Strange Twist in the Novartis Glivec Case: Justice Katju Recuses Himself

The Novartis Glivec saga took a rather strange twist at the Supreme Court, with Justice Markandey Katju recusing himself from hearing the matter.

As noted in a previous blog post, the Intellectual Property Appellate Board (IPAB) held, in what could only be termed as a flight of legal fancy, that since the price of Glivec was too high, it was against "public order" and therefore a patent ought not to be granted in favour of Novartis! It also ruled against Novartis on the grounds of violating section 3(d)--a ruling that may have been a sound one, but for the small quirk that they held, in the same breath, that the drug was "inventive".

Naturally, Novartis appealed, hoping that the Supreme Court would, at the very least, rescue Indian patent jurisprudence from the hands of a flighty IPAB and secure it in more legally tenable moorings. Since the rejection by the IPAB is also based on section 3(d), and standards of determining efficacy are not terribly clear, it is well nigh impossible to predict which way the Supremes are likely to rule.

But enough of the merits of this big ticket patent case. Lets move on to the rather spicy twist in the tale..

As the matter came up today, Justice Katju noted, with a poker face, that it may not be proper for him to sit in on this case. The rumour mill was set in motion, and a dozen theories soon took shape..

One such theory is that he authored a piece in the SCC Journal in 2004 that was critical of pharma patents and MNC's. Titled "Intellectual Property Rights and the Challenges Faced by the Pharmaceutical Industry", he took the reader through the basics of the Indian patent regime and then concluded by noting that:

"The concern of the developing countries, when they are opening their vast markets for international trade by adding safeguards against undue monopolistic exploitation of vital knowledge, techniques or life-saving drugs needs to be taken note of to draw up acceptable standards for protection of intellectual property rights and ensure fair international trade and commerce and bring about some sort of uniformity in this field for all the “convention” countries to follow."

In other words, a balance has to be struck between the need to give monetary inducements to new inventions, and making available these inventions to the broad masses in the underdeveloped countries at affordable prices. At present it is felt that many of the medical drugs available in the market are too costly for the poor people in India. Ways and means should therefore be thought out for making these drugs available to the masses at affordable prices, while at the same time giving inducement to the inventors to continue their research."

I cannot, for the life of me, fathom as to how such a view may be seen as reeking of bias against big pharma patents. In fact, the statements above appear to be quite tempered and balanced. Perhaps he was being overcautious--and if that is so, that will be a "first" for Justice Katju, who is known more for throwing caution to the wind. For those interested, see my article documenting a rather controversial statement, where he equated all bearded individuals with the Taliban.

What is perhaps most paradoxical about this issue is that despite strong allegations of bias, Mr S. Chandrasekharan, former head of the Indian patent office, refused to recuse himself as a member of the IPAB, when it was tasked with the hearing of an appeal against the rejection of Novartis' patent by the Indian patent office. Contrast this with the Honourable Katju who appears to be taking the "Justice must not only be done but seen to be done" aphorism to altogether new heights. Of course, all this assumes that Justice Katju was indeed recusing himself for his innocuous statements published in 2004. And not for some other reason.

Net result: The matter is likely to come up before another bench on Friday or Monday. One hopes that unlike the judges in Roche vs Cipla, the Supremes will not throw away this brilliant opportunity to clarify the scope and ambit of section 3(d), a section that we think is severely creased.

ps: image from here

A "Spurious" Definition: Need to Amend the Drug and Cosmetics Act

As many of you know, the latest amendment to the Drugs and Cosmetics Act came into force on August 10, 2009 vide Central Government notification no. S.O.2076(E). This bill was first introduced in Parliament in December 2003. It was passed as the (Drugs and Cosmetics (Amendment) Act, 2008) by both Houses in October 2008 and received Presidential assent in December 2008.

The fact that this 2008 amendment provides for increased penalties for trafficking in spurious drugs is laudable; however, the rather loose definition of "spurious" is likely to cause severe problems for home grown generic manufacturers. In fact, the recent Bayer vs Cipla drug patent linkage decision by the Delhi High court bears out this fear. Bayer advanced a rather preposterous legal argument claiming that Cipla's generic version of Nexavar would qualify as a "spurious" drug under the Drugs and Cosmetics Act; therefore, it ought not to be approved. As the judge rightly noted, this absurd line of reasoning would effectively mean that no generic could be approved, as all of them would amount to "spurious" drugs. We had presented a similar argument on this blog in an earlier post.

In previous posts, we lauded government efforts that successfully thwarted attempts by the WHO led IMPACT to expand the definition of counterfeit to catch even legitimate generics. It will be a travesty if the government now fails to clean up its own backyard . Given that charity never really began at home, amends must be made to ensure that at least some charity is now shown to be done.

