I’ve deliberately changed the title of this “series” to enable a more constructive engagement with the debates around this theme.
I’ve received a number of emails that continue to query me on why I argue that section 3(d) is incompatible with TRIPS and why my report stated so. I do no such thing. Let me use this post to briefly dispose of this issue.
I’ve argued in an earlier post that section 3(d), according to my reading, is perfectly compatible with TRIPS. It rightly asks whether “new forms” of existing pharmaceutical substances have any increased “efficacy”. If one is unable to demonstrate such increased efficacy, then the new form is not patentable. A very sensible section to me, and perfectly compatible with TRIPS, as this is nothing more than a refined non-obviousness standard in the context of pharmaceutical inventions.
Of course, if the Indian patent office pegs the standard of efficacy so high that no new form ever gets a patent, despite having a significantly enhanced “efficacy”, the section may be subject to attack under TRIPS and/or the Constitution of India as being an “arbitrary” standard, that, in effect, grants patents only to “New Chemical Entities”. Such a reading would also have the effect of rendering section 3(d) redundan--a reading that is to be avoided under most canons of statutory interpretation that I know of.
Be that as it may, the Mashelkar Committee Report was not asked to review section 3(d) or in fact, any section under the current patents act. And in all fairness to the Committee, it did no such thing. It was asked to only review two prospective provisions that were sought to be introduced, but held back since the government apprehended that it wouldn’t comply with TRIPS. Well, not exactly, since the government thought it had already conceded too much to the Left Parties during the course of passage of the Patents Act--and this referral to the Committee was nothing more than a deft move by the government to prevent any further stalling of the Patents Amendment Act, 2005. One of these prospective provisions relates to the controversial “New Chemical Entity” debate and asks:
“Whether it would be TRIPS compatible to limit the grant of patents for pharmaceutical substances to new chemical entities?”
Those of you familiar with pharmaceutical technology will appreciate that new chemical entities are very difficult to come by and in some ways are comparable with “pioneer” inventions in other technology areas. All the other inventions that follow might in some sense be “incremental” as they attempt to build on this pioneer invention/technology. Thus for example, a new cancer drug might be based on a patented “new chemical entity”. CIPLA comes up with a new form of this old drug that is much more effective—i.e. you have less side effects whilst taking the new form by CIPLA. Should CIPLA get a patent on this improvement or this incremental innovation? This is precisely what this referral addresses. If the grant of patents is limited to new chemical entities alone, then CIPLA does not get a patent, despite the fact that it has come up with a “new” and “non obvious” invention, that also has an “increased efficacy” under section 3(d). In fact, if such a prospective section limiting the grant of patents to “new chemical entities” were to be introduced in the law, section 3(d) would be rendered redundant i.e. even if the new form by CIPLA has increased efficacy, it would still not merit protection.
In short, the two issues (the NCE query which the Committee addressed AND the TRIPS compatibility of section 3(d)) are really separate ones and ought not to be conflated.
Wednesday, February 28, 2007
I’ve deliberately changed the title of this “series” to enable a more constructive engagement with the debates around this theme.
Kondapalli toys are the most recent category of handicrafts to obtain Geographical Indications (GI) protection in India, being only the second handicraft from the state of Andhra Pradesh to receive such protection. Made in the village of Kondapalli on National Highway No. 9, 25 km from Vijaywada, this art form can be traced back to the times of Sri Krishna Deva Raya.
Toy making in Kondapalli is an intricate process which even to this day is done only by hand by using a special type of wood known as ‘Tella Poniki’ or white sander, grown specially in the lands earmarked for the purpose in villages surrounding Kondapalli. Each organ of the body is separately carved after the wood is seasoned and cut to appropriate sizes, and joined together with an adhesive paste derived from tamarind seeds. A coating of ‘sudda’ (white lime) is given over the surface. It is then placed on a ‘kumpati’ (charcoal fire) to allow the moisture to evaporate, leaving the toy firm and solid. A cloth is then fixed on top of the makku-covered toy, further reinforcing the strength. The toys are then coated with a primer and the distinctive colours are then applied using a goat brush. Vegetable dyes, oil paints or enamel paints are used for the distinctive colouring of these toys depending on whether they are to be exported sold within India, or are to be used for special occasions respectively.
