Patenting Strategies of the EU Pharmaceutical Industry -Crossroad between Patent Law and Competition Policy. Research Papers in Law, 1/2011

From the Introduction. The pharmaceutical sector inquiry carried out by the European Commission in 2008 provides a useful framework for assessing the relationship between the patent system on the one hand and competition policy and law on the other hand. The pharmaceutical market is not only specifically regulated. It is also influenced by the special characteristics of the patent system which enables pharmaceutical companies engaged in research activities to enter into additional arrangements to cope with the competitive pressures of early patent application and the delays in drug approval. Patents appear difficult to reconcile with the need for sufficient and adequate access to medicines, which is why competition expectations imposed on the pharmaceutical sector are very high. The patent system and competition law are interacting components of the market, into which they must both be integrated. This can result in competition law taking a very strict view on the pharmaceutical industry by establishing strict functional performance standards for the reliance on intellectual property rights protection granted by patent law. This is in particular because in this sector the potential welfare losses are not likely to be of only monetary nature. In brief, the more inefficiencies the patent system produces, the greater the risk of an expansive application of competition law in this field. The aim of the present study is to offer a critical and objective view on the use or abuse of patents and defensive strategies in the pharmaceutical industry. It shall also seek to establish whether patents as presently regulated offer an appropriate degree of protection of intellectual property held by the economic operators in the pharmaceutical sector and whether there is a need or, for that matter, scope for improvement. A useful starting point for the present study is provided by the pharmaceutical sector competition inquiry (hereafter “the sector inquiry”) carried out by the European Commission during the first half of 2008. On 8 July 2008, the Commission adopted its Final Report pursuant to Article 17 of Regulation 1/2003 EC, revealing a series of “antitrust shortcomings” that would require further investigation1.

Patent law revision. Hearings, Ninetieth Congress, first-[second] session ...

Hearings held May 17, 1967-Feb. 1, 1968, pursuant to S. Res. 37, on S. 2, 1042, 1377, and 1691, 2164 and 2597.

Compendium of the patent law : as now amended for protecting inventions /

Includes index.

Law of contracts simplified. An analysis of higher court decisions clarifying law of contracts, chattel mortgage and real estate law, legal status of independent contractors and patent law.

Mode of access: Internet.

Patent law and procedure.

Mode of access: Internet.

Patents; a practical treatise on patent law and procedure,

"Books": p. 273-278

‘Abuse of Rights’ in Belgian and French Patent Law – A Case Law Analysis

This paper examines what types of actions undertaken by patent holders have been considered as abusive in the framework of French and Belgian patent litigation. Particular attention is given to the principle of the prohibition of “abuse of rights” (AoR). In the jurisdictions under scrutiny, the principle of AoR is essentially a jurisprudential construction in cases where judges faced a particular set of circumstances for which no codified rules were available. To investigate how judges deal with the prohibition of AoR in patent litigation and taking into account the jurisprudential nature of the principle, an in-depth and comparative case law analysis has been conducted. Although the number of cases in which patent holders have been sanctioned for such abuses is not overabundant, they do provide sufficient leads on what is understood by Belgian and French courts to constitute an abuse of patent rights. From this comparative analysis, useful lessons can be learned for the interpretation of the ambiguous notion of ‘abuse’ from a broader perspective.

Play a role in the patent puzzle

Discusses the contentious issues surrounding computer software patents and patenting in connection with the Peer-to-Patent Australia project, a joint initiative of Queensland University of Technology (QUT) and New York Law School (NYLS) that operates with the support and endorsement of IP Australia, the government body housing Australia's patent office. Explains that the project is based on the successful Peer-to-Patent pilots run recently in the USA and Japan that are designed to improve the quality of issued patents and the patent examination process by facilitating community participation in that process. Describes how members of the public are allowed to put forward prior art references that will be considered by IP Australia's patent examiners when determining whether participating applications are novel and inventive, and therefore deserving of a patent. Concludes that, while Peer-to-Patent Australia is not a complete solution to the problems besetting patent law, the model has considerable advantages over the traditional model of patent examination

The peer-to-patent initiative : revitalizing patent examination with peer review

Every day we hear someone complain that this or that patent should not have been granted. People complain that the patent system is now a threat to existing business and innovation be- cause the patent office grants with alarming regularity patents for inventions that are neither novel nor non-obvious. People argue that the patent office cannot keep up with the job of examining the backlog of hundreds of thousands of patents and that, even if it could, the large volumes of prior art literature that need to be considered each time a patent application is received make the decision as to whether a patent should be granted or not a treacherous one.

