Written by senior IP counsel at Novartis, Philip Grubb and Peter Thomsen, both also lecturers in academia, this book is a well-written authoritative overview of patent protection for pharmaceuticals, chemistry and genetics that is a “must read” for practitioners and industrialists in this area.
Whilst it is clear that the authors are biased towards the drug development industry, the genetic viewpoint is covered as well and there is an attempt to be fair. The authors acknowledge that most genetic challenges are aimed at secondary patents that attempt to prolong the period of protection and there is even an admission that sometimes patent applications are filed where it is difficult to argue inventive step or even novelty, and the pejorative term evergreening is used to condemn such activities that bring the drug development industry into disrepute.
The book covers the legislative development and main case-law, comparing and contrasting between the practice in the UK, US, Japan and Continental Europe, particularly Germany and the Netherlands. The book is very strong on historical development of the patent system, both for the main regimes, and their former colonies. Thus, where the problems of protection in the developing world is discussed, particularly Latin America, it is pointed out that Spain and Portugal lacked protection for pharmaceuticals until joining the EEC in 1980, which does put things into perspective.
The book has five parts.
Part 1 provides an introduction and background to the Modern Patent System, discussing the nature and origins of patent rights and follows the early history and the historic development over two centuries in the UK and the USA. The evolution of the law in other industrial countries is covered, albeit less thoroughly, and the state of affairs in developing countries is discussed as well. Trends towards harmonization of patent law are discussed at length, particularly the state of affairs in Europe and TRIPS, and criticisms of TRIPS are related to.
In part 2, substantive patent law and procedure is reviewed. The range of patentable inventions is discussed, followed by an overview of what should be filed, when and where. This leads into a discussion of filing abroad, the Paris Convention, European patent applications and the PCT system, and follows with a discussion of petty patents. The examination procedure, allowance, oppositions and maintenance are discussed, followed by the requirement to work the patent and forced licenses. This naturally leads into chapters covering enforcement and invalidity and post grant amendments. Although this section is not specific to the chemical, pharma and biotech industries, it is written from this angle and an overview of patent term extensions and supplementary certificates is included.
One of the strongest sections is Part 3, which discusses the patentability of inventions in specific technical fields. The chapter on chemical inventions includes selection inventions and disclaimers, protecting compounds of unknown structure and synthesis and new uses. Pharmaceutical inventions are covered broadly, including secondary pharmaceutical uses. Supplementary Protection Certificates are discussed together with other exclusivity periods. The chapter on biotechnical inventions managed to concisely various developments including recombinant DNA and Monoclonal Antibodies. The chapter was a well written introduction to the science. The question of patenting life, and transgenic animals and plants is covered, and the morality aspects were covered, albeit largely dismissively. Surprisingly, there was a chapter on software and business methods. This was justified as these fields are often of importance to chemistry and life science players, and case law in one controversial field, may have a knock on effect elsewhere.
The fourth section covers patenting in practice. The difference between US patent agents and patent attorneys is explained, as are licensing requirements in Europe. The expected formal education, general perspectives and areas of competence of newly qualified practitioners in different jurisdictions are compared and contrasted. The application itself is systematically discussed, in terms of the purpose and scope of the background, sufficiency of disclosure, length of text, purpose of claims and the various forms. In addition to Markush, Jephson and Swiss type claims, ‘free beer’ claims – i.e. claiming a desirable result without adequate disclosure and ‘pickled onion’ claims, i.e. the danger of being overly broad in claim drafting, and including well established prior art, were also discussed.
The fifth section covers commercial exploitation. The issue of inventorship is discussed, together with the rights of the inventor in various jurisdictions. The various patenting strategies of different players, such as start-ups, established companies, individual inventors, universities and patent trolls is compared, and the use of patents by pharmaceutical companies is contrasted with the use by microelectronic industries. Infringement and licensing are covered from the perspectives of the patentee and the user, and the various considerations concerning licenses, contracts and agreements between different types of entities is discussed in a manner that makes it clear that the authors have considerable practical experience. The final chapter looks at competition law in Europe and the US, and here the authors are refreshingly sarcastic about probes and position papers written by well-meaning, but ignorant quangos and government committees. A useful glossary and index are also included.
Despite being impressed by and generally enjoying the volume which is well written and well-organized, I do have a number of criticisms regarding personal opinions of the authors regarding preferred practice:
- The authors suggest formulating a policy of where to file, and adopting this as company policy, to be revisited only if the nature of the invention indicates consideration of different markets.
- The authors also advocate developing and managing IP in-house IP, pointing out that the general trend to outsource peripheral activities should not be extended to IP which, unlike IT support, etc., is of central importance to the health and business of the company. As a handbook written by experts, I would expect IP managers to look for and be influenced by such practical advice.
The problem is that for pharmaceuticals, as with other technologies, the IP strategy is built on the dual considerations of protecting potential markets and thwarting competitors. The importance and capabilities of difference countries varies over time in accordance with their economic development and with political change, both international treaties and changes of internal government. It is difficult enough to make decisions that will have an effect in several years time, with continuous monitoring of the situation and rethinking strategy. Deciding that historic practice should become policy that does not generally require revisiting is indeed a way to avoid protracted meetings, but it makes it increasingly likely that expensive patent portfolios will not provide adequate protection.
To this reviewer, a glaring lacuna is that the IP regime in Israel is ignored. Indeed, the only Israel link, was in the discussion on the doctrine of equivalents, where the Epilady case was discussed, and the workings of the German and UK courts was contrasted. Israel is a relatively small market of only some 7 million people, but Israel industry includes some major players. Teva is the world’s most successful generic drug manufacture and currently the fourth largest pharmaceutical group. Makhteshim is the largest generic specialist chemical manufacturer. Compugen has developed a computer gene analysis platform and is leading player is gene discovery and classification. In the past 5 years there have been many changes and the Israel patent office is one of a handful authorized to provide International Search Reports and written opinions for PCT applications. There are however, no specialist IP courts. Whether after due consideration, a chemistry, genetic or pharma company decides to file and prosecute patents in Israel or decides not to, this should be a decision. Israel is too important to be ignored. Although a single volume work cannot be comprehensive, I suspect that other jurisdictions are not given sufficient discussion either.
List price $175 – but already available for less on the Internet. Well worth the money.
Patents for Chemicals, Pharmaceuticals, and Biotechnology, fundamentals of Global Law, Practice and Strategy, fifth edition, by Philip Grubb and Peter Thomsen, ISBN 978-0-19-957523-7 Oxford University Press 2010, 537 pages in hardback.