Author: Jorge Contreras

The Civil Rights Challenge to Gene Patenting

Posted by | Oct 26, 2021 | ,

[Jorge Contreras] In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.

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INTELLECTUAL PROPERTY PLEDGES FOR COVID-19: A SCORECARD

Posted by | Apr 26, 2021 | ,

[Jorge Contreras] Broad public concern over the availability of equipment, diagnostics and therapies needed to address COVID-19 has led numerous companies and institutions to pledge their intellectual property (IP) to this cause on a compensation-free basis (some background on IP pledging can be found here and here). The following table and discussion, adapted from a longer paper forthcoming in the Utah Law Review, summarizes the more prominent of these in roughly chronological order.

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COVID-19 as an Example of Why Genomic Sequence Data Should Remain Patent Ineligible

Posted by | Mar 24, 2021 | ,

[Jorge Contreras] The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly.

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IP Controversies and COVID-19

Posted by | Mar 1, 2021 |

In the ongoing debate over intellectual property (IP), access, innovation and COVID-19, numerous references have been made to high profile instances in which patents and other forms of IP have been perceived as barriers to the research, development, manufacture or supply of products necessary to respond to the pandemic. This short post (which is derived from a longer article forthcoming in the Utah Law Review) collects and summarizes many of these instances for comparison and analysis.

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Intellectual Property Pools and Aggregation

Posted by | Dec 21, 2020 | , ,

Abstract: This chapter in the forthcoming case book “Intellectual Property Licensing and Transactions: Theory and Practice” covers IP pooling, with an emphasis on patents. It begins with a discussion of the theoretical benefit of pooling, including efficiency gains and the avoidance of blocking positions, thickets and anti-commons. It then addresses antitrust analysis of pooling transactions from Standard Oil (Indiana) v. United States (U.S. 1931) through the 2017 DOJ-FTC Antitrust Guidelines. The chapter then turns to pools created to facilitate standard-setting, including the MPEG-2 and 3GPP Pools, and discusses the concept of complementarity and essentiality of pooled assets. It concludes with brief discussions of Princo v. ITC (Fed. Cir. 2010) and the rise of patent aggregators such as RPX Corp.

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Pledging Intellectual Property for COVID-19

Posted by | Dec 9, 2020 | , ,

[Jorge L. Contreras, Michael B. Eisen, Ariel Ganz, Mark A. Lemley, Jenny Molloy, Diane Peters, and Frank Tietze] Abstract: COVID-19 differs from other recent public health crises with respect to its sudden onset, its rapid spread, the lack of any known vaccine or cure and resulting shortages of critical medical equipment. The convergence of these factors has prompted both governments and IPR holders around the world to seek ways to increase the availability of IPR necessary to combat the pandemic. Governmental compulsory licensing, IPR pools and voluntary IPR pledges have all been used in the past, though in situations that differ in important respects from the COVID-19 pandemic. Each is designed to result, to a greater or lesser degree, in a publicly-accessible “commons” of rights and technologies that are broadly available for use to support an important public health goals. Here, we compare and contrast these differing approaches to IPR commons formation and assess their suitability to address the COVID-19 crisis.

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Updates to the PIJIP Patent Pledge Database

Posted by | Nov 13, 2020 | , ,

Patent pledges are voluntary commitments made by patent holders without monetary compensation to refrain from asserting their patent rights to the fullest degree. Such pledges have been around for decades and appear in industries ranging from software to automotive to green tech to biotech… Since the beginning of the COVID-19 pandemic in early 2020, firms and institutions around the world have pledged patents and other intellectual property rights to assist with the pandemic response. These efforts include unilateral pledges such as those made by ventilator manufacturer Medtronic and vaccine maker Moderna as well as coordinated pledge efforts such as the Open COVID Pledge and the Japan-based Open COVID-19 Declaration.

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Deconstructing Moderna’s COVID-19 Patent Pledge

Posted by | Oct 23, 2020 | ,

[Jorge Contreras] On October 8, Cambridge-based biotech company Moderna, Inc., a leading contender in the race to develop a COVID-19 vaccine, publicly pledged not to enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic.” …In the high-stakes market for COVID-19 vaccines, it is worth considering the full range of factors that might motivate a private firm to relinquish valuable intellectual property rights for the public good. A better understanding of these factors could help policymakers to secure additional pledges from firms that have not yet volunteered their intellectual property in the fight against the pandemic.

