Mashelkar vs Correa: Is a Malaysian NGO Taking the Business Standard for a Ride?

Pursuant to our earlier post calling for the dumping of a trashy editorial by the Business Standard, we've received an anonymous comment to our post as below:

"Certain prominent peoples working in a malaysia baseda and Delhi based NGO is behind the wrongful interpretation of carlos correa report. the author of the report in the Business Standard is neither a lawyer who can interpret or a patent expert.

there are few people working in a delhi based and malaysia based NGO is using the above reporter of Business Standard for planting these type of wrongful and nonsense reports to create confusion in the mind of variousstakeholders including the Government of India. The only intention of these people is their upliftment and they will do any fraud in acheving their desired results. I request all the responsible newspapers not to publish these third party instigated reports without checking the veracity of the claims. I appreciate Spicy IP for bringing the real truth by publishing two excellent and quality writings."

Does anyone have any further details on this NGO and the accusation levelled against them? Of course in this climate of "spins", "allegations" and "counter-allegations", it is difficult to know what is true and what is not. But if true, this allegation has serious ramifications for the credibility of the Business Standard (BS). It ought to therefore investigate this unsavoury allegation immediately.

As a first step, the BS needs to publish their email query to Prof Correa, as also his reply to them. This will go someway towards alleviating the suspicion that the BS was taken for a ride and that the story was planted willfully and maliciously by an NGO for its own personal gain.

ps: image from here

The Correa Controversy: Clarifying Popular "Mashelkar Myths"

Pursuant to our last post highlighting the rather trashy editorial by the Business Standard, here is an email exchange I've had with a friend. I am posting this here, only because it appears that that there is still some confusion about the mandate of the Committee. And some very popular "Mashelkar Myths" continue to do the rounds.

For our previous posts on this controversy, please see here, here and here. And for those of you who wish to read all our previous posts on this controversy, please see here.

My friend writes:

"Dear Shamnad

While I would agree that there is confusion about what Carlos Correa said, meant, was reported to have said, etc. I would request you to see whether the following part of the Editorial also merits a comment:

"The Mashelkar committee’s conclusion on micro-organisms — that their exclusion from patent protection would be violative of Trips — is equally contentious. The relevance of micro-organisms goes beyond the pharmaceutical sector to encompass, among others, agriculture, to improve the ability of crops and livestock to withstand pests and diseases. These microbes, billions in number, are an endowment of nature, and not the result of human endeavour. Their discovery or isolation should not, therefore, be entitled to statutory safeguards unless they have been significantly altered through human intervention.

Two arguments weigh in favour of dumping the Mashelkar report. First, its integrity is in question, on not one but two counts. And second, the pharmaceutical industry globally has been finding it increasingly difficult to come up with new molecules and breakthrough drugs; they have resorted therefore to extending the life of old patents by making minor changes to existing products. There is little or no public benefit from such activity, all that results is an increase in the price of drugs."

(All emphases added by me)

As you can see, two separate statements are being made:

On desirability or otherwise of allowing patenting of micro-organisms, which is indeed not a settled issue on philosophical grounds (and perhaps on economic considerations as well, in a developing country, subject to being boxed out of knowledge goods)

On reasons for dumping the Mashelkar Report - Dr. Mashelkar has been a stalwart but has also committed a few rather embarrassing mistakes (The rather sordid Casablanca episode comes to mind where he almost ended up committing India to a rather insidious and devious design to dump her interests on TK and Patents). His credibility did take a beating even in the matter pertaining to two cases of plagiarism.

In addition, I do not see any sensitivity analyses being conducted on the economic ramifications associated with accepting the recommendations. In fact, I have always found absence of such analyses most surprising especially because the laws of IPRs are essentially economic in nature and thus cannot be seen to have a life of their own based solely on legal semantics. TRIPS itself is a legal document of an economic activity.

On a more practical consideration also, we may perhaps be better off being taken to the Dispute Settlement Body and fight for the continuance of our extant provisions than to acquiesce into changing our laws unilaterally (especially when we do not know if the extant provisions are damaging to our own local interests).

Perhaps our debates on such issues need to be based also on a more pragmatic 'Where do Indian interests lie' approach.

I REPLY TO HIM AS BELOW:

"Thanks very much for reacting to this. I think your reply really underscores an important point:

I have failed miserably in communicating the essence of the report and what it stands for. I know that vested interests conflated issues and confused the public with a view to discrediting Dr Mashelkar at any cost. I was under the impression that I did a fairly decent job of deconstructing the several issues that this controversy threw up, but your response tells me that my impression is a sadly mistaken one.

This is not to elevate myself to some grandiose position of the “clarificator” (if you will) --but only in pursuance of my commitment to run a blog that seeks to undertake some fair and relatively objective analysis of IP issues. Let me now respond specifically to each of your concerns:

You note as below:

“On a more practical consideration also, we may perhaps be better off being taken to the Dispute Settlement Body and fight for the continuance of our extant provisions than to acquiesce into changing our laws unilaterally (especially when we do not know if the extant provisions are damaging to our own local interests). Perhaps our debates on such issues need to be based also on a more pragmatic ' Where do Indian interests lie' approach."

Section 3(d) vs The Mashelkar Mandate

In several earlier blog posts, I’ve tried really hard to highlight the fact that the Mashelkar mandate was never to examine the TRIPS compatibility of section 3(d) or any current provision of Indian patent law. Rather it was to examine whether a proposed amendment to the existing 2005 Act that excluded all incremental inventions as a whole, without studying their individual merits, would have violated TRIPS.

The committee rightly concluded that such an amendment (which goes far beyond our existing section 3(d), which at least grants patents to those incremental inventions that demonstrate significant efficacy) would be likely to violate TRIPS. As you know, Article 27 of TRIPS clearly states that patents have to granted, without discrimination, to all inventions, in all fields of technology. Neither the Doha Declaration nor Section 8 nor any of the other provisions in TRIPS can derogate from this clear mandate.

