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Abstract:
In 2005, an article in the highly influential journal Science reported that roughly 20% of human genes are patented. This figure has been widely cited and at times over-interpreted. For example, a popular science fiction author warns the public that their bodies are "owned" by someone else. A bill was introduced in Congress in 2007 that would essentially seek to ban the patenting of DNA. The bill appears motivated in part by a perception that one-fifth of our genes are owned by somebody else, that these owners can do whatever they want with these genes, and that there is "nothing that we can do to stop them" (presumably short of banning the patenting of DNA).

While clearly many US patents have issued that reference human genetic sequences, the actual scope of exclusivity varies dramatically from claim-to-claim as dictated by the actual claim language. Many patents restrict only some very narrow use of the genetic sequence, others are much broader - none cover actual human genes as they exist in their native state. And it should go without saying that none confer actual ownership of human beings, or allow a patent owner to do "whatever it wants" with another person's genes.

In light of the hyperbole and high interest currently surrounding human gene patents, and in an attempt to assess the true impact of these patents, I conducted a search to identify and analyze all instances where a patent relating to a human gene was asserted in a lawsuit. The results suggest that the impact of human gene patents has been felt primarily in the context of biotechnology-derived protein therapeutics, i.e., biologics, the most important fruit of the biotechnology revolution. The impact on genetic testing and assess to research tools has been relatively modest, with some notable exceptions. Furthermore, lawsuits are being filed at a decreasing frequency over time, and it appears that only three human gene patent litigations are currently pending. Two involve patents relating to the production of recombinant erythropoietin, an important biologic drug; these patents claim priority to applications filed in the early 1980s. The third is best characterized as a contract dispute, wherein the licensor of a research tool patent alleges that a licensee has exceeded the scope of its license; this case has been stayed pending the outcome of a court-ordered arbitration of the underlying contractual dispute.

The article concludes with a discussion of some policy implications to be drawn from the results of this survey.

patents, gene, DNA, biologics, biotechnology, genetic testing, forensics, diagnostic testing, biomedical research, research tool, patent litigation, patent infringement

Abstract:
In University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the court established for the first time a new form of patent law's written description requirement, apparently targeted specifically at biotechnology. To this day, the conventional wisdom is that the so-called Lilly written description requirement (LWD) exists as a biotechnology-specific super-enablement requirement, substantially more stringent than the enablement requirement (the conventional standard for patentability), and standing as an impediment to effective patent protection for biotechnology inventions. My objective in writing this article was to test this conventional wisdom, by conducting a comprehensive search for all LWD decisions of the federal courts and the U.S. Patent Office's Board of Patent Appeals and Interferences (BPAI), and collecting and individually analyzing each case. The analysis focuses on the extent to which LWD is actually functioning as a biotechnology-specific super-enablement requirement. For many, the results of this study will likely come as a surprise, because the empirical evidence demonstrates that the impact of LWD in the courts and BPAI has been minimal - for the most part, LWD does not function as a super-enablement requirement but merely as a redundant surrogate for the enablement requirement. The article ultimately concludes that LWD's main impact has been one of doctrinal confusion, rather than imposing any substantial barrier to the patenting of biotechnology inventions, and recommends that the courts effectively discard LWD as redundant and unnecessary. It suggests alternative approaches for addressing the valid policy concerns that implicitly drove the original Lilly decision.

Eli Lilly, Enzo, Written Description, patent, biotechnology, lizardtech, Falkner, enablement, DNA, proteins

Abstract:
The term "reverse payment" has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Reverse payment settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment.

This article begins in Section II with an overview of the diverse array of patent settlement agreements that have been classified within the general taxonomy of "reverse payment settlements." Section III discusses a variety of specific factors that have led to a natural proliferation of reverse payments patent settlements between branded and generic drug companies. Section IV traces the development of the FTC's position, which would find most reverse payment settlements presumptively illegal, focusing in particular on its recent ill-fated enforcement action against Schering-Plough. Section V reviews the courts' response to antitrust challenges against reverse payment settlements, and identifies an emerging consensus position that will find a violation of the antitrust laws only in cases where the challenged agreement contains restrictions on competition that exceed the exclusionary potential of the patent. The article concludes in Sections VI and VII with a discussion of the future prospects for the antitrust treatment of reverse payments settlements, including a suggestion that in evaluating the anticompetitive implications of these agreements more explicit consideration be paid to barriers to market entry facing potential third party generic competitors.