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PUTTING PLEDGED IP TO WORK – IDENTIFYING IP AVAILABLE UNDER THE OPEN COVID PLEDGE

Posted by | Jun 12, 2020 |

[Jorge Contreras] Today, the Open COVID Pledge launched a new feature highlighting some of the valuable intellectual property (IP) that organizations around the world have committed to the fight against Covid-19. Pledged IP covers a broad range of equipment, software, network and device applications useful in healthcare, containment, tracking, diagnostics, emergency response and social distancing. It includes 3D-printed respirators, touch screens that use ultraviolet light to prevent the spread of infection, a Wi-Fi enabled floating hospital, methods for designing grocery stores to ensure social distancing, a low-cost, single-use ventilator, software for accelerating disease diagnosis, algorithms for routing emergency vehicles through traffic, a drive-up booth for Covid-19 testing, and much more. The Open COVID Pledge offers a platform that enables holders of patents and copyrights to commit these assets to the fight against Covid-19 on a royalty-free basis.

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PIJIP Supports the Open COVID Pledge

Posted by | Apr 13, 2020 |

[Sean Flynn, Jorge Contreras and Meredith Jacob] PIJIP is a founding partner of the Open COVID Pledge, https://opencovidpledge.org/, and is providing institutional support for the project. This note explains our history with the project, how the pledge works, and why we think it will be helpful. At the end of this note is a link for organizations that want to support or use the Pledge themselves.

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Patents and Coronavirus – A Role for Patent Pools?

Posted by | Apr 13, 2020 |

Patent pools are private arrangements that enable participants to operate under one another others’ patent rights, to manage and administer the pooled rights on a centralized basis, and often to grant licenses of the pooled patents to third parties, with the proceeds split among the pool members according to an agreed formula. Patent pools have been around for a century in industries ranging from oil refinement to aircraft to semiconductors to digital media. In all of these cases, pools have enabled the efficient consolidation of patents in a manner that has facilitated licensing and commercialization.

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Patents and Coronavirus – The Right to Repair

Posted by | Apr 3, 2020 |

In March, 2020, two engineers in Brescia, Italy used a desktop 3D printing machine to fabricate needed replacement valves for more than 100 ventilator machines being used to treat coronavirus patients at a local hospital. News reports claim that the ventilator valves fabricated in Italy for a cost of about 1 Euro each were previously sold by the manufacturer for 10,000 Euro each. There is some debate about what happened next, but early news feeds reported that a parts manufacturer threatened to sue the engineers for infringing patents on the replacement valve. While the existence of the threat and the patents remains murky, the incident sparked legal commentary regarding the risk that volunteers fabricating parts for lifesaving devices, and the hospitals that use them, could be liable for patent infringement.

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Patents and Coronavirus – Compulsory Licensing, Government Use And March-In Rights

Posted by | Mar 28, 2020 |

The United States has two viable statutory mechanisms for addressing situations in which patent holders are unable or unwilling to supply sufficient quantities of goods or services to combat the coronavirus crisis: march-in rights under the Bayh-Dole Act and governmental use under 28 U.S.C. § 1498. Though each of these mechanisms presents challenges, these should be surmountable in many cases to ensure that diagnostics, vaccines, therapies and support equipment are produced and distributed rapidly and in sufficient quantities.

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Industry Weighs In on DOJ’s Standards Essential Patent Policy Reversals

Posted by | Apr 2, 2019 |

Beginning in November 2017, Makan Delrahim, head of the U.S. Department of Justice Antitrust Division, signaled that he would reverse many of the DOJ’s prior positions regarding technical standardization and, especially, patents covering technical standards (so-called Standards Essential Patents or SEPs) (the 2017 announcement is discussed in detail here). The latest step in this DOJ reversal of direction came in December 2018, when Mr. Delrahim announced that the DOJ would withdraw from a 2013 joint Policy Statement that the DOJ issued with the U.S. Patent and Trademark Office (PTO). The DOJ’s unexpected withdrawal from the Joint Policy Statement has prompted significant reactions within the industries affected by standardization, including statements of strong support for the DOJ’s new position by an inventors’ alliance and a coalition of large SEP holders, and statements urging the DOJ’s reconsideration by the American Antitrust Institute (AAI) [note: the author serves on the Advisory Board of the AAI] and a coalition of technology companies.

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