These toys depict beautifully fashioned single figures of deities or vignettes of rural life. The ‘elephant ambari’, toddy tree and ‘Dashavaatara’ are the most popular of the Kondapalli toys. Fine detailing of form and facial expression is one of the most distinctive aspects of these toys. Experts believe there is a strong influence of Islamic and Rajasthani cultures in the art form and are of the opinion that the artisans are migrants from Rajasthan.
It is in recognition of this inherently distinctive and intricate nature of the art form underlying these toys that the Geographical Indications Registry in Chennai granted GI protection to this art form. The Confederation of Indian Industry’s Andhra Pradesh Technology Development Centre (APTDC) in collaboration with the Lanco Institute of General Humanitarian Trust had facilitated the filing of the application for grant of the GI with the legal assistance of the firm Anand & Anand.
Posted by Shwetasree Majumder at 6:35 PM
Monday, February 26, 2007
Coming as I do from the relatively apolitical world of research and academia, the events of the last two weeks have taken me by surprise and left me wondering as to how easy it is for the substantive issues in any debate to get sidelined.
I thought I’d reflect on the “real” issues surrounding this controversy once the “name” calling and personal/ad hominem attacks had died down. But it only seems to be getting worse. Friends keep asking me as to why I haven't said anything on my blog yet. I therefore thought this an opportune time to attempt to deconstruct some of the arguments that are being flung around in this controversy.
I wrote a letter to the TOI and Hindu in response to the editorials that first sparked off this controversy and include it below.Unfortunately, despite more than a week going by, neither of these papers have published this. Fortunately, the DNA carries some of the key points that I'd stated in the respose to the TOI and the Hindu. See http://dnaindia.com/report.asp?NewsID=1081968.
Also, the Hindu Business Line carried my interview where I have tried to clarify some of the factual inaccuracies regarding this debate--see http://www.thehindubusinessline.com/2007/02/24/stories/2007022402940700.htm
TO THE EDITOR OF THE TIMES OF INDIA
This refers to your article dated 12 February 2007, titled “Patent Wrong” by Chan Park and Achal Prabhala. In the process of critiquing the Mashelkar Committee Report, the authors have called into question my academic integrity, albeit indirectly. They have also alleged that the Committee “plagiarized” key conclusions from my submission.
I first deal with their charge of plagiarism, since I am the alleged “victim” here. They attempt to substantiate their claim of plagiarism by selectively quoting from my blog. They however omit the most critical part of my blog statement in this regard “To be fair to the Committee, they did include the crux of my submission in an Annex to their Report.”
In other words, the Committee did include my submission as an Annexure, as they did with every other submission (about 24 in all) that was made to them. It bears noting in this regard that the Committee received submissions from a variety of IP stakeholders including industry (Ranbaxy, Biocon, IPA, IDMA), civil society groups (ALF, MSF), law firms (Lex Orbis, K&S Partners), IP Associations (AIPPI) and even retired members of the judiciary (Justice Krishna Iyer). Those with the patience to read the entire report including the Annexures would have gathered that some of the Committee’s observations were borrowed from my report to them. This being so, qualifying their borrowing of some of my conclusions as “plagiarism” is incorrect.
Park and Prabhala may not have intended this, but their writing casts aspersions on my academic integrity. If I understand their argument correctly, it runs something like this:
1. Shamnad Basheer is commissioned to write a paper on certain TRIPS issues for the purpose of submission to the Mashelkar Committee.
2. The paper is commissioned by the Intellectual Property Institute (IPI), with funding from Interpat.
3. Therefore, this paper necessarily reflects the industry position of Interpat.
4. Therefore, Shamnad Basheer exercised no independent judgment, but merely reiterated Interpat’s industry position.
5. The Mashelkar Committee was wrong to rely on the conclusions of a paper that reflects Interpat’s position.
These “leaps of logic’ rest on certain incorrect assumptions:
1. Anything funded by the pharmaceutical industry has to necessarily represent an industry view/position, despite the fact that the person commissioned holds himself out as an objective and independent academic.
