Patent Baristas

“I wanted to call this book A Dispeptic Introduction to Intellectual Property, but the publishers understandably said “Um, no.”  ~Dan Hunter

Sometimes, a book comes along that is just so cute you have to pick it up and read it.  Such it is in “The Oxford Introductions to U.S. Law: Intellectual Property,” a little guide to U.S. IP laws by intellectual property scholar Dan Hunter.

The Oxford guide provides a precise guide to the current laws of intellectual property and their history.  It follows the basic, straight-forward areas with chapters on Copyright, Patent, Trademark, Trade Secrets, and Related Rights.  Hunter first focuses on the central origins of intellectual property law.  He then explores the justifications for having an intellectual property system..

Hunter explains how intellectual property first came into modern form in the system of Venice during the fifteenth century..  With the rise of the modern state, European rulers came to issue letters patents, a term derived from the Latin litterae patentes or “open letters.”

These were letters from the sovereigns to everyone, stating that an individual or group now had the monopoly to ply a given trade within the realm of the sovereign.  Unlike today’s system, these were often issued to court favorites in order to control the production of gunpowder or certain types of clothing.

Laws need some reason for being, a very clear set of justifications.  Hunter examines the three basic normative justifications for the existence of various intellectual property laws.  These justifications are based (1) in economic or utilitarian theory, (2) on the labor-desert theory of John Locke, and (3) in the personality theory derived form Hegel and Kant.  Unfortunately, he didn’t mean Katherine Heigl.

This guide is a quick read and a great overview for someone who wants to get up-to-speed on the topic without getting bogged down in all the minutia of IP laws.  We recommend it.

“The Oxford Introductions to U.S. Law: Intellectual Property,” by Dan Hunter, Oxford University Press Inc, 242 pp, is available from Amazon.

About the Author

Dan Hunter is a Professor of Law at New York Law School. He is an expert in internet law, intellectual property, and artificial intelligence and cognitive science models of law. He holds a Ph.D. from Cambridge University on legal reasoning, computer science and law degrees from Monash University (Australia) and an LL.M. from the University of Melbourne. He regularly publishes on issues dealing with intellectual property law, including the regulation of virtual worlds, artificial intelligence, and high technology. He received a Fulbright Fellowship, an American Council of Learned Societies Research Fellowship, a Herchel Smith Research Fellowship in Intellectual Property Law, and a Science Commons Fellowship.

What:

American Conference Institute’s FDA Boot Camp.  Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. — all are critical aspects in the commercialization process for drugs, biologics, and devices which are governed by FDA law and regulation.

Recent court cases, and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts. The changing business dynamics of the life sciences industry have also made it critical for business executives, policy analysts and securities experts who work in this fi eld to have a clear understanding of the dynamics of the FDA.

ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies.

When:

Tuesday, March 20 to Wednesday, March 21, 2012

Where:

Doubletree Suites
Times Square,
New York, NY

But wait, that’s not all:

ACI is also offering informative and hands-on pre-conference workshop and post-conference master classes to get the background and/or the in-depth information you need to maximize your learning and networking experience at this event:

Workshop A: Fundamentals of FDA Regulatory Law will address topics to set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and the essentials of the pre-approval, approval, and post-approval process. Get the background you need to fl ow seamlessly into the conversations at FDA Boot Camp.

Master Class B: Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics will provide an in-depth overview of biosimilars as well as analyses of bioequivalency and exclusivities and their role in patent and product life cycle management.

Master Class C: Post-Approval Marketing Guidance and Preemption Protocols will address issues that arise post-approval, including advertising, promotion, and off -label promotion and enforcement, as well as preemption fundamentals.

Register today by calling 888-224-2480, faxing your form to 877-927-1563 or online at http://www.americanconference.com/fdabootcampnyc.

*Gunnery Sgt. R. Lee Ermey’s Official Site is here.

PatentBaristas.com is a Media Sponsor of this event.  Readers of Patent Baristas are entitled to $200 off the current conference price tier.   The discount code you will need for this is: PB 200.

If you have to participate in Valentine’s Day, at least make it legal when you hand the card to your significant other (hereinafter referred to as “My One True Love”).

Docracy, a website of online legal documents, has posted the “Be My Valentine – Lawyer Edition.” The Valentine form allows you to fill in a number of blanks à la Mad Libs and voilà, you got yourself a genuine “romantic yet legally defensible Valentine’s Day card.”

