Search

Publisher Summary A patent is a legal instrument granting the owner the right to make, use, or sell an invention and to exclude others from doing so. In the United States, an inventor is entitled to a patent if an invention is novel, useful, and unobvious. This chapter provides a synopsis of Patent Law Careers as explained by Alexandra J. Baran, Ph.D., President, A.J. Baran Consulting, Inc. The term “patent practitioner” encompasses both patent attorneys and patent agents. All practitioners must pass a federal bar exam administered by the U.S. Patent and Trademark Office (PTO) before being permitted to represent clients in their quest to obtain patents. Like attorneys, registered patent agents are legal professionals and are required to adhere to strict standards of professional conduct and canons of ethics. A. J. Baran emphasizes that if one happens to be a patent practitioner whose practice comprises mostly direct patent prosecution, a typical day is spent writing applications and preparing responses to PTO examiners. The profession demands one to have analytical abilities, including logical thought, pattern recognition, and classification ability; organizational skills are also important.

This article describes patent prosecution strategies for new biotechnological inventions. The first part of the article discusses general strategies for patent prosecutors, including several prosecution considerations and methods for increasing patent prosecution speed. The second part of the article presents patent prosecution challenges in genomics and bioinformatics-related patents and provides solutions to these challenges. The last part of the article discusses how ethical and public policy issues play a role in the patentability of biotechnological inventions.

This paper presents a brief overview of intellectual property rights and the various areas in proteomics to which intellectual property rights may be applicable. Technology transfer, including licensing and business agreements, are not covered in this paper. Instead, issues and complications related to national and overseas patent prosecution in this relatively new field will be discussed.

The lesson from Festo is that during patent prosecution, what you say (or don't say) and what you do (or don't do) will be used against you.

Out of the Human Genome Project and automated sequencing technology has arisen a controversy over the attempt to obtain patents on fragments of functional genes, known as expressed sequence tags (EST), and the genes themselves. In addition to legal and academic debate over the patent ability of expressed sequence tags, the issue of property rights in these gene fragments raises questions about economics and social policy. The article offers a solution to this debate by proposing a registration stem that, first, avoids the costs of patent prosecution and examination; second, has none of the adverse economic consequences of patenting expressed sequence tags; and, third, recognizes that expressed sequence tags have some value. The article summarizes the science, explains the controversy over ESTs, and outlines a trio of existing models for access to EST sequences. The article continues by analyzing issues of patent law in relation to ESTs and introduces property and economic issues. The article then proposes two possible solutions: limiting to ten the number of ESTs per patent application, as is currently the plan and policy of the PTO; and issuing short-term (ten-year) patents on ESTs alone. This leads to the author explaining, justifying, and defending a registration system that gives less robust property rights than the standard twenty-year patent. Finally, the author addresses some of the philosophical issues pertaining to property rights in genetic material.

One of the oddest things to an outsider about the United States patent system is that due to continuation practice it is impossible for the U.S. Patent and Trademark Office (PTO) ever to finally reject a patent application. Continuation applications have led to abuse of the patent prosecution process. They serve very little useful purpose, and what benefits they confer may be outweighed by their potential for mischief. In an effort to study the pervasiveness of continuation practice, we compiled an original dataset comprising 2,224,379 patents, every patent issued from 1976 through 2000. We found that while continuations are filed in 23% of all patent applications, patents based on continuation applications represent 52% of all litigated patents. Although continuations are used in a minority of all patents, it is the most important minority because it is the minority most likely to end up in litigation. We examine the efforts undertaken to control the problems associated with continuation patents (changing the patent term, publishing applications, prosecution laches) and find them insufficient. The world would probably be a better place if they were abolished. Recognizing, however, that the abuse of continuation practice is not as pervasive as some might think, we propose a number of means by which Congress and the courts could strengthen existing rules designed to limit their abuse while preserving the practice. At a minimum, the empirical data we present can provide litigants and judges with a baseline for assessing the reasonableness of delay caused by the filing of multiple continuations by the patentee in determining the applicability of equitable remedies such as prosecution laches.

