Patent Baristas

It looks like the Patent Reform Act is no longer a done deal.  Tuesday afternoon, Rep. Harold Rogers (Chairman of the House Appropriations Committee) and Rep. Paul Ryan (Chairman of Budget) wrote a letter to Rep. Lamar Smith (Chairman of the Judiciary) insisting on maintaining the power of these two committees to control the Patent Office’s money received as user fees.

Section 22(c) USPTO Revolving Fund-

(1) ESTABLISHMENT- There is established in the Treasury of the United States a revolving fund to be known as the `United States Patent and Trademark Office Public Enterprise Fund’. Any amounts in the Fund shall be available for use by the Director without fiscal year limitation.

In the past, Congress has been very fond of fee diversion — that is, diversion of user fees paid to the U.S. Patent and Trademark Office (USPTO) to other non-USPTO purposes.  For many years, Congress “diverted” about 10% of the fees that the USPTO collected into the general treasury of the United States. Since 1992 close to $1 billion in fees have been diverted.

Reps. Rogers and Ryan think that spending money should only be in the purview of Congress:

We strongly oppose this proposed shift of billions in discretionary funding and fee collections to mandatory spending. … Placing PTO spending on mandatory auto-pilot as outlined in H.R. 1249 would also hand the Congressional “power of the purse” — bestowed in the Constitution — to the Obama White House, and essentially eliminate the ability of Congress to perform substantive oversight of the PTO.

With the U.S. national debt currently at about $14,400,000,000,000 (yes, it’s really that many zeros), you could argue that putting Congress in charge of spending hasn’t exactly turned out swell so far.

Judiciary Committee Chairman Smith, Ranking Democrat Conyers, Subcommittee Chairman Goodlatte, Ranking Democrat Watt, and others on the Judiciary Committee have been committed to ending the diversion of user fees, particularly through support for Section 22 of the Act despite calls to remove it or to amend it in ways that would make it ineffective.

Sen. Tom Coburn then sent his own letter to Reps. Rogers and Ryan telling them to suck it:

Section 22 would not hand the “power of the purse” to the Obama Administration, put the PTO on “auto-pilot,” or eliminate the ability of Congress to perform oversight of the PTO. The “power of the purse” does not provide Congress authority over non-taxpayer funds. Although the PTO is subject to the appropriations process, it does not use taxpayer money. Rather, PTO receives fees paid by users who file patent and trademark applications—fees paid by small inventors, companies, and universities to protect their ideas and technology. Those fees are deposited into the general fund at the Treasury, and then PTO must request appropriations. However, when PTO’s fee income is greater than Congressional appropriations, we spend “excess” fees on other general revenue purposes, rather than providing applicants the high quality PTO services for which they paid.

What Now?

Go to www.house.gov to find your Representative’s contact info.  To schedule a meeting, many offices will want you to FAX in a request letter.   Second best is a phone call to your district office (not the D.C. office).   Third best but better than nothing is an email. You can get help with some of these contacts from Reform AIA.

It’s crucial to act now.

See the Rogers and Ryan Letter to Cantor here.

See the Coburn Letter to Ryan and Rogers here.

Pharma IQ released the first in their series of Pharma IQ Top Blogger Awards. Their ten favorite regulatory and legal blogs are:

Patent Docs:  A great legal blog covering patent issues in a great deal of depth.

Eye on FDA:  Mark Senak charts every significant move of the FDA and other interesting regulatory developments that affect communications and planning.

Patent Baristas:  Lively, accessible and charmingly written intellectual property news and commentary focusing on the biotechnology and pharmaceutical fields.

The Scientific Lawyer:  A veritable treasure trove of scientific legal literature, brought together in one spot.

Generic Pharmaceuticals & IP Blog:  Does exactly what it says on the tin. A great blog that covers Indian issues often missed or skimmed by other sources accompanied by a news feed.

Pharma Compliance:  A slick looking blog that combines useful compliance insights with RSS feeds skimming the best news into manageable topic specific sub categories and a conversation monitor picking up everything that’s hot in the comments below the posts.

