Abstract
Supreme Court to Review Stanford-Roche Case
WASHINGTON, DC 10/30/10—The US Supreme Court has agreed to hear the Stanford-Roche case, which deals with ownership of rights to discoveries made with government money.
Stanford accused Roche of infringing three patents on polymerase chain reaction technology. The inventor,
Holodniy signed an agreement with Cetus saying he assigned to it “my right, title, and interest in each of the ideas, inventions, and improvements,” but he had earlier signed an agreement with Stanford, where he was on the faculty, saying he would assign all rights in his inventions to the university.
The disputed technology covers use of serum concentrations of human immunodeficiency virus as a means of measuring treatment effectiveness and disease progression. Three test kits were developed, which are covered by US Patents 5,968,730; 6,503,705; and 7,129,041.
Stanford maintains that it is entitled to the patents because Holodniy's work was supported by the National Institutes of Health. It therefore claimed ownership under the Bayh-Dole Act.
Roche countered that Stanford did not own the patents and thus had no standing to sue. In 2008, the US District Court for the Northern District of California found that the issue in fact did not arise because the patents were invalid. The Court of Appeals for the Federal Circuit disagreed and decided that Roche owned the patents because Holodniy had not specified a date for his assignment of rights to the school.
Stanford is now arguing that Bayh-Dole overrides an individual's right to grant ownership in an invention. The US government is supporting this position. In its amicus curiae brief, the government said that “Holodniy had no patent rights to assign to Cetus because title to the inventions initially vested in Stanford and Stanford exercised its Bayh-Dole Act rights … The Court of Appeals' decision—which holds that Holodniy's assignment to Cetus limited the patent rights that Stanford could assert under the Bayh-Dole Act—turns the Act's framework on its head.”
National Academy Considers University IP
WASHINGTON, DC 10/5/10—The Committee on Management of University Intellectual Property of the National Academy of Sciences has issued a report, Managing University Intellectual Property in the Public Interest: Lessons from a Generation of Experience, Research, and Dialogue. The document, which is copyrighted by the National Academy of Sciences, first examines the current state of university IP management, listing six important findings:
The document also makes 15 recommendations:
The members of the Committee were:
Mark S. Wrighton, Chair, Chancellor and Professor of Chemistry, Washington University in St. Louis; Mark C. Fishman, Vice Chair, President and Chief Executive Officer, Novartis Institutes for BioMedical Research; Craig A. Alexander, Vice President and General Counsel Howard Hughes Medical Institute; Margo A. Bagley, Professor of Law, University of Virginia; Wendy H. Baldwin, Director, Program on Poverty, Gender, and Youth, The Population Council; Alan B. Bennett, Executive Director, Public Intellectual Property Resource Associate Dean for Agriculture University of California, Davis; Wesley M. Cohen, Frederick C. Joerg Professor of Business Administration and Professor of Economics, Management, and Law, Faculty Director, Center for Entrepreneurship and Innovation, The Fuqua School of Business, Duke University; Robert Cook-Deegan, Director, Center for Genome Ethics, Law, and Policy, Institute for Genome Sciences and Policy, Duke University; Mark S. Kamlet, Provost and Professor of Economics and Public Policy, Carnegie Mellon University; Greg Kisor, Vice President and Portfolio Architect, Intellectual Ventures; David Korn, Vice Provost for Research, Harvard University; Katharine Ku, Director, Office of Technology Licensing, Stanford University; Edward D. Lazowska, Bill and Melinda Gates Chair in Computer Science and Engineering, University of Washington; Marshall C. Phelps, Jr, Corporate Vice President, Intellectual Property Policy and Strategy (retired), Microsoft Corporation; Dorothy K. Robinson, Vice President and General Counsel, Yale University; N. Darius Sankey, Managing Director, Zone Ventures; Jerry G. Thursby, Professor of Strategic Management & Ernest Scheller, Jr. Chair, College of Management, Georgia Institute of Technology; Jennifer L. West, Isabel C. Cameron Professor of Bioengineering and Director, Institute of Bioscience and Bioengineering, Rice University
The editors of the document are Stephen A. Merrill and Ann-Marie Mazza. The ISBN is 978-0-309-16111-4.
PTO Trying to Speed Ex Parte Reexaminations
WASHINGTON, D.C. 8/5/10—The U.S. Patent and Trademark Office today released a description of its Pilot Program for Waiver of Patent Owner's Statement in Ex Parte Reexamination Proceedings (75 FR 47269–47270 [2010]). One goal is to reduce the pendency of reexaminations from the present 25 months. The initiatives being proposed will be implemented in three phases:
In phase I, the USPTO will implement streamlined procedures, as well as optional programs in which patent owners and third party requesters may elect to participate in order to gain the benefit of shorter pendency. In phases II and III, the USPTO will consider the data gathered from phase I and the feedback from the patent owners and other stakeholders, and implement process changes that are likely to improve efficiency.
