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High biologic drug prices have placed substantial strain on the US health care system. The Biologics Price Competition and Innovation Act (BPCIA), passed in 2010 as part of the Affordable Care Act, created an abbreviated approval pathway for biosimilars-versions of "originator" biologic drugs made by different manufacturers-to help address this issue. However, a decade after its passage, the BPCIA has spurred only limited competition. We examined the role that litigation has played in this muted success, reviewing all lawsuits related to the BPCIA filed between its enactment and August 1, 2020. Our review identified two key problems: noncompliance with steps in the complex litigation process established by the BPCIA and large numbers of patents enforced by originator manufacturers. Both actions have contributed to frequent confidential settlements between originator and biosimilar manufacturers that have delayed the availability of biosimilars. To facilitate more timely biosimilar entry, policy makers should consider limits on patent prosecution, compulsory public patent listing, and enhanced antitrust enforcement.

Research summary: Although the link between coordination requirements and vertical integration is theoretically well established, empirical tests of this relationship are hard to implement due to the simultaneous determination of both variables. In this study, we take advantage of regulatory changes in patent prosecution in the United States to provide plausibly causal evidence linking increases in coordination requirements with insourcing. Moreover, we examine the role of plural sourcing, that is, simultaneously making and buying, when responding to changes in coordination requirements. We find that the move toward insourcing is more pronounced for plural-sourcing firms as compared to firms relying on outsourcing. These results are consistent with the view that plural sourcing provides firms with flexibility to switch between sourcing modes when facing changing coordination requirements. Managerial summary: We study the sourcing of patent prosecution services in large innovative companies and show that in-house production is more beneficial when coordination requirements between inventors and attorneys increase. Importantly, we find that plural-sourcing firms, that is, firms that work with both internal attorneys and external law firms, are more likely to respond to these increases and move toward insourcing as compared to firms relying only on outsourcing. This suggests that plural sourcing can be regarded as a strategic investment in sourcing flexibility, allowing firms to respond to changing coordination requirements. This is an adaptive capability which is especially useful in knowledge-intensive sectors.

Empirical economist Professor Ryo Nakajima, from the Faculty of Economics at Keio University in Japan, is investigating unproductive procrastination behaviours in relation to patent examiners. Nakajima is working alongside Associate Professor Ryuichi Tamura, from the University of Niigata Prefecture, and Associate Professor Michitaka Sasaki, from Tottori University, to research US patent examiners and, in particular, how their procrastination behaviors have substantial negative impacts on the quality and efficiency of the patent process. By scrutinising the patent prosecution data, the team will explore unproductive procrastination behaviors of US patent examiners, probe whether these behaviours are caused by present-biased preferences and estimate the magnitude of the problems. Thus, the research will examine the validity of the hypothesised present-biased preferences in a real work environment.

The doctrine of equivalents (DOE) allows a court to hold an accused infringer liable for patent infringement in spite of the fact that the accused product (or process) does not fall within the literal scope of the asserted patent claim(s). Prosecution history estoppel (PHE), which can be triggered by a narrowing amendment of a patent claim during patent prosecution, or by arguments made during prosecution, imposes significant constraints on the ability of a patentee to assert the DOE. The 1990s and early 2000’s saw a proliferation of legal commentary postulating that the DOE would play an important role in protecting inventions arising out of biotechnology, particularly biomolecules (i.e., proteins and DNA/polynucleotides), and stressing the need for biotechnology patentees to avoid amendments or arguments during patent prosecution that might trigger PHE. In fact, however, prior to 2019 the Federal Circuit does not appear to have issued an opinion finding infringement under the DOE in a case in which the relevant claim limitation recites a biomolecule. It finally happened in Ajinomoto Co. v. Int'l Trade Comm'n, with a divided panel of the Federal Circuit holding that a claim limitation reciting a DNA sequence, defined in terms of the amino acid sequence of a protein encoded by the sequence, was infringed under the DOE by a DNA sequence encoding a protein having a different (but similar) amino acid sequence and equivalent function. This article begins with a brief overview of the DOE and PHE, and explains why DOE was at one time seen as particularly critical for the enforcement of patent claims reciting biomolecules. It then summarizes and analyzes the results of a Westlaw search designed to identify any and all Federal Circuit decisions applying the DOE and/or PHE to a claim limitation reciting a biomolecule, including the court’s most recent decision Ajinomoto.

