Patentability Criteria Research Articles

Synthetic biology and patents

The patent system has evolved over many centuries and is considered, by and large, to have successfully promoted innovation. Patents help to stimulate investment in research and development through the provision of a limited monopoly to the inventor, while ensuring full disclosure of the invention to the public. One of the reasons for the long‐lasting success of the patent system is its non‐discriminatory character. The same basic patentability criteria apply to all fields of technology: novelty, inventive step and industrial application. This provides legal certainty to the applicant and third parties because the criteria applied during examination at the patent office—and in courts—are largely independent of the nature of the invention. The World Trade Organization (WTO; Geneva, Switzerland) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which was negotiated in 1994, includes a provision that underlines this technology‐neutral character of patents: Article 27(1) states that “[…] patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application”. Nevertheless, the emergence of new technologies regularly raises the question of whether the patent system, which was historically designed to protect mechanical inventions, and was only later extended to chemical products and processes, is suitable to protect inventions in fields as new as synthetic biology. Perhaps more importantly, it also raises the issue of whether the patent system is, or has been, able to promote the advancement of these new technologies. Similar questions were also raised some years ago, as the patenting of biotechnology and computer‐implemented inventions—that is, software—gathered momentum. The European Parliament (Strasbourg, France), after a 10‐year debate, concluded Directive 98/44/EC on the legal protection of biotechnological inventions; this was later implemented in the regulations of the European Patent Convention …

Limiting the Patentability of Pharmaceutical Inventions and Micro-Organisms: A Trips Compatibility Review

The Patents (Amendment) Act 2005 (hereafter ‘2005 Act’) was India’s last step towards achieving complete TRIPS compliance. This Act has had a long fairly long innings and generated considerable debate, both domestically and internationally. Despite the passing of this Act, which contained a number of safeguards against non meritorious pharmaceutical patents, the Left Parties wanted more and in particular wanted to introduce a provision that would have limited patent grants to only New Chemical Entities (NCEs).Sensing that this could violate TRIPS, the government referred this issue to an expert committee headed by noted technocrat, Dr RA Mashelkar. In particular, it requested the Committee (or Technical Expert Group or TEG) on April 5, 2005 to study: a) whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; andb) whether it would be TRIPS compatible to exclude micro-organisms from patenting.The Technical Expert Group (TEG) solicited the opinions of IP stakeholders and others interested in the issues that it was meant to resolve. In this regard, I was requested by the Intellectual Property Institute (IPI), London to provide a comprehensive and independent opinion on the foregoing issues. My report finds as follows: 1. Limiting the grant of patents to new chemical entities and thereby excluding other categories of pharmaceutical inventions (the ‘proposed exclusion’) is likely to contravene the mandate under Article 27 of TRIPS to grant of patents to all ‘inventions’. Neither Articles 7 and 8 nor the Doha Declaration can be used to derogate from this specific mandate under Article 27.2. The proposed exclusion amounts to an ‘unjustified differentially disadvantageous treatment’ of pharmaceutical inventions and is therefore likely to violate the ‘non discrimination’ mandate under Article 27. 3. If the aim of the proposed exclusion is to prevent a phenomenon loosely referred to as ‘ever-greening’, this can be done by a proper application of patentability criteria, as present in the current patent regime. 4. Lastly, it is important to distinguish the phenomenon of ‘ever-greening’ from what is commonly referred to as ‘incremental innovation’. While ‘ever-greening’ refers to an undue extension of a patent monopoly, achieved by executing trivial and insignificant changes to an already existing patented product, ‘incremental innovations’ are sequential developments that build on the original patented product and may be of tremendous value in a country like India.

Towards in-house searching of Markush structures from patents

Most large pharmaceutical and biotechnology companies now use Oracle RDBMS chemistry data cartridges to manage databases of individual molecules for chemical structure searching. These systems are often linked to processes for new drug discovery and provide a common interface to a diverse range of specific structure databases. Recently some of these cartridges have been extended to handle Markush representations of un-enumerated combinatorial libraries alongside discrete molecules. An obvious extension would be to enable them to handle the Markush structures from chemical patents, though these have features and complexities not required for the representation of combinatorial libraries. The existing publicly available systems for handling patent Markush structures have changed little in the past 15 years and cannot easily be integrated with in-house systems; in-house access to chemical structures from patents is thus restricted at present to databases of specific molecules. A number of technical issues need to be tackled to enable the existing Markush-capable Oracle cartridges to handle data from patents, and several options are available for obtaining appropriate Markush structure databases for use with them. A demonstration system has been developed, using data from Thomson Reuters’ World Patents Index Markush File, and Digital Chemistry’s Oracle cartridge Torus. In-house access to patent Markush data could provide improved informatics support to the drug discovery process, both to enable patentability criteria to be added to computer-assisted drug design, and to expand the techniques available for data-mining in the patent literature.

