From October 2016 to March 2017 the team is joined by Guest Kats Rosie Burbidge and Eibhlin Vardy, and by InternKats Verónica Rodríguez Arguijo, Tian Lu and Hayleigh Bosher.

Sunday, 28 December 2014

Biotechnology and Intellectual Property Rights: a book review

Most often, the IPKat and his friends only publish short notes on IP publications, letting readers know of their existence, making some general comments and hoping that they will form their own opinions. But every so often they have the luxury of being able to post a longer, more carefully considered review. Here the Kats host one such review from Katfriend Suleman Ali (Holly IP). The book in question is Biotechnology and Intellectual Property Rights. Legal and Social Implications, by Kshitij Kumar Singh. As the title suggests, this is an important and timely topic. But does the book live up to its title? This is what Suleman has to say:
This book describes itself as providing insights into ‘the interface between law and genetics’. The author, Kshitij Kumar Singh, is an Assistant Professor at the Amity Law School in Noida, India.

The author has the very laudable aims of trying to convey the ethical and economic issues around patenting biotechnology and the ownership of human genetic resources. However he does not succeed. The informed reader would find this book irritating for being incomplete, failing to get to grips with the issues and providing no fresh thinking. While the author provides a sympathetic perspective to those that might be seen as being harmed by the patent system this is undermined by the polemical nature of the book. On important issues only one side of the argument is presented, and at times the book simply reads like a list of complaints against the patent system, without a proper assessment of the available solutions.

Practitioners will find little of direct interest here because this book is about ‘issues’ and not ‘how to patent biotechnology’, and so its content is more suited to policy-makers and academics. The book starts with looking at the patentability criteria for biotech inventions in the US, Europe, Canada and India, with brief discussions of the important cases which established that most biotech inventions are patentable. The author goes on to describe TRIPS and the well-known issues of the anticommons, patent thickets and the Myriad patents which are being used to prevent other companies developing the same diagnostic test for breast cancer susceptibility. Using database rights to protect DNA sequences is discussed and whether open source is appropriate for biotech. The implications of ‘ownership’ of human genetic sequences is presented as an important issue.

This book is badly written. Much more proof-reading and editing needed to be done to improve the language and reduce the level of repetition. A stray paragraph on the need to file sequence listings in Canada gives the impression that of a lot of the content coming from copying and pasting. However, a more serious criticism is that the writing is unfocused and nebulous. A lot of the time one wonders what the real problem is that the author is discussing and who the actual victims are of the policy.

There is an assumption running through the book that the developing world is being harmed by the patent system. However it is not clear exactly how. Important developing world issues like agricultural innovation and technology transfer are not mentioned. Open source innovation is presented as potentially beneficial to the developing world without any explanation of why. It could be argued that there no viable alternative for developing biotech industries other than one based on patents. This central point is not discussed by the author in any meaningful way. Failure to mention the Trans-Pacific Partnership is a glaring omission. India is occasionally mentioned, but the opportunity to discuss how India is acting to protect its national interests in the field of IP is missed.

Unfortunately the book is very much out of date when it comes to the US. It does not cover the Guidance issued by the USPTO in March of 2014 on eligible matter in view of the Myriad and Mayo Supreme Court cases (recently replaced with the new Guidance issued in December of 2014). The Guidance makes fundamental changes to what is patentable in the field of biotech inventions.

The author focuses on the patenting and ownership of human genetic material, but never explains why this is different from patenting other inventions. The patent system is described as being inadequate for dealing with biotech inventions, without proper discussion of why. The author does not explain what the real problem is. Is biotech research being inhibited by patents with claims which are too broad? Are drugs too expensive as a consequence? These issues are hinted at but not properly discussed.

The ethical and economic issues raised by the patent system are complex. So they need complex thinking for solutions to emerge. Unfortunately this book does not tackle, or even describe, those issues adequately enough to provide insights or solutions. It therefore makes little contribution to the debate of how the patent system should be changed.
Bibliographical data: publisher: Springer, ISBN: 9788132220580, Hardcover, 254 pages, Price: £72. Web page here.

This Kat hopes that the author will rise to the challenge of addressing the issues raised by Suleman. The arguments against patent protection, like the arguments in favour of it, are so important that they deserve to be put at their strongest and to be substantiated as far as possible by any available evidence. Only once the arguments on each side are clarified and strengthened can a meaningful debate begin.


Anonymous said...

Being polemical is easy, but rarely achieves anything. One has to understand both sides of the argument, and as much as possible bring everyone on board in resolving matters. We need to focus on how the biotech industry is best served by the patent system and work on achieving that. Perhaps the best option for the developing world is not to fight the patent system, but to develop it to best suit their national interests.

