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Text of the page (random words):
n contrast they do not observe the same drop in citations associated with product patents covering new molecular entities or in follow on patenting aimed at different disease areas the authors interpret this pattern as reassuring for meaningful follow on innovation firms continue to pursue new compounds and explore new therapeutic indications but the disclosures accompanying marketing authorization make it harder to secure patents on marginal modifications within the same therapeutic space byrski and wang present various additional analyses supporting their interpretation that the decline is driven by prior art generated during marketing authorization they find no similar decline at the end of phase ii trials a milestone that similarly reduces uncertainty about drug quality but involves less comprehensive data disclosure and thus does not create the same prior art obstacles they also show that the post authorization drop is concentrated in citations that signal legal vulnerability examiner generated citations and novelty threatening citations categories x or y in the european patent office search report suggesting that the forgone follow on patents are disproportionately ones that are very similar to the core patent the paper supplements these results with robustness checks including by examining a subset of drugs with constant market exclusivity despite varying approval lags and by conducting an instrumental variable analysis using the time from patent filing to the start of phase i trials these findings add a new dimension to ongoing debates about clinical trial transparency even before disclosure to regulators clinical trials can block later patents though trial sponsors can prevent the trial from becoming prior art with confidentiality agreements but regulators are changing this in the united states most drug trials excluding phase i studies must be registered at clinicaltrials gov within 21 days of enrolling the first participant including details such as the disease and intervention being studied although enforcement has been inconsistent these registrations have been used to invalidate later filed patents new transparency requirements will likely amplify these effects the eu s 2022 clinical trials regulation requires more comprehensive disclosure including mandatory registration of all clinical trials not just those tied to authorization and there is push for the fda to more vigorously enforce the u s requirements to be sure distinguishing strategic patenting from meaningful follow on innovation is difficult and byrski and wang have to rely on proxies with potentially unaddressed confounders but the data they present is suggestive of an optimistic take that mandatory clinical trial disclosures could cut down on low value patents on trivial modifications which may delay generic competition without delivering meaningful therapeutic benefits without obviously discouraging the kinds of follow on efforts that generate new therapeutic value this pattern is also consistent with recent work suggesting that high value follow on innovation is most responsive to forms of protection that meaningfully delay generic entry rather than to incremental secondary patents that raise the costs of generic entry but do little to extend effective exclusivity even so the net welfare effect of these changes to patenting is nonobvious for example by incentivizing all patents to be filed earlier greater clinical trial transparency will also reduce the effective exclusivity period so that some drugs or some new indications for existing drugs on the margins might never be developed at the same time because patent law does not generally require proof of clinical benefit this dynamic may also induce a perverse substitution away from evidence generating clinical trials and toward secondary patenting strategies that avoid disclosure creating trials altogether even where additional clinical evidence would be socially valuable and even if these changes are accompanied by efforts to require disclosure of more evidence before firms may obtain a patent the combination of earlier prior art creation and heightened disclosure requirements could greatly narrow and in some cases eliminate the window between when companies possess patentable information and when it becomes prior art byrski and wang s data cannot resolve how these effects should be balanced but both their conceptual framing and empirical contribution will be important to ongoing policy discussions of regulatory data transparency cite as lisa larrimore ouellette clinical trial transparency and patent prior art jotwell april 30 2026 reviewing dennis byrski lucy xiaolu wang marketing authorization and strategic patenting evidence from pharmaceuticals 247 j pub econ 105415 2025 https ip jotwell com clinical trial transparency and patent prior art dynamic inventorship apr 2 2026 laura pedraza fariña add a comment amy motomura the inventorship fallacy 58 u c davis l rev 2379 2025 laura pedraza fariña inventors and their inventions are the building blocks of patent law there simply is no patent law without inventors who seek to patent their inventions one might think that a concept as foundational as inventorship would be both well settled and extensively argued in legal opinions but that is not the case in fact understanding who counts as an inventor and what constitutes an invention has surprisingly flown below the radar both in patent law scholarship and judicial opinions in her article the inventorship fallacy amy motomura helps us with a deeply researched and carefully parsed analysis of the myriad and often contradictory ways in which courts have defined the inventor and the invention motomura s article makes a number of important contributions to the literature first it sheds light on the inventorship doctrine s hidden role in policing the boundaries of related patent filings what she calls the indirect role of inventorship it then provides a taxonomy for how to think about who counts as an inventor disaggregating the concept into three strands manner timing and substance ultimately her inquiry into how courts define the substance of inventorship that is what a participant must contribute to become a true inventor leads her to a second key descriptive contribution defining who counts as an inventor requires defining what counts as an invention for inventorship purposes this task in turn has no clear doctrinal answer rather the federal circuit has implicitly articulated three mutually exclusive understandings of the invention as reflected in 1 the full scope of the claims 2 only the novel and nonobvious elements of the claims or 3 only the not well known or not publicly accessible elements of the claims normatively there are multiple ways to understand the invention ways that go beyond what is perhaps the most traditional approach of seeing the invention as coterminous with the claims the article closes by considering how these multiple conceptions of the invention address inventorship s direct and indirect functions they are an uneasy fit no single definition of the invention can successfully fulfill both the direct and indirect functions of the inventorship doctrine in large part because inventorship turns out to be a dynamic temporally unstable p 2453 concept inventors must be named early in patent prosecution but all existing theories of inventorship subject inventorship to change either