The generated text explains to your beloved that he or she is being granted the title of “Valentine” and expected to give you the same in turn. There are a couple of clauses specifying that the title can’t be granted to another individual for the duration of the agreement, that there will be some displays of public affection.

Or, you might want to check out the Anti-Valentine’s Day Playlist.

The Hague rendered a judgment in the patent case between Taste of Nature (Koppert Cress) and Cresco on the patentability of a plant (Raphanus sativa) obtained by an unpatentable biological process. Court of the Hague, 408315 / KG ZA 11-1414.

Taste of Nature started the summary proceedings in early December 2011. They were of the opinion that Cresco, by selling their Red Radish Cress (purple Radish sprouts), was infringing the patent of Taste of Nature.

Taste of Nature developed a seedling of radish (Raphanus sativa) that is characterized by a high anthocyanin level. Anthocyanin is an antioxidant that gives the plant a red, purple or black color, and is regarded as a favorable substance from a health perspective.

Taste of Nature holds European patent EP 1 290 938 (the “Raphanus Patent” or “EP 938”),” which relates to a plant and a sprout of a plant of the radish species Raphanus sativa with an increased anthocyanin level, and to methods for its production.

Claim 1 reads as follows.

1. A Raphanus sativa plant, obtainable by screening Raphanus sativa plan far [this should probably be: “plants for”; Summary Proceedings Judge] their ability to produce sprouts with at least some purple coloring, selfing and/or crossing said plants for several generations and selecting progeny having sprouts with purple coloring, characterized in that the sprout of said plant comprises anthocyanins at a level of at least 800 nmol per gram fresh weight of sprout.

The description of EP 938 includes the following sections:

[0012] The Raphanus plant of the invention preferably is a plant of the species Raphanus sativa, more preferably the plant is obtained through breeding and selection from the Raphanus sativa lines CGN 6924, CGN 7240, or both. Most preferably, the Raphanus plants of the invention are obtained through breeding and selection from the Raphanus sativa line V33, (i.e. ATCC No. PTA-3630).

In respect of the patentability of essentially biological processes within the meaning of Article 53, opening lines and (b), of the European Patent Convention (the “EPC”), the Enlarged Board of Appeal (the “EBA”) of the European Patent Agency ruled as follows:

 Hence, in more general terms, the conclusion to be drawn is that a process for the production of plants, which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC.

However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding, which the legislator wanted to exclude from patentability. Therefore, such a process is not excluded from patentability under Article 53(b) EPC but qualifies as a potentially patentable teaching.

The above applies only where such additional step is performed within the steps of sexually crossing and selection, independently from their number of repetitions. Otherwise the exclusion of sexual crossing and selection processes from patentability under Article 53(b) EPC could be circumvented simply by adding steps which do not properly pertain to the crossing and selection process, being either upstream steps dealing with the interpretation of the plant(s) to be crossed or downstream steps dealing with the further treatment of the plant resulting from such crossing and selection process.

Taste of Nature argued that a patentable invention is involved because EP 938 relates to products (a plant, a sprout, a holder with sprouts or plants and material of a plant) obtained by using a certain method, rather than that method itself.

The Summary Proceedings Judge disagreed:

In its provisional opinion it is plausible that under Article 53, opening lines and (b), of the EPC, not only an essentially biological method is unpatentable, such as the “classical breeding” in this case, but also a product directly obtained by using that method, because a method claim also protects the product directly obtained using that method (see Article 64(2) of the EPC). If it were to be ruled that a product-by-process claim is admissible for the directly obtained product of an unpatentable essentially biological method, that would render the exclusion in Article 53, opening lines and (b), of the EPC as interpreted by the EBA in G1/08 pointless, because in that case the same situation would be involved as if the EBA had considered the process claims admissible, which is not the case. The view proposed by Taste of Nature – which, when requested, it was unable to substantiate otherwise than arguing that that the EBA did not expressly state its opinion on a product-by-process claim – is not a useful interpretation of, and does not do justice to, what must be regarded according to the EBA, as stated in its judgment substantiated in detail, as the purpose and scope of Article 53, opening lines and (b), of the European Patent Convention, and is dismissed.

Cresco can now start nullity proceedings, in which the Court is asked to nullify the patent of Taste of Nature in The Netherlands.