The international patent system and biomedical research: reconciling aspiration, policy and practice.

This article reviews how the international environment shapes international patent law and practice with bearing on biomedical innovation. The cluster of issues is encapsulated in two core paradoxes. The first concerns how public goods, such as new pharmaceuticals, may be produced through the deliberate creation of private rights that exclude material from the public domain. The second paradox concerns how "technological neutrality" and overall policy balance in the application of general patent law principles requires technology-specific interventions by regulators. The article illustrates how centrifugal and centripetal trends influence diverse national approaches to applying patentability criteria for pharmaceutical products.

How Innovative is Innovative Enough? Reflections on the Interpretation of Article 27 TRIPS from Novartis v. Union of India

In 2006 a major lawsuit was initiated by Novartis AG against the Union of India. Novartis petitioned the High Court of Madras to declare Section 3(d) of the Indian Patents Act, as amended in 2005, to be non-compliant with the TRIPS Agreement and/or to be unconstitutional. Section 3 of the Patents Act identifies the cases of inventions which are not patentable and its letter (d), as amended in 2005, lists as such 'the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.' On August 6, 2007 the High Court of Madras reached a verdict rejecting all the petitioner's requests. In relation to the non-compliance with the TRIPS Agreement, the Court did not enter into the merits of the question as it held to have no jurisdiction on this issue. The present analysis begins where the verdict of the High Court of Madras ends; while the judgment invites reflection on a number of interesting issues related to the role of WTO law at national level, this paper focuses only on the substantive question (left almost entirely unaddressed by the Indian Court) about the compatibility between Section 3(d) of the Indian Patent Act and the TRIPS Agreement. The core of the question relates to the interpretation of Article 27 TRIPS, and in particular to its paragraph 1 where the criteria for patentability are set (i.e. an invention should be non-obvious, novel and useful); clearly, a narrow or a broad interpretation of these criteria is likely to have a significant impact on patents regimes worldwide. This paper builds an interdisciplinary theoretical framework to answer the compatibility question raised by Novartis AG; it does so by combing a purely legal analysis, based on the general interpretative canons used by the WTO Appellate Body to solve disputes, with an economic analysis that aims at showing the socio-economic impact of different interpretations of the above mentioned criteria. Finally, the paper shows the extent to which this theoretical framework could be applied should such a case ever be brought before the WTO DSB.

The Debacle of Novartis Patent Case in India: Strict Interpretation of Patentability Criteria Under Article 27 of the Trips Agreement

The objective of this article is to analyse a larger question of international importance: the jurisdiction of a national court to test the validity of a provision in an international agreement in the light of the Novartis case. In the second part, freedom of the WTO members to implement of the TRIPs obligations under Article 27 through national legislations and its repercussions on the protection of intellectual property are analysed. At the end of the discussion the controversial discussion of patents v. patients in developing countries were closely examined. The concluding remarks can be used as a guideline for the developing countries in the protection of intellectual property especially in the pharmaceutical sector.

TRIPS post-2005 and access to new antiretroviral treatments in southern countries: issues and challenges

Until 2005 some developing countries with pharmaceutical manufacturing capacities especially India used the transitional period allowing local manufacturers to produce and sell generic versions of first-generation ART drugs patented in industrialized countries and originally produced and sold at high prices by Western pharmaceutical companies. Thanks to international competition between generic manufacturers and these companies significant price reductions were achieved for the large majority of these drugs. This was a key factor in the implementation and strengthening of access to AIDS treatment in developing countries and a strategic element in the World Health Organization (WHO) 3by5 plan. However with the end of the extended deadline for TRIPS compliance the scenario is likely to change radically. Considering the end of the transitional period which effectively will prohibit the free manufacture of newer and innovative antiretroviral generations to mark a key episode in the history of the fight against AIDS in developing countries this review will provide an overview of the meaning and consequences of this turning point and to present some of the new challenges of the post-2005 period. (excerpt)