BioLaw:  A broader, life science offering covering topical and interesting subjects in environmental law, natural resources law, agricultural law, food and drug law, biotechnology, neuroscience, behavioral psychology and evolutionary biology, health law and bioethics.

Validation & Regulatory Compliance:  They say it all when they state “we only post content when we have something of value to offer to the community.”

WHO Guideline:  There are some great resources on this blog if you can pick through the ads; our verdict – persevere, or subscribe by email!

FDA Law Blog:  Well thought out categories, some useful tracker tools and a detailed look at a wide variety of FDA activities make this both interesting and useful to read.

We hope to receive our check soon…

Yesterday, the United States Supreme Court issued its opinion in the appeal of Stanford University against Roche Diagnostics. This case is of significant interest to the Biotechnology Industry Organization (BIO), Association of American Universities (AAU), American Council on Education (ACE), Association of Public and Land-grant Universities (APLU), Association of University Technology Managers (AUTM), and Council on Governmental Relations (COGR) because of its potential impact on university technology transfer, on development and commercialization of university-generated basic technology, and on scientific collaborations between university and private-sector scientists.

The biotechnology industry and the university community rely on effective collaborations to make the products of their research and development efforts available to the public.  The university’s mission of the discovery and dissemination of new knowledge is complementary to the biotechnology industry’s mission of translating basic science into products to benefit patients, farmers, and consumers. The discoveries arising from university research are most efficiently transformed into valuable new products with the participation of companies willing to invest in the long development process that is often necessary to bring new products to market.

By all accounts, the U.S. system of public-private technology transfer that was established under the 1980 Bayh-Dole Act has been extraordinarily successful in moving university discoveries from experimental laboratories to the marketplace through collaborations with private industry. This system has provided a rich return on public funding for basic research, in the form of countless innovative products that today benefit consumers, create jobs, and contribute to U.S. technological leadership internationally.

Although BIO and the undersigned higher education associations held different views on the Stanford v. Roche case, the organizations are united in the desire to ensure that the U.S. technology transfer system continues to generate these public benefits through the robust provisions of the Bayh-Dole statute.  We are committed to working together in light of the Supreme Court’s decision to ensure the continued vibrancy of public-private partnerships and success of our shared objectives.

The U.S. Supreme Court ruled today that Stanford University can’t win its patent infringement case against Roche Molecular Systems because Roche holds an ownership interest in the patents. Board of Trustees of The Leland Stanford Junior University v. Roche Molecular Systems, Inc., et al., Supreme Court of the United States, 563 U. S. ____ (2011).

Question Presented:

“Whether an inventor who is employed by a contractor that elects to retain rights in an invention may defeat the contractor’s right to retain title under the Bayh-Dole Act by contractually assigning his putative rights in the invention to a third party”

Stanford sued Roche and its subsidiaries in 2005, contending that Roche’s HIV test kits infringed Stanford’s patents. Roche responded by asserting that it was a co-owner of the HIV quantification procedure, based on the inventor’s assignment of his rights in a Visitor’s Confidentiality Agreement (VCA) that he signed. Stanford claimed that Holodniy had no rights to assign because the University’s HIV research was federally funded, giving the school superior rights in the invention under the Bayh-Dole Act.

In 1988, Cetus collaborated with scientists at Stanford University’s Department of Infectious Diseases to test the efficacy of new AIDS drugs. Dr. Holodniy joined Stanford and signed an agreement stating that he “agree[d] to assign” to Stanford his “right, title and interest in” inventions resulting from his employment there.

Holodniy’s supervisor arranged for him to conduct research at Cetus to learn about PCR. As a condition of gaining access to Cetus, Holodniy was required to sign an agreement stating that he “will assign and do[es] hereby assign” to Cetus his “right, title and interest in . . . the ideas, inventions, and improvements” made “as a consequence of [his] access” to Cetus. Working with Cetus employees, Holodniy devised a PCR-based procedure for measuring the amount of HIV in a patient’s blood. Upon returning to Stanford, he and other Stanford employees tested the procedure. Stanford secured three patents to the measurement process.

