An IP Policy for the Aam Admi: Is the new UPA Government up for the challenge?

It’s been two weeks since the Indian electorate, defying all poll predictions, voted the Congress led UPA Government back into power (minus the comrades from the Left parties). The resounding victory of the UPA Government is widely seen as the vindication of the UPA’s aam-admi (common man) policies such as the NREGA and the agricultural loan waiver.

Since PM Manmohan Singh’s government has proposed a 100 day action plan for various ministries it is but obvious that we must chip in and propose a revised IP policy which extends the concept of intellectual property to stimulate innovation amongst even the aam admi be it the grass-root innovator or various knowledge rich, resource poor indigenous communities around the country. As you may remember Shamnad in one of his earlier posts urged the creation of more informal IP norms to extend the benefits of IP to even the informal economy. There is no better time to push for such a policy especially since the aam admi is back on the agenda.

The two legislations that I had in mind for this purpose are Firstly a Utility Model Protection System and Secondly a sui generis system for protection of traditional knowledge.

A Utility Model Protection System: One of the drawbacks of the current Patents Act in India is the fact that it lays down a very time-consuming, expensive process to secure patent protection. Additionally the standard of inventiveness under this Statute is considerably higher than the level of innovation that is likely to be demonstrated by a grass-root innovator. Therefore in all likelihood it will be quite difficult for a grass root innovator to secure patent protection for his invention under the patent system. This is to the detriment of only the grass-root innovator but also the economy as a whole.

As demonstrated by the National Innovation Foundation and the Honey Bee Foundation there is immense potential for grass-root innovation in India. In fact the Honey Bee Foundation has an exhaustive directory of grass root innovations in India. As evidenced by the vast amount of literature published on its website there is a desperate need for a Utility Model Protection System in India.

The chief advantages of a Utility Model Protection System (aka Petty Patent System) is that it will be cheaper and easier to get protection under such a system since there will no exhaustive examination of the claimed invention. An exhaustive examination of the invention will take place only if infringement has taken place. Additionally the threshold for protection under this system will be significantly lower. Obviously even the term of protection under such a system will be significantly lower. As a sum of all these advantages the grass root innovator will be in a better position to secure protection for his Intellectual Property. For more on utility model protection system please download this excellent and exhaustive paper on the topic by Dr. Kardam, Assistant Controller of Patents, India Patent Office.

A sui generis TK legislation: From what little I’ve heard a sui generis Traditional Knowledge legislation was drafted and doing the rounds somewhere in India but never saw the light of day. There seems to be a very romanticized notion of traditional knowledge i.e. something which existed in the yesteryears which does not have to be protected. However even Traditional Knowledge needs to be constantly replenished. There is no denying that there is scope for furthering innovation and creativity even in the field of traditional knowledge. In order to replenish the existing traditional knowledge it is necessary to provide the holders of such knowledge with property rights so as to give them an incentive to innovate further. Currently under the Patents Act traditional knowledge is not patentable. One way of getting around this is to have a legislation which focuses on the protection of only traditional knowledge. Several other countries have framed sui generis legislations for protections of traditional knowledge system and these can be viewed on the website of WIPO.

The Biological Diversity Act attempts to provide some kind of incentive to communities which have held traditional knowledge of their environment. This legislation however goes about it the wrong way. It has absolutely no requirement of Prior Informed Consent i.e. the community holding the knowledge has no right to oppose commercialization and utilization of their knowledge. Instead it is the National Biological Authority which decides the terms of commercialization. To an extent this amounts to nationalization of the traditional knowledge held by these communities. It is indeed quite surprising that such a legislation was passed at a time when the rest of the economy was being liberated from the shackles of government control. Regardless to say there is definitely a requirement to empower the holders of traditional knowledge and give them a greater say in controlling the terms on which their knowledge maybe disseminated.

Hopefully the Government of India will consider an IP policy for the aam admi.

WIPO copyright treaty for blind kept on hold

There were a few anxious faces in WIPO, Geneva (and elsewhere) yesterday, as a US-Canada-EU lobby tried to block a copyright treaty proposal protecting the rights of people with disabilities to access digital material. Discussions were left hanging, though, and will continue in the next edition of the Standing Commitee on Copyright and Related Rights (SCCR), tentatively scheduled for Nov 30-Dec 4 2009. The Treaty, which can be accessed here, was introducted by the World Blind Union, and tabled by Brazil, Ecuador and Paraguay.