The rigour of EPO’s patentability criteria: An insight into the “induced withdrawals”

The EPO traditionally grants at least 60% of all patent applications, the rest being either withdrawn (30–35%) or refused (5%). This paper provides quantitative evidence suggesting that up to 54% of all patent withdrawals could be considered as induced by the work of EPO examiners, and hence may be taken as a more appropriate indicator of the rigour of the EPO. “ Induced withdrawals” and refusals occur for up to 23% of all applications at the EPO. This share varies according to (1) the route chosen for an EPO filing; (2) the technological field that is considered; and (3) the country of residence of the assignee. The number of claims only slightly affects the share of withdrawals. However, on average, two additional claims induce an additional communication from the EPO, which in turn prolongs the procedural duration by an additional year.

The Use of TRIPS Flexibilities by Emerging Countries

The patent law has been harmonized at the international level in 1994 by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In practice, this text requires all member States of the World Trade Organization (WTO) to recognize the patentability in all industrial sectors. A pharmaceutical patent shall then be granted for any pharmaceutical invention insofar as it fulfills all three criteria for patentability: novelty, inventive step and industrial application. Thus, developing countries can no longer copy molecules protected by patents. At first glance, the trips Agreement completely prevents the development of pharmaceutical industries in the most advanced developing countries from a technological point of view –emerging countries– and dried up sources of supply of cheap medicines for poor countries. However, if the trips agreement strengthens the protection of intellectual property rights, flexibilities have been provided by the wto law to ease international patent law under certain circums-tances, like public health considerations. The objective of this article is then to show how India, Brazil and Thailand, are using some of these flexibilities to ease the general principle of pharmaceutical inventions patenting according to their development goals, so that other emerging countries can inspire themselves by these examples.

Legal and Policy Implications of Allowing Patents on Genes

This paper would deal with the issue of 'gene patents' by tracing its origins through U.S. case laws and the contemporary place it occupies in the legal theory. Further the paper would draw policy implications of patenting gene sequences from a third world country perspective, especially for India. The first section would trace various important judicial pronouncements in the U.S. and Europe dealing with the patenting of biotechnological innovations up to the watershed case of Diamond v. Chakrabarty. This section would find that a constant expansion in the patentability criteria of law took place in the field of biotechnological innovations to make the law more and more inclusive in its scope. Next section would theorize around the nature and unique characteristics of 'gene sequences' as biotechnological innovations and discuss various episodes of attempts to patent 'gene sequences'. Through a multi-pronged analysis consisting of the established principles of patent law to the ethical dimension it invokes, this section would further study arguments advanced by the advocates of gene patents in various forums. Third section would raise some policy concerns that have been increasingly voiced by several medical practitioners and independent biochemical researchers, who have warned that gene patents would freeze all bio-medical innovations. The last section would argue that implementing gene patents is a bad legal policy choice and highly undesirable for a developing country like India.

Safeguarding Access to Medicines in Developing Countries: Strategies and Principles

The Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) has harmonised standards for intellectual property rights, including patents. For developing countries, these new standards are usually higher than their previous standards. As a result, it will take longer for generic versions of new drugs to enter their markets. This risks compromising access to medicines. This paper points out that developing countries can mitigate the negative impact on access by ensuring that domestic laws contain workable provisions for compulsory licensing and other TRIPS-compliant safeguard mechanisms and by gaining experience in using them. But countries should also avoid issuing trivial patents, for instance by applying strict criteria for patentability. This will, however, require a change in attitude towards and administration of intellectual property rights. Generics companies should nurture and actively support a more critical attitude to pharmaceutical patents.

Patents: to file or not to file?

In the previous paper, the author discussed the three criteria for patentability: novelty, usefulness, and nonobviousness and the practical value of obtaining a patent in terms of discoverability - the ease with which infringement can be determined, and in terms of avoidance - the ease with which a potential user of someone's invention could achieve similar results without using that invention. In this paper, the author continues the discussion of the practical value of a patent. Suppose that you have decided that your invention is novel, useful, and nonobvious. Further, suppose that you have decided that your invention is unavoidable (that is, it is the only reasonable way to do whatever it does), and that infringement would be easily discoverable. The remaining questions as to whether to proceed with a patent application are: Who would be likely to use your invention? Based on your answer to #1, what is the value to you of owning the patent? How much will it cost you to obtain the patent? Will your patent stand up in court if it is challenged?.