The District Court held that the “VCA effectively assigned any rights that Holodniy had in the patented invention to Cetus,” and thus to Roche. But because of the operation of the Bayh-Dole Act, “Holodniy had no interest to assign.” The court concluded that the Bayh-Dole Act “provides that the individual inventor may obtain title” to a federally funded invention “only after the government and the contracting party have declined to do so.”

The Court of Appeals for the Federal Circuit disagreed. First, the court concluded that Holodniy’s initial agreement with Stanford in the Copyright and Patent Agreement constituted a mere promise to assign rights in the future, unlike Holodniy’s agreement with Cetus in the Visitor’s Confidentiality Agreement, which itself assigned Holodniy’s rights in the invention to Cetus.

Therefore, as a matter of contract law, Cetus obtained Holodniy’s rights in the HIV quantification technique through the VCA. Next, the court explained that the Bayh-Dole Act “does not automatically void ab initio the inventors’ rights in government-funded inventions” and that the “statutory scheme did not automatically void the patent rights that Cetus received from Holodniy.” The court held that “Roche possesse[d] an ownership interest in the patents-in-suit” that was not extinguished by the Bayh-Dole Act, “depriv[ing] Stanford of standing.” The Court of Appeals then remanded the case with instructions to dismiss Stanford’s infringement claim.

A majority of Supreme Court justices affirmed that holding.  Justice Roberts, writing for the Supreme Court, said Stanford wasn’t automatically entitled to its researcher’s rights to the invention and the researcher’s agreement with Cetus trumped the contract he had signed with Stanford.

Stanford had based its patent-rights claims on a 1980 federal law that gives schools the ability to retain patent rights on inventions created with federal funding. Stanford argued that universities’ ownership of countless inventions could be threatened if the school loses the case. The current administration and several leading universities filed briefs supporting Stanford’s high-court appeal:

“Here, Holodniy had no patent rights to assign to Cetus because title to the invention vested in Stanford and Stanford exercised its Bayh-Dole 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.” ~Solicitor General

The University and Small Business Patent Procedures Act of 1980 (Bayh-Dole Act) allocates rights in federally funded “subject invention[s]” between the Federal Government and federal contractors. 35 U. S. C. §§201(e), (c), 202(a). The Act defines “subject invention” as “any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement,” and provides that contractors may “elect to retain title to any subject invention,”

The Bayh-Dole Act provides that contractors may “elect to retain title to any subject invention.” §202(a). To be able to retain title, a contractor must fulfill a number of obligations imposed by the statute. The contractor must “disclose each subject invention to the [relevant] Federal agency within a reasonable time”; it must “make a written election within two years after disclosure” stating that the contractor opts to retain title to the invention; and the contractor must “file a patent application prior to any statutory bar date.” §§202(c)(1)–(3). The “Federal Government may receive title” to a subject invention if a contractor fails to comply with any of these obligations.

The Government has several rights in federally funded subject inventions under the Bayh-Dole Act. The agency that granted the federal funds receives from the contractor “a nonexclusive, nontransferrable, irrevocable, paid-up license to practice . . . [the] subject invention.” §202(c)(4). The agency also possesses “[m]arch-in rights,” which permit the agency to grant a license to a responsible third party under certain circumstances, such as when the contractor fails to take “effective steps to achieve practical application” of the invention. §203. The Act further provides that when the contractor does not elect to retain title to a subject invention, the Government “may consider and after consultation with the contractor grant requests for retention of rights by the inventor.” §202(d).

Some of Stanford’s research related to the HIV measurement technique was funded by the National Institutes of Health (NIH), thereby subjecting the invention to the Bayh-Dole Act.  Stanford disclosed the invention, conferred on the Government a nonexclusive, nontransferable, paid-up license to use the patented procedure, and formally notified NIH that it elected to retain title to the invention.

In finding that invention rights go to the inventor, Justice Roberts wrote:

Although much in intellectual property law has changed in the 220 years since the first Patent Act, the basic idea that inventors have the right to patent their inventions has not. Our precedents confirm the general rule that rights in an invention belong to the inventor. It is equally well established that an inventor can assign his rights in an invention to a third party. Thus, although others may acquire an interest in an invention, any such interest—as a general rule— must trace back to the inventor.