Jamie Love of Knowledge Ecology International was tracking the discussions live, and blogged for Huffington Post, detailing the contents of the treaty:
"The treaty seeks to allow the cross-border import and export of digital copies of books and other copyrighted works in formats that are accessible to persons who are blind, visually impaired, dyslexic or have other reading disabilities, using special devices that present text as refreshable braille, computer generated text to speech, or large type. These works, which are expensive to make, are typically created under national exceptions to copyright law that are specifically written to benefit persons with disabilities."

The impetus for such a treaty comes lies in the limited number of accessible works for such disabled persons, compared to the tomes available to "sighted" persons. This is compounded by the limited access to texts in non-English languages. The opposition from the US and others is purportedly because of internal lobbying from publishers whose agenda is to expand rights for copyright owners.

However, this debate is not particularly new, and indeed has its origins in a 1982 WIPO and UNESCO Working Group on Access by the Visually and Auditory Handicapped to Material Reproducing Works Produced by Copyright. As Jamie Love tells us in the KEI blog, "the debate in 1982 was similar in many respects to the debate today, with attention to issues such as remuneration or non-remunerative exceptions, whether or not exceptions should be avoided in favor of private negotiations with copyright owners, and how to prevent the accessible works being used by members of the general public." The parties were near identical on either side of the table. The main difference lay in the present focus on the cross-border transport of works, which was absent in 1982.

Although India does not seem to have been an active participant on this occasion, the timing of this discussion is nevertheless appropriate, for it coincides with the launch of www.readable.in - the world's largest user-generated library of books accessible by the visually-impaired. (There's a screen-grab on the left). The web-resource is a joint initiative of the Centre for Internet and Society and Inclusive Planet, whom you can read more about here. It may be an unrelated link in the sense that the digital material presently available is all out of copyright, and the website has a clear take-down policy here. But it doesn't deny the fact that this is an amazing and much-needed initiative, and promises a lot. If mainstream publishers are enterprising enough, they would actually consider sponsoring uploads. Some of you may find that a tad too fanciful.

I know I sound really old when I say this, but I still remember the days when, as college volunteers, students spent time at neighbourhood schools for the visually impaired or at university, to read out or even record (on analog tapes) entire books (fiction/reference) for students to access. I'm sure this student volunteer support system won't die out immediately in some parts of the world, but it's great to see digital technology and inclusiveness make a rare appearance on the same page.

IP management in Indian agricultural research

The public-funded agricultural research system in India is gradually trying to supplement its "soft" defence against misuse of IP (e.g., through placing assets in the public domain through disclosure) with more aggressive IP protection strategy, in keeping with evolving national and international policy. But IP management in agricultural research in the country continues to be challenged by constraints of scale, human resource, and awareness, among other things. This directly impacts the system's ability to strategically leverage its traditional advantage of being a region rich in agri-biodiversity.

These, and other issues, have been brought to light in an fascinating case study on the Intellectual Property Management Regime in the Indian National Agricultural Research Systems, authored by Dr Kalpana Sastry of the National Academy of Agricultural Research Management (NAARM). This study forms part of a compilation of four such cases on the Institutionalisation of IP Management in Agricultural Research Institutions in Developing Countries brought out by the Central Advisory Service on Intellectual Property (CAS-IP). (Dr Sastry, some of you may recall, is also the Course Director of the PG Diploma on IP and Technology Management in Agriculture, which was profiled some time ago on the blog.)

The paper (which you can read/download here) looks at four countries (India, Tanzania, Nigeria and Kenya), but for this post, I draw your attention to the issues raised in the India study, the stated purpose of which is to "understand and explore modalities to improve the effectiveness of the IP management and technology transfer guidelines in agriculture based public sector institutions in India".

The study itself focuses on the Indian Council of Agricultural Research (ICAR) system, for reasons of its being the nodal agency for agri-research in India. Since 2006, ICAR has been operating with a three-tier decentralised IP management structure, which is applicable to all the organisations that form part of the National Agricultural Research System (NARS) (see image). Through a micro-study of two institutes within this structure, the study brings out characteristics, challenges and opportunities that are present for successfully managing a potentially rich portfolio.

Two key IP management practices in ICAR emerge:

• Plant variety registration and protection has been prioritised for extant varieties of notified crops (subject to meeting conditions of notification) under the Protection of Plant Varieties and Farmers' Rights Act.
• ICAR guidelines also encourage institutes to deposit samples/resoures at the National Bureaus for Genetic resources, including Plants, Animals, Fish and Microorganisms, primarily for reasons of public interest.