A nonprofit cancer research institute has sued biotechnology company Agios and one of its cofounders for more than $1 billion, alleging they took intellectual property developed at the institute and used it to start a for-profit business.

The Leonard and Madlyn Abramson Family Cancer Research Institute, part of the Abramson Cancer Center at the University of Pennsylvania, alleges in the complaint that Dr. Craig B. Thompson and Agios Pharmaceuticals Inc. are developing cancer drugs based on  research conducted while Thompson worked at the institute.  Thompson is currently the President and Chief Executive Officer of Memorial Sloan-Kettering Cancer Center in New York although Sloan-Kettering is not a party to the suit.

According to the complaint filed in the US District Court Southern District Of New York, the Institute was created by an agreement between The Abramson Family Foundation and the Trustees of the University of Pennsylvania. The Foundation donated over $110 Million Dollars to the Institute with the condition that the money was to be used to explore new and different approaches to cancer treatment.

Dr. Thompson later created a for-profit corporation that he concealed from the Institute. After a name change, that entity became the Defendant Agios Pharmaceuticals, Inc. Dr. Thompson did not disclose to the Institute that at least $261 million had been obtained by Agios for what was described as its “innovative cancer metabolism research platform” – i.e., the description of Dr. Thompson’s work at the Institute. Dr. Thompson did not disclose that Agios was going to sell to Celgene Corporation an exclusive option to develop any drugs resulting from the cancer metabolism research platform.

Dr. Thompson joined the Institute in June of 1999 as Scientific Director and his duties included directing, overseeing and managing the Institute’s Cancer Cell Biology Program.  Thompson’s work at the Institute included developing a cancer metabolism research platform that would examine the role that metabolic changes play in the origins and progression and death of cancer cells and discovered that cancer cell growth requires an enzyme not previously implicated in cancer.

In 2005, Dr. Thompson acknowledged in a memo to the Institute that: “Over the past six years, the Institute has developed considerable intellectual property.” That memo further noted that: “Drs. Thompson and [other Institute personnel] are exploring the possibility of forming a non-profit development and therapeutics company through which the Institute could capitalize on its intellectual property.”

In 2007, Dr. Thompson reported that his work at the Institute definitely provided evidence that regular or intermittent use of drugs such as metformin could reduce the risk of cancer. He also reported that researchers at the Institute had found that an agent called AICAR had an effect similar to that of metformin in suppressing the growth of breast cancer cells.

The Institute Agreement provides for Institute-Supported Research, as follows:

“All right, title and interest with respect to all technical information, know-how, trade secrets, developments, software, methods, techniques, formulae, data, processes, inventions, discoveries, improvements, and other proprietary ideas and intellectual property (together ‘Intellectual Property’), whether or not patentable or copyrightable, that are conceived, discovered, developed or reduced to practice pursuant to or in the course of Institute Research Programs whose budgets are funded solely by the Institute (‘Institute-Supported Inventions’) will be the sole property of the Institute, subject to the other provisions of this Article 5 and the [Faculty Rights].”

On August 7,2007,  Agios was incorporated in Delaware under the then utilized name of Cancer Metabolism Therapeutics, Inc., which Thompson did not disclose to the Institute. Thompson is listed as a director of Agios beginning with its 2007 Annual Report, which was also not disclosed.

In 2009, Agios  acknowledged that Thompson was Director of the Abramson Cancer Center at the University of Pennsylvania and that Thompson was one of the three founders of Agios.  It also announced the publication in Science of an article co-authored by Dr. Thompson titled “Understanding the Warburg Effect: The Metabolic Requirements of Cell Proliferation.”

In late 2010, Thompson took a one year leave of absence from the Institute, during which he commenced work as the President and Chief Executive Officer of Sloan-Kettering and continued his affiliation with Agios.  Dr. Thompson terminated his employment  with the Institute and the University on October 31,2011.

As part of the April 15,2010 press release, Agios described itself as “dedicated to the discovery and development of novel therapeutics in the emerging field of cancer metabolism.” Agios further noted that: “The Company’s founders [including Dr. Thompson] and scientific advisors represent the core thought leaders in the field of cancer metabolism responsible for key advances, insights and discoveries in the field.”

An October 2011 reporting noted that “Agios’s scientific co-founders were three of the most renowned pioneers of cancer metabolism,” with one of them being Dr. Thompson. That reporting stated that “Craig Thompson from the University of Pennsylvania” and two others had “discovered that targeting certain metabolic enzymes could fundamentally alter cancer pathways” and took steps “to turn that discovery into a company that could be a ‘prolific discoverer of new products.’”