Physicality in the Information Age : a normative perspective on the patent eligibility of non-physical methods

There has been much conjecture of late as to whether the patentable subject matter standard contains a physicality requirement. The issue came to a head when the Federal Circuit introduced the machine-or-transformation test in In re Bilski and declared it to be the sole test for determining subject matter eligibility. Many commentators criticized the test, arguing that it is inconsistent with Supreme Court precedent and the need for the patent system to respond appropriately to all new and useful innovation in whatever form it arises. Those criticisms were vindicated when, on appeal, the Supreme Court in Bilski v. Kappos dispensed with any suggestion that the patentable subject matter test involves a physicality requirement. In this article, the issue is addressed from a normative perspective: it asks whether the patentable subject matter test should contain a physicality requirement. The conclusion reached is that it should not, because such a limitation is not an appropriate means of encouraging much of the valuable innovation we are likely to witness during the Information Age. It is contended that it is not only traditionally-recognized mechanical, chemical and industrial manufacturing processes that are patent eligible, but that patent eligibility extends to include non-machine implemented and non-physical methods that do not have any connection with a physical device and do not cause a physical transformation of matter. Concerns raised that there is a trend of overreaching commoditization or propertization, where the boundaries of patent law have been expanded too far, are unfounded since the strictures of novelty, nonobviousness and sufficiency of description will exclude undeserving subject matter from patentability. The argument made is that introducing a physicality requirement will have unintended adverse effects in various fields of technology, particularly those emerging technologies that are likely to have a profound social effect in the future.

Is there a physicality requirement at Common Law? : a survey of the Pre-NRDC cases discussing ‘Manufacture’

One of the fundamental issues that remains unresolved in patent law today, both in Australia and in other jurisdictions, is whether an invention must produce a physical effect or cause a physical transformation of matter to be patentable, or whether it is sufficient that an invention involves a specific practical application of an idea or principle to achieve a useful result. In short, the question is whether Australian patent law contains a physicality requirement. Despite being recently considered by the Federal Court, this is arguably an issue that has yet to be satisfactorily resolved in Australia. In its 2006 decision in Grant v Commissioner of Patents, the Full Court of the Federal Court of Australia found that the patentable subject matter standard is rooted in the physical, when it held that an invention must involve a physical effect or transformation to be patent eligible. That decision, however, has been the subject of scrutiny in the academic literature. This article seeks to add to the existing literature written in response to the Grant decision by examining in detail the key common law cases decided prior to the High Court’s watershed decision in National Research Development Corporation v Commissioner of Patents, which is the undisputed authoritative statement of principle in regards to the patentable subject matter standard in Australia. This article, in conjunction with others written by the author, questions the Federal Court’s assertion in Grant that the physicality requirement it established is consistent with existing law.

An empirical study of business method patent applications filed in Australia 2000-2009

This article sets out the results of an empirical research study into the uses to which the Australian patent system is being put in the early 21st century. The focus of the study is business method patents, which are of interest because they are a controversial class of patent that are thought to differ significantly from the mechanical, chemical and industrial inventions that have traditionally been the mainstay of the patent system. The purpose of the study is to understand what sort of business method patent applications have been lodged in Australia in the first decade of this century and how the patent office is responding to those applications.

Patent-busting: The public patent foundation, gene patents and the Seed Wars

This chapter considers the Public Patent Foundation as a novel institution in the patent framework. It contends that such a model can play a productive role in challenging the validity of high-profile patents; working as an amicus curiae in significant court cases; and also promoting patent law reform. However, there are limits to the ‘patent-busting’ of the Foundation. The not-for-profit legal services organization has only had the time and resources to challenge a number of noteworthy patents. Other jurisdictions – such as Australia – lack such public-spirited "patent-busting" entities. This chapter considers a number of key disputes involving the Public Patent Foundation. Part I examines the role of the Public Patent Foundation in the landmark dispute over Myriad Genetics’ patents in respect of breast cancer and ovarian cancer. Part II considers the role of the Public Patent Foundation in litigation between organic farmers and Monsanto. Part III examines the role of the Public Patent Foundation in larger debates about patent law reform in the United States – particularly looking at the Leahy-Smith America Invents Act 2011 (US). The conclusion contends that the patent-busting model of the Public Patent Foundation should be emulated in respect of other technological fields, and other jurisdictions – such as Australia. The initiative could also be productively applied to other forms of intellectual property – such as trade mark law, designs law, plant breeders’ rights, plant breeders’ rights, and access to genetic resources.