CQ Roll Call reported last week that House Judiciary Chairman, Congressman Bob Goodlatte (R-VA), is fast tracking the Innovation Act (HR 3309) despite growing bi-partisan concerns of those on the House Judiciary Committee. Reportedly, a markup of the legislation will be held at some time during the week of November 18, 2013.
But calling the Innovation Act fast-tracked doesn’t do justice to what is really happening. The Innovation Act was only officially introduced on October 23, 2013, and the Committee has not heard from any independent inventors or small businesses. Even the innovator community that stands to lose big is just warming up, this past week with a substantial coalition of University groups and the Biotechnology Industry Organization (BIO) weighing in for the first time, with BIO concluding that the “proposals are not supportable without significant amendment.” The University groups weighing in against the Innovation Act are the Association of American Universities, American Council on Education, Association for American Medical Colleges, Association of Public and Land-grant Universities, Association of University Technology Managers and Council on Government Relations, collectively referred to in their position statement as “the Higher Education Community.”
If Goodlatte is already planning a markup in days and at the same time Universities and BIO are weighing in it almost seems as if the handwriting is on the wall, which it may well be in the House. Still, there are important reasons to want to stop the Innovation Act at least until significant, legitimate concerns are addressed and the bill is amended.
On Friday, July 20, the Federal Circuit heard oral arguments in the remand of the AMP et al. v. USPTO et al. appeal – the case better known as the Myriad Genetics “gene patent” case. The supplemental briefing in this case, and the oral argument itself, continue to reveal how those with diverse perspectives on DNA patents misunderstand each other. Scientists are making dubious assumptions about the operation of patent law. Patent lawyers are making inaccurate assumptions about how the science works. And those who are neither patent lawyers nor scientists just go by what they’ve been told. The Department of Justice’s (DOJ) supplemental amicus brief and oral argument in this case are a good example of the widening disconnect.
“Kitschy, Not Catchy”
Readers will recall that this is not the first time DOJ appears in this case. Two years ago when the Myriad case first reached the Federal Circuit, DOJ filed an unsolicited brief, replete with hypothetical examples of elemental lithium, cotton, coal, isolated electrons, and other things having nothing to do with molecular biology, siding in part with the American Civil Liberties Union (ACLU), and arguing that Myriad’s claims to BRCA-encoding DNA molecules are patent-ineligible under Section 101.
Washington, D.C. (June 21, 2012) – BIO commends the House of Representatives for its unanimous approval of S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).
We appreciate the leadership of Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) as well as of House Energy and Commerce Committee Chair Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA) in reconciling the differences between the user fee packages adopted by the two Chambers and for securing unanimous approval in the House.
“This report provides further evidence that America’s technology transfer system established by the Bayh-Dole Act of 1980 is a key underpinning of our innovation economy,” stated BIO President and CEO Jim Greenwood.
Bayh-Dole enables the patenting and commercialization of federally-funded university and non-profit institution research. Bringing these discoveries from the lab to the marketplace creates new products, new jobs and new companies that expand the economy and improve the nation’s health and quality of life. The BIO study documents the significant return on investment that U.S. taxpayers receive by funding basic scientific research in the academic and non-profit worlds through the Bayh-Dole Act, which The Economist has referred to as the most significant and successful piece of domestic legislation since the end of World War II.
Washington, D.C. (May 24, 2012) – BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).
In particular, we appreciate the leadership shown by Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) to craft a bipartisan measure which will continue to ensure patient safety, access to the newest cures and therapies, and job growth in America. FDASIA reflects the enhancements to PDUFA agreed upon by industry and the U.S. Food and Drug Administration (FDA). It will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review.
Just over three weeks ago the United States Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, which sent much of the patent world into a whirlwind. In that decision the Supreme Court unanimously found that the claims at issue did not exhibit patent eligible subject matter because the additional steps that were added to the underlying law of nature were well known in the industry. A curious ruling for many reasons, and one that will have to be digested over many years as the United States Patent and Trademark Office and the Federal Circuit struggle to figure out how Diamond v. Diehr remains good law (it was not overruled) and remains consistent with a ruling that seems completely inapposite.
To continue to provide a variety of perspectives on this landmark ruling what follows is the reactions of those in the industry. Without further ado…
A dissection of most any patent claim will reveal, at some level, a law or a product of nature. The holding in Prometheus does not hinge on whether a naked “law of nature,” e.g., gravity, is patent-eligible–clearly it is not. Rather, the question we will be grappling with in the coming years is: what additional elements must be included in the claim to render the claim sufficiently “unconventional” or “inventive” so as to confer patent-eligibility? The claims in Prometheus, included steps in addition to the “law of nature” that were determined by the Federal Circuit to be transformative. The Supreme Court, however, concluded that the steps were insufficiently “unconventional” to confer patent eligibility. In contrast, the Court distinguished a patent-eligible “law of nature” claim in the landmark 1981 Supreme Court case Diamond v. Diehr as “add[ing] to the [law of nature] something that in terms of the patent law’s objectives had significance–they transformed the process into an inventive application of the formula.” (Prometheus. at p. 12).
The Subcommittee on Energy and Power held hearings earlier this month on “The American Energy Initiative.” The hearings provided an overview of the challenges and opportunities for alternative transportation fuels and vehicles. The hearing explored a number of issues, including the current status of the Renewable Fuel Standard, and implementation challenges facing regulators, producers, and marketers of renewable fuels. The hearing also discussed the prospects for meeting future conventional and advanced biofuels targets under the Renewable Fuel Standard, and issues related to their incorporation into the gasoline supply, as well as the current status of efforts to expand the use of natural gas and electric vehicles, the cost of driving, the economy, jobs, and national security.
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