Drawing on the above concerns, Nina Mehta has a very interesting article in the Economic Times calling for an immediate amendment to the definition of "spurious" drugs. I reproduce the article below:

Lack of clarity in drugs Act may hit generic companies

By Nina Mehta

Ambiguity in the amended Drugs and Cosmetics Act over the definition of the terms ‘adulterated’ and ‘spurious’ drugs could affect Indian generic drug players. The amendment, which came into force on August 10 this year after receiving the Presidential assent in December 2008, could complicate both patent challenges as well as regulation of companies, industry observers said.

The amended law has provided for stricter punishment for companies charged with manufacturing ‘adulterated’ or ‘spurious’ drugs. Under the new law, evidence of both adulteration and manufacture of spurious drugs needs to be established for a person to be convicted.

However, the punishment for this has been increased to 10 years imprisonment from five years now, which could extend to life. The monetary fine has also been increased to Rs 1 lakh from Rs 10,000.

However, lawyers feel there is still some ambiguity in the Act, which needs to be addressed immediately. Shamnad Basheer, professor of intellectual property law at the National University of Juridical Sciences (NUJS), Kolkata, said, “Although the increase in penalties for dealing in spurious drugs may be welcome, the fact that the definition of ‘spurious’ remains substantially the same is a grave cause for concern. This definition could be interpreted to even catch within its fold legitimately-authorised generics of good quality and this is problematic.”

Loopholes in the law have been noticed both by intellectual property lawyers and companies alike. This was evident in the recent Bayer-Cipla case. Bayer, in the recent drug patent linkage case, suggested that Cipla’s generic version of Nexavar would qualify as ‘spurious’.

“Given that the government is fighting international efforts such as IMPACT which attempt to define counterfeiting broadly to even catch legitimate generics, the government must, as a first step, clean up its own backyard by redefining ‘spurious’. It must ensure that the term ‘spurious’ as used within the context of drug regulation be simply restricted to substandard drugs.

IP issues should not form part of this definition. And in any case, barring straightforward violations of identical trademarks, the DCGI often does not have the institutional competence to decide complex trademark disputes,” Mr Basheer said.

Another point in the law that is of concern is the non-binding power that it gives authorities. Milind Antani, co-head (pharma practice) at Nishith Desai Associates, said, “The purpose of the amendment is to curb the spread of adulterated drugs and that is a welcome move.

But the powers given to authorities like the state Food and Drug Administration are non-binding on them and there are concerns that these may be misused.” Not all adulterated drugs, he said, originate from the manufacturer. Some come in at various points in the supply chain and the concerns are that genuine companies may also be pulled up for such occurrences.

“With the lack of clarity on the definition of adulterated and spurious, large companies are more likely to use this as a way to block generic companies from challenging their patents and manufacturing generics. This could harm the generic industry as a whole and if it is not sorted out soon, we will see more lawsuits against Indian companies on such grounds,” said the CEO of a generic company who did not want to be named.

Claim Construction II

In the last post on claim construction, I had discussed a few preliminary principles; pursuant to requests from readers asking for concrete examples to explain the principles better, I did a bit of reading and thought it best to explain the application of the principles using judgments, instead of merely parroting a standard list of dos and donts on claim construction. I shall discuss a judgment which was delivered early this month in Exergen Corp. v. S.A.A.T Systems by the US CAFC, with the doctrine of inherent anticipation being the focal point of the judgment. I chose this because inherent anticipation being a slightly grey area, provides us with enough meat to chew on and would help in really testing one’s grasp of the concept, not to mention the ability to explain it in a lucid manner.

Before I proceed with the judgment, let’s discuss briefly the concept of anticipation by comparing and contrasting it with obviousness. Why is this CnC exercise necessary and how is it relevant to this post? This exercise is essential because it is important to understand the distinction between the concept of inherent anticipation and obviousness which requires us to go back to understanding anticipation again.

“Anticipation is a matter of fact and obviousness is a mixed issue of fact and law”, so goes the standard adage in patent law. But isn’t every issue a mixed issue of fact and law? Then why are we drawing this glorious distinction between anticipation and obviousness? What is the true import of this distinction in practice? Anticipation refers to a situation where a single document discloses each and every element claimed in an impugned patent. Why does it need to be a single document? And what is the scope of “disclosure” for the document to anticipate the patent?

The emphasis on a single document is for good reason because if a challenger to a patent relies on more than one document, then he and consequently the Court, has to look for gaps or vacuum in the information disclosed in the documents i.e. the analysis becomes one that of obviousness and not anticipation. The reason being the Court cannot rule out the possibility of the patented invention being genuinely inventive despite various elements of the invention having been disclosed expressly in disparate documents. In other words, the degree of subjectivity in an obviousness enquiry is by nature greater than in an anticipation enquiry.

