Click to buy Editorial (4 pages)

In Pursuit of Patents: 21st Century Challenges Robin J.R. Blatt

Abstract: In the mid-1880’s, Jules Verne wrote some of the first science fiction forecasting the invention of subma-rines, airplanes, guided missiles and space satellites. His works, Twenty Thousand Leagues Under the Sea, and Around the World in Eighty Days, carried readers across, above and under the earth, capturing interest in science and the future. Through these tales of adventure, Verne was relatively accurate in predicting the uses of technologies we take for granted today. From a futurist’s perspective, not only is it important to think about what is, but also what will be.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Click to buy Feature Article (7 pages)

MARKMAN AND ITS PROGENY William F. Lee, Simona A. Levi-Minzi, and Kerry S. Burke

Abstract: The scope of a patent is defined by its claims, the numbered paragraphs that appear at the end of the patent. The claim language is the result of the Patent Office procedure in which the Patent Office Examiner requires that the claims comply with the relevant statute. After a patent issues, one of the most important issues in any litigation is what exactly do the claims mean? And what do they cover? The Markman Supreme Court decision has had a dramatic impact on intellectual property rights and, in particular, the manner in which patents are prosecuted and litigated. This article provides a brief overview of the legal developments in the area of patent claim interpretation following Markman and examines some of the broader implications of the Markman decision.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: The litigation of patents in an age of rapidly advancing technology presents a challenge in time. In the past, mature technologies allowed indulgent patience in the time needed to acquire the patent and to procure relief against an infringer. The statutory remedy of damages for past infringement was generally in balance with that of an injunction against future infringement. More recently, however, injunction delayed has loomed as justice denied for patents on inventions facing early obsolescence caused by an accelerating technology. The late award of past damages may well be inadequate to repay the loss of exclusivity in a past market that would otherwise have led to continuing exclusivity in a future market position. The principal challenge of patent litigation in the high technologies of the future increasingly will be the management of time. The plaintiff will seek the earliest possible injunction, while the defendant may well seek to defer such an injunction to the latest possible date. The cutting edge of innovation in the biotechnology field already presents that challenge. Other fast-advancing fields of technology are certain to emerge in the coming years. One traditional trial strategy deserves careful reconsideration as a means of overcoming the harsh dilemma of elapsing time during the typically long wait for trial and final resolution by a permanent injunction: the motion for a preliminary injunction.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: This article explores the implications of the biotechnology industry’s first major product liability disaster—a mass tort action for alleged liabilities regarding the weight loss drug Redux/Fen-Phen. The authors analyze this action in the context of the broad body of product liability jurisprudence. They conclude that, although biotechnology companies may undertake a number of risk-management and contractual risk-allocation measures to minimize susceptibility to such legal actions, no company is immune from product liability claims. The authors propose that companies undertake a complete risk-management process that includes, as one basic element, the transfer of risk through the purchase of insurance.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: Debates about patenting in the European Union (EU) have been growing in intensity over the past year. This article reports on the much debated European Directive on the legal protection of biotechnological inventions presently in passage through the European legislative institutions (cf. Biocolumn by Nicholas Scott-Ram). It considers whether and to what extent the Directive will affect the existing positions in Europe on biotechnology patents. The purpose of this article is to report on the issues as they pertain to patenting human genes, transgenics, and so-called immoral inventions.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: In this article, the authors review the governing doctrine and jurisprudence of the various protections for biotechnology inventions and confirm that recognition of intellectual property rights in these inventions is desirable from the perspectives of both law and economics. The authors analyze the importance of patents for biotechnology companies and address their significance in R&D. The results of empirical research on the value of patents and the alternative mechanisms of protection used by Spanish biotechnology firms are discussed. The authors’ recent study, which assesses the diagnostic and therapeutic fields of biotechnology, determines that diagnostic firms are more focused on commercialization and inclined to use corporate protection strategies other than patents. To test their observations, the authors present a comparative analysis of the U.S. biotechnology sector and identify the differences between the European and U.S. research and development environments.

 ©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: Much of value to science and industry is essentially new information not easily categorized as a process, article of manufacture, machine, or composition of matter. We are said to live in an "information age," and yet there is no statutory protection scheme for the provider of this information. It may be time to rethink our intellectual property paradigm.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: A series of court decisions issued over the past year has highlighted the importance of identifying correctly those who invent technology that is made the subject of a U.S. patent application. Recent decisions show the dire consequences that can occur when the list of inventors given to the Patent and Trademark Office in a patent application does not match the list that a court later determines to be the correct one. Ironically, as will be seen from the cases discussed below, the correction of inventorship by a court is not in itself difficult.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: After some ten years of debate and discussion within the European Community, the Directive on the Legal Protection of Biotechnological Inventions was approved by the European Parliament at its Second Reading in May 1998. Since it was rejected by the European Parliament back in 1995, the Directive has undergone intense negotiation between the interested parties. These have included national governments and their representatives (known as the European Council), the European Commission (which generates new legislation) and members of European Parliament who are elected from each Member State. In addition the biotechnology industry, various patient groups and a range of opponents of the Directive have been actively engaged in a lengthy dialogue. The outcome of this process has culminated in what is known as the Common Position. It is this document which was approved by the European Parliament and which will be adopted throughout Europe within a two-year time limit.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: In January 1997, the European Union (EU) adopted a new regulation harmonizing approaches to risk assessment of new foods introduced into the market within any EU country. The member countries, although involved in the design and drafting of this new regulation, are not required to implement it within their own borders as its passage automatically gives it the force of law in each of the member countries. Regulation (EC) 258/971 of the European Parliament and of the Council of the European Union concerning novel foods and novel food ingredients has now come into force. This regulation requires each Member State to (1) process an application for the marketing of a novel food using the criteria specified in the regulation, or (2) pass the application on to the "competent authority" of another Member State in order to make an initial assessment of the safety of the new food or ingredient. As U.S.-produced commodity crops containing substantial portions of genetically modified plant material arrive in the EU, the ability of the regulatory authorities to react and implement the Regulation will be tested. The purpose of this article is to provide readers of BioLaw with an overview of the Regulation and to discuss its potential impact.

©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top

Abstract: In 1997, the biotechnology industry in the United States raised $5.8 billion in financings, compared to approximately $5.3 billion in 1996. Twenty-seven initial public offerings (IPOs) accounted for $709 million, compared to $1.5 billion for 1996, a decrease of 53%. Strategic alliances totaled an additional $5.9 billion in upfront and milestone payments, while mergers and acquisitions accounted for $3.7 billion, compared to $2 billion and $3.8 billion, respectively, for 1996. Overall, the biotechnology industry in 1997 saw a steady increase in the average value of partnering and licensing arrangements, rising from $25.4 million in the first quarter to $54.8 million in the fourth quarter. In addition, the average value of partnering arrangements for each quarter was higher than the comparable quarter in 1996. The total average amount raised by IPOs in 1997 was similar to 1996, while the total amount raised in private placements into public entities was steady from quarter to quarter.

  ©1998 by The Journal of BioLaw & Business. All Rights Reserved.

 Back to Top