Anonymous said...

Sorry Anonymous @ 14:13, but being polemical is not only easy - but much like propaganda - it works.

That is the reason why you see so much of it, wanting to appeal to the better side of human nature, notwithstanding.

As for "suit their national interests," there too, a too-Pollyanna view misses the point that for some (especially) developing worlds, the best national interests is served by such policies as being a Pirate Nation, or by broad government takings, both of which are antithetical to a strong patent system.

Michael said...

Wow. How refreshing to read a book review that actually explains what a book is about and critiques it, rather than something bland intended for the back cover.

Some polemics are well worth reading. Paltry's books on copyright spring to mind.

Please publish more of these reviews.

Anonymous said...

I agree with Michael.

Thanks for saving me £72.



Graham Dutfield said...

Wow - that was harsh. Having quickly scanned the book myself I would say it's well informed and pretty objective and uncontroversial. Views are expressed quite gently. That suggests to me that the reviewer may be rather intolerant of perspectives he happens not to share, and that is the basis for his attack. To attack the author for not including the USPTO Guidance documents is grossly unreasonable. There is normally a quite substantial time-lag between when a manuscript is submitted to publishers and the book coming out. A law firm pamphlet is another matter entirely. As for the TPP, since the text of the agreement is still under negotiation I don't find omission of discussion on the TPP to be problematic. I should add that the book is published in India mainly, one presumes, for an Indian audience. India is not involved in the TPP negotiations. Academic books are not necessarily written for practitioners and that is perfectly acceptable.

Anonymous said...

Sorry Graham, because I like your books and think you are great, but I don't agree with you on this. I think that academics are so used to reading academic literature that they are no longer sensitive to its nuances and its bias.

You are right that India is not involved in the TPP but I don't think that this is a reason for ignoring it when the Indians have themselves been discussing possible involvement:

Also, while some time lag is always going to happen between submission of a manuscript and actual publication, the Guidance that the reviewer mentions was published in March 2014 while the author's preface is dated May 2014.

Suleman Ali said...

In response to Graham, I mentioned the US Guidance as something that readers of this blog need to be aware of if they choose to buy the book. I accept your point about a time lag happening.

The book does not describe itself as being published for an Indian audience. I thought TPP should have been mentioned given the prominence given to TRIPS and the discussions in the book of trimming back the patent system. Chapter 7 of the book is devoted to suggestions for changes, including changes to interpreting TRIPS. In view of this it seems an omission to not mention a treaty like TPP which will enforce higher standards of patent protection.

Anonymous said...

By coincidence, I've been looking at the negative side of the patent system, and although I'm a patent attorney by profession and support the system, I can see that it's somewhat less than perfect, especially with respect to developing countries. These were often colonies of European powers, who really had no interest in them, apart from sources of cheap raw materials, which they could return as expensive manufactured goods. Plus, the patent system is a product of what one could call the European/capitalist mindset, and the triumph of that model took the patent system with it.

The answer? Sadly, there doesn't appear to be one. Documents such as the Manchester Manifesto and the thoughts of folk such as Prof. Stiglitz (who regard the current system as a driver of inequality) describe the problems but aren't so ready with the solutions. There's a whole mantelpiece of Nobel medals waiting for whoever solves it.

Anonymous said...

Anonymous @ 17:49,

What I think bears more scrutiny is the anti-capitalist mindset endemic to those who wish to assail the patent system.

The models of "manifesto's" along those lines have resulted in utter failures in the real world, whereas, the models that reward hard work through capitalism - while not perfect - have yielded far greater returns on progress and advancements.

Alex M said...

The patent system is not alone in requiring real reform to satisfy the demands of equity, but the best way of achieving this is open to question. However, one thing remains clear: (primarily) developing world organisations such as the BRICS, BRICIS and OIC must develop the kind of IP and legal capacities which would enable them to shape a fairer milieu.

Great article by Dr Ali!

Anonymous said...

I think one must see how patents are part of 'neocolonialism'. Countries with the most patents globally will benefit most from the patent system and defend it as part of defending their interests. Developing countries were pushed into TRIPS and are grudgingly abiding by it. Debt, international agreements, etc mean they are limited in how much they can resist. At the moment though it is difficult to see an alternative to patents, and the good parts of capitalism need to be acknowledged. At some point we need to come out of the present model of competing with each other, and pursue new ways of collaborating. The emerging economies (BRICS, etc) show how much economic growth is possible if things are done in the right way.

Anonymous said...