A process for the non-arbitrary determination of obviousness based on examining actual patenting practices of large groups could improve outcomes.

Nonobviousness is the most critical patentability criterion. Patents covering new molecular entities and second-generation molecules in the pharmaceutical industry are often challenged for prima facie obviousness during prosecution and/or litigation. In such situations, the patentee has to either reject or rebut the same by clear and convincing evidence or demonstrate unexpected results, to establish nonobviousness. This paper tries to show how the lead compound requirement is consistent with 35 U.S.C. § 103; the prima facie obviousness challenge can be overcome; the two-prong approach is consistent with the Supreme Court’s KSR v. Teleflex, 2007 (KSR) decision. The showing is illustrated with the analysis of new molecular entities in the proton-pump inhibitor family.

Pharmaceutical patents listed in the FDA’s “Orange Book” are some of the most valuable patents in the world. Accordingly, for this valuable subset of patents, it is paramount that the Patent & Trademark Office (PTO) correctly issue valid patents and preclude invalid patents from issuing. In this paper, we study what happens to those patents in litigation, reporting the results for every Orange Book patent case that resulted in a merits decision. We find that about 25% of active Orange Book patents were invalidated in court. Since these invalid patents could wrongly increase the costs of prescription drugs, we investigate what happens during prosecution of these patents at the PTO. Our study is the first to link the prosecution of Orange Book patents directly to litigation outcomes. Our goal is to determine if there are ways to identify and prevent the issuance of these later invalidated Orange Book patents. We find that litigated Orange Book patents have unique characteristics that distinguish them from other pharmaceutical patents. They are issued by a relatively small number of examiners. Most litigated patents (90%) are “secondary” patents – patents on smaller tweaks to an existing drug rather than a patent on a new chemical. The owners of these later-litigated patent applications treat them very differently than they do other patents in the same field. They are part of large patent families, suggesting that the applicants are trying to build a patent fence around a known product. They frequently employ a procedural device known as “Track One” to obtain quicker patent prosecution. They are more likely to be subject to rejections based on double-patenting. When initially rejected by the patent examiner, owners of these applications are more likely to fight back rather than amend their claims. All of this suggests that applicants enter prosecution with these patents knowing that they are important and likely destined for litigation, and that they are deliberately creating patent “thickets” to make it harder for generics to enter the market. Remarkably, we find that while patent examiners already have more time to spend on Orange Book patents than on other patents, the prosecution history of many of these invalidated patents are identical. That is, many of these invalidated patents have the same assignee, the same examiner and the same prosecuting attorney cut and paste rejections as well as responses, thus creating identical or very similar prosecution histories. We also find that while the patents that end up being litigated are clearly distinguishable from other pharmaceutical patents during patent prosecution, there is little difference in the PTO between the patents that end up surviving a court challenge and the ones that are invalidated. Our data offer important guidance for reforming the process of prosecuting Orange Book patents. We can and should take advantage of advance knowledge about the importance of these patents to give them a more thorough examination early on. At the same time, the experience with cut-and-paste rejections suggests that we cannot simply give examiners more time and hope that they will do a more thorough job. That not only helps inform the policy suggestions we offer, but it sheds light on a long-standing academic debate about how much time and money we should spend examining patents. Further, our data highlight the importance of secondary patents and patent thickets in Orange Book litigation. We offer a number of suggestions to simplify and streamline patent prosecution and litigation to make it harder to exclude generic entry with a thicket of bad patents.