In accordance with these principles, we have recognized that unless there is an agreement to the contrary, an employer does not have rights in an invention “which is the original conception of the employee alone.” Such an invention “remains the property of him who conceived it.”. In most circumstances, an inventor must expressly grant his rights in an invention to his employer if the employer is to obtain those rights.

Stanford and the United States as amicus curiae contend that the Bayh-Dole Act reorders the normal priority of rights in an invention when the invention is conceived or first reduced to practice with the support of federal funds. In their view, the Act moves inventors from the front of the line to the back by vesting title to federally funded inventions in the inventor’s employer—the federal contractor. See Brief for Petitioner 26–27; Brief for United States as Amicus Curiae 6.

Roberts then uses linguistic jujitsu to come up with a scenario in which the Bayh-Dole Act only convers the contractor (the university) and somehow not the university employees who inherently must make the invention (unless the invention is made entirely by machine, I guess).

Stanford’s reading of the phrase “invention of the contractor” to mean “all inventions made by the contractor’s employees” is plausible enough in the abstract; it is often the case that whatever an employee produces in the course of his employment belongs to his employer. No one would claim that an autoworker who builds a car while working in a factory owns that car. But, as noted, patent law has always been different: We have rejected the idea that mere employment is sufficient to vest title to an employee’s invention in the employer. Against this background, a contractor’s invention—an “invention of the contractor”— does not automatically include inventions made by the contractor’s employees.

The Bayh-Dole Act’s provision stating that contractors may “elect to retain title” confirms that the Act does not vest title. 35 U. S. C. §202(a) (emphasis added). Stanford reaches the opposite conclusion, but only because it reads “retain” to mean “acquire” and “receive.”  That is certainly not the common meaning of “retain.” “[R]etain” means “to hold or continue to hold in possession or use.” Webster’s Third, supra, at 1938; see Webster’s New Collegiate Dictionary 980 (1980) (“to keep in possession or use”); American Heritage Dictionary 1109 (1969) (“[t]o keep or hold in one’s possession”). You cannot retain something unless you already have it.  The Bayh-Dole Act does not confer title to federally funded inventions on contractors or authorize contractors to unilaterally take title to those inventions; it simply assures contractors that they may keep title to whatever it is they already have. Such a provision makes sense in a statute specifying the respective rights and responsibilities of federal contractors and the Government.

My guess is that the Supreme Court did not like the proposed scope of the Act if read to its possible extremes:

The Bayh-Dole Act applies to subject inventions “conceived or first actually reduced to practice in the performance of work” “funded in whole or in part by the Federal Government.” 35 U. S. C. §§201(e), 201(b) (emphasis added). Under Stanford’s construction of the Act, title to one of its employee’s inventions could vest in the University even if the invention was conceived before the inventor became a University employee, so long as the invention’s reduction to practice was supported by federal funding. What is more, Stanford’s reading suggests that the school would obtain title to one of its employee’s inventions even if only one dollar of federal funding was applied toward the invention’s conception or reduction to practice.

It is also relevant that the Court really wanted clear agreements in place:

Stanford contends that reading the Bayh-Dole Act as not vesting title to federally funded inventions in federal contractors “fundamentally undermin[es]” the Act’s framework and severely threatens its continued “successful application.” Brief for Petitioner 45. We do not agree. As just noted, universities typically enter into agreements with their employees requiring the assignment to the university of rights in inventions. With an effective assignment, those inventions—if federally funded—become “subject inventions” under the Act, and the statute as a practical matter works pretty much the way Stanford says it should. The only significant difference is that it does so without violence to the basic principle of patent law that inventors own their inventions.

Justice Breyer, joined by Justice Ginsburg, dissented saying that the question presented in this case is whether rights in inventions arising from federally funded research can be terminated unilaterally by an individual inventor through a separate agreement purporting to assign the inventor’s rights to a third party.