TRIPS vs National Interest

More importantly, the Committee’s mandate was never really to address “national” interest issues, but only to examine the issue from a TRIPS standpoint. Of course, one may question the wisdom of having 3 eminent scientists (Dr Mashelkar, Dr Govardhan Mehta (ex Director of IISC) and Dr Asis Datta (former VC of JNU)) in a committee constituted to undertake a strictly legal “TRIPS” issue. Sadly, this issue was never raised (barring on this blog)...and I think this question ought to have been posed.

Having said this, the committee did have two legal experts (Dr Madhav Menon and Dr Moolchand Sharma) and I assume they’ve really applied their mind this time around after the current controversy.

Viewing this from a pure TRIPS standpoint, the committee was absolutely right in holding that micro-organisms and pharma incremental inventions cannot be banned outrightly as a class. I am yet to come across any convincing study that argues otherwise.

Micro-organism Patenting

Will an addition of a ‘sensitivity” analysis or an econometric study, as you recommend really alter a legal conclusion that is but evident from a plain reading of Article 27? I think not. As you will appreciate, in view of Article 27 (3) (b), it is well nigh impossible to find in favour of a law that outrightly bans patents on micro-organisms.

This does not mean that all micro-organisms can be patented. Rather countries can tailor their existing patent doctrine to limit the grant of patents to only genetically engineered micro-organisms (as Brazil and Argentina appear to do). And not to micro-organisms that are merely isolated. But this is very different from excluding micro-organisms altogether. And the Committee does echo such a sentiment by concluding that:

“The TEG has concluded that excluding micro-organisms per se from patent protection would be violative of TRIPS Agreement.... The group’s conclusion is based on the requirements of Article 27.3 of the TRIPS as articulated in 5.23 above and the provision of Indian Patent Act (Section 3 (j)). However, strict guidelines need to be formulated for examination of the patent applications involving micro-organisms from the point of view of substantial human intervention and utility."

Ad-Hominem Attacks Against Dr Mashelkar

As for the other “personal” issues that you mention (e.g. Dr Mashelkar chairing the Casablanca meet etc), should that really determine the validity of the present conclusions? Can’t we take an issue based approach? For every Casablanca or alleged plagiarism issue, there are hundreds of other instances where this man has furthered the cause of Indian science, technology and innovation, than all of us put together.

More importantly, please remember that the Committee has other members as well who are reputed thought leaders in their domain. Are we to assume that they haven’t bothered applying their mind to this issue—particularly after the last controversy erupted.

The Plagiarism Issue

As for the plagiarism issue, I’ve always maintained that plagiarism connotes a dishonest intent to hide the source. The committee did no such thing with my work. They may have failed to attribute it in the closest footnote to their text—but they did include the entire text of my submission to their report—which makes clear that the place where they got the allegedly “plagiarised” portions was from my submission. As this wikipedia entry correctly states:

"The controversy got highlighted in the media, since some of the text in the report was reported, without attribution to the original source, especially that of Prof. Shamnaad Basheer. There was an accusation of plagiarism. This accusation was highlighted through two editorial pieces published simultaneously in the Times of India[10] and The Hindu.[11]

According to Prof. Shamnaad Basheer, this allegation was unfounded. As cited on his blog he wrote "It is unfortunate that my blog has been selectively quoted to support allegations that the Committee ‘plagiarised’ from my report. This is not correct, as amply borne out by the last sentence in the blog: "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 the key points in my submission as an Annexure, as they did with every other submission (about 24 in all) that was made to them. Merriam Webster defines ‘plagiarising’ as "presenting as new and original an idea or product derived from an existing source." 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 and not 'plagiarised'.

Plagiarism was just a convenient (and perhaps "dishonest") tool used by some to discredit Dr Mashelkar. Note this sentiment in this "Nature Medicine" piece by one of India's leading science journalists, TV Padma:

"In the meantime, the plagiarism charge has proven useful for activists trying to discredit the report on grounds of bias. "The public can understand plagiarism better than intricate intellectual property issues," says Mira Shiva, board member of Health Action International-Asia Pacific, a non-profit global network working toward equitable access to medicines."

However, blame must lie where it is due. As I'd noted earlier on this blog, the committee consisting of reputed experts simply failed to deliver a well researched report. The report was poorly reasoned and shoddy. Now that those issues have been taken care of in the revised report, why are we still taking issue? What kind of an axe are people really grinding here?

Conclusion

In any case, does any of this really affect the substantive conclusions arrived at by the Committee? Have you seen any convincing study that argues in favour of the TRIPS compatibility of India’s proposed statutory exclusions that were referred to the Committee? I haven’t.

ps: Picture from here

Cancellation of NUJS IP Talk by Raj Gandesha

Unfortunately, owing to some visa issues, Raj Gandesha will not make it to NUJS for his talk on section 3(d) and incremental innovation tomorrow. Our apologies for the inconvenience caused to those of you who planned to attend.

The "Correa" Controversy: Dump Mashelkar or Dump the Business Standard?

After the rather curious note in the Business Standard suggesting that Professor Correa is miffed over the apparent "mis-quote" of his statements by the Mashelkar Committee in their revised report, the Business Standard (BS) now carries a terribly misguided editorial.

I'm not sure if this editorial was motivated by forces that wish to engage in a further character assassination of Dr Mashelkar and bring him down at any cost...however, what is obvious is that this editorial represents a real "low" in journalism. Not only has the author not bothered to understand the fundamentals of patent law and TRIPS, he/she has based their entire argument on a questionable initial report, which failed to reproduce any part of the alleged email sent by Prof Correa.