through new information about the content of the prior art or through changes in claim construction given motomura s diagnosis the pressing question becomes what next professor motomura leaves a normative solution for another article emphasizing that the doctrinal ambiguities and failures she has unearthed make the case for reform but provide no answers for how that reform should proceed in the next few paragraphs i consider three avenues for future research that the article opens up 1 a deeper analysis of the relationship between inventorship s indirect functions and the structure of patent law 2 how do actual inventive communities decide whom to name as an inventor how do these naming conventions overlap with conventions around scientific authorship understanding the actual on the ground naming practices of innovator communities might give us a grounded way to reconstruct what inventorship should normatively look like and finally 3 given inventorship s temporal instability should the pto adopt the broadest reasonable inventive unit in a manner akin to its approach to claim construction during prosecution inventorship s indirect functions and the privileging of stable inventive entities professor motomura highlights how inventorship structures the relationship among related patents first inventors matter for continuation practice because to claim priority to an earlier filed application the later application must have at least one inventor in common with the earlier one second if two patent applications are filed by the same inventive entity that is if they share identical inventorship the earlier filed application will not count as prior art vis à vis the second one so long as it is filed within a year of the earlier filed application becoming publicly available third if two patents are sufficiently related and have identical ownership obviousness type double patenting will allow both to issue so long as their patent terms expire at the same time through the filing of a terminal disclaimer taken together these three rules and in particular the last two give significant preference to stable inventive teams in other words an inventive team is allowed to obtain what in effect amounts to broader patent rights both by avoiding having to show later filed patents are both novel and nonobvious over earlier ones and through obviousness type double patenting in an earlier piece professor motomura engaged with the justifications for these own prior art exceptions 1 she reasoned that own prior art exceptions exist because innovation does not occur in discrete fully formed jumps rather inventive entities make continuous often incremental innovation 2 nevertheless by tying own prior art exceptions to the stability of an inventive entity patent law appears to have created a prospect like right that enables a single inventive entity to build broad patent estates incrementally if this perspective is correct the indirect functions of inventorship not only structure the relationship among patents but reveal a latent prospect feature of the patent system that concentrates patent ownership and management into the inventive entity s hands on the ground inventorship norms professor motomura recognizes the dynamic nature of inventorship and closes her article by asking are applicants naming inventors based on their subjective view of what is patentable their view of what is not well known the full language of the claims given the doctrinal ambiguity applicants are surely inconsistent in their approaches to naming inventors p 2472 these questions are ripe for on the ground investigation a rich literature in scientific authorship norms provides a promising starting point for example in the collective author peter galison details the complex set of authorship norms that emerged in the community of physicists at the stanford linear accelerator center project and which aimed to balance both unity in the creative team and individual attribution 3 and mario biagioli has written about how in scientific communities authorship seeks to both assign credit and responsibility for a particular set of results 4 interestingly one scientific journal used the word substantial contribution to police who should be added as an author on a scientific paper a standard that is somewhat reminiscent of the federal circuit s requirement that an inventor s contribution be not insignificant in quality p 2444 conversely critics of this approach have called for listing as a contributor to a scientific work each person who has added usefully to the work a more inclusive approach 5 perhaps current debates about scientific authorship mirror latent conceptions of inventorship in patent opinions and these debates as well as the on the ground practices of scientific communities may help inform who ultimately should count as an inventor the broadest reasonable inventive unit finally the dynamic nature of inventorship may counsel a precautionary approach of sorts the pto could take the position that during patent litigation when important extrinsic facts about inventorship are not yet known the relevant unit of analysis will be a capacious broadest reasonable inventive unit mimicking the pto s approach to claim construction this approach would have the virtue of sidestepping disagreements among different theories of inventorship on the other hand it may prove too inclusive allowing tenuous claims to inventorship from individuals who did not contribute to the invention s point of novelty and undermining patent law s incentive and attribution functions amy motomura innovation and own prior art 72 hastings l j 565 570 2021 the patent act has been amended over time to include provisions giving limited preferential treatment to original patent applicants that allows the original applicant to patent otherwise unpatentable innovation id peter galison the collective author in scientific authorship credit and intellectual property in science 325 53 mario biagioli peter galison eds 2003 mario biagioli rights or rewards changing frameworks of scientific authorship in scientific authorship credit and intellectual property in science 253 262 mario biagioli peter galison eds 2003 id at 265 cite as laura pedraza fariña dynamic inventorship jotwell april 2 2026 reviewing amy motomura the inventorship fallacy 58 u c davis l rev 2379 2025 https ip jotwell com dynamic inventorship inspiration versus authorship mar 3 2026 david fagundes add a comment mark a lemley authoring while dead 59 ga l rev 2025 david fagundes abe lincoln was fond of relating a story about a lawyer who tried to argue that a calf had five legs by calling its tail a leg the folksy lincolnian upshot was that this lawyer not only lost but also looked foolish in the process because simply calling a tail a leg does not make it so mark lemley s authoring while dead spins a copyright version of abe s old yarn songwriters have recently begun listing as co authors of their musical works artists who cannot be regarded as authors under any remotely plausible reading of the copyright act lemley s vivid article explores the origins and rapid ascension of this industry practice he explains with welcome drollery why this is the copyright equivalent of calling a tail a leg he further offers a caution why what may seem like mere formalism in fact poses serious problems for copyright law the first thing i liked lots about authoring while dead was that i discovered something that was entirely new to me in the past couple o...