This section features contributions by patent lawyers and business people concerning biotechnology patent issues of current interest, and identifies recently published articles related to biotechnology patents.

PATENT PROTECTION FOR PLANTS: A COMPARISON OF AMERICAN AND EUROPEAN APPROACHES
Geertrui Van Overwalle
IDEA - The Journal of Law and Technology
Volume 39, Number 2 - 1999

Citing provision in the United States by the 1985 Utility Patent Act for plant patent protection, the author argues that the ongoing uncertainty and ambiguity as to plant patentability in Europe can only be settled by parting from a semantic approach, i.e., by no longer arguing about the exact meaning and scope of the phrase "plant variety" in Article 53(b) of the European Patent Convention (EPC), and by looking instead to intrinsic arguments to justify the patentability of plants. The author concludes that the European Patent Office should realign itself with current United States patent policy and take appropriate steps to abolish Article 53(b) of the EPC.

The author argues that because the value of molecular sieves far exceeds their intrinsic worth, the lost-sales-revenue or royalty calculations currently used by the patent system to measure damages inadequately address a patentees' losses due to infringement. The author concludes that a better and more appropriate damage calculus should include a reach-through royalty that would have been agreed to by a willing licensor and licensee in a hypothetical license prior to infringement.

Somatic cell gene therapy attempts to affect the somatic cells of a patient such that any genetic alteration will exist only in the cells of the individual and would not be passed on to offspring of that individual. Germline gene therapy involves attempts to affect the germ cells of a patient such that the genetic alteration will exist in all cells of the organism and would be passed on to each of the offspring of the treated individual. The article describes the factors involved in less controversial somatic cell gene therapy and explains how novelty, utility and nonobviousness standards of patentability relate to gene therapy.

BIOTECH COLLABORATIONS AND MAXIMIZING PATENT PROTECTION: TWO HYPOTHETICALS
Eric K. Steffe, Heidi L. Kraus, and Robert C. Millonig
AIPLA Quarterly Journal
Volume 27, Number 2, Spring 1999

Due to the basic nature of biotech research, an initial discovery is often less important commercially that later discovered improvements. The article discusses this issue and its relationship to 35 USC 102 (e), 35 USC 102 (f), 35 USC 102 (g), and 35 USC 103 (c) through two hypotheticals along with recommendations for increasing the likelihood of obtaining patent protection for both the initial discovery and the improvement. The first hypothetical involves the situation where the original research team collaborates with additional researchers at the same company. In the second hypothetical, the collaboration involves researchers at different institutions.

EMPIRICAL EVIDENCE ON THE VALIDITY OF LITIGATED PATENTS
John R. Allison and Mark A. Lemley
AIPLA Quarterly Journal
Volume 26, Number 3, Summer 1998

The article provides a statistical assessment of the outcomes of all 239 written, final validity decisions by either district courts or the Federal Circuit reported in the United States Patents Quarterly during the period from early 1989 through 1996. The article tests a number of hypotheses about what accounts for the success or failure of challenges to patent validity. The authors found that approximately 54% of all litigated patents are held valid. The authors also found that 5 of the 9 litigated biotechnology patents (56%) were held valid. The grounds for invalidity of the 4 biotechnology patents that were held invalid included lack of enablement or adequate written description, or claim indefiniteness.

Have you bargained away patent rights?
by Breffni X. Baggot
info@biotechlawyer.com

Inventors and entrepreneurs need to consider a recent Supreme Court ruling in their patent strategies. The United States Supreme Court recently considered whether the "on-sale" bar should apply to inventions "substantially completed" at the time of sale-as the United States Federal Circuit would have it-or when the invention is "fully completed." The result clarifies a slippery area of patent law, with implications for holders and seekers of patents on electronic, chemical, and biotechnological inventions.
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PATENTING TRANSGENICS IN THE EUROPEAN UNION Contradictory Rulings by the EPO have provoked new EU Legislation directed at making transgenics patentable
By Breffni Baggot, Esq., of Manchester, Connecticut.
INTELLECTUAL PROPERTY LAW
P.O. BOX 1215
MANCHESTER, CT 06045-1215 USA


Bill Gates of Microsoft (Redmond, WA) has been quoted as saying that the computer revolution is taking place at an exponential rate. There are many reasons to think that with respect to genetically engineered plants and animals, we are on the eve of a biotechnological revolution that will take place at an even faster rate. How can that be?
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A Different New Matter Standard For Biotechnology Patent Applications Accompanied by a Deposit
Heidi L. Kraus
AIPLA Quarterly Journal
Volume 25, Number 1, Winter 1997

The article discusses whether a biological deposit can and should overcome a deficiency in the disclosure of a biotechnology patent application due to a material error, so that the error can be corrected without adding new matter. The article discusses disclosure requirments of the first paragraph of section 112, the effect of an error on the disclosure, the correction of errors, and the prohibition of new matter. The author contends that, in certain cases, a biological deposit may render material errors inconsequential because the error would be obvious to one skilled in the art upon examination of the deposit. The deposit may serve as evidence that although there was a material error in the disclosure, the applicant had possession of the invention and was capable of enabling it at the time the application was filed.

