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Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman

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A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …

In Juno V. Kite The Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation In Car T-Cell Therapy, Christopher M. Holman

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Chimeric antigen receptor T-cells (also known as CAR T-cells) are T-cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy. In recent years CAR-T cell therapy has emerged as an important new modality of cancer treatment, particularly for blood-borne cancers like leukemia. As would be expected, important advances in the development of CAR T-cell therapy have been the subject of extensive patenting and licensing activity. Juno v. Kite, a recent decision of the Court of Appeals of the Federal Circuit striking down a foundational CAR T-cell therapy patent, has raised serious questions as to …

The Federal Circuit Continues To Grapple With The Question Of Patent Eligibility For Diagnostic Methods, Christopher M. Holman

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This article considers the current state of affairs at the Federal Circuit with regard to the patent eligibility of diagnostic methods. Diagnostics v. Mayo Collaborative Servs. I then look at all of the decision decisions I could find in which the court strikes down diagnostic method claims as patent ineligible under Mayo v. Prometheus, of which there are quite a few. Finally, I turn to the handful of cases, all decided in 2018 or later, in which the Federal Circuit has upheld the patent eligibility of diagnostic claims, the most significant of which I believe to be Vanda Pharmaceuticals v. …

Government Involvement In Pharmaceutical Development Can Come Back To Haunt A Drug Company, Christopher M. Holman

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The U.S. government has long played a significant role in pharmaceutical innovation, often through the funding of research, or collaboration in clinical trials. Unfortunately, government involvement can come at a cost for innovative drug companies, leading to allegations that taxpayers are being required to “pay twice” for the resulting drugs, particularly when the drug is considered essential and is offered at a price that is seen as “unreasonably” high. This Article discusses two aspects of ongoing efforts to leverage government involvement in pharmaceutical development and commercialization as a means for regulating of drug prices. The first is the assertion that …

Branded Drug Companies Are Successfully Asserting The Doctrine Of Equivalents In Hatch-Waxman Litigation, Christopher M. Holman

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This article reports the results of a study analyzing every Federal Circuit decision the author could find dating back to 2005 that applies the doctrine equivalents (DOE) in the context of pharmaceutical patent litigation, and in particular infringement lawsuits brought against Abbreviated New Drug Application (ANDA) applicants by branded drug companies under the Hatch-Waxman Act. The results of this study show that pharmaceutical innovators were prevailing against would-be generic competitors under the DOE both prior to, and subsequent to, a 2007 article by Professors Lemley and Allison describing the demise of the doctrine equivalents, but that patentees’ success rate has …

In Minerva V. Hologic, The U.S. Supreme Court Reins In The Equitable Doctrine Of Assignor Estoppel, Christopher M. Holman

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Assignor estoppel is an equitable remedy that prohibits an assignor of a patent, or one in privity with an assignor, from attacking the validity of that patent when he is sued for infringement by the assignee. On June 29, 2021, the U.S. Supreme Court issued its decision in Minerva v. Hologic, holding that while AE remains a viable doctrine, the Federal Circuit has on many occasions, including the instant case, applied the doctrine in an overly expansive manner, particularly in cases where the patent claims at issue differ substantially from any patent claims that were in existence at the time …

Congress Should Decline Ill-Advised Legislative Proposals Aimed At Evergreening Of Pharmaceutical Patent Protection, Christopher M. Holman

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There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, …

Ajinomoto V. Itc, The Doctrine Of Equivalents, And Biomolecule Claim Limitations At The Federal Circuit, Christopher M. Holman

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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 …

Gilead Sciences Sued For Failing To Bring A Follow-On Version Of Truvada To Market Sooner., Christopher M. Holman

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In 2012, the United States Food and Drug Administration (FDA) approved Truvada as the first drug for use in the prevention of HIV infection in healthy people who are at high risk of acquiring HIV through sexual activity. Developed and marketed by Gilead Sciences, Inc., Truvada is a fixed-dose combination of two antiretroviral compounds, tenofovir disoproxil fumarate (TDF) and emtricitabine. The World Health Organization (WHO) has identified both TDF and the combination of TDF and emtricitabine found in Truvada as “essential medicines.” In 2015, Gilead began marketing products containing tenofovir alafenamide fumarate (TAF) as a safer and more effective alternative …