As a first step therefore, the Business Standard (BS) should immediately make available a copy of the email that Prof Correa sent them. Else, Prof Correa should make this available to settle the matter once and for all.

As I'd demonstrated in an earlier post, unless "Indian English" is drastically different from "Argentine English", Prof Correa's governing philosophy of TRIPS interpretation in relation to the categorical exclusion of any pharmaceutical categories from patentability is in consonance with what the Mashelkar Committee has opined. If what the BS states is indeed true, I fail to understand why Prof Correa takes issue with being cited by the Committee.

Provocatively titled "Dump the Mashelkar Report", the BS article notes:

"Even as the government accepts the revised report of the technical expert group on patent law issues, headed by RA Mashelkar, a key conclusion of the group has run into fresh controversy over the reasoning on which it is based.

A globally-acknowledged Brazilian patent expert, Carlos M Correa, who has been quoted in the report to support the group’s contention that patenting cannot be limited to new chemical entities, has disclosed that his views have been misinterpreted. This is an even more serious charge than the previous one (of plagiarising paragraphs from other documents to protect the commercial interests of multinational drug companies) that had forced the group to withdraw its original report. Regardless of how the group or its chairman responds to this allegation, the matter is serious enough for the government to take note; it should revisit its decision to approve the report.

The issue before the group was whether it would be compatible with the provisions of the global agreement on trade-related intellectual property rights (Trips) to limit patents for pharmaceutical substances to new chemical entities. (The other issue referred to the group concerned Trips and the exclusion of micro-organisms from patenting.) The group held that India is obliged to extend patent protection to incremental changes made to known medical entities which have significant therapeutic value. It argued that limiting the patentability of pharmaceutical substances to new entities amounts, prima facie, to ‘statutory exclusion of a field of technology’, which was not Trips-compliant.

Mr Correa, on the other hand, feels that WTO-member countries enjoy flexibility and can deny patent protection to incremental innovations in pharmaceuticals that are non-inventive but the result of routine experimentation and known techniques."

Duh? No one in their right mind would ever advocate the grant of patents for "inventions that are non-inventive, but the result of routine experimentation and known techniques". And the Mashelkar committee is no exception.

Despite this fundamentally flawed understanding of the issue, the author goes on to recommend that the Mashelkar findings be dumped! Perhaps its time to dump a newspaper that publishes editorials that challenge our intelligence.

ps: image from here

Delhi HC refuses to let 'patent linkage' in through the back door

The Delhi High Court on the 18th of this month in a judgment delivered by Justice Ravindra Bhat dismissing a writ petition filed by Bayer Corporation. Bayer Corporation sought to restrain the grant of a license under the Drugs and Cosmetics Act (henceforth referred to as Drugs Act) to Cipla for its drug “Soranib”. The landmark judgment also awarded costs amounting to Rs 6,75,000 which is payable in equal shares to the Union of India and Cipla. (There has been a previous post on the issue before the delivery of the judgment.)

The Petitioner (Bayer Corporation) argued that the drug “Soranib” for which license was sought was a “spurious drug” under Section 17B of the Drugs and Cosmetics Act. Bayer relied on Section 2 of the Drugs Act to contend that the legislative intent is to read the provisions of the Drugs Act in conformity with Section 48 of the Patents Act. Bayer attempted to bring in the concept of “patent linkage” by reading Section 2 of the Drugs Act and Section 48 of the Patents Act. Bayer also claimed that since the Drug Controller is aware of patent status of the drug (Section 18, Form 44, under Appendix 1 to Schedule Y of the Rules) granting of marketing approval would amount to contravention of Section 48 of the Patent Act. A distinction was sought to be made between a generic drug and a spurious drug by pointing out that “generic drugs can only be legally produced for drugs which are free of patent protection”. Bayer placed reliance on the judgments in the cases of Cattle Remedies and Anr. Vs. Licensing Authority/ Director of Ayurvedic and Unani Services (2007 (2) AWC 1093 and Hoechst Pharmaceuticals Vs. C.V.S. Mani, (ILR 1983 Delhi 548). Bayer also attempts to emphasize on its interpretation of Section 2 by pointing out that under Section 156, a patent granted under the Act has the same effect on the government as on others. And since the Drug Authority is a functionary of the Central Government, it should be equally bound by and respect the patent granted to Bayer.

Cipla however argued that the grant of a regulatory approval by the Drug Controller does not amount to infringement of the patent and that infringement needs to be established in a court of law in accordance with the provisions of the Patent Act. It cannot be assumed on the basis of statements of the patentee or decided by the Drug Authority which is institutionally incapable of delaying with complex issues relating to scope of the patent, its validity and infringement. Cipla pointed out that Section 107A of the Patents Act clearly exempts from patent infringement any of acts of making, using or even selling a patented invention, in so far as such acts are necessary to obtain information for the filing of a drug regulatory application before the Authority. Thus, it is rightly pointed out that the ‘Bolar provision’ or Section 107(a) would be rendered redundant if the approval by the Drug Authority amounts to infringement. Even with respect to a new application that potentially infringes an existing patent, the Controller can only direct that a reference to an earlier patent be made. In the absence of a specific statutory provision to that effect an authority like the Drugs Authority which lacks expertise cannot assess issues relating to infringement of a patent. Cipla also contended that Soranib cannot be a ‘spurious drug’ under Section 17(b) as Cipla was not trying to pass of its drug as that of Bayer’s. Reference was made to the different schemes of the Patent Act (and the existence of an exhaustive opposition and infringement proceedings) and the Drugs Act and the lack of a specific legislative provision providing for an overlap; essentially amounting to attempting backdoor entry of ‘patent linkage’. The Drugs Authority, which is publicly funded, cannot be used to further the enforcement of the private rights of a patentee. The Drug Authority has pointed out that it lacks the institutional expertise to deal with complex patent issues and the Indian Pharmaceutical Alliance supported the stand.