Ergo, theoretically and crudely speaking, in an anticipation enquiry, what one does, is compare the elements disclosed in a document with the elements claimed in the impugned patent. This is expected to be a mere factual enquiry as opposed to obviousness where the Court dons the mantle of a person ordinarily skilled in the art to comment on the mental leap required by a practitioner to arrive at the impugned invention with state of prior art being the starting point of enquiry. But how true is this in practice? Even assuming that this is the accurate picture on the ground, how does one explain and justify the use or the very presence of the doctrine of inherent anticipation?

It must be understood that be it anticipation or obviousness, the knowledge of a person skilled in the art (aka POSITA) is a relevant factor in inferring what has been disclosed, more so when such disclosure is not express, but implicit. But how often and to what extent can this factor be used in an anticipation enquiry retaining its nature as an anticipation enquiry? This is precisely the question that one needs to answer if the doctrine of inherent anticipation is to be demystified. To find the answer, let’s move to the judgment.

Parties, Forum and Decision
Appellant/Defendant: SAAT Systems
Patentee/Respondent: Exergen Corp.
Forum: US CAFC (Courts of Appeals for the Federal Circuit)
Decision: Decision delivered in favour of the appellants

Facts of the Case
The trial court found SAAT guilty of infringement of Exergen’s US patents 5012813 (‘813), 6047205 (‘205) and 6292685 (‘685). For the purposes of our discussion, what is relevant is that the CAFC held the ‘205 patent to have been inherently anticipated by a prior US patent 4602642 (‘642) granted to another patentee and hence there could be no infringement of an invalidly granted patent.

Technology Covered by the Patents
Infrared thermometers used for measuring human body temperature were the subject-matter of these patents. The thermometers first detected the surface temperature of the human body, such as the temperature of the tympanic membrane or the skin of the forehead and related it to the internal temperature of the body after adjusting it for ambient temperature. The internal temperature was calculated based on the equations provided in the patent and was finally displayed in a digital readout which formed part of the equipment.

Discussion
The ‘205 patent disclosed a thermometer that detected radiation from the tympanic membrane but broadly claimed detection of radiation from a “biological tissue”. The thermometer manufactured by SAAT on the other hand detected radiation from the skin that covers the temporal artery which was subsequently converted to the patient’s oral temperature. Exergen alleged that SAAT’s thermometer infringed its ‘205 patent to which SAAT countered that the ‘205 patent was anticipated by the ‘642 patent.

To resolve the issue, the Court had to construe claims, which means terms had to be ascribed a particular meaning which both parties at issue would find agreeable. Let’s take a look at the independent claim of the impugned Exergen patent (‘205), which read thus:

A method of detecting temperature of biological tissue comprising:
Providing a radiation detector for sensing infrared radiation from an external target;
Sensing radiation from multiple areas of the biological tissue with the radiation detector; and
Electronically detecting the peak radiation from the multiple areas to obtain a peak temperature signal.

The key term which upon literal interpretation is wide in its ambit is “biological tissue”, precisely for this reason it is imperative that this term be imputed a specific meaning bearing in mind the context of its use. Accordingly, “biological tissue” was agreed by both parties to mean “a living layer of external human tissue having a temperature that can be measured”.

“Internal temperature” was the next term construed by the Court to mean “temperature of the region beneath the surface of the biological tissue targeted for measurement”.

Having construed the key terms in the independent claim, to establish anticipation, we would have to compare the elements claimed in the independent claim with the elements disclosed in the anticipatory literature i.e. ‘642 patent. Following are the elements of the ‘642 patent:

1. It discloses a method and apparatus for measuring the internal temperature of a patient’s body by sensing infrared emissions from the external ear canal
2. The apparatus has a probe unit which is heated for calibration upto normal human temperature i.e. 98 F by a chopper unit.
3. Upon calibration, the probe unit is detached from the heating unit (chopper unit) and has to be inserted in the external ear canal within ten seconds of detachment.
4. The probe unit records seven radiation readings per second right from the time it is detached from the heating chopper unit to the time it is inserted in the ear canal. This means that until the time it is inserted in the external ear canal it would have taken 70 readings.
5. Upon insertion, the probe unit is scanned for the maximum reading which is then displayed as the tympanic temperature.

Upon comparison of these features of the ‘642 patent with Exergen’s ‘205 patent, it might be apparent that the former anticipated the latter; but Exergen didn’t think so and following were its contentions to support its stance that ‘642 did not anticipate its ‘205 patent:

1. Since the apparatus described in the ‘642 patent had a heating unit, it meant that the probe unit measured its own radiation in addition to the radiation of the surroundings (which was not stated in express terms in the ‘642 patent); and
2. The ‘642 patent, according to Exergen, measured the radiation only from one spot i.e. the ear canal and not “multiple areas” as claimed by Exergen’s patent.

