Gene Patents Research Articles

Intellectual Property Challenges for the Modern Biotechnology Enterprise

The paper investigates the IP protection in the field of biotechnology among new innovators. Incompatibilities of the development process in modern biotechnology and the current IP systems are highlighted. Development process in biotechnology is notoriously slow, characterized by long delays in obtaining experimental data and marketing approvals. Initial development stages have been accelerated by the development in silico, by the global competition and accessibility of information. Thus, the most valuable part of the innovation (e.g., genetic sequence, protein structure) may be known years before the full experimental data. This significantly increases the risks of losing IP protection due to competing development, espionage, accidental disclosure, urging the premature patenting despite lack of resources to maintain global patents. Moreover, in biotechnology enterprise prohibitive costs of international patenting deplete the limited development resources and adversely affect both patenting and development. Costs are compounded by the increasing complexity of obtaining IP protection. Some of the complexities are recognized and underline multiple legislative interventions in establishing special regulations for biotechnology. The market also adjusted through practices such as evergreening. Unfortunately, legislative and market responses are not serving new innovators and may be contributing to the biotechnology patenting conundrums. The paper suggests that new legal innovation is needed in order to sustain healthy innovation in biotechnology and address the needs of new innovators. Several general and specific features for advancement of the legal protection of biotechnology are proposed for further research and discussion.

????? Innovation Model? The Realization of Patent Law's Social Purpose through Gene Patents

????? Innovation Model? The Realization of Patent Law's Social Purpose through Gene Patents

Systematic Analysis of GWAS Data Reveals Genomic Hotspots for Shared Mechanisms between Neurodegenerative Diseases

Objective: In this study, we have tried to reveal molecular mechanisms underlying “shared genetic variants” and developed a strategy to identify candidate mechanisms for shared aetiology of a pair of diseases, to uncover biological relationships between quantitative traits or related neurodegenerative diseases. Methods: Genetic variants were collected from GWAS catalog, belonged to multiple disease association studies. Meta-analysis was performed by using Metal (a whole genome association analysis toolset), and normalized them for their different sample sizes. LD analysis was done with Haploreg DB V.4.0. Subsequently, the ENSEMBL variant database was used as a reference database. Additionally, these shared SNPs were interpreted with Regulome DB V.1.1 and finally ranked the variant lists according to predicted functional consequences attributes. Afterwards evidences were collected from gene expression studies, patents, knock-out studies and other literature. Results: Pair-wise analysis also revealed that AD and PD have the largest number of shared disease-associated loci. Additionally, tau locus is discovered in a very novel and unique perspective of stress induced shared pathology of AD and PD, which provides suggestive evidence that the molecular mechanisms influencing aetiology and progression of selective neurodegenerative diseases are at least partly interrelated. Conclusion: Genetic overlap between these diseases suggests that genomic locus should be considered to investigate the effects of GWAS variants rather than individual genetic variants, particularly to investigate shared pathology.

Nagoya Protocol and Genetic resource related patent: Impact on Korean Trading

Nagoya Protocol and Genetic resource related patent: Impact on Korean Trading

Cancer patent scenario in Brazil: Analysis of competitive advantages

The present study describes the geographical and sectorial profile of chemical and biotechnological patents, regarding prevention, diagnosis, and treatment for the most frequent cancer types in Brazil that are currently registered in the Brazilian National Institute of Industrial Property – INPI, from 1998 until 2013. The steps taken to generate competitive advantage in the Brazilian oncological drug market are discussed and an analytic sectional survey was performed using the INPI database. In addition, a literature review on technology and scientific development was conducted using the Porter’s Diamond of National Advantage model. From 503 requests for patents, 41.4% corresponded to breast cancer, 13.7% lung cancer, 38.6% prostate, and 6.4% cervical cancer. Regarding the sectors and countries involved, the vast majority (74.4%) came from the pharmaceutical industry: mainly from the USA and Switzerland. According to the analysis and the Porter Diamond Model, we concluded that Brazil is uncompetitive in cancer R&DI.

The Unnerving Frontier: Human Gene Patenting in Canada

The biotechnology industry is one of the world's fastest growing markets and contributes an estimated $87 billion per year. There is an escalating trend of an increasing reliance by biotech companies, even universities, in developing patent portfolios with potential for great economic returns. In 2002 the Canadian Intellectual Property Office granted approximately 2,100 gene patents, which was a rate similar to the number of gene patents granted by the US Patent and Trademark Office on a per capita basis. Gene patenting is highly contentious within the scientific and legal communities. The purpose of this paper is to provide a legal analysis of whether or not patenting human genes can even be valid under under Canada's current legal framework.