Under the rule of prosecution history estoppel, patent applicants who amend their claims during the course of patent prosecution assume a significant risk: namely, the risk that a court will later construe the changes as concessions that should be read to limit patent scope. This risk is exacerbated by strong evidentiary presumptions under which courts are to assume, unless the patentee presents sufficient evidence otherwise, that every change triggers estoppel, and that the resulting estoppel forfeits everything except that which the revised language literally describes. The justification for these presumptions is that, implemented in this fashion, prosecution history estoppel makes patent scope more predictable. In this Article, I argue that the benefit comes at too high a price. Drawing on a large empirical study of patent prosecution, I show that, because of these evidentiary presumptions, estoppel is dangerously sensitive to differences between patent examiners and differences across technology categories. That is, estoppel treats similar applications in dissimilar ways, not because of differences on the merits, but instead because of the personal characteristics of the examiners involved and because of differences inherent to the types of technology at issue. A better rule, I argue, would minimize the significance of examiner and technology disparities by reversing the current evidentiary presumptions and thus recognizing estoppel only where there is clear evidence that the applicant and the examiner intended to forfeit a given scope of coverage.

Once the decision to file a patent application has been made, a number of important strategic considerations are necessary to guarantee that a commercially valuable patent will eventually be granted. This decision-making process, beginning with the formulation of an appropriate claim strategy for the US application and continuing through the choice of foreign countries for foreign prosecution, is vital to the success of a patent application both in the Patent and Trademark Office and, eventually, in the marketplace.

This paper explores the conflict between the PTO Rules of Professional Conduct and the state rules of ethics. This conflict is not readily apparent as a patent attorney would be justified in assuming that conduct deemed ethical under the state requirements would be acceptable under the PTO ethics rules. However, the PTO's "Duty of Candor" potentially presents the patent attorney with a seemly unresolvable conflict. Specifically, the "Duty of Candor" may require the patent attorney, during simultaneous patent prosecution, to disclose confidential information from the file of one client in order to properly prosecute the patent of another client. The courts have made it clear that the attorney-client privilege is applicable to all communication between a patent attorney and the client. In light of this ruling, the question becomes whether federal rules of ethics preempt the applicability of state ethics rules. We specifically explore the conflict between state confidentiality/privilege rules and the PTO Duty of Candor and the ramifications of failure to resolve this conflict for both the attorney and the client. An overview of patent prosecution is included as well as a comparison of the of the ABA Model Rules of Professional Conduct and the PTO Code of Professional Responsibility. We argue that the state rules of ethics should dominate the practice of all law and should supercede enforcement of the PTO Duty of Candor where conflicts arise during simultaneous patent prosecution.

EFFECTIVE NOVEMBER 29, 2000, the U.S. Patent and Trademark Office (PTO) changed its policy of preventing the public from obtaining information about patent applications. Patent applications that claim priority to applications filed after November 29, 2000 will now be published 18 months after their earliest filing date for which they claim priority. This change in U.S. patent law helps the United States conform with trade agreements it made in the 1990s (i.e., the General Agreement on Tariffs and Trade and TradeRelated Aspects of Intellectual Property Agreement [GATT/TRIPs]). There are exceptions to the new rule regarding publication. The 18-month publication rule does not apply to (1) design applications, (2) provisional applications, (3) express requests by an applicant to not publish the application along with a certification that the application is not being filed in another country which requires 18-month publication, and (4) applications that are subject to a secrecy order. Applicants who are only filing in the United States or are filing in another country which does not abide by the 18-month publication rule may prevent publication by promptly filing a request that the application not be published. However, if the application is later filed in Europe or some other country that requires publication after 18 months, the applicants must inform the PTO of this change within 45 days of filing in the other country, or risk losing their U.S. application. Although the rule provides that provisional applications are not published, if an utility application claims priority to a provisional application, and the application issues as a U.S. Patent, then the provisional application will become available as part of the file history of the patent. This change in U.S. patent law has a number of implications. First, it potentially increases one’s awareness of what one’s colleagues and competitors are developing by publishing patent applications and allowing one to request copies of the file histories for published applications from the PTO before a patent issues. This represents a drastic change in U.S. patent law. Second, it provides applicants with a right to obtain a reasonable royalty during the period beginning on the date of publication and ending on the date the patent actually issues (see 35 U.S.C. § 154 (d)). Third, it may expedite the patent prosecution process by forcing applicants to comply with formality requirements for patent applications at the beginning of prosecution. However, on a practical basis, where most significant applications are being foreign filed, typically through the PCT, and published at 18 months, this change makes little difference with respect to availability of the information. The significant change is with regard to the potential right to obtain royalties for the period between publication and issuance. A key factor in obtaining royalties will be whether or not the product which is sold (and for which royalties are therefore due) is adequately described and claimed in the published application.