patent, hatch-waxman, generic drugs, antitrust, reverse payment, settlement, exclusion payment, pharmaceutical, paragraph IV certification

Abstract:
On June 8, 2005, Congressman Lamar Smith introduced H.R. 2795, the Patent Reform Act of 2005, aimed at improving the quality and certainty of issued patents, simplifying the patent procurement process, harmonizing U.S. law with international practice, and reining in abusive patent enforcement practices. Congress has set the legislation aside for the time being, but will likely revisit the issue again shortly. The biotechnology industry, one of the fastest growing sectors in the United States economy, strongly opposes many of the proposed reforms. This paper considers the Congressional testimonies of the Biotechnology Industry Organization ("BIO") and other representatives of biotechnology's interests, and finds that the industry's adamant opposition to many of the proposals is driven largely by a belief that biotechnology patents function primarily as tools for securing investment funding, and the fear that investment in biotechnology will be adversely impacted if investors perceive that patent reform has weakened the rights of patent owners and inventors. The paper also considers how the biotechnology sector might be impacted if the proposed reforms are enacted into law, and describes some recent biotechnology cases wherein the outcome might have been different if the reforms had already been in place.

biotechnology, patent, H.R. 2795, patent reform, pharmaceutical, drug, reform, smith, congress, testimony, hearing

Abstract:
A vigorous discussion exists regarding the need to provide exclusive patent rights as incentives to invent and to disclose so-called "research tools," whether such exclusive rights should apply to all uses and users of patented research tools, and whether exclusive rights to prohibit all uses of research tools would unduly discourage sequential invention. This article summarizes recent developments under U.S. patent laws of particular relevance to the debate over the patenting of research tools, and provides some insights into the practices of various academic sciences, industries, and government agencies regarding the treatment of these important inventions. The article provides a brief history of the experimental use and regulatory approval exceptions to patent infringement liability and summarizes recent cases interpreting the regulatory approval exception and its application to research tool patents subsequent to the Supreme Court's 2005 Merck v. Integra decision. It then surveys empirical studies that examine the practices of scientific researchers and patent holders, and describes recent changes to patenting and licensing policies and behaviors in the public and private sectors. The article reviews and explains recent and proposed changes to the patent system that may affect patents for and use of research tools. Finally, it discusses a variety of alternatives to the experimental use and regulatory approval exceptions that could facilitate access and continued use of patented technologies in scientific research and commercial development.

patent, research tool, experimental use, regulatory approval, compulsory licensing, exceptions and limitations, licensing, enforcement, patentability

Abstract:
Recombinant proteins form the basis for most of the products of biotechnology, including drugs, diagnostics, research reagents, genetically modified organisms and industrial enzymes. However, the nature of proteins and the rules of patentability conspire to make it difficult to achieve adequate patent protection for novel proteins and the polynucleotides that encode them. Narrow patent claims limited to protein sequences sharing a high degree of structural identity can generally be designed around by introducing structural changes in the claimed protein, thereby avoiding the patent without substantially altering the protein's function. However, inventors are generally restricted in their ability to broadly claim protein inventions by the patent law's written description and enablement requirements.

In this paper, I propose a novel approach to claiming genuses of related protein sequences by means of what I refer to as a similarity score. The similarity score is essentially a modified version of the BLAST score, a standard approach used by biologists to measure the degree of structural similarity between related protein sequences. The primary advantage of the similarity score approach compared to conventional protein claiming techniques, such as by percent identity or hybridization, is that it is much more predictive of conserved function. The genus of related proteins defined by similarity score will include a substantially higher percentage of variants that retain function than a similarly sized genus defined using the conventional techniques. Policy objectives are served by allowing the inventor to better protect against trivial design around, while at the same time limiting the tendency of unduly broad patent claims to encompass proteins having substantially divergent structure and function.

biotechnology, BLAST, similarity, patents, written description, enablement, percent identity, similarity score, proteins, DNA, sequence