As a first step, the PTO is allowing patent owners to waive their right to file a patent owner's statement in response to an Office request. “This will enable USPTO in suitable cases to issue the first Office action on the merits together with or soon after the reexamination order, and thereby reduce the pendency of the proceeding by about three to five months.”
Blogger Critical of Terminator Technology
THE INTERNET 11/10/10—A posting today by
“For centuries now, farmers have been practicing agriculture by saving seeds from the harvest and using it for next year's crop. … This is their security blanket to keep poverty at bay as well as ensure crop genetic diversity.
“However, with the myriad of seed patents being granted to the handful of agricultural giants controlling the world, farmers worldwide are being threatened. So is biodiversity.” These patents require farmers to buy new seed every year, either by contract or, increasingly, because the seeds produced by the crop are sterile: “terminator technology.”
What is known as Genetic Use Restriction Technology (GURT) was developed by Delta and Pine Land Company with the aid of an R&D agreement between the company and the Agricultural Research Service of the US Department of Agriculture. Most of the patents on the technology are held by Syngenta; a lesser player is Delta Pine & Land, along with BASF, DuPont (Pioneer), Monsanto, Purdue Research Foundation, and the Cornell Research Foundation.
Commenting on the technology, Menezes writes:
It is not to say that GURTs have no advantages. Indeed, such a one-sided view would be unbecoming of a lawyer. They enable a producer to restrict trait expression especially during an onslaught of diseases which affect crops or farm animals. However, the potential impact on biodiversity is a lot more dire and outweighs the advantages. …
The most important repercussion if GURTs become commercially viable would be in terms of market power. The few companies that own the patents in GURTs would set non-competitive market prices. Seed supply would become a potential problem. Traditional methods of farming like seed-saving would not be allowed anymore and farmers would lose their security blanket of being able to save seeds for next season. In the event that some disaster befalls the company providing seeds, the farmer would be left high-and-dry.
Mymetics to Get Virosome Patent
EPALINGES, SWITZERLAND 11/29/10—Mymetics Corp announced today that the US Patent and Trademark Office has issued a Notice of Allowance for the patent application Phospholipid Virosome, based on WO 04/071492. The patent covers a higher-yield production method and the use of virosome technology against enveloped viruses other than influenza. The company has two such vaccines in preclinical development, one against respiratory syncytial virus and the other against herpes simplex virus.
Virosomes are lipid membranes based on an enveloped virus that can incorporate virus-derived proteins to allow the structure to fuse with target cells.
MMR Global Revives Five Patent Applications
LOS ANGELES, CA 11/12/10—MMRGlobal, Inc., has revived five US patent applications related to its B-cell vaccine and anti-CD20 antibody-related technology acquired in a reverse merger with Favrille, Inc. Prosecution of the applications had earlier been terminated; something of which the Favrille Board of Directors and MMRGlobal were unaware.
The applications cover anti-CD20 antibodies, methods of treating B-cell lymphomas using anti-CD20 antibodies, manufacturing methods for idiotype vaccines to treat B-cell disease, methods for treating B-cell malignancies with vaccines, and methods for using the vaccines as combinational therapies with chemotherapeutic agents. A patent on treatment of B-cell malignancies, US No. 6,911,204, has already issued.
MMRGlobal specializes in electronic medical records storage.
More Comments on the Myriad Genetics Decision
“It Is Not Every Day That One Governmental Entity Presumes to Tell Another That It Has Been Going About Things All Wrong”
…From the government's perspective, the “fundamental question” of patentability under §101 is “whether the inventor has created something through the application of human ingenuity or merely exposed something previously unappreciated in nature.” The government's position is that isolated genes, including the BRCA-1 and BRCA-2 genes subject to Myriad's patents, fall into the latter category.
There are several key takeaway points from the government's amicus brief, but the most significant may be the fact that there is a brief to review at all. … .
It is not every day that one governmental entity (the DOJ) presumes to tell another (the PTO) that, despite everything it may think it may know within its area of expertise (patents), it has been going about things all wrong. But that, more or less, is what appears to have happened here.
It is extremely unlikely that the DOJ reached this conclusion completely on its own initiative. Which leaves us to speculate that the decision to reverse federal course on gene patents originated higher up the federal food chain. … [G]iven the former-junior-Senator-from-Illinois' interest in genomics and personalized medicine, and the obvious importance of gene patents to the future of personalized medicine, it would not come as a surprise to find that the White House has taken an active interest in the outcome of the Myriad litigation.