The first contention shouldn’t have been raised in the first place because it is common knowledge that the thermometer, be it in the ‘642 patent or Exergen’s impugned patent, would measure its own radiation in addition to the radiation emitted by the target surface since it was integral to the process of radiation measurement; this point was conceded by Exergen as well. Also, the Court rightly pointed out that since the term “comprising” had been used in ‘205’s independent claim, the measurement of radiation was not limited to the target surface and included self-radiation (or irradiation) as well.

As for the second contention, the Court again drew Exergen’s attention to ‘642’s specification and pointed out that the probe unit measured readings right from the time of its detachment from the chopper unit till the time it was inserted in the ear. In other words, it did measure readings from “multiple areas” and this was an indispensable feature of its working. The fact that this was not disclosed explicitly in the description did not mean that the feature was not anticipated.

Stated otherwise, a feature or an element or a fact which would per force form part of the invention’s working had to be construed as being inherently disclosed by the anticipatory literature and the absence of an express disclosure of such a necessary feature would not take away anything from the challenger’s claim of anticipation. A crude example to explain this would be that the presence of a nut indicates the presence of a bolt or a mating feature which need not be mentioned explicitly because a person skilled in the art would anyway take its presence for granted.

This is also the key distinction between inherent anticipation and obviousness. Something which a person skilled in the art would have to assume to be indispensable or necessary would fall within the scope of inherent anticipation; however, something which a POSITA may or might have done without much ingenuity on his part would fall within the scope of an obviousness enquiry.

In the next post, we shall continue our discussion on claim construction and look at a few more judgments and critiques on inherent anticipation.

The Mashelkar Committee Report on Incremental Patents: A 3-D Perspective

The Mint carried an editorial of mine on the revised Mashelkar Committee Report. As with other previous posts on this blog, this is an attempt to bust prevailing myths regarding the Committee report and its association with section 3(d).

Encouraging Drug Innovation

The Mashelkar committee report on drug patent law may have stirred controversy, but it sets the right tone

Shamnad Basheer

In a momentous decision for Indian patent law and pharmaceutical innovation policy, the government this month accepted the revised recommendations of the Mashelkar committee. This committee had been constituted in 2005 by the government to study whether a proposed amendment to India’s patents Act that would effectively deny patents to incremental pharmaceutical innovations would violate TRIPS, an international intellectual property agreement under the World Trade Organization. The committee answered in the affirmative.

Not only is this a logical and sound reading of TRIPS, it also ensures that India has taken a step in the right direction to encourage domestic pharmaceutical innovation.

When the report was first issued in 2005, it was mired in controversy, including an allegation that the committee had “plagiarized” bits of a report commissioned from me by a UK think tank. And though I was painted as the alleged victim of plagiarism, I consistently maintained that since the committee had annexed my report to the final report, there was no “plagiarism”. Since then, the committee has retracted the report; it resubmitted it earlier this year, after correcting the allegedly plagiarized portions and reasoning out its key conclusions in a stronger manner.

A large part of the opposition to the Mashelkar report earlier had stemmed from the mistaken belief that the report condemned the existence of section 3(d) of the Indian patents Act, a controversial section introduced at the behest of public health activists and the Left Front in 2005. Thankfully, the committee has now made clear that the report has nothing to do with section 3(d).

Section 3(d) says that any new form of an existing pharmaceutical substance will qualify for patent protection, if it demonstrates increased efficacy. However, the proposed amendment referred to the Mashelkar committee goes far beyond this section and seeks to deny patents to even those new pharmaceutical forms that demonstrate a significantly enhanced benefit. Naturally, such a provision will violate TRIPS, which mandates that patents be granted without discrimination to all inventions in all fields of technology.

It’s worth reiterating that Mashelkar’s brief was never to examine the legal validity of section 3(d). Once again this aspect was lost or deliberately ignored by critics, many of whom were only interested in ad hominem attacks and in discrediting Mashelkar at any cost. They have not, as yet, been able to proffer any convincing critique of Mashelkar’s substantive conclusions on the TRIPS compatibility of the proposed amendment.

Notwithstanding Mashelkar’s recommendations, section 3(d) is, in fact, severely convoluted and requires some heavy-duty ironing by a court of law. Almost every word is riddled with an ambiguity or two, ambiguities that are already proving to be a litigators’ landmine. Little wonder then that the committee recommended that the government issue guidelines to clarify the scope of the section.

My own view is that rather than issuing guidelines at this stage, the government ought to wait for courts to interpret this section. Once we have a good body of case law, the government can proceed to issue guidelines that encapsulate the essence of such judicial pronouncements. In fact, a recent patent case being fought between Roche and Cipla over the patentability of Tarceva, a lung cancer drug, is scheduled to be listed before the Supreme Court in another two weeks. This, therefore, presents the perfect occasion for the apex court to step in and clarify the law relating to section 3(d).