The Court began with an elucidation of the objectives and schemes of the Patents Act and the Drugs Act. It said that the enactments have distinct and disparate objectives. The Drugs Act prescribes standards of safety and manufacturing practices among other things. The Patents Act on the other hand, is not a regulatory law and serves to confer monopoly rights on inventors subject to the satisfaction of certain conditions. The Court said that accepting Bayer’s position would confer jurisdiction on one set of agencies denuding the powers, jurisdiction and meaningful role conferred lawfully on another set of specialized statutory authorities, under the Patents Act. The Court rightly emphasized on the point that the absence of specific legislative enactments in favour of patent linkage portrays the legislative intent to exclude it. If the Drugs Authority can decide on patent infringement, the provisions of the Patent Act would be reduced to “useless lumber”.

The Court, most importantly made a reference to the European Union Competition Authority’s Preliminary Report on the Inquiry into the Pharmaceutical Sector (The Final Report was presented on July 8, 2009). The report made a detailed inquiry into the reasons for delayed entry of generic versions into the market and highlighted the losses caused to consumers and governments owing to this. Patent linkage is unlawful in the EU. Bayer’s definition of ‘spurious drug’ would include every generic drug within its definition. Section 17-B was introduced to prevent adulterated drugs from flooding the market.

The Court points out that the following undesirable results which would follow owing to paten linkage:

(1) It clothes regulatory authorities, which are executive bodies solely concerned with scientific quality, efficacy and safety issues, with completely new powers, and into areas lack in expertise, i.e. patent rights policing.

(2) It transforms patent rights which are private property rights that depend on the owners’ promptitude and desire to enforce them, into public rights, whose enforcement is dependent on statutory authorities, who are publicly funded.

(3) Such linkage potentially undermines the “Bolar/Early Working” exception that encourages quick access to the post patent markets for generic medicines. This is a major public policy consideration in India, which faces a host of public health challenges.

(4) Article 27 of TRIPS requires that patents are made available without discrimination by field of technology. As the patent linkage system is not available outside of the pharmaceutical sector, or in the US, even for biologic products, extending it, as is sought, would potentially violate Article 27, without any debate, or mandate of law.

In conclusion,

Delayed generic entry will detrimentally affect consumers and governments (in the form of increased spending on health). A system which permits patent linkage is detrimental to immediate generic entry and the interests of generic manufacturers for the following reasons:

(i) It effectively amounts to extension of the patent period of the drug as generic drug manufacturers can begin the proceedings to obtain license only after the expiry of the patent period.

(ii) It can lead to multiple proceedings against the generic manufacturer. This will to wasted time and resources in litigation.

(iii) The system breeds uncertainty with respect to the legal status of the drug.

(iv) Including ‘generic drugs’ under the definition of ‘spurious drugs’ will lead to bolstering the misinformation campaign of branded drug manufacturers against generic drugs.

In this context, the Court is moving in the right direction by awarding damages amounting to Rs.6,75,000 that might serve to deter ‘vexatious and luxury’ litigation by branded drug manufacturers. The Court condemned the petition in strong words as “speculative foray; an attempt to 'tweak' public policies through court mandated regimes.” Even if the final outcome of the litigation is ultimately in favour of the generic manufacturer, the branded manufacturers gain in terms of the delay in the introduction of the generic drug, the increased uncertainty and draining of the resources of the generic company. The only way this can be prevented is through the awarding of damages that come close to covering the actual costs incurred by the generic manufacturer in litigation.

National Law School of India Review: Call for Papers

The National Law School of India Review has issued a call for papers for publication in Volume 22(1). Here is the call:

The National Law School of India Review (NLSIR) is the flagship journal of one of India's premier law institutions, the National Law School of India University, Bangalore. The NLSIR is a peer-reviewed journal, and is published twice a year. The latest issue - Volume 21(1) - included contributions from Justice S.B. Sinha, Judge, Supreme Court of India; Mr. Hans Koechler, Professor of Philosophy and International Observer at the Lockerbie trials; Mr. Arvind Datar, Senior Counsel, Mr. Geoffrey Loomer, Said Business School, Oxford and others. Full-text articles can be downloaded from here. Volume 21(2) - a symposium issue focusing on arbitration - is scheduled for publication in the coming month.

The NLSIR is now accepting submissions for Volume 22(1). The issue will be published in early 2010. Submissions may be made as Long Articles (approximately 10000 words), Essays (approximately 5000 words) or Comments (approximately 2500 words); on any legal topic of interest to an international readership. Submissions may be made via email at the email id mentioned on this page and queries regarding submission or subscription information may be made at the same email address.

In particular, from the point of view of Spicy IP readers, it is editorial practice at the NLSIR to make available a list of illustrative cases on which comments can be written. The list will be available on the NLSIR website soon, but I am given to understand that several cases which we have blogged about earlier will be on that list, including Nokia v. HMRC, Author of a Blog v. Times, Roche v. Cipla, and Colgate v. Anchor.

Mashelkar Committee on Patents and Prof Correa: Court(quote)ing a New Controversy?

A very curious article popped up in the Business Standard (BS) yesterday. Apparently, Prof Carlos Correa is miffed that the Technical Expert Group (TEG, headed by Dr Mashelkar) has misquoted him. I've combed through Correa's article and the revised report by the Masehelkar Committee and can't exactly fathom as to how Correa claims to have been misquoted. The record would suggest that the expert committee rightly (and contextually) cited Prof Correa.

This is what the BS stated:

"Patent expert says his views were ‘misinterpreted’ to support conclusion that India’s patent laws could not be tightened.