“The Department of Justice Filed an Amicus Brief … That Would Destroy the US Biotechnology Sector”
On Friday, October 29, 2010, … the Department of Justice filed an amicus brief … that would destroy the US biotechnology sector. In an astonishing and irresponsible policy shift that directly contradicts the long-standing policy of the United States federal government and a variety of agencies, the Department of Justice is promoting the dialing back of what is considered patentable subject matter and is urging the Federal Circuit to rule that “isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 USC §101.”
[If the Court of Appeals for the Federal Circuit accepts the DOJ position, it] will cost tens of thousands of jobs and hundreds of billions of dollars of corporate value to be erased. Pensions invested in the stock market will be destroyed and a double dip recession will be virtually assured. This is irresponsible and has to be demoralizing to the United States Patent and Trademark Office and other agencies throughout the federal government … .
Unfortunately, the Department of Justice's brief—to the extent it fails to fully support the patentability of such DNA-based inventions—is inconsistent with the position that agencies of the US government, through both Democratic and Republican Administrations, have taken domestically and internationally for more than two decades. If adopted, the Department of Justice's position would undermine US global leadership and investment in the life sciences, harm US economic growth and competitiveness at home and abroad, and be counterproductive to the Administration's own initiatives to fight cancer, develop renewable sources of energy, and clean the environment by reducing dependence on fossil fuels such as petroleum.
… The DOJ position also throws the Patent Office under the bus, as well as NIH and other agencies. It seems as if the Department of Justice is effectively working against the Department of Commerce, the Department of Health and Human Services and the Department of Energy. …
In terms of substance, if you actually read the Department of Justice amicus brief it will become clear they know very little about patent law, innovation or the importance of a stable set of laws in general.
Unfortunately, the lunacy of the Department of Justice position does not stop with re-writing patent laws and infusing tremendous uncertainty to a question as fundamental as patentable subject matter. The DOJ brief actually says: “the isolated DNA segment itself remains, in structure and function, what it was in the human body.” This logical construct is actually rather brilliant because it allows the DOJ to skirt the real issue and ignore the direct and controlling Supreme Court precedent. Notice that the DOJ wants to really say that the isolated DNA segment is the same as what is in the human body, but that is not what they are saying. In order to attempt to make a statement that is not scientifically incorrect they merely say that the structure and function of the isolated DNA is the same as that segment within the human body that is not isolated. … .
In nature there is no such thing as an isolated segment of DNA. The segment of DNA is inextricably intertwined with the rest of the DNA, and only through human intervention is the segment of DNA capable of being extracted, thereby resulting in something that affirmatively does not exist in nature; namely an isolated segment of DNA. …
The vast majority of the cases relied upon by the Department of Justice are from the 1920s and the 1930s, except for those that are from the 1880s and a concurring opinion here and there. So the DOJ is acknowledging that they are promoting a view that would require the overturning of well settled law and a return to our un-enlightened view of patentability prior to World War II, a time when genetic innovations like the ones being made today could never have been imagined.
“When the Government Is Interpreting the Law Contrary to the Way the Law Has Been Applied, That's Uncharted Territory”
Merely by taking the position that isolated DNA is not patentable—a stance contrary to long-standing U.S. Patent and Trademark Office practice—the Department of Justice has increased the chances that thousands of patents for isolated products of nature will end up nixed …
“When the government is interpreting the law contrary to the way the law has been applied, that's uncharted territory, and how that affects all of these patents is a gray area,” said
The stakes of the case on appeal are high to begin with, not only for Myriad's seven patents-in-suit, but for thousands of others whose validity depends on the Federal Circuit reversing Sweet's decision. …
One possibility is that the courts will adopt the DOJ's policy, upholding Sweet's invalidation.
That would likely lead to a raft of litigation against holders of patents for isolated DNA, which is used in the life sciences and medical testing industries, according to attorneys.
Patents for similar isolated compounds, including proteins, hormones and DNA from plants, could also be threatened …
“Uncertainty regarding the patentability of innovations in personalized medicine hinders investment in that field,” Reines explained. …
In fact, the debate may not even reach the merits, she added, pointing out that the issue of standing has also been raised on appeal. … .
The USPTO has said publicly that it will not change its patent policy until the case reaches conclusion.
“Eric Holder … Flunks Patents 101”
An e-mail sent by
Wegner believes the Myriad Genetics case and the DoJ's amicus brief could make it more difficult for the US to persuade other countries to protect intellectual property. “We're telling the rest of the world to have high minimum standards to protect software, pharmaceuticals,” he said, “and we're violating minimum standards ourselves.”