Abstract:
The patent eligibility doctrine serves a gatekeeper role in excluding from patent protection natural phenomena, principles of nature, abstract ideas, and mental processes. Beginning around 1980, the U.S. patent system embarked upon a pronounced expansion in its definition of patent eligible subject matter, particularly with respect to software and business method inventions, but also in the life sciences. In recent years, however, we have seen a backlash, with many critics from the public and private sectors arguing that the threshold for patent eligibility needs to be raised in order to ensure that patents fulfill their constitutional objective of encouraging innovation rather than impeding it. The courts and PTO appear to have heard these critics, and have begun to actively rein in the scope of patent eligible subject matter. This shift in the swing of the patent eligibility pendulum will likely have a profound impact on the patentability of innovations arising out of the pharmaceutical and biotechnology industries, particularly those relating to diagnostics and personalized medicine. In this article, I discuss the current status of the patent eligibility doctrine, how it is that we got here, and what the future might hold, particularly for the life science industries.

Patents, Biotechnology, drugs, Bilski, patent eligibility, patentable subject matter, Labcorp, personalized medicine, diagnostics

Abstract:
Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB legislation, and that Congress should not include a pre-approval patent dispute resolution process (“PPRP”). The FTC Report bases its conclusion that a substantial DEP is unnecessary to adequately incentivize innovation in biologics in part on a misapplication of the results of a study I conducted in 2007 on the written description doctrine of patent law.

In this article I offer a response to some of the conclusions and recommendations set forth in the FTC Report. In particular, I think it is important to clarify the scope and implications of my study on the written description doctrine, and explain why I believe that the FTC over-interpreted the results of the study to arrive at a conclusion that is unsupported by the data. In my view an extended DEP for innovators is justified and should be included in FOB legislation enacted by Congress. I also disagree with the FTC's conclusion that a PPRP is unnecessary and unwarranted for biologic drugs; such a process is appropriate and would be important to maintain adequate incentives for innovation. Some of the proposed FOB legislation would discriminate against the developers of innovative biologic drugs, not only with respect to FOB producers, but also in comparison to the treatment currently afforded conventional drug innovators. These discriminatory provisions should be removed or rectified to provide a more balanced approach to promoting competition while maintaining adequate incentives for investment in biotechnology.

follow-on biologics, biosimilars, biogenerics, biologic drugs, Hatch-Waxman, FTC, patents, biotechnology, FDA, data exclusivity

Abstract:
Many policies governing biobanks revolve around ownership and control of the materials and information in them. Those who manage biobanks may be tempted to seek the broadest legal rights possible over material and data. However, we suggest that even if ownership and control were clearly defined by the law and readily obtained by biobanks, how legal rights are used in practice matters as much or more than the rules for ownership. We draw lessons from the stories of genetic testing for Canavan disease and inherited breast and ovarian cancers. In both cases, the use or assertion of legal rights led to preventable controversy and suboptimal outcomes. The attempt to acquire and exercise intellectual property rights antagonized and alienated stakeholders, whom we define broadly to include the donors, patients, doctors, research institutions, health care providers, governments, and citizens with an interest in research and its outcomes. By analogy, even if biobanks could acquire expansive and clear property rights over materials and data, biobanks that want to maintain productive relationships with stakeholders must not lose the trust of those who contribute material or others with an interest in research.

biobank, biobanks, genetic testing, genomic testing, Canavan, Myriad, BRCA, research ethics, gene patents, genes, patents, ethics, business models, public health care, clinicial genetics

Abstract:
In 2007, I published an article entitled "The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent Litigation," in which I reported the results of a project to identify and characterize all instances in which a human gene patent was asserted in a lawsuit. For the purposes of this study, I essentially treated any US patent claiming a product or process involving one or more specific human genes as a "human gene patent."

In the present article I explore in greater depth some of the implications of the 2007 study, and discuss some general trends and findings not addressed in the earlier article. For example, a number of commentators have assumed that because genes and genetic information constitute such fundamental and foundational elements of human biology, gene patents are inherently more difficult to circumvent than most other patents. However, my study identified numerous instances where gene patents were successfully circumvented, either by employing alternate technology that successfully skirted the scope of the patent claim or by using the patented technology outside the United States and beyond the reach of US patent law.

The article analyzes and synthesizes the outcomes of cases in which human gene patents were asserted in the context of biologics, research tools, and genetic diagnostic testing, including litigation outcomes, intensity and duration of litigation, and the roles of technical and geographic circumvention. Trends and predictions for the future role of human gene patents in these areas of technology are also considered.