The Mashelkar Committee report on patent laws, which was re-drafted recently to rectify certain controversial "technical errors", has run into trouble again.

Carlos M Correa of Brazil, a patent expert of international repute whose views have been widely quoted by the Mashelkar committee to support its conclusions, has complained of “misinterpretation” of some quotes from a published article titled “Integrating Public Health Concerns into Patent Legislation in Developing Countries”.

Two years ago, R A Mashelkar, former chief of Council of Scientific and Industrial Research (CSIR) who headed the panel, withdrew the report after some portions of it were found to be copied from one of the submissions made by a UK-based researcher. The "technical errors" were later rectified and the government had recently approved the report.

The current allegation turns serious because the Mashelkar panel had included Correa's quotes to establish that under World Trade Organisation (WTO)’s TRIPS agreement, India will not have the right to limit the granting of patents for pharmaceutical substances to strictly new medicines.

Correa, in an email response to Business Standard. said the the Mashelkar committee had misinterpreted the text quoted from his study to convey a meaning that he had not suggested.

In other words, while Mashelkar committee says India is obliged under WTO rules to extend patent protection to incremental changes made to known medicines (that have significant therapeutic benefits), Correa feels that a WTO member-country has the flexibility to prevent patent protection to incremental innovations in pharmaceuticals that are non-inventive but the result of routine experimentation and known techniques."

"Inventive Step"

Let's begin with the last sentence in the quoted text above (marked in bold). This is but an obvious proposition well known to most folks with even an elementary understanding of patent law. And most countries do include "inventive step" as one of the pre-requisites for patentability.

Nowhere does the Mashelkar Committee Report suggest that "non inventive" inventions that are merely routine or that deploy well known techniques should be granted patents. In fact, the Committee clearly states that while “incremental innovations” involving new forms with significantly enhanced efficacy need to be encouraged, it is “important for the patent office to be vigilant about setting high standards of judging such innovations so that efforts on ‘evergreening’ are scrupulously prevented”. In other words, "non inventive" incremental inventions that are merely routine ought not to be patentable.

Section 3(d) vs. The Mashelkar Mandate

At this juncture, it may be relevant to once again reiterate and clarify that the mandate of the Mashelkar Commmitee was never to examine the TRIPS compatibility of section 3(d). Rather, it was to examine the TRIPS compatibility of a provision advocated by the Left Parties (who were part of the ruling coalition at the time that the 2005 amendments were passed), that would have completely excluded patentability for all pharmaceutical derivatives.

The difference between section 3(d) and the proposed amendment that the Left Parties wanted to bring in is this: Under section 3(d), a derivative of an existing pharmaceutical substance would merit a patent, if it demonstrated a significant enhancement in "efficacy" over and above the earlier known pharmaceutical substance. Under the proposed amendment, no "derivative" would gain patent protection, whether or not it demonstrated significantly increased therapeutic benefits.

Correa Paper

If one were to go only by the Business Standard report above and the apparently similar sentiments echoed by both Prof Correa and the Mashelkar Committee, one is at a loss to understand as to what Correa's quibble really is. Perhaps he will clarify in the days to come. Digging deeper, one finds that Correa's classic report titled "Integrating Public Health Concerns into Patent Legislation into Developing Countries" states the following:

"The TRIPs Agreement obliges all WTO Members to recognize patents in all fields of technology (Article 27.1)24. When fully in force, this obligation will have eliminated the varying patent policy approaches that previously existed.

Literally interpreted, Article 27.1 does not permit the exclusion from patentability of medicines in general or, arguably, of specific groups thereof. Under this interpretation, WTO Members could not exclude from patentability even the “essential medicines” listed by the World Health Organization (WHO).

There are two exceptions in the TRIPs Agreement under which pharmaceuticals might conceivably be excluded from patentability, but neither appear sufficient to justify an exclusion, except in limited circumstances."

The two exceptions that Prof Correa mentions, but is very skeptical of, is the "morality" exclusion under Article 27.2 and a proposed exclusion under "Article 8" of TRIPS.

Let's take the proposed exclusion under Article 8 of TRIPS first. This article stipulates that a member states is free to customise its patent law to cater to public health concerns. However, the article also makes clear that such customisation cannot violate any of the other express provisions of the TRIPS agreement including, presumably, Article 27 which clearly mandates that patents shall be granted, without discrimination to all inventions in all fields of technology.

Immoral Drug Patents?

As for the morality exclusion, Article 27.2 of TRIPS provides that member states may exclude from patentability those inventions that violate "public ordre" or morality". The key limitation in excluding pharmaceutical patents from patentability on this ground is that a member state would also then have to ban the sales or commercialisation of any products based on such patents. In other words, unless India bans the sales of patented pharmaceutical products, it may not be able to deny patents to such products on the ground that such patents are "immoral". In any case, given the recent ruling by the Delhi High Court in the Naz Foundation case, where the court read down Article 377 of the Indian Penal Code to permit consensual non penile sex between adults, and in the process drew a distinction between constitutional and public morality, it may be very difficult to label a pharmaceutical drug as an "immoral" invention!

Correa goes on to note that the only kind of patent exclusion under Article 8 that might be justifiable is a case where patents on a certain class of pharma inventions are excluded in order to address an "emergency" situation. However, even here such exclusions can be maintained only till such time as the "emergency" subsists.

Prof Correa then summarises his key conclusions by noting:

"In sum, under the current TRIPs Agreement, a straightforward exclusion from patentability of pharmaceuticals -- even the category of essential medicines -- does not seem to be a viable option. The admissibility of exceptions based on ordre public will depend on the interpretation of both Article 27.2 and Articles 7 and 8, but does not seem a promising basis for exclusion from patentability.