In his view, the answer to this question is likely no. But because that answer turns on matters that have not been fully briefed (and are not resolved by the opinion of the Court), he would return this case to the Federal Circuit for further argument.

Congress enacted this statute against a background norm that often, but not always, denies individual inventors patent rights growing out of research for which the public has already paid. This legal norm reflects the fact that patents themselves have both benefits and costs.

The importance of assuring this community “benefit” is reflected in legal rules that may deny or limit the award of patent rights where the public has already paid to produce an invention, lest the public bear the potential costs of patent protection where there is no offsetting need for such protection to elicit that invention. Why should the public have to pay twice for the same invention?

Justice Sotomayor agreed with the opinion but only because Stanford didn’t raise the issues of Breyer and said “I understand the majority opinion to permit consideration of these arguments in a future case.”

BioOhio is offering a free, 45-minute webinar on clinical trials with BioOhio members DATATRAK and Loretta Cipkus Dubray.

Title:      Finding Quality in Your Clinical Trials
Date:      Tuesday, June 7, 2011
Time:     10:00 AM – 10:45 AM EDT

Quality should be the hallmark of any clinical trial. Cutting corners to save money at the cost of compliance is never a good idea. During this webinar, we will discuss the importance of quality in three aspects of your clinical trial: clinical supplies, protocol, and clinical data. We will highlight the deliverables for each of these areas, and what can occur when quality practices are not followed.

Reserve your webinar seat now by clicking here.

After registering you will receive a confirmation email containing information about joining the Webinar.

For questions, contact Matt Schutte, Director of Corporate Communications at BioOhio at mschutte@BioOhio.com.

In my review of “Privacy: The Lost Right” by Jon L. Mills (Oxford University Press, USA; 408 pages), I found the book to be a good summary of the law as it relates to individuals protecting their privacy, but I was disappointed that it focused too much on threats to privacy of individuals as such, and didn’t give a sufficient treatment to threats to privacy caused by the commoditization of information.

On one level, this was likely a function of the fact that existing law, and existing horror stories, focus on individuals. For example, in the “Worst-Case Scenarios” chapter, the author describes a case where a stalker obtained home and work addresses for one Amy Boyer by requesting her credit report, then used that information to find and kill Ms. Boyer. This makes for a memorable fact pattern, which caused an easily understandable harm, and can be used to explain existing duties.

By contrast, when there is a huge data security compromise, and millions (or tens, or hundreds of millions) of credit card numbers are stolen, the fact pattern is less memorable (generally, these breaches are the result of mistakes in computer systems of security practices that people do not have firsthand knowledge of), the harms are much more diffuse (everyone has a slightly elevated fraud risk, some people may be victims of fraud who otherwise would not be), and it is not clear that our current legal tools will let people get any kind of compensation (generally, elevated risk of fraud cases haven’t done well).

While it’s clearly more trouble to write about data security compromises (e.g., you might have to do statistics to see if there really is an elevated fraud risk, you might have to talk to security experts who could explain how increased fraud and remedial countermeasures lead to increased costs for consumers) part of the reason I was interested in the book is because I had hoped that this author had taken that trouble. Sadly, by the time I got to the end of the book, my hopes had been dashed.

With that said, I want to reiterate that the book was a good summary of how privacy has been protected in the past, and how modern technology makes traditional privacy violations easier and more common. For example, in the section on why privacy is disappearing, the author points out that there is something qualitatively different about someone publishing a description of some private event, versus someone distributing a video of that event, and that the ubiquity of video cameras and internet video distribution technology makes the later type of intrusion much more common than it has been historically.

The book even includes a discussion of federal statutes that are used to protect privacy, and mentions the problems raised by data brokers and expanded data collection. However, the treatment of data brokers and the implications of data commoditization was not nearly as detailed or memorable as treatment of (for example) publication of private facts.

In the end, if you want a book that discusses what has been done to protect the privacy of individuals from individual intrusions, Privacy: The Lost Right is a good resource.  If you want a book that can explain the threats to privacy of an economy based the commoditization of consumer information, and what can be done to address those threats, Privacy: The Lost Right comes up short.