It is common to assert that the Patent and Trademark Office does a bad job of examining patents, and that it should spend more time and money weeding out bad patents. In this article, Professor Lemley challenges that conventional wisdom. Using available data regarding the cost and incidence of patent prosecution, litigation, licensing and other uses of patents, he demonstrates that strengthening the examination process is not cost effective. The core insight is that very few patents are actually litigated or licensed; most simply sit on a shelf unused, or are used only for noncontroversial purposes like financing. Because of this, society would be better off spending its resources in a more searching judicial inquiry into validity in those few cases in which it matters than paying for a more protracted examination of all patents ex ante. In economic terms, the patent office is "rationally ignorant" of the objective validity of the patents it issues.

In high technology areas such as biotechnology and computer software, the U.S. Patent and Trademark Office (PTO) is poorly informed about the relevant prior art. In these cases, it may be optimal for the PTO to provide incentives to the patentee to produce a complete prior art disclosure. Such incentives could accord a specific, high presumption of validity to the prior art disclosed by the patentee, thereby limiting the use of the disclosed prior art for invalidation purposes in subsequent (i.e., post-issuance) litigation. Building upon Grossman and Hart's model of incomplete contracts, we show that a regime that trades a reduction in post-issuance litigation uncertainty for a complete prior art disclosure maximizes social welfare because it benefits both the patentee and the PTO. The patentee favorably views the reduction in litigation uncertainty and greater control over the possibility of the public's perspective, a fuller prior art disclosure may allow the PTO to grant patent rights commensurate with innovation and to avoid the detrimental consequences of an overbroad patent grant. In sum, this proposal is an incentive-capatible trade that maximizes joint social surplus. The optimal policy for high technology inventions (characterized by asymmetric information and high productivity effects) provides incentives for well-informed patentees to reveal information regarding the relevant prior art to the PTO during patent prosecution. This is consonant with a body of contracting literature that proposes that when parties are asymmetrically informed, default rules that penalize the more informed party will be welfare-enhancing by inducing that party to reveal information. However, in our case, we do not impose a penalty on the better-informed party, the patentee. Rather, we permit a transfer of ex post bargaining rights (i.e., reduce the public's residual right to invalidate the patent) in order to induce the better-informed party to reduce the informational asymmetry between the patentee and the PTO.

