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.
Washington, D.C. (April 15, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the America Invents Act, H.R. 1249, which passed the House Committee on the Judiciary yesterday:
“BIO has consistently praised House Judiciary Committee Chairman Lamar Smith (R-TX) for his introduction of a comprehensive patent reform bill similar to the bill adopted by the U.S. Senate earlier this month by a nearly unanimous vote. Unfortunately, given the addition of the Goodlatte supplemental examination amendment, added to the bill during Committee consideration, we have no choice but to oppose floor consideration of the bill until this issue is repaired.
Professor David Hricik, on both ethics related afternoon panels
On tap this afternoon at the BIO IP Counsel Meeting is ethics. There are two separate panels schedule, the first which will address the ethical issues associated with joint inventorship and joint representation. The second panel dealing with ethical issues as they present particularly for in-house IP counsel.
The moderator of the first panel is Donald Ware of Foley Hoag, who is leading a discussion of pitfalls that may arise from prosecuting joint inventions conceived in the course of research collaborations among multiple institutions, including companies, universities and hospitals. On the panel is Irene Pleasure, Associate General Counsel and Director of Patent Law at Genentech, who discussed the in-house perspective on managing patent issues in research collaborations. Rounding out this first panel discussion of the afternoon will be David Hricik, Professor of Law at Mercer University School of Law and co-author of two patent ethics treatises, namely Patent Ethics – Prosecution (2009) and Patent Ethics – Litigation (2010). Hricik, who is also on the second panel, addressed the professional responsibilities of patent attorneys involved in the prosecution of jointly-owned patent applications.
Richard Marsh, Executive Vice President & General Counsel, Myriad Genetics
Next on the agenda at the BIO Intellectual Property Counsels Committee Conference meeting in Seattle is the so-called Myriad case, Association of Molecular Pathology v. U.S.P.T.O, moderated by Andrew T. Serafini, Ph.D., Partner, IP Group & Life Sciences Practice, Fenwick & West LLP. I have been following the case closely since its beginning, so I am keenly interested in the case. I am separately working on a “readers digest like” summary of the oral arguments that took place at the Federal Circuit on April 4, 2011, so look for that in the coming days.
The first speaker on the second panel was Debra Greenfield, an attorney and Adjunct Assistant Professor, UCLA Center for Society and Genetics. It was a bit difficult for me to follow her presentation, oddly enough, because she was reading her presentation. Time and time again it seemed as if she was phrasing her background of the case and what is at stake as one who supports the ACLU challenge, ending with she looks forward to defending her position in the question and answer session. As it turns out, she is in favor the the ACLU position, which caught me by surprise. Let’s face it, the BIO IP attorneys are not exactly a friendly audience for her, but kudos to the program committee for attempting to provide a balance perspective of the case despite the obvious biases (which I share) of those in the audience.
Kenneth Dow, BIO IPCCC Chair and Vice President, Johnson & Johnson, opening the Conference
I am sitting in a ball room at the Hotel 1000 in downtown Seattle, Washington, attending the Biotechnology Industry Organization (BIO) IP Counsels Committee Conference. The Conference kicked off yesterday with an excellent presentation giving an insider’s perspective of the U.S. Supreme Court and the Solicitor General’s Office, given by Traci L. Lovitt, a partner in the Boston office of Jones Day (more on this forthcoming). This morning the first panel discussion is focusing on Stanford v. Roche, titled Who’s Rights Are They Anyway? The first speaker, Maggie Shafmaster, Ph.D., Vice President and Chief Patent Counsel, Genzyme Corporation, lead off by pointing out something that everyone largely seems to agree with, namely that the facts of the case are still largely in dispute, which makes me wonder why would the Supreme Court take such a case. Be that as it may, Shafmaster went on to say that this case is one that makes in-house attorneys and those representing Universities lay awake at night. She characterized the case as “an academic/industry collaboration gone wrong.” And we are off to the races!
BIO praises House Judiciary Committee Chairman Lamar Smith (R-TX) for his introduction of a comprehensive patent reform bill similar to the bill adopted by the U.S. Senate earlier this month by a nearly unanimous vote.