Pharmaceutical patents represent some of the most valuable intellectual property assets for drug companies. These patents can be worth billions of dollars if found valid and infringed. Correspondingly, if invalidated, generic drug manufacturers can get to market earlier, generating billions of dollars of added revenue. Accordingly, drug patents are associated with high-value, high-cost, bet-the-company type prosecution and litigation. Women, however, are noticeably absent from pharmaceutical patent practice. Women represent only 30% of pharmaceutical patent litigators, and only 33% of pharmaceutical patent prosecutors. Some commentators argue that this lack of representation is due to a “pipeline” problem: we don’t see. women in STEM-focused legal careers because women are underrepresented in STEM undergraduate and graduate programs. Proponents of the pipeline argument contend that the solution to gender and racial homogeneity in patent practice is to simply graduate more women from STEM programs or to adopt more flexible requirements for entering patent practice. This study focuses on pharmaceutical patent litigation from 2009-2021. Specifically, this study reviews: (1) the patent prosecutors who obtained these valuable drug patents; (2) the USPTO patent examiners who reviewed these patents; and (3) both the generic and brand pharmaceutical patent litigators. We find significant gender disparities in the private sector lawyers at both the prosecution and litigation levels. The empirical study presented in this article refutes the pipeline argument when it comes to women in pharmaceutical patent prosecution and litigation. It shows that, for over a decade, women have consistently obtained undergraduate, masters, and doctorate degrees in the biological sciences at higher rates than men for over a decade.6 Furthermore, the study finds that women make up over two-thirds of law students with a health professions degree and over half with a natural sciences degree. Yet, despite having more education in the sciences, women are still underrepresented in private sector pharmaceutical patent prosecution and pharmaceutical litigation. Interestingly, however, this gender disparity does not carry over to public sector work in patent law. The study finds the U.S. Patent and Trademark Office (USPTO) is the one place where we see near parity between men and women in the pharmaceutical patent field: 45% women versus 55% men. Women at the USPTO Solicitor’s Office argue about the same number of cases at the Federal Circuit. Further, women make up nearly half of the Court of Appeals for the Federal Circuit. Finally, unlike the private sector, women at the USPTO are paid at the same rate and stay for the same amount of time as their male counterparts at the USPTO. Drug companies and law firms all state that diversity is an important aspect of their business models. But, as this study shows, there is a disconnect between rhetoric and action. The problem does not seem to stem from a lack of education or a lack of participation in the legal system. The problem may be a lack of opportunity given to women to participate in this type of valuable litigation. The solution may have to come from within the industry, specifically those who have control over hiring outside counsel. Law firm clients may have to use the power of the purse to help encourage greater diversity.

What is it about patent legislation? Speaking for the Supreme Court in 1981, Justice Dickson, later Chief Justice, said of the disclosure provision in the Patent Act (now subsection 27(3)) that: "[i]t gives the impression of a melange of ideas gathered at random rather than an attempt to enunciate, clearly and concisely, a governing principle or principles. This is perhaps understandable in that the section is the product of amendment over a period of many years. The language simply does not lend itself to a tight, literal interpretation. It is, and should be treated as, a parliamentary pronouncement, in general terms." Nearly 40 years later nothing much seems to have changed. Take the new section 53.1 of the Patent Act that took effect in 2019. It was not the product of amendment over many years, nor did it present a random melange of ideas. It had only one idea. That was to reverse a 2000 decision of the Supreme Court in Free World Trust v Electro Sante Inc and allow what transpires in the Patent Office (“PO”) during the processing of a patent application — its “prosecution history” — potentially to affect the scope of the patent eventually granted. Subsection 53.1(1) could have simply said that: i.e., a patent’s prosecution history is relevant and admissible to aid in the construction of a patent claim or specification. Instead its drafting suffers from the malady highlighted by Justice Dickson. Its governing principles are not clearly and concisely stated. They seem rather to be “secreted in the interstices of procedure.” To give the section “a tight, literal interpretation,” as some courts have already done, therefore seems inappropriate. That approach runs counter to the Interpretation Act’s direction that all statutory provisions are “deemed remedial” and so require “such fair, large and liberal construction and interpretation as best ensures the attainment of [their] objects.” Patent legislation is not immune from these strictures. An ineptly drafted provision may indeed sometimes need to be treated the way Justice Dickson treated subsection 27(3), as “a parliamentary pronouncement, in general terms.”

The underlying basis for patent law is a quid pro quo: the inventor discloses how to make and use the invention and in exchange for that disclosure, the public gives the inventor an exclusive right to practice that invention, for a limited time. Pervasive use of Artificial Intelligence (AI) technologies such as Generative Pre-trained Transformer 3 (GPT-3) and other similar AI tools may shift the balance of power envisioned in the patent system away from the public and towards the inventor. Specifically, GPT-3 and other AI products may allow inventors to claim significantly more in their patent than they originally invented, thus inequitably enlarging their exclusive rights without benefiting the public. Patent law has built in tools such as the enablement, utility and definiteness requirements to help limit the possible unjustified expansion of patent rights caused by pervasive use of AI. Additionally, if AI wholly disrupts the quid pro quo established by Congress, then patent law may have to adjust by moving from a peripheral claiming approach back to central claiming approach.