Clearly, the research system is still coming to terms with utilising mainstream IPRs. This is something that will dominate discussion in the months to come with resumed activity on the Protection and Utilisation of Public Funded IP Bill, and tangible results have a while to present themselves.

Of more interest is the issues that need attention and intervention, identified through detailed questionnaires set for the institutions under scrutiny. This list is culled from the case study itself, and some of these are generic and/or well-established, but readers are welcome to highlight other distinctive issues in agri-IP-management that may be of relevance here:

• Lack of awareness, knowledge and training among scientists. One responding institute said that only *two* scientists had ever attended awareness programmes at ICAR!
  
• Speedier processes for registering extant varieties, considering that this is a policy priority for ICAR.
• Streamlining systems to test for Distinctiveness, Uniformity and Stability (DUS) for registering plant varieties, and subsequent filing procedures. At present, responsibility/accountability issues have led to duplicate filings, which eat up time and other resources.
• Building, and learning how to build, stronger IP portfolios.
• Exhaustively inventorise, audit and value IP, which is made available through a transparent information system.
• Assessing freedom to operate.
• Systematise agreements with external collaborators and sponsoring agencies.
  

There remains some cloud over fundamental questions surrounding IP protection - of how the public sector as a major holder of IP in agriculture would affect access to resources, and other key public interest matters. Again, this demonstrates the problem of lack of engagement and discussion with scientists and participants in the system, something that has been highlighted time and again by those tracking scientific research in India.

Although there is the immense caveat that this case study comes from within the ICAR system itself, it does serve as an insight into the workings of this giant elephant that is Indian agricultural research, which could come from nowhere else but from within. More than anything else, it offers an opportunity for policymakers in ICAR to "listen" to its own people, and initiate immediate reforms in its internal IP management to minimise subsequent criticism from the outside.

"Quinn" Poll for Leading Patent Blog: Please Vote

For those interested, Gene Quinn of IP Watchdog is conducting a poll of the top patent blogs.

He has listed 50 leading patent law blogs and is calling for readers to indicate their favourites. SpicyIP is grateful for making this shortlist.

Gene's survey comprises two key questions:
i) Which is your favourite blog (only one selection can be made here)
ii) Which blogs do you regularly read (multiple selections can be made here)

Voting continues till 30 June and the results are expected at the start of July.

If you think us deserving enough of your vote, would you please take a moment and click here? Thank you for your time.

"Bullet" Kurian Unleashes More Reforms To Indian Patent and Trademark Office

"Bullet" Kurian, the swift high energy Controller General of the Indian Patent and Trademark Office, has struck again. And this time with a good 5-6 policy measures aimed at streamlining the functioning of India's patent and trademark administration and making it more transparent and efficient. Some of the prominent ones are listed below:

1. Specialised Work Allocation

An oft cited problem with the Indian patent office is the fact that patent applications are often allocated arbitrarily to examiners, without regard to their specific qualifications . In other words, an examiner with a background in IT is often confronted with a biotechnology patent application.
Kurian seeks to tackle this issue through an order dated April 29, 2009 which reads in pertinent part as below:

"At present there is no uniform practice of allotment of patent applications for examination at the Patent Office..... The existing practice of attaching examiners to a particular controller is not on scientific basis, with the result that the controllers/examiners are getting patent applications outside their field of expertise for examination...."

In order to rationalise the allotment of patent applications and to further improve the quality of examination, the order goes to divide examiners and controllers into 4 subject specific groups:

i) Chemistry and Allied Sciences

ii) Biotechnology and Microbiology

iii) Mechanical and Allied Subjects

iv) Electrical, Electronic and Allied Subjects

Each group will have a group leader, who is responsible for co-ordinating the process of ensuring that applications that fall within his/her respective group is allotted to examiners within that group.

Complementing the above order are two further orders:

2. Conformity to the Indian Patent Classification (IPC)

An order dated May 20, 2009 calls for strict compliance with the International Patent Classification (IPC) in the classification and screening of Indian patent applications.

3. Transfers

Several orders transferring officials between the four branches of the Indian patent and trademark office (IPTO) have been issued. CH Unni covers this in a Mint article. These transfers are interalia meant to further the objective of the specialised work allocation agenda outlined above. Illustratively, if Chennai has an excess of biotech examiners, and Delhi a deficit, then examiners are transferred from Chennai to Delhi. All these orders are available on the Patent Office website.