Biotechnology Patenting in Small Countries—Strategies for the International Marketplace

Abstract The article investigates the conventional strategy for obtaining international patent protection by starting with the national patent application, then converting it to the international P...

Whither gene patenting and the patenting of diagnostic methods post-Mayo and Myriad? The need for certainty in navigating the high seas of policy

ABSTRACTThis paper is prompted by a series of recent high-profile decisions emanating from the apex courts in the US and Australia – namely, Mayo and Myriad – on the patent eligibility of gene-based inventions. Adopting a comparative approach, this paper critically examines whether isolated gene sequences and diagnostic methods qualify as patentable subject matter in several leading jurisdictions, including the US, Australia, Europe and the UK. An attempt will also be made, after carefully considering various arguments on both sides of the policy debate, at predicting what the future might hold (or, perhaps more accurately, at suggesting what the future ought to be) for gene patenting and the patenting of diagnostic methods in the global biotechnology landscape.

Myriad's impact on gene patents.

Three years later, the landmark Myriad decision on gene patents has led to some striking and unforeseen implications.

Evolution of Hereditary Breast Cancer Genetic Services: Are Changes Reflected in the Knowledge and Clinical Practices of Florida Providers?

We describe practitioner knowledge and practices related to hereditary breast and ovarian cancer (HBOC) in an evolving landscape of genetic testing. A survey was mailed in late 2013 to Florida providers who order HBOC testing. Descriptive statistics were conducted to characterize participants' responses. Of 101 respondents, 66% indicated either no genetics education or education through a commercial laboratory. Although 79% of respondents were aware of the Supreme Court ruling resulting in the loss of Myriad Genetics' BRCA gene patent, only 19% had ordered testing from a different laboratory. With regard to pretest counseling, 78% of respondents indicated they usually discuss 11 of 14 nationally recommended elements for informed consent. Pretest discussion times varied from 3 to 120 min, with approximately half spending <20 min. Elements not routinely covered by >40% of respondents included (1) possibility of a variant of uncertain significance (VUS) and (2) issues related to life/disability insurance. With regard to genetic testing for HBOC, 88% would test an unaffected sister of a breast cancer patient identified with a BRCA VUS. Results highlight the need to identify whether variability in hereditary cancer service delivery impacts patient outcomes. Findings also reveal opportunities to facilitate ongoing outreach and education.

D’Arcy v. Myriad Genetics: A Demand for the “Made” or “Non-Information” and Clear Subject Matter?

In October 2015, the High Court of Australia (HCA) handed down D’Arcy v. Myriad Genetics and overturned the Full Court of the Federal Court of Australia by holding that key product claims from Myriad Genetics’ BRCA1 gene patent did not constitute manners of manufacture. Two years earlier, the Supreme Court of the United States (SCOTUS) had similarly ruled against certain product claims from Myriad Genetics’ BRCA1 and BRCA2 patents, finding that simply isolated genetic sequences are not patentable subject matter. From their results, one could easily make the mistake of seeing the two decisions as being identical and placing Australia and the US at odds with Europe. However, as this article highlights, Australian law is conceptually different from US law and, strictly speaking, the HCA did not rule that isolated genetic sequences can never constitute patentable subject matter. However, at the end of the day, it is arguable that the laws are very similar in effect. This article examines the HCA decision and compares and contrasts it to that of SCOTUS.

Biotechnology patenting caught between Union law and EPC law: European bundle patents, unitary patents and intentional harmonization of decisions in the internal market

Although in the European Union (the Union) the substantive rules for the patenting of biotechnological inventions are governed by Directive 98/44, the actual examination and grant of patents in Europe is provided by the European Patent Office (EPO), which is not part of the Union legal order and acts according to a non-Union legal instrument, the European Patent Convention (EPC). This hybrid situation results in legal uncertainty and can lead to partly inconsistent applications of patentability requirements, since the EPO is not bound to Union law and cannot refer questions to the Court of Justice of the EU (CJEU). Thus, there is no guarantee that the Union and Unified Patent Court (UPC) judiciaries, on the one hand, and the EPO judiciaries, on the other hand, will come to comparable conclusions regarding the patenting of identical biotechnological subject-matter in the Union, irrespective of whether it concerns a classic European patent or a unitary patent. However, the unitary patent is introduced in the framework of fostering the functioning of the internal market and ensuring undistorted competition, and it provides uniform protection. The CJEU has given a very limited interpretation only to this concept of uniformity, leaving room for inconsistent decisions. Hence, it would appear that only intentional, determined harmonization efforts of the diverse judiciaries involved can increase consistency between decisions of the Union and the non-Union legal systems, although the judiciaries are unrelated. This call for coherency becomes even more pressing with the establishment of the unitary patent. Given this complex situation it may be questioned whether in the Union the law-makers of Directive 98/44 can fully achieve their aim in regulating and harmonizing biotechnology patenting.