Exclusions to meet specific public health emergencies, especially if limited in time, might be justifiable if they are a necessary part of an overall strategy for addressing the emergency. "

Conclusion: Quote, Misquote or a Faulty Understanding of English?

Reading all of the above, I am at a loss to understand as to how Prof Correa claims that he has been misquoted by the Mashelkar Committee, which reproduced one of his key paragraphs above to support its conclusion. We'll have to wait for the actual text of the letter that Prof Correa wrote to Business Standard to verify what he really meant.

In any case, even assuming that there was a "misquote", would this really impact the conclusions laid down by the Technical Expert Group (popularly known as the "Mashelkar Committee"), which also included noted legal experts such as Prof (Dr) Madhav Menon, the founder director of the National law school and Prof (Dr) Moolchand Sharma, the Vice Chairman of the UGC.

Would Professor Correa suggest that India could exclude incremental pharmaceutical innovations as a class without violating TRIPS? And this is where it is important to appreciate that despite the passage of two years from the date that this first controversy broke out, with several groups levelling plagiarism charges against the Committee and even going to the extent of labelling Dr Mashelkar as an "anti national", none of them have come forward with a substantive critique of the conclusions put forward by the Committee.

In other words, till date, there is no convincing paper explaining as to how India's proposed move to deny patents to the entire gamut of incremental pharmaceutical drugs, irrespective of whether or not such drugs were actually inventive and yielded significant therapeutic benefits, would be compatible with TRIPS. We could argue about whether or not such an exclusion might be in India's national interest. However, the Committee's mandate was not to examine the issue from a "national interest' perspective, but solely from the vantage point of TRIPS, to which India is signatory. And from a TRIPS standpoint, I fail to see how such an amendment might have passed muster.

I reproduce the key paragraph of Prof Correa's paper that was quoted by the Mashelkar committee and resulted in the present controversy:

“Literally interpreted, Article 27.1 does not permit the exclusion from patentability of medicines in general or, arguably, of specific groups thereof. Under this interpretation, WTO members could not exclude from patentability even the ‘essential medicines’ listed by the World Health Organisation (WHO).”

After quoting the above from Prof Correa's paper, the Committee goes on to note that

"The statement that `Article 27.1 does not permit the exclusion from patentability of …… specific groups thereof’ is directly pertinent to the TOR of TEG."

The Mashelkar Committee's key conclusion is that a blanket exclusion of the entire "class" of incremental pharmaceutical innovations, without an independent enquiry into the merits or otherwise of the invention in question is likely to violate TRIPS. If the statement by Prof Correa above (that was in fact quoted by the Committee) is not supportive of that conclusion, I really need to go back and relearn my English!
ps: Contrary to what the BS report states, Prof Correa is an Argentine and not a Brazilian national. Though I'm sure that the Brazilians would love to claim him.

NUJS IP Talk: Raj Gandesha on Section 3(d) and Incremental Innovation

Raj Gandesha, a patent litigation attorney with White and Case, New York, will visit NUJS on the 25th of this month (coming Tuesday) and speak on “Pharmaceutical Innovations: A 3-D Perspective”. The event will be held in Room 006 of NUJS, starting at 4 pm and expecting to finish at 6 pm.

In particular, Raj will discuss a report that he authored on behalf of the US India Business Council (USIBC) on this theme. This report has proved controversial owing to the alleged involvement of Mr Anand Sharma, India's commerce minister, at a USIBC event where this report was first announced. We had blogged on this controversy earlier here and here.

I hope this will prove a lively session, as I plan to contest some of the findings of this report. I hope you can make it, if you’re free. Attendance is free. But if you plan to attend, please send an email to shouvikkumarguha[at]gmail.com.

In terms of speaker background:

Mr Gandesha represents clients with respect to a wide variety of intellectual property and commercial litigation matters, including complex patent, trade secret, copyright and antitrust litigations. Mr. Gandesha also advises and counsels clients with respect to data protection and privacy issues, including cross-border transfers of personal data, security breach notification issues, Internet and email marketing, and Internet privacy policies. Mr. Gandesha has represented and advised national and multinational clients in the pharmaceutical, oil, telecommunications, IT, consumer health, entertainment and financial services industries.

Education
JD, University of Toronto Faculty of Law, 2002
BA, (Hons.), Politics, Philosophy and Economics, Oxford University, 1991

Indian "Bayh Dole" Conference at NUJS in September

Details of a Conference that the IP Chair at NUJS (along with IPTLS and Share) is organising on the 12th of September at the NUJS Auditorium, Salt Lake Kolkata. Registration is free. However, if you wish to attend, please email Prakruthi Gowda (prakruthipgowda@gmail.com) indicating your name, designation etc.

Publicly Funded Patents and Technology Transfer: A Review of the Indian “Bayh Dole” Bill

In January 2009, the government introduced the Protection and Utilisation of Public Funded Intellectual Property Bill, 2008 in the Rajya Sabha. The bill is currently undergoing scrutiny by a Parliamentary select committee, after which it will be placed before the two houses of Parliament. The Indian bill is based to some degree on the US Bayh-Dole Act, which according to The Economist unlocked "all the inventions and discoveries that had been made in laboratories throughout the US with the help of taxpayers' money" and one that helped "reverse America's precipitous slide into industrial irrelevance."

This conference will aim to generate more awareness around the Bill and what is stands for. For one, the Bill is not an instrument that enables university patenting for the first time. Rather, under the present legal regime (most notably the patents act), all institutes and researchers working with such institutes are free to patent the results of their research, irrespective of whether or not such research comes out public funding (unless there is a contractual bar by the funding agency). Such protection of publicly funded research through patents and subsequent use is not specifically regulated and scientists and institutes can use their patents in whatever way they wish (subject to safeguards under current Indian patent law and other laws such as competition law). Therefore, the Bill presents a great opportunity to regulate publicly funded research and patenting activities associated with this for the first time.