Congress Considering Legislation Aimed At Increasing Competition In Pharmaceuticals, Christopher M. Holman

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The U.S. Congress is currently considering a large number of bills that would attempt to bring down drug prices by a variety or means, including some aimed at reform of certain patent-related aspects of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This Article begins with a brief overview some key provisions of Hatch-Waxman and the BPCIA that have been targeted by these legislative initiatives. It then turns to a discussion of some specific bills currently being considered by Congress that would seek to promote greater competition in the market for pharmaceuticals by amendments …

Helsinn V. Teva: Lingering Ambiguity After The U.S. Supreme Court Holds The Aia Did Not Alter The On-Sale Bar To Patentability, Christopher M. Holman

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The American Innovation Act of 2011 (AIA) retained §102 of the pre-AIA Patent Act’s “in public use” and “on-sale” bars to patentability, but introduced an additional “or otherwise available to the public” category of prior art. Federal Circuit precedent pre-dating the AIA has held that, as a general matter, a sale or offer for sale can create an on-sale bar to patentability even if the sale or offer for sale is “secret” and does not render the invention available to the public. Some believed that the AIA’s introduction of the phrase “or otherwise available to the public” altered the meaning …

Congress Considering Legislation Intended To Reverse The Recent Trend Toward Devaluation Of The Us Patent Right, Christopher M. Holman

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Decisions of the United States Supreme Court spanning the last quarter of a century that have, in the aggregate, substantially devalued the patent right. The Court’s four decisions reinvigorating and substantially raising the patent eligibility bar have probably resulted in the most critical commentary, but a host of other decisions have also served to erode the patent right in multiple dimensions, including the scope of potentially patent-able subject matter as well as the strength and enforce-ability of issued patents. In 2011 Congress joined in when it enacted the America Invents Act (AIA), which includes multiple provisions tending to devalue patents, …

The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman

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In a span of three weeks during the spring of 2017, the U.S. Supreme Court issued three patent decisions, bringing the total number of patent decisions for the 2016-2017 term to six. This means that the October 2016 term ties the previous record of six patent decisions in the October 2014 term. This represents a tremendous increase in the number of patent decisions compared to earlier times, and particularly the early days of the Federal Circuit. For reference, during the first quarter of a century the Federal Circuit was in existence, the Supreme Court heard on average less than one …

In Defense Of Secondary Pharmaceutical Patents: Response To The Un's Guidelines For Pharmaceutical Patent Examination, Christopher M. Holman

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In 2015 the United Nations Development Programme issued a document entitled Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The heart of the Guidelines is a category-by-category examination of eight types of “secondary” pharmaceutical patent claims: Markush claims; selection patents; polymorphs; enantiomers; salts; ethers and esters; compositions; doses; combinations; prodrugs; metabolites; and new medical uses. The Guidelines advise patent offices to apply heightened patentability requirements to these claims in a manner that would effectively deny patent protection to important pharmaceutical innovations currently afforded patent protection. In particular, the Guidelines postulate that many forms …

Some Key Things U.S. Entrepreneurs Need To Know About The Law And Lawyers, Lawrence J. Trautman, Anthony J. Luppino, Malika Simmons

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New business formation is a powerful economic engine that creates jobs. Diverse legal issues are encountered as a start-up entity approaches formation, initial capitalization and fundraising, arrangements with employees and independent contractors, and relationships with other third parties. The endeavors of a typical start-up in the United States will likely implicate many of the following areas of law: intellectual property; business organizations; tax laws; employment and labor laws; securities regulation; contracts and licensing agreements; commercial sales; debtor-creditor relations; real estate law; health and safety laws/codes; permits and licenses; environmental protection; industry specific regulatory laws and approval processes; tort/personal injury, products …

The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman

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Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …

Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman

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While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term “synthetic biology” has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …

Supreme Court Asked To Consider Role Of Post-Filing Evidence In Assessing Obviousness Of Pharmaceutical Inventions, Christopher M. Holman