“Privacy: The Lost Right” by Jon L. Mills (Oxford University Press, USA; 408 pages) is available from Amazon.

About the Author

Jon L. Mills is Dean Emeritus and Professor of Law at the University of Florida Levin College of Law.

Today’s post is by Guest Barista William Morriss, a patent attorney in Frost Brown Todd’s Cincinnati office and contributor to Ephemerallaw.

The U.S. Court of Appeals for the District of Columbia has lifted the injunction on federal funding of embryonic stem-cell research. The ban was set last year by a federal judge who said all embryonic stem-cell research at the National Institutes of Health amounted to destruction of embryos, in violation of congressional spending laws.  Sherley, et al. v. Kathleen Sebelius, et al., U.S. Court of Appeals for the District of Columbia Circuit (10-5287).

The opinion by Circuit Judge GINSBURG. Dissenting opinion filed by Circuit Judge HENDERSON.

Two scientists brought this suit to enjoin the National Institutes of Health from funding research using human embryonic stem cells (ESCs) pursuant to the NIH’s 2009 Guidelines. The district court granted their motion for a preliminary injunction, concluding they were likely to succeed in showing the Guidelines violated the Dickey-Wicker Amendment, an appropriations rider that bars federal funding for research in which a human embryo is destroyed.

Dickey-Wicker prohibits the NIH from funding:

(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 C.F.R. 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).  Pub. L. No. 111-117.

The DC Circuit court concluded the plaintiffs are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.

Stem cells have the potential of yielding treatments for a wide range of afflictions because scientists can cause them to function as any one of a number of specific types of cell. Generally, there considered two different classes of human stem cells: adult stem cells, which are somewhat specialized, and ESCs, which are pluripotent, meaning they can develop into nearly any of the 200 types of human cell.

ESCs can be found only in a human embryo; isolating an ESC requires removing the “inner cell mass” of the embryo, a process that destroys the embryo. The stem cells among the 30 or so cells in the inner cell mass are then placed in a culture, where they will divide continuously without differentiating, thus forming a “stem cell line” of identical cells.
Drs. Sherley and Deisher and a number of others filed this suit in August 2009 and moved the district court for a preliminary injunction.

The text of Dickey-Wicker bars federal funding specifically for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in uteros.” The district court held that, because an embryo had to be destroyed in order to yield an ESC, any later research project that uses an ESC is necessarily “research” in which the embryo is destroyed.

The Government argued the text is not an unambiguous ban on research using embryonic stem cells because Dickey-Wicker is written in the present tense, addressing research in which embryos “are” destroyed, not research for which embryos “were destroyed.” The DC Court decided that the use of the present tense in a statute strongly suggests it does not extend to past actions.

The plaintiffs argued that because research using an ESC includes derivation of the ESC, the derivation does not predate but is an integral part of the research.

Under Chevron, the court must uphold the NIH’s interpretation of Dickey-Wicker if it isreasonable. The NIH determined Dickey-Wicker does not bar its funding a project using an ESC that was previously derived because a stem cell is not an embryo and cannot develop into a human being. The plaintiffs argued the NIH is not entitled to deference because it never offered an interpretation of the term research.

The Government pointed out at oral argument that “stem cells are not pre-labeled cells that you can simply extract,” and argued “the scientific process” of derivation, in which cells are “extracted and put into mediums where [they] can grow” before being examined and chemically treated, “itself involves experimentation.

The DC Circuit held that:

Rather than rely upon that account of derivation qualifying as research, let us assume for the sake of the plaintiffs’ argument derivation involves no scientific inquiry; it does not follow that the NIH may define derivation as “research” only if or insofar as the derivation is tethered to some later project using the derived cells. Although an understanding of “research” that includes the derivation of stem cells is not the ordinary reading of that term, it is surely as sensible as the plaintiffs’ alternative, in which the derivation of a cell line is deemed part of every one of the scores if not hundreds of subsequent research projects — although pursued by different scientists, perhaps many years later — to use one of the derived cells.