In the Festo decision, the Federal Circuit significantly changed the scope of the doctrine of equivalents in patent law. The doctrine of prosecution history estoppel precludes a patent owner from claiming during litigation to own ground given up during patent prosecution. Under the old rule, called the "flexible bar," estoppel was based on a multi-factor test and would apply only if the patentee had no choice but to amend its claims in the way it did. Festo replaced the flexible bar with an "absolute bar," under which virtually any amendment to a patent precludes resort to the doctrine of equivalents for that claim element. The Supreme Court is now considering whether the flexible or absolute bar is the right rule. We believe there is middle ground in this debate that has been ignored with both parties. Whether prosecution history estoppel applies to any given amendment should depend on the reasonably foreseeable effect of that amendment. Normally, patentees will understand that they are surrendering coverage by amending their patent claims, and so a rule precluding them from reclaiming that ground makes sense. But in some cases the absolute bar will produce unexpected and unintended results. We argue that the application of estoppel should turn on whether the effect of a change would be foreseeable to a reasonable patentee at the time of the amendment. This "foreseeable" bar better balances the competing policies of strong protection for pioneering inventors and notice to improvers who wish to design around a patent.

We have studied a large, random sample of U.S. patents issued between 1996 and 1998. We collected a variety of information about these patents, including area of technology, national origin, the number of inventors, nature and size of the owning entity, the number and type of prior art references, and the time spent in prosecution. We seek to establish relationships between a number of variables in issued patents-such as number of inventors, numbers and types of references to the prior art, numbers and types of claims, and length of time between application and issuance-and a number of defined areas of technology. We identify the countries in which particular inventions originated--almost one-half of all issued U.S. patents cover inventions originating in other countries--and test for relationships between the above variables and countries of origin. We also evaluate relationships between countries of origin and areas of technology. The conclusions are somewhat surprising, and point to a patent system that is far from unitary in the way it treats different inventors and different inventions.

Inequitable conduct in patent prosecution is found whenever “material” information is withheld or mischaracterized to withhold the truth from the Examiner, § 503 (“Important Information * * *”), and the applicant knowingly withheld or mischaractered the material information for the purpose of deceiving the Examiner in order to allow at least one claim of the patent, § 507 (“Kingsdown, The Intention Element”).

Last Term, in Festo Corporation v. Shoketsu Kinzoku Kogyo Kabashuki Co., the United States Supreme Court missed perhaps the most important opportunity for patent law reform in two decades. At the core of the failure to grasp the implications of "prosecution history estoppel" - a judicially-crafted principle limiting the enforceable scope of patents based on acts occurring during their application process - is the heretofore universal (but ultimately unsupportable) view of the doctrine as an arbitrary ex post limitation on patent scope. This Article demonstrates the serious flaws in this traditionalist approach, and develops a new theory of prosecution history estoppel based on its ex ante effects. This shift of focus from the allocation of liability during infringement (ex post) to the way the rule generates incentives both during and before inventors apply for patents (ex ante) offers substantial insights into the central role that this venerable doctrine plays in the modern patent administrative system. In particular, the Article argues that prosecution history estoppel is best viewed as an information-forcing default penalty rule, where the possibility of lost patent scope induces patentees to produce socially-valuable information early in the life of the patent. Other benefits include the internalization of costs related to certain activities during patent prosecution, and increased enforcement of the institutional arrangements between the Patent Office and the Judiciary. Indeed, the considerable analytic advantages observed in this context strongly suggest that the Article's methodological approach of reconsidering the patent law in an explicitly ex ante framework has applications well beyond prosecution history estoppel.

PATENT practice has changed with time and use—responding somewhat to changing needs. Yet, the changing needs and new forces of today appear to be considerably greater and more critical than those of earlier times when the trade and commerce of the land did not depend so heavily upon scientific research, particularly in the chemical and related fields. Thus, patent practice, as a dynamic thing, well deserves the attention of the inventing public and the patent bar. Patent practice may be defined as the unwritten rules followed by the Patent Office and by the present bar relating to patent prosecution. This practice is based on precedent, custom, and interpretations of written rules, statutes, and court cases. The term has a broader meaning, but for the present purpose it may be characterized as changeable and flexible. The patent system, on the other hand, has remained more or less firmly upon its constitutional foundation for over a century. ...

