The human use of humanoid beings: chimeras and patent law

As biotechnology advances, the day may soon come for the creation of a self-aware, human-nonhuman chimera. The USPTO has ruled on whether a patent may issue on such an organism, but Congress must still legislate a dividing line between human and non-human patentable subject matter.     

Patents – a practical perspective

Patent Update is a regular column dedicated to the complex issues that affect patents in the genomics and proteomics field. In each issue, there are two sections compiled by patent attorneys. The first section, Patents – a Practical Perspective, is a commentary on current issues, landmark patents, useful patent resources and how to search them, and legislative changes that impact the pharma and biotech industries. The second section, Patent News, provides brief synopses of recently issued patents and other patent events, and their significance to drug discovery R&D.     

Patent perspective

Patent Update is a regular column dedicated to the complex issues that affect patents in the genomics and proteomics field. In each issue, there are two sections compiled by patent attorneys. The first section, Patents – a Practical Perspective, is a commentary on current issues, landmark patents, useful patent resources and how to search them, and legislative changes that impact the pharma and biotech industries. The second section, Patent News, provides brief synopses of recently issued patents and other patent events, and their significance to drug discovery R&D.     

Proliferating Patent Problems with Human Embryonic Stem Cell Research?

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position of certain patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore.     

Bioengineered bugs, drugs and contentious issues in patenting

Bioengineered bugs, as is the scope of this journal, have great potential in various practical applications. A corollary to bringing useful products to the market is that such products need protection from copying by other people or businesses. Such government-sponsored protections are legally enforced through a patent, copyright or trademark/trade secret system commonly known as intellectual property rights. A condition for obtaining a patent is that the invention must not be disclosed to public either through seminars, informal public disclosures or publications in journals, although in the United States, there is a one year grace period that is allowed to obtain a patent after public disclosure. This article describes my personal experience in obtaining a patent in 1980 on a genetically manipulated bacterium designed for oil spill cleanup. This patent application went through a series of court cases that finally ended up in the Supreme Court of the United States. I also mention a similar contentious legal issue that is on the horizon and that the readers of Bioengineered Bugs should be aware of. Finally, I have taken the opportunity to describe my current efforts to bring to the market some unique potential multi-disease-targeting candidate drugs from Pseudomonas aeruginosa and gonococci/meningococci that, if found non-toxic and efficacious in humans, will revolutionize the drug industry. To ensure their marketability, we are trying to develop a patent portfolio that will ensure that they will be legally protected and such protections will be broad-based and enforceable.     

Invisible genomes: the genomics revolution and patenting practice

In the mid-1990s, the company Human Genome Sciences submitted three potentially revolutionary patent applications to the US Patent and Trademark Office, each of which claimed the entire genome sequence of a microorganism. The patent examiners, however, objected to these applications, and after negotiation they were eventually re-written to resemble more traditional gene patents. In this paper, which is based on a study of the patent examination files, we examine the reasons why these patent applications were unsuccessful in their original form. We show that with respect to utility and novelty, the patent attorney's case built on an understanding of the genome as a computer-related invention. The patent examiners did not object to the patenting of complete genome sequences as computer-related inventions on moral grounds or in terms of the distinction between a discovery and an invention. Instead, their objections were based on classification, rules and procedure. Rather than patent examiners having a notion of a genome that should not be patented, the notion of a 'genome', and the ways in which it may be different from a 'gene', played no role in these debates. We discuss the consequences of our findings for patenting in the biosciences.     

从Myriad案谈基因专利的正当性及美国对基因专利授权实质性要件分析

按照专利制度构建的本质,基因专利的作用在于激励产业创新,促进基因研究的发展。但基因专利从产生以来就一直存在着争议。2011年美国Myriad案对分离DNA序列的可专利性具有不同的观点,从Myriad I案认为分离的DNA是不可专利的客体,到Myriad II上诉案中联邦巡回上诉法院推翻地方法院的观点,认为分离的DNA具有不同的化学结构,满足专利客体的适格性,但同时也反射出了对DNA序列可专利性的怀疑。Myriad案引起了美国、欧洲和澳大利亚司法审判中就基因专利适格性问题的较大争议。本文结合美国Myriad案来分析DNA序列作为专利客体的适格性以及目前美国对基因专利授权的实质性条件。     