Furthermore, the district court decided that the “balance of hardships weighs in favor of an injunction” because, for ESC researchers, “the injunction would simply preserve the status quo and would not interfere with their ability to obtain private funding.”  On the other hand, the court thought it certain that increased competition would “threaten [the plaintiffs’] very livelihood.”

The DC Circuit thought differently:

[A] preliminary injunction would in fact upend the status quo. …  it is necessarily uncertain whether invalidating the Guidelines would result in the plaintiffs getting any more grant money from the NIH. Accordingly, we cannot say that, if the plaintiffs are to litigate this case without the benefit of interim relief, then the 2009 Guidelines will place a significant additional burden upon their ability to secure funding for their research.

The hardship a preliminary injunction would impose upon ESC researchers, by contrast, would be certain and substantial. The injunction entered by the district court would preclude the NIH from funding new ESC projects it has or would have deemed meritorious, thereby inevitably denying other scientists funds they would have received.

All this is to say the balance of equities tilts against granting a preliminary injunction. That, combined with our conclusion the plaintiffs have not shown they are likely to succeed on the merits, leads us to hold the district court abused its discretion in awarding preliminary injunctive relief.

Circuit Judge Henderson dissented

The majority opinion has taken a straightforward case of statutory construction and produced a result that would make Rube Goldberg tip his hat. Breaking the simple noun “research” into “temporal” bits, Maj. Op. at 5, 6, 16, narrowing the verb phrase “are destroyed” to an unintended scope, id. at 11, dismissing the definition section of implementing regulations promulgated by the Department of Health and Human Services (HHS) (in case the plain meaning of “research” were not plain enough), id. at 11 n.*, my colleagues perform linguistic jujitsu. I must therefore respectfully dissent.

The Illinois Institute of Technology and Ocean Tomo have worked together to create the only graduate level program focused on intellectual property management, the Illinois Institute of Technology Masters Program in IP Management & Markets.

While some universities offer undergraduate as well as graduate courses in Intellectual Property Management, IIT offers the first interdisciplinary master’s degree program focusing on IP and intangible assets that will produce highly qualified professionals for this growing business need.

The program consists of full-time study (30 credit hours) starting in the fall term and running through the following summer.  Courses track the life cycle of intellectual property from its inception to full exploitation.  The curriculum was developed by a group of IIT faculty led by Harold J. Krent, Dean and Professor of Law, IIT Chicago-Kent College of Law, and Dennis A. Roberson, Vice Provost for New Initiatives.

Patent Baristas talks with Jacqueline Leimer, former vice president and associate general counsel, global intellectual property, for Kraft Foods and now Director of the IPMM Program:

Patent Baristas:  You are the IPMM Director.  In a nutshell, what is the IPMM and who is your likely student?

Jacqueline Leimer:  The Illinois Institute of Technology Master’s in IP Management & Markets program provides a foundational understanding of IP that integrates the perspectives and skills of five key disciplines:  Business, Engineering, Design, Computer science and law.  The program consists of one year of full time study with courses designed to track the life cycle of intellectual property from its inception to full exploitation.  At the conclusion of the program, a capstone course provides an experiential learning opportunity that integrates the students’ newly acquired knowledge, experiences and expertise.

The profile of our target student is quite broad including those currently involved in IP, such as technology transfer managers, IAM professionals, marketing managers, licensing professionals, patent agents, IP and general lawyers, inventors, product developers, legal analysts, R&D managers, IP contract managers, financial and accounting managers, investment bankers along with new college graduates who seek a career as an IP professional.

PB: You have experience in both private law practice and in-house legal counsel.  How did you arrive at being the director of the IPMM?

JL:  While I was thinking about retiring from Kraft Foods (after 13 years there and nearly 30 years in IP law practice) I had the good opportunity to meet Dean Hal Krent from Chicago-Kent College of Law who was working on the framework for this new degree program and seeking input from industry. I knew that I wanted to become involved in education in my “semi-retirement”, so I leapt at the chance to work on this cutting-edge program.  IIT is the only university in the US to offer this interdisciplinary approach to IP education.