And for those who think that section 3(d) is a mere paper tiger, consider the following statistics that emerged from a study I, along with one of my students, undertook:

Out of 68 cases so far where a pharmaceutical patent application was opposed by generic companies and/or public health groups, the patent office rejected the patent in 46 cases (i.e. approximately 68% of the time). And of these 46 rejections, a good 60% (28) were based on failure to comply with section 3(d).

This not only rules out any patent office bias in favour of patentees, but demonstrates that this section appears to be a potent weapon that is being actively deployed in the fight against frivolous pharmaceutical patents.

However, as stated earlier, the language of section 3(d) leaves much to be desired. And this ambiguity can be interpreted in a manner that either lets in frivolous patents or leads to the denial of patents to genuinely incremental inventions.

The Mashelkar committee report sets the right tone for this interpretative judicial exercise by noting 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”, referring to the practice of extending patents by only tinkering with the substance. That’s a fairly logical proposition and one that does not require any complex vision or character assassination to comprehend.

Shamnad Basheer is the ministry of human resource development professor in intellectual property law at the National University of Juridical Sciences, Kolkata (NUJS). He thanks Shouvik Guha, a fifth-year student at NUJS for research assistance. Comments are welcome at theirview@livemint.com

Breaking News: Supreme Court Dismisses Roche "Tarceva" Petition

Earlier today, the Indian Supreme Court dismissed the special leave petition filed by Roche, challenging the order passed by the division bench of the Delhi High Court. However, the bench consisting of Justice Dalvir Bhandari and Justice MK Sharma (both formerly of the Delhi High Court) ordered that the ongoing trial at the Delhi High Court be expedited. They also stated that nothing in the Delhi Division bench order would bind the trial court judge, who is expected to decide the case on final merits.

By way of background, Roche dragged Cipla to the Delhi High court, alleging that Cipla infringed their patent rights over Tarceva, an anti cancer drug (sold as "Tarceva"). The trial judge, Justice Ravindra Bhat, refused to grant an interim injunction on the ground that since Cipla was selling the drug at 1/3rd of the price of Roche, an injunction would have meant lack of affordable access for a large number of cancer patients in India. Therefore, "public interest" demanded that no injunction (restraining order) be granted.

Roche then appealed to the Division Bench, whose order proved much more detrimental for Roche. Not only did the appellate bench uphold the key findings of the trial judge, it went on to impose costs on Roche for suppression of material "patent" information. It also went on to find that Roche had not established a prima facie case of infringement, since the patent in question did not seem to be implicated by Cipla's generic product. And in any case, the court suggested that Roche's patent was susceptible to a serious validity attack. As we noted earlier on the blog, this order was very poorly reasoned and demonstrated the relative lack of sophistication of Indian judges with complex patent disputes.

The Trial:

In the meantime, the final trial in this case had also begun and a retired judge (SM Chopra) was appointed as a court commissioner to hear evidence in the matter. We are given to believe that the trial is proceeding relatively quickly (by Indian standards) and the key witness of Roche (their constituted attorney, Mr SM Laud) has been examined by both sides. Another 2 expert witnesses of Roche remain to be examined (and cross-examined). And after this, Cipla will put its own witnesses on the stand. All this is expected to take another 4-6 months or so.

Being aggrieved by the order of the Delhi Division bench, Roche approached the Supreme Court by way of a special leave petition, stating that since the Delhi Division bench order raises very important questions of law, the Supreme Court must admit the matter. Justice Dalvir Bhandari and Justice MK Sharma (both formerly of the Delhi High Court) dismissed the special leave petition. The key reason for this dismissal appears to have been the fact that the matter has anyway proceeded to trial on final merits. Were the Supreme Court to take up this matter now, the trial itself could be delayed.

The judges therefore, while dismissing the petition also ordered that the trial be expedited. As I'd remarked in an earlier interview given to CH Unnikrishnan of the Mint:

"Given that Cipla has been selling the drug for more than a year now, it is unlikely that the Supreme Court will now grant an injunction in favour of Roche.

More so, the final trial is now proceeding in the trial courts,” said Shamnad Basheer, professor of intellectual property law at the National University of Juridical Sciences in Kolkata. “At best, the Supreme Court may order that the trial be expedited...”

Although the Supreme Court ordered an expedition of the trial, it refused to indicate any firm time line for doing so. Upon Mr Andhyarjuna's (senior counsel appearing for Roche) request that the court order the trial to be completed in 3 months, Justice Bhandari quipped: "You've anyway taken 4 months (from the date of decision by the Division Bench) to file this appeal...!"