The conference will examine the framework of the current Indian bill, with a view to helping improve it. In particular, the conference will try and examine the current structure of university research and technology licensing in India and see if the Bill can be tailored better to help promote the permeation of more university research to society in the form of useful products/services and/or knowledge transfer. The conference will also examine whether, and to what extent, concerns of public interest can be addressed in the present bill. Illustratively, it will seek ways in which the Bill can promote more non-exclusive licensing, which in turns is likely to enable a wider utilisation of publicly funded research. It will also examine whether, and to what extent, the current Bill can be improved to promote more transparency in publicly funded research (and the results thereto) by creating a list of public funds, the recipients, the usage of such funds and the dissemination of such research through technology and knowledge transfer to the public.

Lastly, the conference will aim to iron out some of the creases in the current wordings of the Bill, creases that are likely to lead to litigious waste.

DRAFT PROGRAM

1. Welcome Introduction: Prof (Dr) MP Singh, Vice Chancellor, NUJS (9.00 am)

2. Keynote Address: Dr MK Bhan, Secretary, Department of Biotechnology, Govt of India (9.15 am and 9.40 am)

3. Overview of the Issues: Prof Shamnad Basheer, Ministry of HRD Chair, NUJS (9.45 am to 10.10 am)

Session 1: Bayh Dole and the International Experience

1. A Review of the US Bayh Dole and Lessons for India: Professor Josh Sarnoff, Amercian University (10.10 to 10.30 am)

2. Global “Bayh Dole” Type Models and Lessons for India: Susan Finston, Founder, BayhDole 25 (10.40 to 11.00 am)

Coffee Break: 11.10 to 11.30 am

Session 2: Patents and Technology Transfer in India

1. "Drivers of academic research in India and the role of IPR: Some Econometric Evidence" Amit Shovon Ray, Professor of Economics, Centre for International Trade and Development, JNU Amit Shovon Ray, Professor of Trade, JNU, Delhi (11.30 to 11.50 am)

2. Patenting and Technology Transfer: The CSIR Experience: Zakir Thomas (12.00 am to 12.20 am)

3. Patenting and Technology Transfer: The IIT Kharagpur Experience: Dr Vivekanandan, Dean, Rajiv Gandhi School of law, IIT Kharagpur (12.30 pm to 12.50 pm)

Lunch: 1.00 am to 2.00 pm

Session 3: The Triple Helix Model and Technology Transfer: Evolving a Framework for Developing Countries

The Triple Helix Model: An Assesment: Shaswat Purohit, Franklin Pearce Law Center (2.00 pm to 2.20 pm)

The Technology Transfer Eco System: Ground Realities: Parthiban Srinivasan, Founder, Patent Eagle (2.20 to 2.50 pm)

Coffee Break: 3.00 to 3.20 pm

Session 4: Specific Issues with the Indian Publicly Funded IP Legislation

1. Implications of extending the Bayh Dole concept to copyrights and trademarks: Dr NS Gopalakrishnan (3.30 pm to 3.50 pm)

2. Roundtable Discussion on specific aspects of the Indian Bill : Chaired by Shamnad Basheer: 4.00 to 5.30 pm

Moderators: Mr PH Kurian, Controller General of Patents

Ameet Datta, Partner, Luthra and Luthra

CH Unnikrishnan, IP Journalist, Mint

Venue: NUJS, Salt Lake, Sector III, Kolkata

Date: 12^th September, 2009

Registration is free. However, if you wish to attend, please email Prakruthi Gowda (prakruthipgowda@gmail.com) indicating your name, designation etc.

Our Sincere Gratitude:

We thank the following for their generous contributions, as a result of which we've been able to put this conference together:

1. Patent Eagle, a leading patent analytics firm

2. Luthra and Luthra, a leading full service law firm

3. Sai Krishna Associates, a leading IP litigation firm

4. Lex Orbis, a leading patent firm

The Music Compulsory Licensing Wars: Copyright Board Chairman Likely to be Replaced?

Continuing from an earlier post which laid some tentative doubt on the competence of Dr Raghbir Singh to be appointed as Chairman of the Copyright Board, I've now posted a more detailed constitutional law analysis at Law and Other Things. Whilst opining that the evidence on hand suggests that Dr Singh does not qualify to be a Chairman of the Board, I note as below:

The Copyright Act requires that the post of Chairman be occupied by a person who is qualified to be a High Court judge. Preliminary investigation led me to Dr Singh's CV, which does not carry any prima facie evidence of him having been an advocate of the High Court for at least ten years.

As many of you know, Article 217 (2) of the Constitution requires that:

"A person shall not be qualified for appointment as a Judge of a High Court unless he is a a citizen of India and- (a) has for at least ten years held a judicial office in the territory of India; OR

(b) has for at least ten years been an advocate of a High Court or of two or more such Courts in succession;"

Dr Singh, a PhD in law has had a very distinguished legal career including the following appointments:

1. Indian Legal Service of the Government of India as Parliamentary Counsel/legislative draftsman (September, 1980 – March, 2000)

2. Joint Secretary & Legislative Counsel (21.08.1991 to 20.08.1996) and Additional Secretary (21.08.1991 to 31.12.1997) in the Indian Legal Service in the Legislative Department, Ministry of Law, Justice and Company Affairs, New Delhi.

3. Secretary , Legislative Department, Ministry of Law, Justice and Company Affairs, New Delhi (01.01.1998 – 31.03.2000). 4. Secretary, National Commission to Review, the Working of the Constitution, New Delhi (01.04.2000 to 30.04.2002).

