for Autonomous Bootstrapping of Unified Sentience. Courts in the EU, US and UK have initially held that only humans can be inventors on patents, but South Africa and Australia have disagreed. The question of whether an AI device should be permitted to be a named inventor on a patent opens up a host of rich questions – including both policy and philosophical ones. What are some of the awkward implications of AI inventorship?
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