On November 17,2011, it was publicly reported that Agios received an additional $78 million investment from existing and new funding sources to focus on “inborn errors of metabolism.”

The Institute now believes that Thompson may have conveyed to Agios rights and/or interests related to intellectual property and inventions funded in part or in whole by the Institute, including, but not limited to, the cancer metabolism research platform that formed the focus of Dr. Thompson’s work, that was funded in part or in whole by the Institute.

Accordingly, the Institute claims to have suffered damages in an amount estimated to ultimately exceed $1 billion.

Ultimately, this will come down to facts that can be proven through written documents.  You can bet that the Institute will be subpoenaing every written document, email, telephone record and any other bit of digital fingerprint they can find to try to determine what was invented as well as when and where it was invented.

An invention takes two steps, conception and reduction to practice.  The trick will be showing who knew what and when did they know it.

Other famous IP Theft cases

A U.S. District Court ordered Nobel Prize winner and former Yale University professor John Fenn, 87, to pay Yale $545,000 in royalties and penalties, and pay their legal bills of almost $500,000 calling Fenn’s actions “fraud” and “civil theft” when he licensed the rights to U.S. Patent No. 5,130,538 to a company he partly owned.

More on the Fenn case here.

In one of the few cases where the inventor went to jail, Petr Taborsky, a former student at the University of South Florida, went to jail as a result of a dispute over technology ownership. In that case, Taborsky worked as undergraduate lab assistant on a sponsored research project and discovered a potential way to make kitty litter useful in cleaning human waste water. He was convicted of grand theft and theft of trade secrets and sentenced to probation.

Read about the tale of Taborsky here.

The USPTO is seeking nominations for the 2012 Medal of Technology and Innovation (NMTI), the nation’s highest honor for technological achievement, bestowed by the President of the United States on America’s leading innovators. A nomination form and detailed information about submission requirements can be downloaded here. All completed nominations must be submitted to the USPTO by 5:00 p.m. (ET), Mar. 31, 2012.

The medal is awarded annually to individuals, teams (up to four individuals), companies or divisions of companies for their outstanding contributions to America’s economic, environmental and social well-being. The purpose of the National Medal of Technology and Innovation is to recognize those who have made lasting contributions to America’s competitiveness, standard of living, and quality of life through technological innovation, and to recognize those who have made substantial contributions to strengthening the nation’s technological workforce.

By highlighting the national importance of technological innovation, the medal is also meant to inspire future generations of Americans to prepare for and pursue technical careers to keep America at the forefront of global technology and economic leadership.

Established by the Stevenson-Wydler Technology Innovation Act of 1980, the medal was first awarded in 1985. On August 9, 2007, the president signed the America COMPETES (Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science) Act of 2007, amending Section 16 of the Stevenson-Wydler Technology Innovation Act of 1980.

Selection Process

The National Medal of Technology and Innovation Nomination Evaluation Committee, a distinguished, independent committee appointed by the Secretary of Commerce, reviews and evaluates the merit of all candidates nominated through an open, competitive solicitation process. The Committee makes its recommendations for Medal candidates to the Secretary of Commerce, who in turn makes recommendations to the President for final selection. The National Medal of Technology and Innovation Laureates are announced by the White House and the Department of Commerce once the Medalists are notified of their selection.

Contact Information

Program Manager
Phone: (571) 272-8400
Fax: (571) 270-9100
e-mail: NMTI@USPTO.GOV

What:

American Conference Institute’s Advanced Summit on Medical Device Patents.

A medical device specific intellectual property conference to provide you with practical and tactical strategies for patent filings and challenges, which are more critical than ever in this time of sweeping change.

In response to the challenges facing the device industry in this daunting economic climate including the looming medical device tax, ACI’s Advanced Summit on Medical Device Patents provides a forum for the key players- preeminent in-house IP counsel, patent prosecutors and litigators, the PTO, and judges – to unite and share their collective knowledge to provide you with the most up to date strategies you can immediately incorporate into your practice. Featuring first-hand insight from the USPTO and retired judges in medical device litigation hotbeds including the Eastern District of Texas, this event is the premiere conference for medical device companies to devise strategies to strengthen patent rights and seize market share.

