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Text of the page (random words):
r generic companies to enter the market before all method of use patents have expired it allows a generic manufacturer to submit a statement to the fda essentially saying we only want approval to sell this drug for older unpatented uses we are not seeking approval for the use that is still under patent to legally utilize the section viii pathway the generic manufacturer must remove or carve out all instructions marketing and references related to the patented use from their product s packaging and informational inserts this specific dispute centers on vascepa a brand name drug developed by the respondent amarin vascepa was initially approved in 2012 for a small group of patients suffering from severe hypertriglyceridemia sh in 2019 following a five year study involving 8 000 patients the drug received approval for a second indication for reducing the risks of cardiovascular events cv the petitioner hikma subsequently developed a generic version of vascepa icosapent ethyl and obtained fda approval to sell the drug exclusively for the sh indication using the section viii pathway notably there are 11 companies with generic versions of icosapent ethyl approved for sh and many of these generics seven at the time the respondent s brief was filed are already on the market even though all generic pharmaceuticals are legally required to have the same labels carving out the cv indication amarin only sued hikma because according to amarin hikma alone chose to publish statements that healthcare providers would interpret as encouraging prescriptions that infringe respondents patents under 35 u s c 271 b inducement liability requires that a party actively induce d a direct infringer to take specific action that suffices for infringement of a patent hikma contends it can be liable only if it actively encourages medical professionals to prescribe its generic icosapent ethyl specifically for the cv indication and that none of its actions rise to this level it argues that its skinny label encourages only non infringing use and that its external statements do not actively induce specific conduct hikma emphasizes that the only time the patented cv indication was mentioned on the label was to warn of the drug s potential side effects in people who have heart cardiovascular disease this warning hikma argues cannot plausibly establish active inducement of the cv treatment method therefore the case should be dismissed for failure to state a claim under the rigorous iqbal twombly pleading standard read more posted at 4 21 pm labels infringement pharma scotus wednesday december 10 2025 charles tait graves can you sue to protect a trade secret you misappropriated from someone else posted by camilla hrdy who has standing to sue for trade secret misappropriation can a person sue to protect a trade secret they misappropriated from someone else is mere possession of the trade secret enough for standing to sue and entitlement to a remedy or does a complainant have to prove they are the owner of the trade secret in a more formal sense a new case suggests the answer may be yes a person can probably sue to protect a trade secret that they misappropriated from someone else at least under state law but not under federal law a recent tenth circuit case snyder v beam addresses this question in this post i ll discuss snyder and its implications and i will also highlight a 2023 article by charles tait graves revealing that this issue had been boiling up on the state law side for some time snyder did not come out of the blue rather the passage of a federal trade secret statute with a divergent rule has simply brought the issue to the fore read more posted at 11 38 am labels ai trade secret friday october 17 2025 common questions on ai and trade secrecy posted by camilla hrdy i have been giving some talks on my article keeping chatgpt a trade secret while selling it too which is now published in the berkeley technology law journal the article addresses a legal puzzle how can companies protect generative ai technology through trade secret law while also selling new ai products to the public i have gotten some really interesting questions from audience members on ai and trade secrecy i thought i d share them along with my answers if you disagree with my answers or how i am characterizing the technology i d really love to hear your thoughts read more posted at 10 49 am labels ai trade secret monday june 9 2025 ecofactor and alternate expert theories posted by michael risch hello world i ve finished my long stint as an administrator and suddenly find myself with time to do the things i used to do like writing blog posts it s been slow around here but i am glad written description is alive and kicking i hope to blog on a regular basis going forward i ve missed it for my first post in a while i thought i would tackle ecofactor v google the first en banc utility patent case heard by the federal circuit in many years with the help of a firm in texas i filed one of only two substantive amicus briefs in favor of ecofactor i ll discuss the case a bit what my position was and my take on the ruling the case itself was a run of the mill patent infringement case ecofactor won and presented expert testimony on a reasonable royalty for damages google did not present an expert a key evidentiary problem is that all the prior actual licenses were lump sum and they were for multiple patents the expert used recitals in the contract as well as an ecofactor witness to extrapolate a per unit royalty he testified that the licenses agreed to an x royalty note that i m not waffling the actual amount has been kept secret for some reason the expert also testified that the addition of other patents didn t really affect the rate because the technology was all the same a divided panel affirmed the infringement and the damages the en banc court vacated and asked for briefing on the court s role as gatekeeper for expert testimony under the daubert case google and amicii submitted briefs on this and also argued that apportionment was improperly done the federal circuit instructed parties to leave the apportionment question aside and i think rightly so as discussed in my paper on patent portfolios and by parchomovsky and wagner here the value of any given patent in a portfolio is zero and in the aggregate is basically the royalty rate google and its amicii argued unsurprisingly that daubert requires the judge to ensure that all damages calculations follow the law and that obviously hadn t been done here parties favoring neither side emphasized that courts should not exclude experts just because facts are disputed i won t discuss these much more there are plenty of summaries around they all basically say the same thing when not focused on policy with the variation being how strict people think the court should be in determining reliability of damages opinions i tend to agree with most of the legal arguments folks made it is hard not to there are decades of precedent on admission of expert testimony at least at the general level the primary dispute was really on the facts and how those rules should apply to this case and so i decided to file a brief based in part on my paper un reasonable royalties which discusses the history of royalty remedies as well as a discussion of expert witnesses our argument pretty simply was that the opinion was well within the norm of reliability experts often extrapolate