Kumar Padma Prasad Case: Meaning of "Judicial Office"

Impressive though they may be, do the above appointments qualify as "judicial offices" within the meaning of the Constitution? No, says the Supreme Court of India in Sri Kumar Padma Prasad v Union of India : (1992) 2 SCC 428, an important case concerning the validity of appointment of a certain Mr Srivastava to the Gauhati High Court.

The court effectively ruled that any post that is effectively controlled by the Executive (such as the post of Legal Remembrancer-Cum-Secretary, Law & Judicial, held by Mr Srivastava) could never qualify as a "judicial office" within the meaning of Article 217. In pertinent part, the court also endorsed the ruling in Chandramohan that although our Constitution does not envisage a strict separation of powers doctrine, it clearly advocates an independent judiciary: in fact such independence forms part of the basic structure of the Constitution.

Coming back to the Copyright Board matter, it is clear that Dr Singh has never held a "judicial office" for the purpose of Article 217(2), as almost all of his appointments were under the control of the Executive. He does not therefore qualify to be a High Court judge and thereby, is not fit to sit as Chairman of the Copyright Board. Of course, this takes his current bio-data at face value and assumes that he has never been an advocate for ten years or more.

If the above holds true, the government ought to immediately review the situation and take steps to replace Dr Singh as Chairman. Else, these compulsory licensing proceedings, which are the first of their kind in India are susceptible to vitiation at a later stage. Clearly, more billing hours for the lawyers. But a sheer drag on the justice machinery in our country and a tremendous waste of resources for litigants who continue to operate in a climate of legal uncertainty.

PRS to hold a Bill Analysis competition

PRS is holding their annual ANALYSIS competition in which the participants are to take and analyse one of the draft bills that will be coming up for debate in the Parliament. We take a special interest in this years edition since it includes the Draft National Innovation Bill which we have blogged on in earlier posts.

"ANALYSIS 2009 is a national-level legislative analysis competition
organised by PRS Legislative Research, New Delhi.

Participants are expected to produce a succinct three-page analysis of
a Bill likely to come up for debate in Parliament with Members of
Parliament as the target audience.

Eligibility: The competition is open to all law students and current post-graduate students from any discipline.

Prizes:
First Prize: Rs. 20,000
Second prize: Rs. 15,000
Third Prize: Rs. 10,000

For rules and further details visit: http://www.prsindia.org/analysis2009

Last date for submissions: August 30, 2009"

Past panelists for judging this event have included Mr. B. G. Verghese (eminent journalist and Visiting Professor, Centre for Policy Research), Prof. M. Ramdass (former Member of Parliament), Dr. R. Senthil (former Member of Parliament), Justice Ruma Pal (former Judge at the Supreme Court), Governor Ved Marwah (Visiting Professor, Centre for Policy Research) and Justice Y. K. Sabharwal (former Chief Justice of India).
We, at SpicyIP, applaud this effort by PRS at increasing awareness and participation in the happenings of the legislative process.

Pharmexcil Conference on Pharma Patent Litigation and Trade Barriers

Pharmexcil (Pharmaceuticals Export Promotion Council) is organising what promises to be an interesting one day conference on "Patent Litigation and Trade Barriers for Indian Generic Companies" this Friday (21st) in Mumbai. This program has been put together by Dr Gopakumar Nair, Founder of Patent Gurukul on behalf of Pharmexcil.

Details of the conference below:

Chief Guest

Shri Arun Jha, IAS,

Jt. Secretary, Dept. of Pharmaceuticals,

Govt. of India.

Date & Venue

On Friday, 21^st August 2009

At Sunville Banquet & Conference rooms,

9, Annie Besent Road, Worli, Mumbai.

Register at info@pharmexcil.com, romumbai@pharmexcil.com, patents@pharmexcil.com

PHARMACEUTICALS EXPORT PROMOTION COUNCIL

Agenda

“Patent Litigation as Barrier in International Trade”

Full Day Programme

Date: Friday, 21st August 2009.

Venue: Sunville Banquet & Conference rooms, 9, Annie Besent Road, Worli, Mumbai.

9:30 AM – 10:00AM	Registration*
10:00 am- 10:15am	Welcome Address / Introduction of the theme & the speakers
Morning Session
10:15 am- 10:30 am	Address by Chief Guest: Shri Arun Jha, IAS, Jt.Secretary, Departmet of Pharmaceuticals, Govt. of India.
10:30 am – 11:15 am	1. Key Note Address: Barrier to International Trade through patent litigation and new trade agreement By Prof. (Dr.) Shamnad Basheer, Professor in IP Law, National University of Juridical Sciences, Calcutta, Govt. of India
11:15 am – 11:30 am	Tea Break
11.30 am –12.15pm	2. Patent Opposition Procedures & Strategies. By Mr. Essenese Obhan, Obhan & Associates, New Delhi.
12.15pm – 1:00pm	Q & A
1:00pm – 2:00 pm	Lunch
Post Lunch Session Deals with Specific Case Studies
2:00 pm – 3:00 pm	a.) Omni Active Ltd., Mumbai- Kemin filed its suit against OmniActive on July 17, 2007 at the US District Court for the Middle District of Florida for infringing on methods pertaining to the isolation and purification of lutein and lutein compositions.
3:00 pm – 3:45 pm	2. Custom Clearance Litigation on Dual SIM cards and Potential Impact of same types of litigations on Pharma industries. By Mr.Ameet Datta, Luthra and Luthra Law offices, New Delhi
3:45 pm – 4:00 pm	Tea Break
4:00 pm – 4:45 pm	3. Cross Boarder Seizures By Dr. Alka Mehta, Patent Attorney, Cipla Ltd., Mumbai.
4:45 pm – 5:15 pm	4. More Case studies from members have been invited
5:15 pm – 5:45 pm	Panel Discussion
5:45 pm – 6:00 pm	Vote of Thanks

*Note: Registration Fees: Rs.300 (Including Lunch)