A leading industry report estimated that the device industry was worth more than $300 billion in 2011 with the U.S. representing the largest market with sales in excess of $95 billion. At this conference, expert international and domestic practitioners will arm you with the tools to heighten patent protection in both established and emerging markets.

When:

Tuesday, February 28 to Wednesday, February 29, 2012

Where:

The Omni Parker House
Boston, MA
Reservations: 212.887.9400 or 800-352-8683

But wait, that’s not all:

ACI is also offering informative and hands-on workshop:

Pre-Conference Interactive Working Group Session: Mastering the Intricacies of USPTO Practice Post-Patent Reform

Monday, February 27, 2012; 9:00 a.m. – 12:00 p.m. (Registration and continental breakfast begin at 8:00 a.m.)

How:

Register today by calling 888-224-2480, faxing your form to 877-927-1563 or online at www.AmericanConference.com/devicepatents.

PatentBaristas.com is a Media Sponsor of this event.  Readers of Patent Baristas are entitled to $200 off the current conference price tier.   The discount code you will need for this is: PB 200.

“There are three kinds of lies: lies, damned lies, and statistics.”  ~British Prime Minister Benjamin Disraeli

Surveys are everywhere and poll results are available for every imaginable topic.  In the U.S.,   there were concerns about the admissibility of surveys for hearsay reasons but legislative amendment (Rule 702 of the 1975 Federal Rules of Evidence) eliminated  objections, making surveys a legally acceptable form of evidence. In fact, the submissions of survey evidence in trademark cases have become commonplace, and judges and juries afford great weight in these types of cases to survey results.

In “Trademark Surveys: A Litigator’s Guide,” authors James Berger and Mark Halligan provide a legal guidebook on developing and critiquing trademark surveys. In addition to describing the process and different types of surveys that may be employed, the authors offer strategic insight into how best to use these surveys to save time and money.

In addition to describing the process and different types of surveys that may be employed, the authors provide strategic insight into how best to use these surveys to save time and money. The last chapter offers practical considerations when requesting the services of a survey expert, and the appendices provide a series of sample survey protocols.

A survey for litigation is a market research survey that, when properly conducted, is intellectually and methodologically closer to a controlled scientific experiment than to most forms of traditional market research. Survey evidence is useful to measure the impact of a mark or competing marks in the marketplace. For a survey to be admissible and persuasive at trial, it must be done correctly.

Consumer surveys that provide evidence of confusion are common in trademark litigation, yet the frequency of their application does not mean the method is accepted without challenge. First, it should be noted that every survey actually consists of a sampling plan, a set of questions (the survey instrument), and a method of administering the questions. Each aspect, the sample, the instrument, and the implementation, must be designed according to scientific and accepted research practice.

Surveys for litigation are used in matters involving trademarks, trade dress, false advertising and unfair competition, and have numerous purposes. They can be used to determine the likelihood of confusion between marks, that a mark has acquired secondary meaning, or whether a word, color or shape has trademark or generic significance. Additionally, survey evidence may show that a mark is famous or that use of an infringing mark is causing dilution.

The challenges in designing surveys includes 1) locating the correct population; 2) determining the appropriate form of survey administration; 3) determining how to use technical language; 4) setting up the research to accurately reflect the market conditions; and 5) evaluating the appropriateness of  trademark survey questions.  Generally, the survey should be designed such that all potential sources of bias are minimized and the questions address the specific issue required for the litigation.

If you want to conduct trademark surveys — or defend against them — it’s a must-read!  You may also want to take a look at “Linguistic Battles in Trademark Disputes“ by Roger W. Shuy.

“Trademark Surveys: A Litigator’s Guide,” by Berger and Halligan, Oxford University Press Inc, 304 pp, is available from Amazon.

About the Authors

James T. Berger is the founder of Market Strategies, a Chicago consulting firm that specializes in market surveys. He has testified or served as an expert witness in more than a dozen trials and has been deposed nearly 50 times. He has written more than a dozen articles on the subject of trademark surveys. He combines the real-world, practical orientation of a professional business person with the theoretical knowledge of the academician.

R. Mark Halligan is a partner at Nixon Peabody, where he has developed an extensive practice as an intellectual property litigator in both federal and state courts in all aspects of intellectual property law. In addition to writing many articles over his 30-year career, Mr. Halligan is a frequent lecturer on intellectual property issues and serves on the adjunct faculty of John Marshall Law School in Chicago.