Exploiting Abstract Possibilities: A Critique of the Concept and Practice of Product Patenting

Developments in biotechnology and genomics have moved the issue of patenting scientific and technological inventions toward the center of interest. In particular, the patentability of genes of plants, animals, or humans and of genetically modified (parts of) living organisms has been discussed, and questioned, from various normative perspectives. This paper aims to contribute to this debate. For this purpose, it first explains a number of relevant aspects of the theory and practice of patenting. The focus is on a special and increasingly significant type of patents, namely product patents. The paper provides three general arguments against the concept and practice of product patenting. The first argument briefly considers the claim that patents are legitimate because they promote socially useful innovation. Against this claim, it is argued that product patents may hamper rather than promote such innovation. The second and main argument concludes that product patents are not adequately based on actual technological inventions, as they should be according to the usual criteria of patentability. The principal moral issue is that product patents tend to reward patentees for inventions they have not really made available. The final argument proposes a method for patenting the heat of the sun. Assuming that granting this patent will be generally considered absurd, the argument exposes a further, fundamental problem of the concept and practice of product patenting.

Are DNA patents bad for medicine?

This paper considers the potential benefits and harms of DNA patenting for biomedical research and medical practice. It argues that, all things considered, the benefits of patenting DNA outweigh the harms, although societies should adopt policies designed to prevent or mitigate the harms associated with patenting. Some of these policies include: (1) reinforcing the research exemption for academic researchers, (2) raising the “bar” for the criteria of patentability, (3) restricting the scope of patents, (4) disclosing conflicts of interest related to DNA patents, (5) sharing the economic benefits of patenting with patients, and (6) providing insurance coverage for some types of genetic tests.

Establishing a new intellectual property rights regime in the United States: Origins, content and problems

Major changes have been made over the past 20 years in the US intellectual property rights regime. These include the fact that the regime has been opened up to software patents and to business models, on one hand, and to living entities on the other—all within a general environment marked by the relaxation of patentability criteria. They have resulted in major changes in the US system of innovation—more specifically in the increasing privatisation of knowledge domains and activities that were previously public. The changes result from the combined effects of a response to US perceptions of increased foreign competition, of the emergence of major new technological opportunities in biotechnology and ICT, and of a series of regulatory changes that have paved the way for the financial sector’s increased involvement, via direct investments in firms whose main activity is comprised of R&D. Contemporary doubts about the viability of these changes reflect, the harmful long-term economic effect of the privatisation of basic knowledge (especially in the biopharmaceutical sector) and the difficulties that the financial sector has faced in ensuring the sustainability of the necessary pre-conditions that allow for the development of innovation.

Romania—recent developments in industrial property

Industrial property law in Romania has undergone far-reaching changes over the last decade. This article outlines the changes following (i) the collapse of the communist government, (ii) the need to enforce various regional and international treaties and agreements, such as TRIPS, the European Directives on Biotechnological Inventions, on Trademarks and Geographical Indications, and on SPCs, the Trademark Law Treaty, the Patent Law Treaty, and the European Regulation on the Community Trademark, and (iii) the need to harmonize domestic patent law with the EPC (preparatory to joining in July 2002) and—in due course—with the European Union. These changes cover virtually every aspect of IP law in Romania, including patents, trademarks, industrial designs, and integrated circuit topographies. The revised patent law provisions for patentable subject matter, patentability criteria, filing date, scope of protection and infringement are summarized. Similarly the revised trademark and industrial design laws are also summarized and the enforcement measures described.