The "Influence" of the Division Bench Order

Interestingly, the judges also stated in their order that nothing in the Division Bench order will bind the trial judge who will ultimately determine the final merits of the matter (i.e. whether, on the full evidence, Roche's patent is a valid one. And whether or not, Cipla infringes). Readers following this case closely will recall that the Delhi Division Bench itself had stated in its order that:

"It is however made clear thatthis order will not influence the decision of the learned Single judge in the pending application IA No.1402 of 2008 and the counter­claim of the defendant in the aforementioned suit."

Conclusion:

While the Supreme Court appears to have taken a sensible route in shifting the focus to the trial, where the matter will be heard in detail and disposed off after an extensive review of evidence and arguments, my own view is that the court threw away a brilliant opportunity to clarify the law relating to interim injunctions in India. For this law is in a state of disarray and the standards deployed by courts are often confusing and inconsistent.

SpicyIP Tidbits: coconut-picking and musician-forgetting

Where have all the nariyals gone?

The industries department of the Government of Kerala has announced a reward of Rs 10 lakh who can invent a coconut-picking machine. According to this report from the BBC, the reward is open to anyone in the world who can create a machine that reaches coconuts at 30 metres. Apparently, professional pickers are becoming a rare species, and coconut palms are bearing the burden. (Image from here)

I second the search whole-heartedly, not least because I am partial to the occasional elneer (tender coconut water). On a recent trip to Kerala, I was disturbed to learn that the best tender coconuts could be found only in neighbouring Tamil Nadu (and I actually drove across to have my share). In addition to the fact that most palms are privately owned, could labour shortage have anything to do with this?

[As an addendum, I would also support any project that ensures the delivery of fresh coconuts to deprived areas. In the parts where I live, we have on offer only dried and very sad-looking tender coconuts that come not from the south of India, but from the eastern coast. Not a patch on what I have had elsewhere.]

UPDATE: At least two of our readers have pointed us to inventions that are already extant in the art, which may be of use here - an Indian invention (patent no. 194566) here and a US invention available here. We hope someone in the ministry is reading this!


Musical memory-loss

Elsewhere, if, like me, you have seen the early days of cable television in India, and are a movie buff to boot, you will surely be looking forward to that dashing cowboy superhero of yore with guntastic talents, Quick Gun Murugun. The movie soundtrack has already found itself a fan following, with some interesting performances by Raghu Dixit and that SaReGaMa veteran Vijay Prakash, but some feathers have been ruffled: Fox Studios and Sony Pictures had apparently forgotten to credit Sagar Desai, the music composer in the credits (and perhaps other people as well), as this rediff news item points out.

As an update to this, I have information that suggests Sagar Desai will be going to court on this matter, seeking to be credited/attributed for his music creations. No formal news on this is out, but if this is true, it is a rare opportunity to study how performer's rights issues are played out in India. We shall be all ears on this front.

Update: Sagar Desai's "Mind It" tactic worked, and he and Fox/Sony/PhatPhish have reached an out-of-court settlement in this matter. No money has changed hands, but credit has been given where it is due. See this story and this story.

IP outsourcing threatens national interest?

The New Wave of Protectionism is here, in IP, too. Outsourcing in IP/law seems to be the latest target of the anti-outsourcing brigade in the US, going by a letter that is doing the rounds. Apparently authored by a Patent Agent at a US law firm, this letter argues that outsourcing in IP, which is "foolish and dangerous", threatens "national interest".

With a subject line that refers to the "Blatent (sic) Disregard or Violation of U.S. Commerce and Trade Regulations by Outsourcing of Patent Applications", the letter is a template that invites readers to forward personally addressed versions of it to their respective (US) Congressional Representatives, and moots for stopping the unlawful export of subject matter of U.S. patent applications being prepared abroad for filing in the U.S.A. (Image from: Flatclassroom)

IPKat has a delightful note on this, which I would urge all of you to read, with not-to-be-missed line-by-line commentary. Check out also the comments that follow the post, noting particularly Anonymous at 7.11.

Surely you're joking, Mr Goel?
Apart from the fact that I suspect it may be spam (spelling error in subject line? - 'erm, this is not a blog post. You're not forgiven'), there's a comic twist to this letter that had me rolling on the floor laughing - the author of the letter is apparently one Mr Gaurav Goel, a Registered Patent Agent with a firm in Texas. I shall not say more on that front.

Ringing death knells with notices?
Meanwhile, the letter indirectly draws attention to a USPTO notice on “the Scope of Foreign Filing Licenses”, which is essentially a reminder to patent applicants and registered patent practitioners that a foreign filing license does not authorize them to send invention disclosures abroad to draft patent applications for eventual first filings in the United States.

This is not a new issue, as readers would recall. Shamnad had blogged on this over a year ago, in an early analysis of the notice, which was followed by a detailed guest post from Dr Sushil Kumar of Clairvolex, a leading Indian LPO in IP, critically analysing the notice and its implications for Indian practitioners. Dr Kumar particularly pointed out that the notice was hardly a "death knell" for the LPO industry, as many had mistakenly feared.