Despite many empirical studies having been carried out on examiner patent citations, few have scrutinized the obstacles to prior art searching when adding patent citations during patent prosecution at patent offices. This analysis takes advantage of the longitudinal gap between an International Search Report (ISR) as required by the Patent Cooperation Treaty (PCT) and subsequent national examination procedures. We investigate whether several kinds of distance actually affect the probability that prior art is detected at the time of an ISR; this occurs much earlier than in national phase examinations. Based on triadic PCT applications between 2002 and 2005 for the trilateral patent offices (the European Patent Office, the US Patent and Trademark Office, and the Japan Patent Office) and their family-level citations made by the trilateral offices, we find evidence that geographical distance negatively affects the probability of capture of prior patents in an ISR. In addition, the technological complexity of an application negatively affects the probability of capture, whereas the volume of forward citations of prior art affects it positively. These results demonstrate the presence of obstacles to searching at patent offices, and suggest ways to design work sharing by patent offices, such that the duplication of search costs arises only when patent office search horizons overlap.

Over the past five years, the Supreme Court has embarked upon a drastic and far-reaching experiment in patent eligibility standards. Since the founding era, the nation’s patent statutes have afforded patent protection to technological innovations and practical applications of scientific discoveries. However, the Supreme Court’s 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories imposed a new limitation on the scope of the patent system: that a useful application of a scientific discovery is ineligible for patent protection unless the inventor also claims an “inventive” application of the discovery. The following year, the Court ruled that discoveries of the location and sequence of DNA compositions that are useful in diagnosing diseases are ineligible for patent protection. And in its 2014 Alice Corp. v. CLS Bank International decision, the Court ruled that software-related claims are ineligible for patent protection unless the abstract ideas or mathematical formulas disclosed are inventively applied. These decisions sent shock waves through the research, technology, business, and patent communities. Medical diagnostics companies experienced a dramatic narrowing of eligibility for core scientific discoveries. Reactions within the information technology community have been mixed, with some applauding the tightening of patent eligibility standards on software claims and the opportunity to seek early dismissal of lawsuits, particularly those filed by non-practicing entities, and others criticizing the shift in patent eligibility. Several members of the Federal Circuit bluntly criticized the Supreme Court’s shift in patent eligibility standards on jurisprudential and policy grounds. Additionally, the Patent Office has struggled to apply the Supreme Court’s new and rapidly evolving standards. As this sea change unfolded, many patent practitioners, scholars, PTO officials, and jurists hoped that the Supreme Court would provide fuller and clearer guidance on patent eligibility standards. In the aftermath of the Supreme Court’s rejection of the invitation to reexamine its Mayo decision, many stakeholders have shifted their attention toward legislative reforms. This Report summarizes the presentations and discussion of a workshop of leading industry representatives, practitioners, scholars, policymakers, and a retired jurist exploring the legal background and effects bearing on legislative action. Part I contains a lightly edited version of the background document circulated to participants prior to the workshop. Part II summarizes the four workshop sessions leading up to the discussion of legislative proposals: (A) legal background; (B) effects on research and development (RD (C) effects on patent prosecution; and (D) effects on patent assertion, litigation, and case management. Part III summarizes the discussion of legislative proposals and sets forth a framework for seeking compromise on reform legislation.