Patent protection for cancer treatments is critical to safeguard the considerable time, effort and expenses involved in such endeavors. The United States Patent Office has a special program that enables cancer researchers to obtain patent protection for their inventions with unprecedented speed (less than one year!) and without any additional fees required. The Cancer Immunotherapy Pilot Program has been extended to June 30, 2022. This program has proven to be exceptionally useful in advancing the protection and commercialization of cancer treatments and should be employed by everyone in the cancer research field. Andre Gide once said, “One doesn't discover new lands without consenting to lose sight of the shore for a very long time.” The journey every single inventor makes through the patenting process is admittedly uncertain, with no assurances that it will result in an issued patent. But a terrific program implemented by the United States Patent and Trademark Office (USPTO) makes such a journey far shorter than it would otherwise be. The “Patents 4 Patients” program, also known as the “Cancer Moon Shot” program, was introduced in 2016 and has now been extended until June 30, 2022, now entitled “Cancer Immunotherapy Pilot Program.” This program permits patent applications pertaining to cancer immunotherapy to be advanced out of turn for examination and reviewed earlier (accorded special status). It provides for the extremely prompt examination of qualifying patent applications – without any additional fees – and has resulted in the issuance of over 400 patents in the last few years – which otherwise would not have issued for years to come. The number of Americans who contract cancer each year is about 1.7 million, with almost 590,000 dying annually from the disease. With the issuance of patents, entities financially backing inventors of cancer therapies a re provided with the certainty they desire, permitting them to focus their resources on implementing such new , lifesaving technologies, as well as giving them an incentive to take further risks in attempting to secure patent rights for the latest cancer re lated innovations. The patent process is uncertain and variable due to a var iety of factors, including the art unit assigned the case, the examiner, the prior art at issue, how the claims are drafted, etc. The time it takes to get to a No or Yes as to patent allowance is also uncertain – putting pressure on those responsible for deciding whether they should continue to spend precious resources to attempt to protect inventions that are believed to be promising but that have not yet proven themselves. Hence, the critical question: Is it worth the time and expense of attempting to patent an invention in view of such uncertainties? At least for cancer related inventions – the answer is an unequivo cal “yes.” The Patents 4 Patients program puts a patent application on a “fast track” at the USPTO , a ccelerat ing patent prosecution to cut in half the time it takes for the patent examiner to arrive at either a Notice of Allowance or a final rejection of t he presented claims. Petitions to enter the program are granted with unprecedented speed, typically within about 30 days, and complete prosecution of a case is performed in less than 12 months after the petition is granted. In the cancer field, the cost o f drug development has been estimated to be as high as $1.3 billion per drug . To fend off generic competition, companies desire some confidence that they will be afforded patent protection. The Patents 4 Patients program, while in no way eliminating the r isks inherent in the patenting process , provides a far more timely assurance that embarking on the patent journey will be more akin to a direct jet flight rather than a slow boat cruise. In practice, the Patents 4 Patients program is truly simple. The pet ition must be filed either at least one day before a first Office Action is issued or with a proper request for continued examination (RCE). Moreover, if a cancer immunotherapy method has entered phase II or III clinical trials, then a petition may be file d even after a first office action (but before a final office action) from the USPTO. Such petitions are acted upon within about a month and the vast majority (over 90%) are promptly granted . While only 20 total claims (3 independent) can be pursued, with at least one directed to a cancer treatment, and despite there being no option to seek extensions of time to respond beyond the 3 months afforded after an office action, the program is extremely efficient in moving the case forward. One of the best aspects of the program is that it is entirely FREE. Normally, requesting a “fast track” examination costs a large entity (one that has over 500 employees) $4000, with a small entity being charged $2000. Moreover, it has been the author’s experience that the p atent examiner’s focus and attention is increased under the expedited examination, as he/she does not suffer the significant delays encountered in the typical patent prosecution process, which requires the examiner to revisit and re - learn the case and the prior art at issue. Thus, both the speed and quality of the patent examination are enhanced. From updated statistics generated by the USPTO on January 5 , 202 1 , there have been a total of 661 submissions under the Program. Of those, 608 were granted and only 21 dismissed (the remainder undecided) . That means that the chances of having a patent application accepted under the Program is 9 7 %. The average number of days from the grant of a petition to a first office action on the merits is a mere 29 days. The number of “closed” cases totals 527 (“closed” meaning that the case was either allowed, a final office action issued or it was abandoned), with another 81 pending. As of January 5, 2021 – 420 unique patents have issued under the program . During his tenure as the director of the USPTO, Andrei Iancu has improved the functioning of the patent examining corps and his directives have increased the quality of patent examination, as well as reduced the variability and uncertainty observed across art units . One of the best programs ever implemented by the USPTO - and that Director Iancu continues to administer - is the Patents 4 Patents program – and for all the reasons set forth above, all cancer researchers should avail themselves of this special opportun ity to obtain patent protections for their inventions, thus hastening the day when we can all celebrate effective treatments for the scourge that is cancer.