PB: The Illinois Institute of Technology and Ocean Tomo are collaborating to offer the first interdisciplinary master’s degree program focusing on IP and intangible assets.  Who are the main participants in delivering the program?

JL:  Instructional teams for the IPMM courses are drawn from five IIT colleges.  Nearly all classes draw instructors from at least two disciplines.  Our students also benefit from our collaboration with practicing IP professionals.  Ocean Tomo, LLC serves as adjunct instructor for the programs valuation and merchant banking content drawing from its staff of IP trained damage experts, appraisers, investors, risk managers and transaction advisors.

PB: Is the focus too narrow for a fast changing world?  Why is IP important in management?

JL:  We have moved from a “bricks and mortar” economy to a knowledge economy, where the majority of a company’s assets are intellectual in nature. As such, management is keenly interested in insuring that those intellectual assets are managed so as to maximize the return on investment and gain competitive advantage. The focus of our program is not at all too narrow…..in fact, we are teaching our students how to manage intellectual  assets in a variety of changing environments. For example, we offer courses on “IP and Business Strategy” and “Global IP Management”, which teach students essential strategic thinking skills and how those skills can be applied in a global environment. The course that is taught by the Ocean Tomo team exposes our students to cutting-edge thinking regarding future financial trends, including global IP markets.

PB: How does the program integrate the legal aspects of IP with technology commercialization and IP management?

JL:  Many of our courses are team taught, and the subject matter from the different disciplines is fully integrated into the course. For example, our students begin the Program by taking an intensive four-credit course which introduces the four regimes of IP protection (patent, trademark, copyright and trade secret) along with an introduction to the innovation process. The students learn how to think about IP protection as an essential part of the development process, along the same time-line. Another example is our course on “Acquiring IP”. This course teaches the legal foundations of successful IP transfers in the context they arise in business, e.g., technology licensing, joint development agreements, as so forth.

PB: Will there be a market for the students long-term?

JL:  We believe that as companies increasingly recognize the importance of their intellectual assets, there will be an increasing number of roles for IP managers, as well as an increased need for IP service providers, such as IP consultants, valuation experts, software system suppliers and the like. Our first class is graduating next month, and they are finding a wide range of employers interested in them, for a wide range of roles.

PB: What currently pending patent case do you see as having the most potential for broad impact on patent law?

JL:  There are a number of important cases pending, but if I had to name one I think it is Microsoft v. i4i. That case has the potential to change the evidentiary standard for proving invalidity, which some say would level the playing field in federal court litigation.

PB Bonus Question:  Which do you prefer, in-house, private practice or program director?

JL:  I have to say that I’ve thoroughly enjoyed each role, for its unique aspects:  I was fortunate to start my career in law firms where I had the opportunity to learn from exceptional IP lawyers.  When you work in-house you have the opportunity to directly impact business results, especially since IP is really at the intersection of law and business. And there is nothing more rewarding that watching students grow and develop into future business leaders. I’ve been lucky to do it all.

PB:Thank you for your time.

Jacqueline A. Leimer is the IIT  IPMM Director.  Most recently she was vice president and associate general counsel, global intellectual property, at the world headquarters of Kraft Foods, in Northfield, Ill., with responsibility for the overall management of intellectual property legal issues worldwide from 2005 to 2009. She started her affiliation with Kraft in 1996 as chief trademark counsel.

Prior to joining Kraft, Ms. Leimer was a partner at Kirkland & Ellis in Chicago, concentrating in trademark, copyright and advertising law matters. She also has 10 years of in-house intellectual property experience with The Quaker Oats Company. Ms. Leimer was president of the International Trademark Association in 2004 and has served for many years as a director of that organization. She was appointed by Secretary of Commerce Carlos Gutierrez to serve on the Trademark Public Advisory Committee, which provides oversight of U.S. Patent and Trademark Office operations, from 2006 to 2009. She is a frequent speaker on intellectual property issues.

She is admitted to practice before the U.S. Supreme Court, the U.S. District Court for the Northern District of Illinois, and the Illinois state courts.