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18. Patents and Trademarks: empirical evidence on 'evergreening' from Australia

Author

Moir, Hazel V J, Palombi, Luigi, Moir, Hazel V J, and Palombi, Luigi

Abstract

Evergreening is a strategy employed by pharmaceutical companies to extend patent protection around their branded medicines beyond 25 years. It involves claiming modifications to the original active pharmaceutical ingredient (API) as separate "inventions" to extend the period during which pharmaceutically equivalent products are denied market entry. Evergreening refers only to patents taken out by the company owning the original API. Similar improvement/modification patents taken out by other entities are referred to as secondary patents. Such delayed or reduced competition translates into an increase in the cost of healthcare. Brand pharmaceutical companies, of course, argue that these "lifecycle management" patents provide improved health outcomes to the community. They meet the (low) patentability thresholds of novelty, inventiveness and utility. Critics argue that the claimed improved health outcomes are usually either very small or non-existent. If the improved health outcome is negligible the evergreening patents incur a social cost rather than providing a social benefit, as the healthcare costs associated with delayed generic entry are large. This paper complements the existing empirical evidence by providing an in-depth analysis of a small number of Australian cases where evergreening of brand medicines has occurred. With two exceptions, the cases discussed here involve litigation. Evidence from court cases is useful in identifying rules that encourage or delay generic entry. For some cases PBS data allow partial estimates of the costs of evergreening. Analysis of the case material identifies types of evergreening patents and their market effects. This highlights some key issues in the impact of evergreening on market competition and healthcare costs and points to areas of patent and health policy that need reform. The paper also looks at the role of trademarks in evergreening by establishing branding distinctions. These are used by sales forces to encourage

Published
2013

24. Association for Molecular Pathology v Myriad Genetics (US) and D'Arcy v Myriad Genetics (AU): Are Gene Patents in Europe a Threatened Species?

Author

Palombi, Luigi

Subjects
ASSOCIATION for Molecular Pathology v. Myriad Genetics Inc., GENE patent lawsuits, PATENTS
Abstract

The Biotechnology Directive, passed by the European Parliament in 1998, provides that biological materials, even when they are isolated from the human body, are patentable subject-matter. However, two recent decisions of the highest appellate courts in the US and Australia cast doubt on the legitimacy of the Directive. These two decisions not only overruled patent office practice that had stood unchallenged for more than 30 years, but they demonstrate how differences in patent law statutory language and jurisprudence are irrelevant when it comes to determining what is an "invention Given that TRIPS mandates that patents be granted only for "inventions", in light of these decisions it is arguable that the Biotechnology Directive is inconsistent with TRIPS. [ABSTRACT FROM AUTHOR]

Published
2016

33. Patenting of Naturally Occurring 'isolated' Biological Materials.

Author

Palombi, Luigi

Subjects
*LEGAL judgments, *BIOLOGICAL products, *PATENT law, *BIOTECHNOLOGY laws, AGREEMENT on Trade-Related Aspects of Intellectual Property Rights (1994), EUROPEAN law
Abstract

The US Supreme Court in American Molecular Pathology v. Myriad Genetics has unanimously held that naturally occurring biological materials that have been isolated, that is, removed, from their natural environments are not patentable subject matter under US patent law. The decision not only overrules two decisions of the US Court of Appeals for the Federal Circuit (CAFC) directly on point, but overturns 30 years of US Patent and Trademark Office practice. The implications of the decision transcend the US patent law and impacts upon international law in so far as international agreements and conventions concerning patents are concerned. The two most important are the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the European Patent Convention (EPC) with specific emphasis on the Biotechnology Directive 98/44/EC (Directive). The decision means that the US patent law and the European patent law are inconsistent. The word 'invention' in Art. 27.1 TRIPS is not defined, yet the apparent trans-Atlantic inconsistency on such an important issue as the patentability of naturally occurring 'isolated' biological materials, leads inevitably to the conclusion that the basic premise upon which the Directive is constructed is not only fundamentally flawed but that it is in violation of TRIPS. Moreover, the decision brings into question the propriety of national patent laws of the member countries of the European Union to the extent that they are permissive of the patenting of naturally occurring biological materials isolated from their natural environments. [ABSTRACT FROM AUTHOR]

Published
2013

34. Something Weird's Going Down in the Patent Office.

Author

PALOMBI, LUIGI

Subjects
PATENT law, GENETIC mutation, UNITED States. Patent Office, HUMAN genes, BREAST cancer, OVARIAN cancer
Abstract

The article discusses the court battles over the patenting of the genetic mutations to the BRCA1 and BRCA2 human genes linked t familial breast and ovarian cancers in the U.S. and Australia. It relates the amicus brief filed by doctor James Watson in the court battle over the validity of patents owned by Myriad Genetics. It says that a total of 4270 U.S. gene patents were owned by 1156 different patentees by 2005. Moreover, the patent rights were defended by Myriad Genetics by filing its defence and relying on the isolation of the BRCA1 and BRCA2 genetic mutations as the point of distinction that justified the U.S. Patent Office.

Published
2012

35. The Patent Amendment (Human Genes and Biological Materials) Bill: No Barrier to Biotech Patenting.

Author

Palombi, Luigi

Subjects
GENE patents, MEDICAL laws, BIOTECHNOLOGY industries, INTELLECTUAL property, RESEARCH & development, BIOLOGICAL research, MEDICAL research
Abstract

The article offers the author's insights on the Patent Amendment (Human Genes and Biological Materials) Bill that was introduced to the Australian Senate in 2010 which aims to ban gene patents. Professor Ian Frazer wrote that if the bill has been enacted, it will prevent development of new products of biomedical research. The author mentions that the origin of the problem is a common statement by the patent offices of the U.S., the European Union (EU), and Japan that was released in June 1988. He argues that the proposition relies on a conventional legal precedent, and is false in relation with law. Moreover, the U.S. government, under its existing patent law, consents that biological materials which have been secluded from their natural environments are not patentable subject matter.

Published
2011

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