Current Law Journal Content
Washington & Lee Law School
Current Law Journal Content
an index to legal periodicals
Bio-Science Law Review
Volume 8, Issue 3, 2005/2006
SEEKING APPROVAL OF FOLLOW-ON PROTEIN PRODUCTS: A PERSPECTIVE FROM THE UNITED STATES
JANE M. LOVE
Major advances in the fields of molecular biology, immunology and biochemistry over the last two decades have resulted in the validation of recombinant proteins for use as therapeutics in humans. Some would say that we are entering a golden age of biotechnology because the effectiveness and specificity of certain recombinant proteins go far beyond the reach of traditional, small, organic molecules. As we enter a time when key patents covering FDA-approved proteins are expiring, the question of how and when follow-on protein products may enter the marketplace is left unanswered. Unlike Europe, the U.S. Government has not yet promulgated a set of regulations governing an abbreviated approval process for follow-on protein. This article explores the issues at the fore in the United States, which arise at the intersection of the patent law, the drug approval process administered by the FDA, and the statutory law. As an example, the article discusses the recent FDA approval of Omnitrop(tm) - a follow-on recombinant human growth hormone.
EMBRYONIC STEM CELL TECHNOLOGY: A CRISIS POINT FOR EUROPEAN LAW?
R. STEPHEN CRESPI
A European patent application covering a culture of primate embryonic stem cells has been referred to the Enlarged Board of Appeal of the EPO after rejection by the Examining Division. These stem cells are derived directly from an embryo and so the case falls under the morality provisions of the EPC Article 53(a) and the interpretation of Rule 23d(c) of the EPC Regulations which excludes the patenting of 'uses of human embryos for industrial or commercial purposes'. The issues before the Enlarged Board are analysed and possible approaches to their resolution are offered.
DEATH OF THE ONCOMOUSE
ANDREW SHARPLES, DUNCAN CURLEY
More than twenty years after the application was first filed, the opposition to the Oncomouse patent has finally been concluded. The patent was upheld by the European Potent Office's Technical Board of Appeal on the basis that although the claimed technology was likely to give rise to the suffering of animals, this was outweighed by a potential benefit to man. However, having spent many years fighting and eventually winning the substantive arguments, the patentee then allowed the patent to be revoked on a technicality. Nethertheless, the case has crucially shaped the way in which the European Patent Office approaches the assessment of inventions the publication or exploitation of which would be contrary to ordre public or morality.
IS GERMAN UTILITY MODEL PROTECTION AVAILABLE FOR BIOTECHNOLOGY INVENTIONS?
MARTIN GRUND, RIK RICHLY, STACEY J. FARMER
Α German utility model (or 'Gebrauchsmuster') provides a quick and cost-effective means for obtaining intellectual property protection for new technologies in the same way as a conventional German patent. However, the German Utility Model Act, the body of law governing the issuance and enforceability of utility models, expressly states that both methods and processes are excluded from protection. Consequently, many practitioners have logically presumed that use claims are also excluded, as these types of claims fall readily into the category of 'method claims'. In two recent decisions, the German Federal Supreme Court has defined what language constitutes a 'method claim' and how this exclusion should be applied. First, the Court held that a claim relating to the use of active substance in a therapeutic compound for a specific medical use may be a permitted claim format. Notably, the court reasoned that a claim relating to the use of a known drug for a new medical indication is more akin to an allowable product claim rather than a method claim. Second, the Court held that this rationale only applies to pure method claims, while inventions having an ambiguous nature are not per se excluded from utility model protection. Hence, any applicant wanting to quickly secure an enforceable intellectual property right relating to a novel medical use for a known substance should give serious thought to seeking a German utility model right.
EUROPEAN PATENTS ON DIAGNOSTIC METHODS: WHAT ARE THE REQUIREMENTS AND PERSPECTIVES FOR APPLICANTS
Now that the requirements for patentability of diagnostic methods are established by the Enlarged Board of Appeal at the European Patent Office ('EPO'), applicants seeking for patent protection in Europe may carefully consider the criteria of this decision when drafting their patent claims in order to avoid an unwanted exclusion from patentability. However, there is good news for the applicants in that the Board confirmed the established case law of the EPO, that is, the legal requirements for an exception of diagnostic methods from patentability must be interpreted narrowly. Only methods that are practised on the human or animal body and containing all of the preceding steps which are required for making a diagnosis, including the deductive medical or veterinary decision phase, are considered to be diagnostic methods and consequently excluded from patent protection. The article highlights the most important facts and summarises the background of the opinion of the Enlarged Board of Appeal. Furthermore, some practical guidelines for applicants are provided that could be helpful to define whether a method falls within the exemption from patentability or not.
REVERSE MERGERS BETWEEN GERMAN AND US BIOTECH FIRMS
HENNING MENNENOEH, PETER KOHL AND WOLFGANG KIRCHER
Facing increasing difficulties raising capital through traditional channels, especially venture capital, IPOs and follow-on financing, German biotech companies are finding public listings in more established markets increasingly attractive. Some of these companies have recently explored creative transaction structures like the "reverse merger" into a publicly held U.S. company as a way to access U.S. capital markets. Using this year's reverse merger between Micromet and CancerVax as an example, the article describes potential advantages of this transaction model for German biotech companies and the legal structure and steps to achieve a reverse merger of a German biotech with a US NASDAQ-listed company.
GREECE - Pharmaceuticals - Glaxo claims victory in Greek Parallel Trade Dispute - NEW ZEALAND - Traditional knowledge - indigenous flora and fauna claim reactivated - UNITED KINGDOM - Practice - CPR change: Access for non-parties to documents field at court - EC DIRECTIVES - Implementation of the Good Clinical Practice Directive - New requirement that serious breaches of GCP or Trial Protocol be notified to MHRA - WORLD TRADE ORGANISATION - GM crops - WTO rules in favour of the US over the EU GM crop moratorium
UNIVERSITIES AND INTELLECTUAL PROPERTY: OWNERSHIP AND EXPLOITATION, MONOTTI AND RICKETSON