Machine translation represents a revolution in the patent system. It facilitates access to a vast amount of patent information on a global level during the different stages of patent prosecution, especially in searches for prior art documents. Moreover, disclosure represents one of the main arguments to justify the existence of patent rights, but how much of this information is actually disclosed by machine translation? The present research aims to investigate the level of disclosure of patent information made possible by machine translation and its implications for patent law. The guiding research question is: How and to what extent is patent content actually disclosed by machine translation? In order to reach the results, a manual method of translation quality assessment was used to analyse a sample of 100 patents, combined in different pairs of languages. Machine translated patent texts were also submitted for evaluation by researchers skilled in the art. The research is also based on a review of legal and theoretical sources. The results proved that, although improvements in patent machine translation are still necessary, most of the content of the patent is disclosed through it, with the average disclosure being almost 80%. As the concept of disclosure is a central one to patent law, it is hoped that this research will contribute to a better understanding of the current role of machine translation in patent law.

We advance research on corporate diversification by joining insights from the demand-side and relational views in strategy to offer a novel theory of client-led diversification. We propose that client-led diversification results from a combination of the customer-driven opportunities emphasized in the demand-side view and the creation of added value through relational assets that is a central tenet of the relational view. Furthermore, we hypothesize that suppliers’ client-specific knowledge, clients’ relational commitment to suppliers, and growth opportunities in clients’ markets (relative to the suppliers’ own markets) will magnify the client-led diversification effect. We test our hypotheses using a longitudinal dataset on patent law firms and their diversification into new domains of patent prosecution work for their corporate clients. Managerial abstract Explanations of why firms diversify into new lines of business have largely concerned the redeployment of underutilized resources, with little regard to opportunities or influences stemming from firms’ existing customers. In our paper, we show how the changing scope of business needs from a knowledge-based supplier firm's set of existing clients is a central driver of supplier firm diversification, and this especially the case when the level of relational assets shared between a supplier and its clients is higher. In a competitive landscape where suppliers compete intensively for the business of clients, our results show how managers can increase the likelihood of capturing additional business from its existing exchange relationships rather than bearing the risks of seeking new exchange relationships.

Pharmaceutical firms’ use of secondary patents to extend periods of exclusivity generates concerns among policymakers worldwide. In response, some developing countries have introduced measures to curb the grant of these patents. While these measures have received considerable attention, there is limited evidence on their effectiveness. We follow a large sample of international patent applications in the US, Japan, the European Patent Office, and corresponding filings in three developing countries with restrictions on secondary patents, India, Brazil, and Argentina. We examine cross-country comparisons of primary vs. secondary grant rates, consider the differential fates of “twin” applications filed in multiple countries, and undertake detailed analyses of patent prosecution in the three developing countries. Our analyses indicate that measures to restrict secondary patents in developing countries are having limited impact. In none of these three countries are specific policies toward secondary patents the principal determinant of grant rates. Our analyses also suggest the importance of other procedural aspects of patent systems, beyond the formal policies targeting secondary applications, that affect outcomes for these applications in developing countries.