The lone inventor: low success rates and common errors associated with pro-se patent applications

A pro-se patent applicant is an inventor who chooses to represent himself while pursuing ("prosecuting") a patent application. To the author's knowledge, this paper is the first empirical study addressing how applications filed by pro-se inventors fare compared to applications in which inventors were represented by patent attorneys or agents. The prosecution history of 500 patent applications filed at the United States Patent and Trademark Office were analyzed: inventors were represented by a patent professional for 250 of the applications ("represented applications") but not in the other 250 ("pro-se applications"). 76% of the pro-se applications became abandoned (not issuing as a patent), as compared to 35% of the represented applications. Further, among applications that issued as patents, pro-se patents' claims appear to be narrower and therefore of less value than claims in the represented patent set. Case-specific data suggests that a substantial portion of pro-se applicants unintentionally abandon their applications, terminate the examination process relatively early, and/or fail to take advantage of interview opportunities that may resolve issues stalling allowance of the application.     

Patent border wars: defining the boundary between scientific discoveries and patentable inventions

Drawing an appropriate boundary between unpatentable natural phenomena and patentable inventions is crucial in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued that purport to claim a novel product or process but that, in effect, encompass any practical application of a fundamental biological principle. Examples include gene patents, which Congress is considering banning, and patents relating to biological correlations and pathways, such as the patents at issue in the headline-grabbing LabCorp v. Metabolite and Ariad v. Eli Lilly litigations. In view of the mounting concern, it seems likely that Congress and/or the courts will address the issue, and perhaps substantially shift the boundary.     

Patenting antibodies in Europe

As a complement to the series of articles beginning in this issue on obtaining, maintaining and enforcing antibody patents in the United States, this article provides a comparison of the requirements for patenting antibodies in the United States and Europe and provides examples illustrating the application of European patent law to antibodies.     

Creation of first malaria vaccine raises troubling questions about "intellectual racism". Interview by Kirsteen MacLeod.

Some of the problems caused by malaria, which places a huge roadblock in front of economic progress in the Third World, may be solved by a new vaccine created by Dr. Manuel Patarroyo, a Columbian physician and researcher. "Imagine how things would be if Canadians had malaria," he says. "Episodes last 10 days, then there are 10 days of recovering. This leaves only 10 days each month in which to do some productive work. Then imagine killing the population of Toronto each year, and you can see the huge toll in terms of the number of yearly deaths globally from malaria." His discovery also raises the issue of "intellectual racism" because of criticism of Patarroyo''s methods by Western scientists. Patarroyo, meanwhile, turned down a $60-million offer for his vaccine, and instead donated the patent to the World Health Organization.     

我国转基因水稻产业化中的知识产权问题——对“遭遇国外专利陷阱”的回应

摘要：转基因水稻的产业化对缓解我国乃至世界的粮食危机和对保障我国的粮食安全都有重要的意义,而知识产权作为转基因水稻产业化进程中的基础性问题一直得到广泛的关注,尤其是关于我国是否会遭遇专利陷阱的问题。通过对我国知识产权制度以及所进行的转基因水稻专利检索数据的分析来看,转基因水稻的产业化并不会使我国遭遇专利陷阱,专利侵权的指控也并不存;但在整个产业化进程中,为保障转基因水稻知识产权的良性发展,还应当从如何促进技术优势转化为产业优势、如何对国外专利技术加以运用、如何维护稻农利益以及如何加强知识产权行政保护和司法保护等方面加以完善。     

The Patentability of Biomolecules – Does Online Bioinformatics Compromise Novelty?

Researchers are becoming increasingly concerned that the confidentiality of their novel biomolecule sequences is being jeopardised, particularly when these sequences are either submitted to sequence databases or uploaded as query terms onto internet-based bioinformatic software suites. The researcher's fears stem from the fact that the actual uploading of their sequences acts as a novelty destroying prior disclosure or publication, and that this may subsequently preclude valid patent protection for the sequences. This article addresses the key issues involved in the analyses of biomolecules, highlighting potential risks taken by many researchers in regard to patent protection and suggests possible ways in which these risks may be mitigated.     