In Re Ochiai, In Re Brouwer and the Biotechnology Process Patent Act of 1995: The End of the Durden Legacy?
Jeremy (Je) Zhe Zhang
IDEA - The Journal of Law and Technology
Volume 37, Number 2, 1997

Zhang reviews the case law pertaining to the nonobviousness of "analogous processes" prior to Durden, and examines the controversial In re Durden and Amgen v. International Trade Commission decisions and reviews how these decisions negatively impacted the biotech industry. The article summarizes the judicial and legislative responses to the criticism of Durden, with a focus on the legislative history of the Biotechnology Process Patent Act of 1995 and the debate surrounding the various predecessor bills of the Act. The article discussesOchiai and Brouwer, examines the costs and benefits of a per se nonobviousness rule, and concludes that the Act is justifiable as a temporary measure to protect the United States biotech industry against unfair foreign competition.

New Drug Discovery Technologies And Patents
Philippe Ducor
Rutgers Computer and Technology Law Journal
Volume 22, Number 2, 1996

The article argues that due to their nature and unprecedented efficiency, new drug discovery technologies might lead to a plethora of products that are unpatentable because they are obvious or have a lack of utility. The article provides the scientific background which underlies traditional drug discovery and hybridoma technology, examines the most recent drug discovery technologies, and describes the various patent law issues that arise in discovering new drugs.

A "Dogma of Empiricism" Revisited: Daubert v. Merrell Dow Pharmaceuticals, Inc. and the Need to Resurrect the Philosophical Insight of Frye v. United States
Adina Schwartz
Harvard Journal of Law & Technology
Volume 10, Number 2, Winter 1997

Concerning the admissibility of scientific evidence, and the standard for determining when a subject matter counts as an area of scientific expertise abouit which a properly qualified expert can testify, the article address a critical assumption on which Daubert's alternative to Frye is based - that judges can resolve disputes about whether expert testimony is genuinely scientific by rational ly and uncontroversially determining whether the scientific method was followed in developing the theory or technique at issue. The article questions Daubert's unanimous holding that, as a matter of statutory interpreation, the Federal Rules of Evidence supersed Frye.

"Patents and Antitrust: A Rethinking in Light of Patent Breadth and Sequential Innovation"
John H. Barton
Antitrust Law Journal
Volume 65, Issue 2, Winter 1997

The article argues that, with the creration of the Court of Appeals for the Federal Circuit, we have replaced the 1970s pattern of weak patent law and strong antitrust law with a 1990s pattern of strong patent law and weak antitrust law. Patents are enforced more strongly and now cover basic research tools.

DNA is Different: Legal Obviousness and the Balance Between Biotech Inventors and the Market
Anita Varma and David Abraham
Harvard Journal of Law & Technology
Volume 9, Number 1, Winter 1996

The article provides a general overview of the technology involved in DNA litigation, a more detailed description of the technology and prior art references, discussion of the doctrine of legal obviousness in the context of patent prosecution of DNA cases, an analysis of the Federal Circuit cases In re Bell and In re Deuel, a proposal for a new legal test to for obviousness, and application of the new test to fact patterns. The article argues that current case law has shifted the balance of public and private interests undesirably in favor of the patent applicant by applying "ill-fitting" and "inapplicable" traditional chemical patent law doctrines.

Intellectual Property Activities In U.S. Research Universities
Steve L. Bertha
IDEA - The Journal of Law and Technology
Volume 36, Number 4, 1996

The article describes the management of intellectual property at the University of Illinois at Chicago as proactive, efficient, and successful. The article describes all aspects of the University's intellectual property: disclosure, protection, marketing, negotiating and licensing, as well as intellectual property provisions in the University's research agreements, material transfer agreements, option agreements, and licensing agreements.

Utility and Non-Operability Standards in Biotechnology Patent Prosecution: CAFC Precedent Versus PTO Practice
Kevin C. Hooper
IDEA - The Journal of Law and Technology
Volume 36, Number 2, 1996

The article reviews the historical underpinnings of the utility and enablement standards developed through case law, analyzes case law and the PTO's reaction, shows how and where the PTO has deviated from these standards, examines the supporting arguments of the patent bar and the PTO positions on these standards, discusses the PTO's proposed changes to the examination procedures in Group 1800, and argues for the formation of a joint PTO-industry advisory committee to proactively identify and resolve future PTO deviations from judicial precedent.