Research summary: Buyer firms respond to supplier employee mobility by reshuffling work among suppliers. However, the extant literature has not considered plural-sourcing firms which can bring work back in-house. In this paper, we develop a governance framework in which buyers engage in a comparative assessment of the costs associated with different sourcing modes following supplier employee mobility. Due to the imperfect transferability of social capital and associated uncertainty, buyers face increased contracting costs when supplier employees move. This prompts plural-sourcing buyers to increase their reliance on insourcing when the costs of adjusting in-house capacity are relatively low and when the costs of switching to alternative suppliers are relatively high. The analysis of data on patent prosecution activities and patent attorney mobility provides support to our theory. Managerial summary: This study provides a decision framework for buyer firms when their suppliers experience employee departures. Buyers may choose to (a) stay with the suppliers suffering employee losses or (b) follow mobile employees to their new suppliers. However, in both cases contracting becomes more difficult due to the disruption in supplier relationships or the need to work with new suppliers. There is a third option (c) though which is to bring work in-house. We explain that buyers opt for option (c) when it is easy to expand in-house capacity and when the costs of switching to alternative suppliers already in use are relatively high. Thus, supplier employee mobility may lead buyer firms to adjust their reliance on outsourcing even when there are no buyer employee departures.

Throughout the history of patent law, the manner of representation of invention influenced the process of the patent office in prosecuting them. This chapter traces how changes in the representation of the invention — from material to textual to digital — transformed patent prosecution. Early inventions were represented by working models, the materialised invention that needed little or no examination by the patent office, as they were the inventions themselves. Substantive examination became necessary when the representation of the invention shifted from material to textual, the point in history where the invention became textualised and represented by the patent specification, the written document that encompassed the invention. The textualised invention apart from effecting critical changes in patent prosecution, centralised the operations of the patent office. With the adoption of new technologies like blockchain and Artificial Intelligence, the manner of representation of invention will undergo yet another change resulting in the further evolution of patent prosecution. Like digital photography which changed the representation of images by radically changing the backend process, the digitalised invention will change the backend process of the patent office, i.e. patent prosecution. The most significant systemic consequence of the digitalisation of the invention will be the decentralisation of patent system.

Qualified women are unnecessarily excluded from membership in the “patent bar” as a result of the perpetuation of an institutionally biased and outdated set of scientific and technical requirements by the United States Patent & Trademark Office (USPTO). While the USPTO has not failed to recognize the lack of equal gender representation among innovators (i.e., inventors) in the United States, it has remained silent on the lack of gender diversity within its own patent bar. Still further, even when the gender gap within the patent bar has been acknowledged, there have been few, if any, attempts to abolish the systemic obstacles that seem to exclude women from participation. This paper explores and criticizes the various obstacles prohibiting women from equal representation in the patent bar, and proposes possible solutions to reach greater gender inclusion therein. Specifically, the USPTO can foster greater inclusion and innovation in the U.S. patent system by (1) expanding the enumerated technical degrees that automatically satisfy the scientific and technical requirements for patent bar eligibility; (2) removing the undue requirements regarding program accreditation (for computer science degrees) and coursework; and/or (3) implementing an apprentice model as an alternative path to patent bar eligibility.

Disclosure is an important part of both the USPTO patent application process and the FDA regulatory review process. The specific disclosures that are required by the USPTO and the FDA can sometimes be potentially problematic for those who are involved in both the patent application process and the regulatory review processes. Generally speaking, disclosures that are made to the USPTO need to also be made to the FDA, and vice versa. Failing to make a disclosure when disclosure is required can lead to a finding of inequitable conduct during prosecution of the patent, which can result in the patent being invalidated, and/or can prompt the FDA to initiate an investigation as to whether significant questions regarding data integrity and reliability with respect to a regulated product have been raised for a medical device product that is under review. Being aware of disclosure requirements, and the consequences for failing to comply with those requirements, can help avoid serious pitfalls during the patent prosecution and regulatory processes.