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On January 20, 2015, Bristol-Myers Squibb petitioned for certiorari in Bristol-Myers Squibb v. Teva Pharmaceutical, asking whether an assessment of obviousness should "consider post-filing evidence showing the actual differences between a patented invention and the prior art." The district court had found patent claims directed towards Entacavir (an anti-hepatitis drug) obvious in view of structural similarity between the drug and a prior art compound, in spite of the fact that the prior art compound was highly toxic and therefore not a viable candidate for use as a human drug. A Federal Circuit panel affirmed the district court's decision to disregard …

Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response To Our Divided Patent System, Christopher M. Holman

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On October 14, 2014, Stanford’s Professor Mark Lemley tweeted “My new study with Allison & Schwartz shows that software and biotech patent lawsuits overwhelmingly lose.” He was referring to an article entitled Our Divided Patent System, co-authored by Lemley and two other prominent law professors. Taken at face value, the assertion that “biotech patent lawsuits overwhelmingly lose” would seem to hold troubling implications for biotechnology. In order to better understand the basis for Lemley’s assertion, I reanalyzed the underlying data and found that the situation is not nearly as bleak as his tweet might suggest. My significantly different interpretation of …

Bowman V. Monsanto Co.: Bellweather For The Emerging Issue Of Patentable Self-Replicating Technologies And Inadvertent Infringement., Christopher M. Holman

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The inherent tendency of patented seeds to self-replicate has led to fears that farmers might face liability for inadvertent patent infringement. To address the perceived problem, some have proposed severely limiting the availability of effective patent protection for self-replicating technologies. Typical examples include denying patent rights to "second generation" self-replicating products, and even broadly declaring such technologies ineligible for patent protection. The fact is, lawsuits against inadvertently infringing farmers remain of largely hypothetical concern. However, changes in the market could soon render such lawsuits a reality. In addressing the resulting policy concerns, Congress and the courts have at their disposal …

Will Gene Patents Derail The Next-Generation Of Genetic Technologies?: A Reassessment Of The Evidence Suggests Not, Christopher M. Holman

UMKC Law Review

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that …

Will Gene Patents Impede While Genome Sequencing?: Deconstructing The Myth That 20% Of The Human Genome Is Patented, Christopher M. Holman

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A 2005 Science article by Jensen and Murray is widely cited for the proposition that 20% of human genes are patented, and has led to a pervasive assumption that thousands of human genes cannot be used, studied or even 'looked at' by researchers and healthcare providers without infringing a gene patent. Many have voiced concern that this perceived thicket of gene patents will impede the implementation of next-generation genetic technologies, particularly personal whole genome sequencing (WGS). In fact, Jensen and Murray only showed that, with respect to 20% of human genes known at the time they conducted their study, either …

Unpredictability In Patent Law And Its Effect On Pharmaceutical Innovation, Christopher M. Holman

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In recent years, the major innovator pharmaceutical companies have experienced two pronounced and significant trends: a decreasing output of innovative new drugs and cutbacks in research and development (R&D) investment. The two phenomena probably are not unrelated and raise significant concerns for a society intent upon providing affordable health care for an aging population. While the root causes of these trends are complex and diverse, we should not overlook the critical role patents play in creating the necessary incentives for the substantial investment required to develop pharmaceutically-interesting chemical compounds into actual drugs and to take them through the clinical trials …

Bilski: Assessing The Impact Of A Newly Invigorated Patent Eligibility Doctrine On The Pharmaceutical Industry And The Future Of Personalized Medicine, Christopher M. Holman

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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 …

Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman

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Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …

Maintaining Incentives For Healthcare Innovation: Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

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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 …

Learning From Litigation: What Can Lawsuits Teach Us About The Role Of Human Gene Patents In Research And Innovation, Christopher M. Holman

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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 …

The Perils Of Taking Property Too Far, Christopher Heaney, Julia Carbone, E. Richard Gold, Tania Bubela, Christopher M. Holman, Allessandra Colaianni, Tracy R. Lewis, Bob Cook-Deegan

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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 …

The Impact Of Human Gene Patents On Innovation And Access: Survey Of Human Gene Patent Litigation, Christopher M. Holman

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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 …

Protein Similarity Score: Simplified Version Of The Blast Score As Superior Alternative To Percent Identity For Claiming Genuses Of Related Protein Sequences, Christopher M. Holman

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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 …