Oh, but what about 'National Interest'?
This letter, on the other hand, wishes to import meaning where none exists, specifically suggesting that US trade rules were being flouted, hinging its argument substantially on the existence of certain groups on the business networking site LinkedIn.com. The letter makes a couple of assumptions on this basis, and I quote from the version at IPKat: that "either the U.S. government is allowing a massive number of U.S. patent disclosures to be sent abroad for preparation, or this is being done without the appropriate government clearances."

It continues:

"If the former is true, then this suggests the U.S. government is undermining our own national interests. If the latter is true, it suggests that many patent owners are exporting subject matter in violation of U.S. commerce and trade policies, while trying to gain advantage of those very same commerce policies, i.e., patent protection, here in the U.S.A. The activity evident on the website LinkedIn.com alone suggests this is being done on a massive scale. There is even a Linkedin group called Outsourcing of Legal Services with a very strong representation of foreign patent workers preparing U.S. applications and correspondence to the U.S.P.T.O."

"National interest" appears to be the primary concern of the letter-writer, repeatedly referred to in the course of the missive, which is apparently threatened by this kind of "foolish and dangerous" outsourcing. It seems futile to go into an explanation of what the US trade rules actually are, and how it impacts an outsourcing country like India. For the moment, I believe an Economics 101 might be overdue, with an International Relations minor thrown in for good measure. (DS curve from here)

CENTAD Conference on Compulsory Licensing and Access to Patented Knowledge

One-Day Preliminary National Consultation on Access to Patented Knowledge

Organized by: Centre for Trade and Development (Centad), New Delhi

Topic:

“Patents and Platform Technologies: Understanding Implications for Research and Development in Malaria and Tuberculosis”

Date: 9^th September 2009 (Wednesday)

Venue: Magnoria Hall, India Habitat Centre, New Delhi

The International Development Research Centre (IDRC), Canada, commissioned a study to Centre for Trade and Development (Centad) in the area of access to patented knowledge. Centad is among the six worldwide research based organizations selected for conducting the study. The title of the study is “Utilizing Compulsory License as a Means to Access Platform Technologies in the Healthcare Sector” The study is with special reference to research and development in malaria and tuberculosis (TB). The overall objective of the study is to explore the possibilities of utilizing compulsory licenses to secure access to ‘platform technologies’, so as to promote greater access to healthcare technology in the country. In this regard, the study proposes to:

Ø Document the platform technologies essential to develop treatment for malaria and tuberculosis and trends in patenting thereof.

Ø Study their implications for downstream products and implications for the treatment of malaria and TB and recommend technologies qualifying to be compulsorily licensed.

Ø to draw a correlation between the current state of research and those technologies which are not openly available, so as to make a case for compulsory licensing of technologies where necessary

Ø Evolve a regulatory response by using compulsory license as a means to access platform technologies- through the patent law and competition law framework.

Ø Explore ways and means to integrate the concept of “Right to Compulsory License” into the administrative and judicial processes, in order to facilitate access to upstream technology.

Ø Explore linkages between the “Right to Health”, access to technology and compulsory licenses.

As part of this study, Centad is organizing a preliminary national consultation with an aim to elicit views and expert opinion for arriving at a formal understanding of bottlenecks in research and development of drugs, diagnostics and vaccines (including prophylaxis) relating to TB and malaria presented by the patenting of ‘platform technologies’ in India. First, the consultation would provide an opportunity to understand the current state of malaria and TB research, globally and in India. It would also provide an overview of current technologies being used and explored in developing new drugs, diagnostics and vaccines, including trends and patterns in their ownership. Second, the consultation would help to conceptualize and contextualize patenting of ‘platform technologies’ and access related issues. Third, it aims to provide a brief understanding of key challenges in articulating a possible regulatory response from a patent law and competition law perspective. Fourth, the consultation would help the research team to possibly identify a framework for conducting a field audit in India for further mapping/identification of such specific technologies, including trends in patenting thereof. This is with a view to draw potential implications of patenting of platform technologies on downstream & follow-on research and development.