royalties from lump sums the language in the agreements at least supported what a willing buyer would want and there was other evidence in the record not mentioned in the expert report that supported the royalty the en banc court ruled 8 2 that the expert testimony should have been excluded one ground for reversal was that the court didn t explain the ruling admitting it why it was reliable this is important for future courts the second ground which we ll discuss here was that the expert s testimony that the royalty rate agreed to in the contracts was x was not supported by contract interpretation as a matter of law and therefore the opinion was unreliable and non salvageable by other evidence in the case which was a primary point of contention with the dissent in reaching this decision the court cited a lot of precedent on daubert all of it my thoughts on the case are below read more posted at 9 00 am labels damages tuesday may 13 2025 oswald do trade secret injunctions last forever posted by camilla hrdy an injunction in a trade secret case should generally end when the trade secret does but new empirical research by professor lynda oswald sheds new light on the actual lifetime of these injunctions the results are surprising oswald finds that in the vast majority 80 of cases in her dataset courts simply grant an open ended injunction without a fixed term while defendants could in theory move to dissolve the injunction when the trade secret ceased to exist oswald found no evidence this happened in effect the injunctions appear to have remained in effect indefinitely lynda oswald is the louis and myrtle moskowitz research professor of business and law at university of michigan s school of business professor oswald s article an empirical analysis of permanent injunction life in trade secret misappropriation cases has now been published in the iowa law review read more posted at 11 45 pm labels empirics trade secret tuesday march 4 2025 openevidence v pathway the legal battle over ai reverse engineering posted by camilla hrdy can generative ai models like chatgpt be reverse engineered in order to develop competing models if so will this activity be deemed legal reverse engineering or illegal trade secret misappropriation i have now written a few articles exploring this question including trade secrecy meets generative ai and keeping chatgpt a trade secret while selling it too but when i first asked this question a year and a half ago i was getting responses purely in the negative i asked a panel at a trade secret conference at georgetown in 2023 can chatgpt be reverse engineered several members of the panel laughed i would talk to ai experts and the answer i got was along the lines of it s not going to happen this post is cross posted on patently o read more posted at 9 14 am labels trade secret sunday february 9 2025 fagundes perzanowski a new framework for conceptualizing the end of ip rights posted by camilla hrdy dave fagundes and aaron perzanowski have just posted a very interesting and thought provoking paper draft on ssrn called how intellectual property ends the paper which follows up on their prior work on copyright abandonment closely examines how ip rights come to an end through doctrines like expiration forfeiture or abandonment the paper seeks to provide a taxonomy for thinking about how ip rights end the authors argue that imprecise or inconsistent uses of terms like abandonment and forfeiture deprives these terms of meaning and obscures the underlying logic of the doctrines as originally developed at common law 5 they instead posit a single unified framework for consistently conceiving of termination that can work across the four ip regimes read more posted at 10 51 am labels copyright trademark monday january 27 2025 buccafusco masur varadarajan does trade secrecy have an information paradox posted by camilla hrdy one of the key purposes of trade secret law is to address the arrow information paradox the information paradox posits that there is a fundamental challenge in information exchange it is difficult to assess the value of information without first sharing it but once the information is shared it becomes vulnerable to being copied leaving the originator without compensation and without a competitive advantage read more posted at 7 43 pm labels trade secret monday june 3 2024 guest post diversity pilots initiative comment on proposed changes to ptab practice posted by lisa larrimore ouellette guest post by ashton woods a jd candidate and member of the juelsgaard intellectual property and innovation clinic at stanford law school this post is part of a blog post series by the innovator diversity pilots initiative dpi which advances inclusive innovation through rigorous research dpi will be hosting its second conference at emory university law school in atlanta on friday september 20 2024 indicate your interest by signing up here on february 21 the uspto issued a notice of proposed rulemaking for expanding opportunities to appear before the patent trial and appeal board ptab and dpi filed one of seven comments on the proposal dpi s full comment can be found here currently parties appearing before the ptab who are represented by counsel must designate lead and backup counsel lead counsel must be a uspto registered practitioner meaning that they have technical training and have passed the registration exam commonly known as the patent bar exam backup counsel may be non registered if they are recognized pro hac vice under the proposed rule counsel can switch roles with a non registered practitioner acting as lead counsel and a registered practitioner acting as backup counsel additionally parties who can show good cause including financial hardship can waive the backup counsel requirement though the party s sole counsel must still be a registered practitioner finally the proposed rule streamlines the pro hac vice recognition process for non registered practitioners though they still must be accompanied by a registered practitioner in the lead or backup role as explained in more detail in the full comment dpi views the proposed rule as a modest step toward reducing the accessibility gap for potential patentees patent practitioners and patent challengers the goal of the proposed rule is laudable and it may provide a solid foundation for future efforts to diversify the patent bar and the patent system more broadly if it can effectively expand the pool of eligible practitioners in proceedings before the ptab the proposed rule may support wider uspto efforts to increase the participation of underrepresented communities in the innovation ecosystem read more posted at 3 03 pm labels diversitypilots thursday may 30 2024 gaia bernstein on unwired gaining control over addictive technologies posted by camilla hrdy guest post by gaia bernstein technology privacy and policy professor of law co director of the institute for privacy protection and the gibbons institute for law science and technology seton hall university school of law based on her recent tedx talk nine years ago when i sat down to research in a coffee shop took out my laptop kindle and phone but hours later realized that i accomplished little but felt fatigue what happened i realized the hours were wasted on emails texts and mostly aimless web surfing i started understanding them that something was wrong read more posted at 5 03 pm labels health innovation science saturday may 25 2024 catalog of court mandated ai disclosures cf us...