2. The IPI is an “industry think-tank” that always resonates industry positions on all issues, despite the fact that its website (http://www.ip-institute.org.uk/) makes clear that is an independent charitable organisation which organises and peer reviews IP research.
3. The Mashelkar Committee blindly relied on the conclusions of my paper, without exercising any independent judgment of its own, despite the fact that it comprises members who are highly distinguished in their respective fields and known for their integrity.
Most importantly, the Park and Prabhala paper does no more than beg the question: is there something wrong with the analysis of TRIPS undertaken by me and relied on by the Committee? Park and Prabhala brush off this rather nuanced issue on TRIPS compatibility with broad statements such as “the report overlooks these (TRIPS) flexibilities—even the judgment of the WTO on this matter”.
Their note omits to explain as to what these “flexibilities” are, or where, in their opinion, the said flexibilities stem from and more importantly, which judgment of the WTO they are relying on—particularly, when there is not “one” but several WTO panel decisions dealing with TRIPS.
Article 27 of TRIPS mandates that patents shall be granted to all “inventions” in all “fields of technology”, provided such inventions are new, non obvious and have utility. Having studied TRIPS in some detail and now teaching it to graduate students at the George Washington University, my own view (as expressed to the Committee in more than 35 pages in a report that is now the subject matter of controversy) is that the term “invention” as used in Article 27 of TRIPS is to be vested with some basic meaning i.e. at the very least, it denotes something of “technical” import. Were it to be a term “freely” interpretable according to the whims of member states, we could end up with a situation where a member state may argue that it needn’t grant patents at all, since its unique lexicon suggests that nothing ever amounts to an “invention” under Article 27. In short, the term invention would be rendered redundant and such a result would fly in the face of a basic tenet of treaty interpretation that is well accepted under international law—that one cannot read a treaty term in a manner as to render it redundant.
Incremental pharmaceutical inventions are very “technical” in nature, and ought to fall within even the lowest common denominator that any sensible reading of the term “invention” would offer. As such, their exclusion from patentability (when the other patentability criteria of novelty, non obviousness and utility are satisfied) is likely to contravene the mandate under Article 27 to grant patents to all “inventions”.
Unfortunately, Park and Prabhala fail to engage with any of these substantive TRIPS issues. They may have had the best of intentions, but what they’ve engaged in amounts to what can at best be described as an adhominem argument which, according to Wikipedia, “consists of replying to an argument by attacking or appealing to the person making the argument, rather than by addressing the substance of the argument. It….. consists of criticizing or personally attacking an argument's proponent in an attempt to discredit that argument.”
The authors also reference section 3(d), a highly controversial section that is the subject matter of a lawsuit by Novartis in this debate, when the Committee never really speaks about section 3(d) in their report. It bears noting that the Committees mandate was never to examine the TRIPS compatibility of section 3(d) or of any existing provision in the Indian Patents Act and to be fair to them, they never engaged in this exercise.
This being so, it is rather far fetched to allege a “conspiracy” theory, simply because the Mashelkar Committee chose to adopt some of the positions advocated in my paper and to use some of the language from my paper. One has to bear in mind that this Committee was commissioned by the Government to come to a conclusion as independent technical experts. They were entitled to deliberate, seek outside guidance and then come to their own conclusions as they deemed fit. Of course, as I point out in my blog, although they got their conclusions right, the key failing of the Committee is in not demonstrating how they worked through the TRIPS issues/analysis in their report. Park and Prabhala conveniently ignore this not so “waxing jubilant” reception to the Committee Report in my blog.
A “thin analysis”, appears to be their main grudge against the Mashelkar Committee Report. It’s a sheer pity that the authors failed to use this fantastic opportunity (very rarely does one get space in the editorials of two leading newspapers on the same day) to “fatten” their own analysis.
The author is the Frank H Marks Visiting Associate Professor of Intellectual Property Law at the George Washington University law School, where he teaches a course on TRIPS, pharmaceutical patents and public health.
Frank H Marks Visiting Associate Professor of Law
George Washington University Law School
Washington DC-- 20052
Ph: 001 (202) 957 3442