Healthcare in Australia.

No single issue has dominated health practitioners' ethical debates in 2014 in Australia, but a controversial decision on gene patenting and the media focus on "Dr. Death," euthanasia campaigner Dr. Philip Nitschke, have given new life to these two familiar (and global) debates. Currently a dying with dignity bill, drafted by the Australian Green Party, is under examination. The Senate inquiry into the bill received more than 663 submissions, with 57% opposed and 43% in support of the bill, which has now been referred to a Senate committee. Will this be another of Australia's failed attempts to legalize euthanasia? The trial of Dr. Nitschke begins on November 10, 2014.

Pesquisa e propriedade intelectual envolvendo material humano: afinal, de quem são nossos genes?

O presente artigo discute aspectos éticos, científicos e jurídicos sobre o patenteamento de genes humanos, partindo de um contexto histórico sobre propriedade intelectual de seres vivos e passando pela decisão da Suprema Corte dos EUA relativa ao caso Myriad Genetics, conflito em torno da patente dos genes BRCA1 e BRCA2, relacionados ao câncer de mama e de ovário. Além disso, o artigo aborda diplomas normativos sobre o assunto, considerando tanto a legislação brasileira quanto a internacional. Por fim, contrapõe posições distintas sobre patente de genes humanos, adotando posicionamento crítico que o assunto merece.

How Gene Patents May Inhibit Scientific Research

In this paper, we point out three possible ways gene patents could impede scientific research. First, gene patent laws might exacerbate the culture of secrecy ubiquitous in science. Second, gene patents may limit researchers’ ability to study poly or multigenic diseases without access to all genetic etiologies. Third, gene patents could result in a “patent thicket”.

A study on Genetic Resources Patent and WTO TRIPs Non - discrimination principle; Focusing on the Nagoya Protocol Article 11 Section 1 Transboundary Cooperation

A study on Genetic Resources Patent and WTO TRIPs Non - discrimination principle; Focusing on the Nagoya Protocol Article 11 Section 1 Transboundary Cooperation

Persistent confusion and controversy surrounding gene patents.

The development of patent-specific educational resources and prompt resolution of patentability rules unsettled by recent US Supreme Court decisions are urgently needed in the genomics industry.

Does it pay to stand on the shoulders of giants? An analysis of the inventions of star inventors in the biotechnology sector

Previous research has highlighted the importance of star inventors for invention success and firm performance. However, we have limited knowledge regarding the indirect influence of star inventors on knowledge generation and how the ideas of star inventors influence subsequent invention performance. Therefore, this study uses biotechnology patents to investigate the extent to which star inventors influence the value of subsequent inventions. It explores whether non-star inventors can build, just as successfully, on the ideas of star inventors as star inventors. The results show that having a star directly involved in the generation of an invention, and building upon other star invention/s, is positively related to invention performance. However, stars are not better than non-stars at building upon earlier star inventions, and in fact, stars building upon their own, previous, inventions negatively affects the outcome/s of their future inventions. Furthermore, these results hold true for both general and high-value inventions. Overall, this study highlights the importance of stars in cumulative knowledge generation, but also shows the limits of self-referencing and individual path-dependency.

Intellectual Property in Vaccine Innovation: Impact of Recent Patent Developments.

This chapter examines the issues on patentability of microorganisms and human genes under the US laws and analyzes their influence on vaccine innovation. The analysis will focus on three aspects, namely, the naturally existing state, unmodified isolated form (i.e., mere extraction from the natural environment), and human-modified/genetically engineered structure. The outcome of the assessment suggests that the impact of the recent US patent jurisprudence on vaccines may differ significantly depending on whether the preparation of a vaccine in question involves natural or man-made DNA material.

Gene patents – short report

Gene patents – short report