4. Calling for More Professionalism by Patent and Trademark Attorneys

In a rather bold move, PH Kurian has lambasted attorneys who submit shoddy applications noting as below:

"During the past four months of my experience as CGPDTM, it has come to my notice that a majority of the patent and trade marks applications are not complying with the legal formalities. It is a matter of shame for me that the patent/trade marks agents who have passed the examination and qualified themselves to be agent are continuously making such mistakes in the applications thereby creating lot of constraints on IP administration system in sending notices to comply with simple legal formalities, whereas you as a qualified /registered agent is expected to be well aware of the legal formalities.

I personally appeal to you to be diligent while prosecuting the patent/trade mark application. Your care and caution will go a long way in making the system efficient to serve you and your client in a better fashion."

5. Identity Cards to Curb Corruption

In yet another bold move, Kurian passed an order restricting entry to the IPTO. Henceforth only authorised agents with valid ID cards (issued by the IPTO) will be permitted to enter the IPTO offices. One might hazard a guess that this move to regulate entry and exit into this office is interalia with a view to quelling corruption and other cosy relationships that have a greater propensity for taking root in an unrestricted environment.

6. Soliciting Officers on Deputation

In a very important move, Kurian is now soliciting qualified officers and academics to come on deputation to the IPTO from other government departments, public sector undertakings and even from Universities. As one will appreciate, this will add more manpower and expertise to an office that is crunched for resources. Importantly, it is a terrific opportunity for government folks and even academics to experience the workings of an institution that is growing in global importance (and efficiency) each day. For those interested in taking up these positions, apply soon.

Given past allegations of corruption and inefficiency, these measures will go a long way towards correcting some of the institutional infirmities that unfortunately crept into the workings of the Indian Patent and Trademark Office (IPTO). More importantly, one hopes that these bold measures to increase transparency and efficiency continue unabated long enough to help this office attain the best international standards. And to convert it to a govt agency that others (both in India and abroad) consider worth emulating.

Susbscription to SpicyIP Posts

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"IP" Centric Law Degree by IIT-K Threatened

As some of you may be aware, a generous bequest by US billionaire Vinod Gupta helped kickstart the Rajiv Gandhi School of Intellectual Property law (RGSOIPL), India's first specialised law school, focusing on intellectual property law (IP). This school, which is based out of IIT-Kharagpur has been operational since 2006 and has strong ties to the George Washington University law school, one of the top IP law schools from the US.

Although this law school does not only teach IP, but a string of other legal courses normally taught at the other law schools, it restricts admissions to candidates with a first degree in science. In pertinent part, the IIT-K website notes: "The School presently has one programme: Six-Semester, Three-Year Full-Time residential LL.B. Programme leading to the Degree of Bachelor of Law with specialization in Intellectual Property Rights, at par with the LL.B. Degree requirements of the Bar Council of India."

Just as this novel experiment in specialised legal education produced its first set of law graduates this year, it has been hit with a legal challenge. Express Buzz reports:

"The Supreme Court has issued notices to the Bar Council of India, Indian Institute of Technology, Kharagpur and to the Secretary, Ministry of Human Resource Development on a writ petition questioning the propriety and correctness of the Bar Council of India in giving permission to IIT, Kharagpur to start a course in LLB in Intellectual Property Rights. A Bench comprising Chief Justice K G Balakrishnan, Justice P Sathasivam and Justice Deepak Verma directed issuance of notice after briefly hearing advocate Sanjay Parekh.

The petition filed by M Chandrasekhar, an advocate of the apex court, pointed out that the eligibility for joining an LLB course is a graduation in any discipline, that is BA, B. Com, BSc etc. The petitioner pointed out that LLB is an entry-level professional course in law wherein a candidate is taught basic principles of law in a number of subjects. If any candidate desires to specialise, he can opt for LLM course in a subject of his choice like Constitutional Law and Contracts. But, for the first time, the general character of the LLB course is sought to be changed by IIT Kharagpur by starting a specialised course in Intellectual Property Rights and that too restricting admission only to BE, B Tech, MBBS, M Pharma, MSc, MBA with Science/Engineering background, the petitioner averred."

Towards Specialised Law Schools?

Given the sheer dearth of skilled patent lawyers in this country, I am very partial to the idea of a specialised IP law school. Particularly since the premier legal institutes in the form of the National law schools do not focus on science at all, a discipline that is absolutely essential for churning out decent patent lawyers. The National Law University (NLU), Jodhpur does offer a B.Sc. LLB, but I am not entirely sure if the level of the science taught as part of the BSc is adequate. The head of the IP Division of a big Indian pharma company once confided to me that these candidates were of no use to them, as the science taught was fairly elementary.