The America Invents Act is a clear improvement over prior House versions of patent reform legislation. We are pleased that the legislation will end, once and for all, the diversion of fees collected by the U.S. Patent and Trademark Office, allowing the agency to use all of its fees to hire more examiners, reduce the backlog of pending applications, and make other improvements to its operations. We also commend the inclusion in the bill of many other reforms that will improve the patent system and enhance patent quality, including transition to a “first-to-file” system, the elimination of other subjective elements of patent law, and a new supplemental examination proceeding for use by patent owners.
Last week the amicus briefs were due in support of i4i in their dispute with Microsoft, which is now at the United States Supreme Court. In what can only be characterized as a huge development, the United States has decided to participate openly on behalf of i4i and has argued that the presumption of validity must remain the same as it exists now. There were a number of interesting amici filings, portions of which appear below to create something of a readers-digest version of the amici in support of i4i. The five that I highlight here are the U.S. government brief (which is excellent), the venture capital brief and BIO brief (both which eloquently discuss the negative impact there would be on investment if Microsoft’s position is adopted), the brief filed by Dr. Triantafyllos Tafas (of claims and continuations rule fame) and the brief of Ron Katznelson (making an economic argument based on asymmetry of risks).
What becomes clear in reading these briefs (and the excerpts below) is that despite what you might have heard to the contrary the Supreme Court has already previously addressed this issue and has done so in support of a standard appreciably higher than the mere preponderance supported by Microsoft. The argument of those in support of Microsoft has been that at least some Circuit Courts of Appeal had a lower presumption of validity prior to when the Federal Circuit announced the clear and convincing standard of proof and thereby settled patent law. While that may be true it seems abundantly clear that law setting a preponderance standard was directly in conflict with the clear and unambiguous Supreme Court precedent directly on point. In fact, there is even Supreme Court precedent directly on point saying that more than a mere preponderance is necessary even when the prior art has not been previously considered. So perhaps i4i and the amici, including the U.S. government by and through the Solicitor General and the USPTO General Counsel Bernie Knight can convince the Supreme Court not to overrule its own prior decisions and keep an appropriately high standard.
“When you consider the most significant problems facing our world today, such as health, the environment and our food supply, it is clear that biotechnology is uniquely positioned to uncover ground-breaking solutions,” said BIO President and CEO Jim Greenwood. “The Biotech Humanitarian Award offers us the opportunity to highlight our biotech innovators – the men and women who are pioneering real solutions to improve people’s lives and the health of our planet.”
Erik Iverson is is Associate General Counsel with the Bill & Melinda Gates Foundation, working exclusively with Foundation’s Global Health initiate. He will be the keynote speaker at the BIO IP Counsels Committee Conference, which will be held in Seattle, Washington from April 13-15, 2011. As a prelude to his presentation at BIO Mr. Iverson agreed to go on the record with me. Part 1 of my interview with Mr. Iverson was published last week, and what appears below is the final segment of our discussion. We pick up with discussion of crowd sourcing techniques to enhance innovation and the humanitarian work of the Gates Foundation, as well as the humanitarian work of all those engaged in the life sciences, which Iverson says is “all about helping people and saving lives.”
Erik Iverson is Associate General Counsel with the Bill & Melinda Gates Foundation, working exclusively with Foundation’s Global Health initiate. Mr. Iverson works with grantees in the development of intellectual property management plans, collaboration agreements and global access strategies with respect to the health solutions being funded by the Foundation. On Thursday, April 14, 2011, he will be the keynote speaker at the BIO IP Counsels Committee Conference, which will be held in Seattle, Washington from April 13-15, 2011. Mr. Iverson’s presentation at the BIO Conference is titled: “The Business Case for International Humanitarian Approaches to IP Management and Collaborations.” Several of my contacts at the Biotechnology Industry Organization (BIO) graciously put me in touch with Inverson and facilitated the coordination of an interview. The transcript of part 1 of the interview appears below.
How to Write a Patent Application is a must own for patent attorneys, patent agents and law students alike. A crucial hands-on resource that walks you through every aspect of preparing and filing a patent application, from working with an inventor to patent searches, preparing the patent application, drafting claims and more. The treatise is continuously updated to address relevant Federal Circuit and Supreme Court decision impacting patent drafting.
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