This article illuminates the recent developments in the field of the subject matter eligibility of the inventions and offers a resolution to the crucial issues in the field. The solution for resolving of the crucial issues combines the current U.S. approach of affirmative defining of the scope of the subject matter of the patents and the approach of the European Patent Convention, of both affirmative and negative defining of the patentable subject matter. In particular, the article provides a draft legislation as a more sustainable and precise solution that emerged from the comparison between the experience of the participants in the U.S. patent prosecution and litigation procedure and the experience of the participants in the patent procedure in the European Patent Organization. The legislative proposal includes the current text of Section 101 of the U.S. Patent Act enhanced with a new part concerning the excluded invention matter from the scope of the patentable subject matter. Several court decisions involving patentable subject matter eligibility of inventions in the field of business methods, software and life sciences, make this approach necessary and the resolution of the overall problem pressing. Also, the article critiques the proposed amendment of Section 101 of the Patent Act currently being considered in the U.S. Congress and explains how the proposed draft legislation in the paper offers a better solution.

Five years later, what are the wider impacts of the US Supreme Court's Myriad decision on subject-matter eligibility and patent prosecution for nature-based products beyond isolated DNA?

A product-by-process claim was initially developed when the invention could not otherwise be adequately defined. In the US, a patent applicant can use a product-by-process claim for a new product, no matter whether the product can also be defined by using structure features. However, the applicant mainly bears the burden to establish the novelty between the claimed product and the prior art product. Moreover, in terms of infringement, the very recent CAFC cases indicate that the product must be made by a process recited in the claim to infringe a product-by-process claim. Thus, an assignee almost can not take advantage from product-by-process claims during the patent enforcement by comparing with process claims. From the points of the burden during patent prosecution and confined scope in determining infringement, the benefit of using a product-by-process claim would be very limited.

Getting a patent through the US patent application process generally takes two to three years, but there are ways to accelerate that process if you're in a hurry. The Web extra at https://youtu.be/pnPksToYXDA is an audio recording of author Brian M. Gaff reading his column.

The economic literature emphasizes the importance of patent citations, particularly forward citations, as an indicator of a cited patent’s value. Studies have refined which forward citations are better indicators of value, focusing on examiner citations for example. We test a metric that arguably is closer tied to private value—the substantive use of a patent by an examiner in a patent office rejection of another pending patent application. This paper assesses how patents used in 102 and 103 rejections relate to common measures of private value—specifically patent renewal, the assertion of a patent in litigation, and the number of patent claims. We examine rejection data from U.S. patent applications pending from 2008 to 2017 and then link value data to rejection citations to patents issued from 1999 to 2007. Our findings show that rejection patents are independently, positively correlated with many of the value measurements above and beyond forward citations and examiner citations.

In 2014-2015, policymakers made changes to the patent system that were intended to decrease abusive litigation and increase the quality of patents and complaints. The changes included the Octane Fitness & Highmark (fee-shifting, Alice (patentable subject matter), Teva, and Williamson cases (definitness) and Form 18 reform (pleading standards). Have they worked, based on looking at complaints and applications pre-and post-change? In this analysis, initially presented to the FTC's Hearings on Innovation and Competition in Oct 2018, and performed with Santa Clara Law Students Nicholas Halkowski, Marvin Mercado, Priyanka Vyas, we document the following changes: patent complaints across technology areas are much more likely to contain claim charts and product details than they were in the pre-2014 period; using a differences in differences approach, software claims are longer, narrower (based on unique words), and software applications are longer, relative to non-s/w claims; we also find a decline in scale (10+) and NPE (both PAE and non-PAE) assertions. The data suggests that patent reform has had one of its intended impacts, of increasng the quality of patent applications and complaints.

Addresses conflicts of interest in patent practice, including patent prosecution, patent opinion work, and patent litigation.

Problem: Technical writers rarely work on patent applications, but the typical documents writers prepare during research and development are important during patent disputes. Patent disputes are so costly that the potential for these disputes weighs heavily on the minds of those preparing patent applications. The relationship between technical documentation and the legal processes surrounding research and development need to shape a writer's documentation practice. Research question: What legal concepts do technical writers need to know when working in research and development? Key concepts: Patent prosecution is the process of obtaining a patent. Technology transfer is the communication that places an innovation into the marketplace. Patent disputes arise when a party believes its patent rights have been infringed. The work of technical writers becomes relevant during patent disputes. Two Supreme Court cases inform the process for reconstructing the meaning of patent claims during a dispute: ${\rm Markman \,v.\, Westview\, Instruments, \, Inc.}$ and ${\rm Phillips \,v. \, AWH Corp. \, Markman}$ limits the audience who determines the meaning of a claim to the judge instead of a jury, and Phillips establishes the role written documents have in a patent dispute. The ${\rm Phillips}$ case shows how a judge might use technical documentation to determine the meaning of a patent claim or term. From these cases, we can draw strategies for preparing technical documents. Key lessons: While impossible to know prior to a patent dispute how a document will affect the outcome of the dispute, technical communicators can adopt three strategies for preparing precise and complete documents. First, technical writers can adopt a “liminal” practice—the ability to interact as needed with different disciplines. Second, technical communicators can approach new subjects with assent, a type of seeking understood in order to fully explore a new technology. And third, technical communicators can approach writing about research and development as a technical translation practice to translate highly scientific or technical language into precise plain language. Implications to practice: By developing a liminal practice, technical communicators can build a robust documentation practice that includes the contextual nuances essential for work in patent prosecution and technology transfer.

