Contracting to counter gene patents – a 21st Century solution to access and innovation

By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GiM article Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Continue reading

Two new publications on “European patent strategies under the UPCA” and on “Synthetic Biology & Intellectual Property Rights”

By Timo Minssen

I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2)  “Synthetic Biology & Intellectual Property Rights”:

1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published  in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.

Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.

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Tomorrow: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Harvard Law School
LOCATION CHANGE: Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave.
Cambridge, MA 02138

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.

10/6/14: Legal and Ethical Issues in Healthcare Start-Ups

vaccines_slideLegal and Ethical Issues in Healthcare Start-Ups

Monday, October 6, 2014 4:00 PM

Wasserstein Hall, Milstein East B, Harvard Law School, 1585 Massachusetts Ave.

The full list of panelists is available on our website here.

New healthcare start-ups face a range of legal and ethical challenges as they develop new products and services and solicit financial support from investors. Building on the success of the President’s Challenge at the Harvard Innovation Lab, which invites teams of Harvard students to develop innovative solutions to a range of global issues including healthcare accessibility and affordability, the Petrie-Flom Center will host a discussion of the issues that past winners of the President’s Challenge have faced as they seek to move their ideas out of the lab and into the private sector.

The panel discussion will be followed by the Petrie-Flom Center’s Annual Open House reception. Join us to learn more about our work!

This event is supported by the Oswald DeN. Cammann Fund.