Christopher M. Holman

Trends in Human Gene Patent Litigation

Fears surrounding human gene patents have, for the most part, yet to manifest themselves in patent litigation.

Debunking the myth that whole-genome sequencing infringes thousands of gene patents

The fear that human gene patents pose a threat to whole-genome sequencing is based largely on widely held misconceptions.

Clearing a Path through the Patent Thicket

Patents do not always promote innovation, particularly when they restrict access to fundamental scientific discoveries and the tools of basic research. However, there are legal and policy approaches that may help to ameliorate problems associated with patenting these sorts of inventions.

Advances in DNA sequencing lead to patent disputes.

Will next-generation DNA sequencing technologies be hindered or helped by todays more aggressive patent acquisition and enforcement practices?

Copyright for Engineered DNA: An Idea Whose Time Has Come?

The rapidly emerging field of synthetic biology has tremendous potential to address some of the most compelling challenges facing our planet, by providing clean renewable energy, nutritionally-enhanced and environmentally friendly agricultural products, and revolutionary new life-saving cures. However, leaders in the synthetic biology movement have voiced concern that biotechnologys current patent-centric approach to intellectual property is in many ways ill-suited to meet the challenge of synthetic biology, threatening to impede follow-on innovation and open access technology. For years, copyright and patent protection for computer software have existed side-by-side, the two forms of intellectual property complementing one another. Numerous academic commentators have rejected the notion of copyright for engineered genetic sequences (the primary output of synthetic biology), based in large part upon a misinterpretation of copyright law and/or a failure to appreciate the profound advances in synthetic biology that have occurred in recent years. This article makes a case for extending copyright protection to engineered DNA, based in large part upon the striking analogy between engineered genetic sequences and computer programs, made more compelling by the growing convergence of software engineering and synthetic biology. The major doctrinal leap occurred 30 years ago when Congress and the courts sanctioned the use of copyright to protect computer programs. A further extension to engineered DNA would represent a comparatively modest incremental expansion, and would be comfortably supported by current copyright doctrine without any need to amend the Copyright Act (although certain clarifying and limiting amendments would be desirable). The article critiques, and to a large extent refutes, a variety of doctrinal and policy arguments that have been raised by commentators against extending copyright protection to engineered DNA, and concludes by outlining a number of positive policy objectives that could be addressed with you when you such an extension of copyright law.

Response to ‘pervasive sequence patents cover the entire human genome’

A response toPervasive sequence patents cover the entire human genome by J Rosenfeld and C Mason. Genome Med 2013, 5:27.See related Correspondence by Rosenfeld and Mason, http://genomemedicine.com/content/5/3/27 and related letter by Rosenfeld and Mason, http://genomemedicine.com/content/6/2/15

In Defense of Secondary Pharmaceutical Patents: A Response to the UN's Guidelines for Pharmaceutical Patent Examination

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 of pharmaceutical innovation are inherently routine, and absent some sort of exceptional circumstance should be treated as obvious/non-inventive, and hence unpatentable. In my experience, however, the Guidelines’ assumption that many types of pharmaceutical inventions are inherently obvious and undeserving of patent protection is incorrect, and based on an oversimplified view of how these inventions come about. This article provides an evidence-based response to the Guidelines that refutes, or at least qualifies, some of the significant conclusions and recommendations set forth by its author.

Bilski: Assessing the Impact of a Newly Invigorated Patent Eligibility Doctrine on the Pharmaceutical Industry and the Future of Personalized Medicine

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.