Journal article (editorial) Patents are legal documents, but they capture and preserve rights to important engineering ideas. For this reason, they are very important to the corporations and research institutions that employ engineers. And as a result, it is pretty difficult for a good engineer to avoid getting involved in the patenting process at some point in his career. Or if you happen to be a company owner or senior manager, you will also find patents are going to enter your day-to-day workflow from time to time. Hopefully, not too often, but when they do, you need to know what they mean. peer-reviewed

To demonstrate the influence of the US Supreme Court's KSR case, our analysis has shown that the ratio of obvious ruling increased from 0.42 to 0.62 after this case, whereas the ratio of non-obvious ruling decreased from 0.47 to 0.28. Therefore, without the rigid application of a "teaching, suggestion or motivation" test, the trends of obvious and non-obvious CAFC rulings significantly increased and decreased, respectively. Based on this analysis, biotech inventors should contemplate the factors that have resulted in ruling of obviousness, which include claims that are too broad, the lack of secondary considerations, the reasonable expectation of success, and the reason or motivation to create a structure based on structural similarity. The presence of these factors most likely would result in the rejection of the claim during patent prosecution or the invalidation of the claim in patent litigation. Two immunotherapy and vaccine cases have applied these factors to overcome the obvious rejections.

Release of the United States Patent and Trademark Office (USPTO) Office Action Research Dataset for Patents marks the first time that comprehensive data on examiner-issued rejections are readily available to the research community. An “Office action” is a written notification to the applicant of the examiner’s decision on patentability and generally discloses information, such as the grounds for a rejection, the claims affected, and the pertinent prior art. The relative inaccessibility of Office actions and the considerable effort required to obtain meaningful data therefrom has largely prevented researchers from fully exploiting this valuable information. We aim to rectify this situation by using natural language processing and machine learning techniques to systematically extract information from Office actions and construct a relational database of key data elements. This paper describes our methods and provides an overview of the main data files and variables. This data release consists of three files derived from 4.4 million Office actions mailed during the 2008 to mid-2017 period from USPTO examiners to the applicants of 2.2 million unique patent applications.

Several patent prosecution practices have been materially changed by the AIA. Indeed, the AIA repealed the statute providing authority for the publication of patent applications as statutory invention registrations, added prioritized examination as an additional option for expediting patent examination, modified the third-party preissuance submission practice in an effort to entice third parties to play a more active role in patent examination, and clarified the statute pertaining to patent term extensions. This chapter will provide a discussion of these changes to patent prosecution practices and provide analyses of the practical implications of the same.

Patent prosecution needs to be faster. The 2-year wait for the first office action must be reduced to 6 months, and the office action turnaround time cut in half for cure-related applications. The novelty and prior art restrictions must be relaxed as well. This will make all medical knowledge in the public domain patentable and the refiling of expired and terminated patents. The goal is to open up all of the science landscape to patenting for the purpose of cure-related uses.

Patent examination is a complex and information-intensive process. For researchers and policy analysts studying this process, it is important to have a basic understanding of how patents typically proceed through examination and how the behaviour and incentives facing examiners might influence (or be influenced by) this process. This document provides a simplified overview of the patent examination process and the Performance and Appraisal Plan (PAP) for patent examiners. As the title indicates, this is a primer that provides a researcher-friendly introduction. Additional references are provided throughout the document to direct readers to more authoritative and detailed sources of information on each of the topics covered.