It is no secret that some Patent and Trademark Office (PTO) examiners operate more quickly than others. Previous studies have shown that an applicant’s ability to obtain a patent is inexorably linked to the random assignment of a patent examiner. However, not all patent examiners are created equal. Some patent examiners allow patent applications quickly within just one or two Office Actions resulting in only a few months of substantive patent prosecution. In contrast, other patent examiners constantly reject patents applications, which can result in unnecessarily delaying prosecution and years of substantive patent prosecution. This study focuses on how different examiners use prior art rejections to prolong or compact prosecution. This study demonstrates how two different populations of patent examiners (slow vs. fast) can achieve and even exceed their production goals by either an allowance or rejection strategy. The allowance strategy relies on granting a large number of applications with only a few rejections and usually within one or two office actions. The rejection strategy relies on rejecting a large number of applications using a wide variety of different rejection types. Unlike many studies, this is the first paper that evaluates patent quality based on individual examiner characteristics at the patent prosecution level focused on non-prior art rejections. In particular, high volume biotechnology examiners reject applications based mainly on obviousness type double patenting and indefiniteness rejections, while issuing fewer obviousness or anticipation type rejections. In contrast, low volume examiners reject applications based mainly on obviousness rejections. Furthermore, number of pages in the low volume examiners’ office actions are more than three times more than high volume examiners. Thus, low volume examiners are writing longer office actions and rejecting based on a wide variety of statutory authorities, while high volume examiners are writing shorter office actions based mainly on obviousness type double patenting issues. We find that different types of examiners use different strategies to maximize their “counts” in order to keep their production numbers high. Specifically, low volume examiners will generally reject applications creating lengthy prosecution histories while forcing the applicant to narrow claims. In contrast, high volume examiners will usually only make one rejection then allow the case, thus creating a small prosecution history with only small amendments to the claims. This results in a dramatic range of patent prosecution times as well as a large difference in claim scope. Slow examiners take approximately 5.85 years to issue a patent while fast examiner only take approximately 1.64 years. The added four years of prosecution greatly increases direct costs to the inventor (both in PTO and attorney fees) as well as indirect costs such as reduced growth in employment, sales and follow on innovation. Finally, there may be harms to not only the inventor, but to rivals in the form of diminished access to external capital and slower growth of follow on innovation.

India, like many developing countries, only recently began to grant pharmaceutical product patents. Indian patent law includes a provision, Section 3(d), which tries to limit grant of “secondary” pharmaceutical patents, i.e. patents on new forms of existing molecules and drugs. Previous research suggests the provision was rarely used against secondary applications in the years immediately following its enactment, and where it was, was redundant to other aspects of the patent law, raising concerns that 3(d) was being under-utilized by the Indian Patent Office. This paper uses a novel data source, the patent office’s first examination reports, to examine changes in the use of the provision. We find a sharp increase over time in the use of Section 3(d), including on the main claims of patent applications, though it continues to be used in conjunction with other types of objections to patentability. More surprisingly, see a sharp increase in the use of the provision against primary patent applications, contrary to its intent, raising concerns about potential over-utilization.

Technology commercialization managers are often faced with (1) training inventors on intellectual property (IP) laws and IP policies, (2) evaluating invention disclosures for patentability and marketability, (3) drafting and implementing invention marketing plans, and (4) working closely with patent counsel on patent prosecution. This study begins with the fact that expediency is important because the amount of time taken to evaluate invention disclosures and file patent applications often conflicts with inventors’ desire to publish their findings. Yet, very few technology transfer managers use project management job scheduling tools to minimize processing time. Next, this study describes the development of a novel job scheduling tool for university technology transfer using simulated annealing in R programming. A description of experimentation follows and the test results follow. Next, the discussion provides that the primary implication for technology managers is that the tasks involved in technology transfer can be scheduled quite easily and speedily with this proposed job scheduling tool. A limitation to the study is that a hypothetical set of TTO staff job tasks was scheduled. Also, faculty inventors’ tasks are not included. Thus, future research should include further experimentation in actual university technology transfer offices using the job tasks that their specialists need to schedule in real time.

Examiner interviews are one of the most powerful tools to help both inventors and examiners understand and overcome specific issues during prosecution. Direct discussions between an applicant and an examiner can help bridge the gap between misunderstandings of prior art, the invention or statements in the specification. When used correctly, examiner interviews can dramatically decrease the time in prosecution and help applicants quickly reach a final disposition. This study reviews approximately 1.1 million patent applications corresponding to every patent application with an examiner interview between 2007 to June 2020 to determine the effectiveness of examiner interviews. This study establishes that examiner interviews dramatically decrease the number of Office Actions needed to reach a final disposition (allowance or abandonment).