To date, the record of actual human gene patent litigation provides little support for the notion that a "patent thicket" of human gene patents is adversely impacting biomedical progress. For example, according to the patent thicket theory DNA micro-arrays should be a prime target for human gene patent litigation, but in fact micro-arrays have apparently never been the subject of a lawsuit involving a human gene patent. There is also little evidence of patent troll activity by human gene patent owners.

The role of universities and other non-profit public institutions in human gene patent litigation is specifically addressed. Although universities are the source of a disproportionate number of the human gene patents have been asserted in lawsuits, particularly in the context of genetic diagnostic testing, they have generally not been the target of lawsuits, particularly with respect to basic noncommercial research,

patents, gene, DNA, biologics, biotechnology, genetic testing, forensics, diagnostic testing, biomedical research, research tool, patent litigation, patent infringement, patent thicket, anticommons, university patenting, gene patents, DNA micro-array

Abstract:
Drawing an appropriate boundary between unpatentable natural phenomena and patentable inventions is critical in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued which purport to claim a novel product or process but which in effect encompass any practical application of a fundamental biological principle. Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headline-grabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that Congress and/or the courts will address the issue, and perhaps substantially shift the boundary.

patentable subject matter, research tools, genes, patents, gene patents, research tools

Abstract:
Patents do not always promote innovation, particularly when they restrict access to fundamental scientific discoveries and the tools of basic research. This article discusses a variety of legal and policy approaches that might help to ameliorate problems associated with patenting these sorts of inventions, with a particular emphasis on promoting innovation in the biotechnology sector.

patents, biotechnology, patent thicket, research tools, research use, Bayh-Dole, upstream patents, junk patents, open source

Abstract:
Regents of the University of California v. Eli Lilly established a novel interpretation of the written description requirement, referred to herein as Lilly written description (LWD), which unlike traditional written description applies to originally filed claims. The LWD test for “possession” has in the vast majority of cases been applied in a manner that is essentially redundant with the enablement requirement. However, LWD can and sometimes does function as a super- enablement requirement for patent claims reciting proteins and DNA sequences. With respect to these claims, LWD has sometimes been applied in a manner that imposes biotechnology-specific requirements of “possession” more stringent than the enablement requirement, referred to in this brief as the "species possession requirement" and the "genus possession requirement." These biotechnology-specific possession requirements have been applied in an inconsistent and arbitrary manner lacking any basis in science, and at times precluding adequate patent protection for important inventions relating to proteins and DNA molecules.

Assessing the degree of disclosure necessary to support the patenting of biotechnological inventions, and achieving optimal claim scope for genus claims reciting proteins and DNA, are undoubtedly challenging and important issues that patent law must address in order to maintain adequate incentives for innovation without unduly inhibiting subsequent innovators. But the enablement requirement, which prior to Lilly was invoked as a potent and largely effective doctrinal tool for calibrating biotechnological patent claims to a scope commensurate with the disclosure, is better suited to the task. In deciding Ariad v. Eli Lilly, the en banc Federal Circuit should rule that there is no Lilly written description requirement applicable to originally filed claims.

Ariad, Eli Lilly, biotechnology, patent law, written description requirement, amicus

Abstract:
In Prometheus v. Mayo, the district court erred in characterizing an entirely man-made biological correlation, which did not and could not exist absent human intervention, as an unpatentable “natural phenomenon" under 35 U.S.C. § 101. Contrary to the district court’s conclusion, the mere fact that the breakdown of a man-made, non-naturally occurring drug (i.e., drug metabolism) involves natural processes in the body does not render the breakdown of the drug a natural process, nor does it render a correlation between these non-naturally occurring drug breakdown products (i.e., drug metabolites) and the optimal dosage of the drug a natural phenomenon. If not reversed, the decision below could cast doubt on the patentability of many important innovations, particularly in the area of diagnostics and personalized medicine. In re Bilski did not obviate the necessity to accurately distinguish between non-natural and natural phenomena, and the instant case provides appropriate facts for this Court to provide critical guidance for future courts faced with this important inquiry.

Prometheus, Mayo, Bilski, patentable subject matter, patent eligibility, diagnostics, personalized medicine, biotechnology