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Tentative Programme Schedule

9:00 am to 9:30 am– Registration

9:30 to 10:15 am – Inaugural Session

Welcome [5 minutes]: Centad

Introduction to the Study and the Consultation [5 minutes]: Project Convener

Key note address [20 minutes]: Prof. Samir Bramhachari, Director General, CSIR (TBC)

“Research and Development in TB and Malaria in India: Key Challenges Ahead”

Vote of Thanks [5 minutes]

10:15 – 11:00: Session I: TB and Malaria India Factsheet Chair: P. R Narayanan, Former Director, TRC, Chennai (TBC)

Ø TB Disease burden and disease profile [20 minutes]- Prof. D. Behera, Director, LRS Institute of TB and Respiratory Diseases, New Delhi {Confirmed}

Ø Malaria Disease burden and disease profile [20 minutes] – Prof. A P. Dash, Regional Advisor, WHO SEARO, New Delhi {Confirmed}

11:00- 11:15 – Tea Break

11:15 to 12:15 – Session II: Current state of research in TB and Malaria: Overview of the global scenario and Indian efforts- Chair: Dr. Weerasuriya, WHO {Confirmed}

Ø Current state of global research and expected outcomes in TB: Dr. Vanaja Selvakumar, Scientist, TRC, Chennai (TBC)

Ø Current state of global research and expected outcomes in Malaria: Dr. Sarala Subbarao, INSA Sr. Scientist in the ECD Division of ICMR and former Director, National Institute of Malaria Research {Confirmed}

Ø Research institutions and areas of research: Focus on the Indian scenario- Dr. S. Visalakshi, Former Scientist, NISTADS [15 minutes] {Confirmed}

12:15 – 1:30: Session III: Technology Identification and Proprietorship- Chair: Dr. Sarala Subbarao, Former Director, NIMR (TBC)

Ø Technologies/ Methods employed in TB research [15 minutes] Dr. Selvakumar, Scientist, TRC Chennai {Confirmed}

Ø Technologies/ Methods employed in Malaria research [15 minutes]: Dr. Harish Padh, Director, PERD Centre, Ahmadabad (TBC)

Ø Novel technologies for Malaria vector control: Challenges in development and deployment [15 minutes]: Dr. S S. Vasan, Visiting Research Fellow, University of Oxford and Head of Public Health, Oxitec, England {Confirmed}

Ø Ownership patterns in TB and Malaria technologies [15 minutes]: Dr. Subramaniam, SNA Patent Attorneys- New Delhi {Confirmed}

1:30 to 2:30 pm Lunch Break

2:30- 4:00 pm – Session IV: Considerations in Accessing Patented Platform Technologies – Chair: Prof. A P. Dash, Regional Advisor, WHO SEARO, New Delhi; or Dr. Subramaniam, SNA Patent Attorneys (TBD)

Ø Conceptualizing platform technologies and challenges in accessing patented research [10-15 minutes] –Dr. Ravi Dhar, Staff Scientist, Hear IPR Office, National Institute of Immunology, New Delhi {Confirmed}

Ø Some examples of blocking patents and impact of patenting intermediate and platform technologies for follow-on research [15 minutes each]

o Dr. Ram Vishwakarma- Director, IIIM, Jammu {blocking patents in intermediate chemical technologies} {Confirmed}

o Dr. Raghuram, Scientist, IP University, New Delhi- {cases of blocking biotechnology patents} {Confirmed}

Ø Industry views – Considerations in selecting/adopting platform technologies [Technical and financial considerations/ Price and non-price constraints in use of patented technologies- technology lock-in; Licensing issues]

o Dr. K K. Rao, C & MD, Transgene Biotek Ltd. Hyderabad {Confirmed}

o Dr. P K. Ghosh, Managing Director, KEE-GAD Biogen Pvt. Ltd. {Confirmed}

Ø Patenting Public funded Research: Is there a case for open access to platform technologies? [10 minutes]: Subbaih Arunachalam, Distinguished Senior Fellow, Centre for Internet and Society, Bangalore {Confirmed}

Ø Alternative mechanism for Drug Discovery and possible challenges posed by patents on platform technologies: A view from the OSDD Initiative [10 minutes]- Zakir Thomas, Project Director, CSIR- OSDD{Confirmed}

4:00 to 4:15 pm: Tea Break

4:15 – 5.30 pm: Session V- Is the regulatory framework prepared for the uncertain? Chair: Prof. Biswajit Dhar, Director RIS, New Delhi (TBC)

Ø An exposition on “workable solutions” in accessing patented knowledge: How far have they worked?- Yogesh Pai, Associate Fellow, Centad [15 minutes] {Confirmed}

Ø Standards of patent law threshold: A view from the patent office: T V. Madhusudhan, Asst. Controller of Patents & Designs. [15 minutes] {Confirmed}

Ø Accessing patented knowledge: Compulsory license under patent laws in India (K M. Gopakumar, Legal Advisor and Senior Researcher, Third World Network) [ 20 minutes] {Confirmed}

Ø Accessing patented knowledge: Compulsory license under Competition law- Shamnad Basheer, Professor, MHRD Chair on IPR Law, NUJS, Kolkata [20 minutes]{Confirmed}

Ø Concluding Discussion {10- 15 minutes}

­­­RSVP: Yogesh Pai Associate Fellow, Centad, New Delhi

Ph: +91-11-41459226 (o); Fax: +91-11-41459227

Email: yogesh.pai@centad.org ; legaloracle@gmail.com