Révolution technologique, mondialisation et droit des brevets

The patent system is complex and can only be really understood from an interdisciplinary standpoint. The article’s objective is modest – to provide some far from exhaustive comments on the law on contemporary patents without going into too much technological detail. Intellectual creation is not fundamentally prone to appropriation: though it can easily be copied or reproduced. Its protection and hence private appropriation come under secrecy (whenever possible) or the law. Companies have become the focus of interest for intellectual property systems in general and patents in particular. The most important changes to the patent system over several decades were made to systematically strengthen the patent-holder’s rights whilst lessening the responsibilities and constraints imposed upon him. We can thus legitimately address the question of whether the general interest is really being served. We will be making some comments upon matters which have characterised the current evolution of patent law. Firstly, there is the globalisation of this law. Then we will discuss the evolution of the criteria for patentability of inventions. In this context, we will tackle the problems raised by « new areas of protection » such as living matter – biotechnology in particular, software and financial and commercial systems. Then we will examine related issues and then attempt to air some more general reflections inspired by this examination. This study of contemporary patent law will be made in the light of various longstanding preoccupations fundamental to patent law: such as the encouragement of innovation and the sharing of knowledge whilst at the same time respecting a balance between interested parties and public interest. Previously, intellectual property was tolerated in international trade as a private monopoly, now it is perceived by the companies controlling the major part of technology as the guarantor of this trade. Hence the patent has moved on from an obstacle to competition to the status of an instrument against competitors and worldwide competition. The new function assigned to patents does not place as much importance on the responsibilities of the holder, specifically the requirement for industrial exploitation, but requires on the other hand a strengthening of the patentee’s rights at world level. Briefly, the contemporary evolution of patents has led to protection being widened, requirements weakened and rights strengthened. All members of the World Trade Organisation are obliged to adopt legislation highly protective of intellectual property and in particular inventions to eliminate the possibility of the legal imitation long time in operation in most countries during some stage of their industrial development. What will be the consequences for the development of domestic industries in a large number of countries included the developed ones. Clearly it is too early to say but we can address the question of whether we are not moving towards an increasing dualisation of the world economy : with on one side the few innovating countries where large multinationals are concentrated providing the majority of innovations and hence holding keys to scientific and technical progress and on the other the mass of countries – developed included – with little innovative capacity, no longer able to imitate to learn how to innovate because they are threatened with serious sanctions by the TRIPS agreement. Beyond the question of whether the current patent system is a determining factor of higher American than European competitivity and whether the patent system and in particular patent holder rights need to be strengthened to foster innovation in our own countries, a more fundamental issue which needs to be addressed in Europe is whether we need to systematically follow the United States in its rush to patent with the risk of losing our European « soul» or do we necessarily have to develop a humanist European model aiming at a balance between economic, social and ethical considerations. It should also be pointed out that a distinction should be made between the patent system and the rules governing it and its operation.

Innovation needs patents reform

The international patent system demonstrates many failures to adapt to new ways of producing information. The coming of antibiotics finally forced it to take account of the shift from “individual” to “corporate” invention by establishing new criteria for patentability. However, these favour industries which can operate a “portfolio” approach in their R&D, to the disadvantage of other industries and smaller firms in all industries. In complex technologies, whose economic importance has been growing rapidly, patents are now used as much as a bargaining currency to prevent “lock-out” from use of state-of-the-art components developed by competitors, as they are as a stimulus to R&D. Changes which have been proposed to deal with these problems, including empirical supporting evidence, are discussed. These include compulsory expert arbitration of disputes with legal aid for the respondent party in the event of an appeal to the Courts, an “Innovation Warrant” as a supplementary type of protection, and “shared-risk” compulsory licensing as a practical way of changing from time to money as the measure of a grant. This would give multiple innovators access to inventions as early as possible, while maintaining or even improving incentives to invest in invention and innovation.

Intellectual property rights in the support of scientific research

Intellectual property rights have long been regarded as a matter for specialists of a branch of law, their impact on competitiveness was referred to in the mass circulation press only in the past ten years, in particular in relation to international negotiations like the GATT agreement. After a brief description of the nature of intellectual property rights as they appear in support of scientific research, the deficiencies of the presently fragmented systems of national patents of the European as well as Community patents are presented with their consequences in terms of cost, reliability, and predictability. The difficulties related to their enforcement and to the differences of interpretation on patentability criteria in a world of global competition are also emphasized. The role of intellectual property rights in the evaluation and reward of researchers, their importance in the process of the creation of new enterprises, and the necessity to develop information and awareness in the population of researchers wherever they are, constitute the main factors which contribute to placing intellectual property rights on the management agenda priority list in the context of the increasing impact of immaterial investment in the creation of wealth. © 1997 by John Wiley & Sons, Ltd.