Anonymous @9:54

You write "The emerging economies (BRICS, etc) show how much economic growth is possible if things are done in the right way". I assume you are not referring to Russia. As for the rest, China's "right way" seems to have been largely based on shamelessly copying/stealing foreign products and technologies and in letting money into the country but not easily letting it out again. As for Brazil, it seems to me that much of its growth is illusory and is based on the low starting-point for measuring it. That just leaves India, which protects its own generics interests in pharma but is quite happy to see copyright protection when Bollywood interests are threatened.

Graham Dutfield said...

Well, we're all entitled to our views. It's not for me to defend a young scholar's first book. He should be able to do that himself. (At least he's attracted a lot of attention to his work!). Just to say, the book was published by Springer India. Therefore it is primarily for an Indian readership. Second, some people write and submit the foreword and acknowledgements sometime after the rest of the manuscript has gone to the publishers. Happy New Year everyone.

Anonymous said...

Thanks Graham for pointing out that this book is intended for an Indian readership. Do I then assume that, therefore, if a book on biotechnology and IP is intended for a US or UK readership, it should equally fail to give a balanced account?

Surely, while IP rights in biotech are plainly working to the benefit of some countries and to the detriment of others, values like truth and academic integrity don't stop at national borders.

Let's encourage this young author by all means, but in the age of the internet it's unrealistic to think that scholarship can be divided up by national boundaries.

Anonymous said...

This is a crazy blog. So many comments on a book review, for goodness sake!

Anonymous said...

A very interesting thread - and perhaps in an unintended way, one that contrasts sharply with the goings on over at the preeminent US patent blog.

To wit: here criticism of a book is being vetted and underlying assumptions (patents are neoclassic control vehicles - read that as EVIL) are being rooted out.

In contrast, the American blog is trying (yet again) another experiment in "political correctness" in attempts to constrain dialogue through a forced mechanism of non-anonymous and non-pseudonymous commenting. A blatant attempt at the "if you are not guilty, you have nothing to fear" meme. It appears that the "shhhh, you might 'offend'" meme is alive and well as a vehicle for quashing counter views that albeit might be sharp and even polemic, nonetheless point out "inconvenient" truths.

Great comment by the way from Anonymous @ 10:06 - someone with an understanding of history and the evolution of patent protection within a sovereign.

Anonymous said...

The Heller Paper on the tragedy of the commons/anti-commons:

goes back to 1998. What have we learned since then?

Countries in East Asia (JP, KR now CN have moved from weak to stronger patent laws as their national interest required. Presumably India will ramp up the strength of its copyright and patent laws as the ongoing national interest dictates.

The multi-nationals don't yet decide how strong a country's patent law shall be. Or do they?

Graham Dutfield said...

There are quite a lot of people called "Anonymous" here so let me just respond to s/he whom I shall call "Anonymous of 30 December at 11.15". I shall then try to withdraw from further communication on this matter and others raised in this thread, as like everybody else I presume, I have a life to lead. First, have you read the book and are able to say there is a lack of balance? Or are you just drawing assumptions from the review? Second, should the message or coverage of a book necessarily be a balanced one anyway? (And by the way, the book is not in fact anti-IP, in case there is some misunderstanding from some people about this). One can entertainingly and informatively present a very partisan point of view in a book, and that is quite legitimate (for example see the book by Boldrin and Levine which one can enjoy reading and learn from without agreeing at all with the thesis). It's fine for books to be provocative as long as there is good evidence and sound argument, whether or not one agrees overall. (Or am I misunderstanding your meaning of 'balance'?). Of course a cynical selectivity among a body of facts to make an argument that a fairer selection would show up as being unsustainable is not good scholarship, and I would not defend that. Lastly, returning to the book in question, you infer that the author's work lacks truth and academic integrity. That's a personal criticism, possibly not based upon a reading of the book. Are you sure you want to stand by that under your cover of anonymity? For my part, I have seen a few really terrible books published on IP for a more global audience by more experienced and better established scholars who might be a better target for one's attacks. I can think of a few recent books which, for example, rely so much on favoured postmodern gurus that they are basically incomprehensible to most readers and in my view should not be published at all, at least not in the form that they are published.

Anonymous said...

Graham, I am "Anonymous of 30 December at 11.15".

I do have a copy of the book, which incidentally cites your own writings, and I remain disappointed with it.

Apart from the frequent appearance of unsupported statements (does this suggest that the author assumes that they are self-evident?), the book would benefit from better proof-reading and/or copy-editing.

The absence of a list of cases and tabled of statutory provisions and treaty provisions cited makes the book hard to navigate.

In essence, my disappointment is not so much that this is a bad book but that, with a little more attention to detail and care in framing arguments, it could have been a very much better one.

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