Legal Regulation of Plant Genome Editing with the CRISPR/Cas9 Technology as an Example

The product-oriented and the process-oriented legal approaches to the regulation of genome editing technologies, CRISPR/Cas9 in particular, are considered. The relevant legislation of the United States and the European Union and some international treaties are analyzed. The issue of genome editing that is within the scope of GMO legislation and general legislation on risk assessment and regulation is addressed. The issue of patenting of gene editing technologies in the legislation of the United States and the European Union and under international law is considered. “Patent wars” between research teams that developed the CRISPR/Cas9 technology are described. The possibilities of obtaining patent protection for plants produced by genome editing are considered.     

Patent pools and diagnostic testing

There is increasing concern that overlapping patents in the field of genetics will create a costly and legally complex situation known as a patent thicket, which, along with the associated issues of accumulating royalty payments, can act as a disincentive for innovation. One potential means of preventing this is for the patent holders to enter into a so-called patent pool, such as those established in the electronics and telecommunications industries. Precedents for these also exist in the field of genetics, notably with the patents pertaining to the SARS genome. In this review, we initially address the patent pool concept in general and its application in genetics. Following this, we will explore patent pools in the diagnostic field in more detail, and examine some existing and novel examples of patent pools in genetics.     

Impact of the US Patent System on the Promise of Personalized Medicine

The biotechnology revolution promises unfathomable future scientific discovery. One of the potential benefits is the accelerated introduction of new diagnostics and treatments to the general public. The right medication for the right patient is the goal of personalized medicine, which directly benefits from many of biotechnology's biggest and most recent advances. The US patent system rewards innovation in medicine and other arts and sciences by granting innovators, for a period of time, the right to exclude others from using what was invented. One of the purposes of the patent system is to trade that right to exclude, and in its stead obtain the patent holder's obligation to fully and publicly disclose the essence of the innovations so that they can be improved, thus advancing the common welfare. A tension exists between personalized medicine's need for access to and use of scientific advances and the patent system's reward of exclusive use or nonuse to innovators. This tension may result in fewer diagnostic and therapeutic tools brought to the market and generally adopted. The risk seems particularly acute with respect to the diagnostic and therapeutic tools arising from genetic testing that hold specific value for a subset of the population. The judicial system has introduced ethical exceptions that overcome a patent holder's right to exclude; these judicial overrides relate to the provision of certain types of medical procedures and the development of certain types of new drugs, and not, apparently, to the use of diagnostic and therapeutic tools essential to the success of personalized medicine. A serious question exists as to whether legislative action is necessary to increase public access to genetic testing.     

Extending the market exclusivity of therapeutic antibodies through dosage patents

Dosage patents are one way to extend the market exclusivity of an approved drug beyond the lifetime of the patent that protects the drug as such. Dosage patents may help to compensate the applicant for the long period where the active pharmaceutical ingredient as such is already under patent prosecution, but not on the market yet, due to lengthy development and approval procedures. This situation erodes part of the time the drug is marketed under patent protection. Dosage patents filed at a later date can provide remedy for this problem. Examples of successful and unsuccesful attempts, and the reasons for the respective outcomes, are provided in this article.     

Patenting in biotechnology: a review of the 20th Symposium of ECB8

The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. It stands still in the foreground of interests since this is the only technical field where the living material itself may be the subject matter of patents. In consequence ethical problems have arisen first of all in the patenting of human cells and genes in which there is no agreement between R&D firms, patent offices and green movements. This has called for the elaboration of special Directives. On the other hand, patent systems are instrumental in safeguarding biodiversity. This review gives a picture of the patenting situation in biotechnology in the European Patent Office and in Hungary, the host country of the Congress. It also gives practical advice to biotechnological researchers on how to draft the applications and to observe the time limits, as well as on the necessity and possibilities of the deposit of microorganisms.     

Rituximab

Because drug development is not a static process, a drug’s market authorisation may change over time. In many cases, the number of indications for which a drug is approved increases. Because this facet of drug development also comes at significant costs, a corresponding patent filing strategy is required to protect these investments. The strategy as applied to rituximab, which is approved for a variety of indications, is discussed in this review.