NUJS offers a very curious BA/BSC LLB degree, but there is no science taught at all. Dr Madhav Menon, the founding director of this law school may have intended for this law school to provide a science option as well, but this never really kicked off. The nomenclature seems more of a historic relic now.

Anyway, back to the dispute at hand and legal challenge mounted against the grant of approval to RGSOIPL's 3 year LLB course. I don't necessarily see a problem with a specialised "IP" focus in an entry level LLB course, provided other foundational legal courses such as contracts, torts, criminal law, constitutional law etc are also taught. I'll try and bring you a more detailed note on the specific legal issues once I lay my hands on the petition. In the meantime, let me try and highlight some of the broader issues raised by this recent controversy:

i) To what extent do law schools comply with the Bar Council of India (BCI) norms?

ii) Should the BCI (in its current form) be permitted to regulate legal education at all? Does it have the institutional competence to do so?

Compliance With Bar Council Rules?

To answer the first question, a couple of months back, I checked the Bar Council of India (BCI) requirements applicable to the five year integrated law degrees (BA LLB, BSc LLB etc) and found that none of the law schools were likely to comply with the fairly onerous requirements spelt out by the BCI. In particular, given that these schools accord rather step motherly treatment to the BA component (having a mere 5-6 courses of history, economics and political science), they are likely to fall foul of the BCI mandate that the BA or BSc syllabus "has to be comparable to the syllabus prescribed by leading Universities in India in three year bachelor degree program in BA, B.Sc, B.Com, BBA etc taking into account the standard prescribed by the UGC/AICTE and any other respective authority for any stream of education".

The BCI norms appear to require a good 14-20 courses to cover the "BA" component--which is way beyond the current 5-6 course offerings in this regard by the law schools.

Institutional Competence of the BCI?

As for the second question, most academics abhor the thought of having legal education in India solely dictated by the BCI, most of whose decision makers are practitioners with no real insights into legal education policy. And this sentiment has been echoed by the National Knowledge Commission as well, which recommended that course curriculum etc be designed by a new standing committee on legal education under a proposed Independent Regulatory Authority for Higher Education.

Arun's paper titled "The Waning of a Magnificent Obsession: An Abridged Story of the History of Legal Educational Reform in India" (which I referred to in an earlier post on Law and Other Things) has some fascinating insights into this issue. He discusses the Gajendragadkar Committee Report of 1964 in this regard and notes:

"The Committee had noted the distinction made under the Advocates Act, 1961 according to which, theoretical or scientific legal education would be in charge of the Faculties of Law working under the different Universities in India and the practical or technical legal education would be in charge of the State Bar Councils. To remedy the situation, the Committee had recommended that the Bar Councils and the Universities should act in concert and agree upon evolving suitable criteria for both theoretical and practical forms of education. However, the Committee felt that a more substantive and long term solution to the problem would be the creation of a statutory body called the Council of Legal Education which could be given supervisory control over all aspects – theoretical, practical and incidental – of legal education in the country. The Gajendragadkar Committee was of the opinion that the Council should be constituted on a high-power basis and be composed of judges, law teachers, members of the Bar, and representatives of industry or other fields which would have an interest in law.

The Committee did not elaborate on the details of the constitution of the Council or on its powers, but felt that the constitution of such a Council by Parliament would facilitate the progress of legal education along healthy lines. Similar suggestions have, over the years, been made by several persons who have had some experience with policy making in the field of legal education, and recent fiascos like the V.Sudeer case only serve to heighten the urgency of the requirement of such a unified authority."

Customs Authority as Copyright Watchdogs: A Welcome Initiative?

It all started with an order dated 28.03.2008 passed by the Commissioner of Customs (Export), JNCH, Nhava Sheva, in the matter of AMI International v. Commissioner of Customs (Export), MANU/CM/0028/2009, confiscating 626 cartons of Printed Books that were being consigned from Mumbai by a company named M/s Ami International, to the Ethiopian Ministry of Education. On examination, it had been found that the books under export were not original books, but photocopies of the same (as many as 23 different titles, no less!) bound in book form.

Despite being asked by the customs authorities to produce the details of copyrights of the books under export and to furnish license from the copyright owners, permitting such photocopying, M/s Ami International failed to do either. However, the latter did state of having procured a tender from the Ethiopian Ministry of Education, through an agent to photocopy various titles of books for the purpose of use in libraries of Bahirdar University, Ethiopia by the students and that the said books were not meant for sale. They also stated that the buyer, i.e. the Ethiopian Ministry had provided original samples of the books for photocopying.

On further enquiry, the Customs Authorities discovered that the copyright for one of the books rests with M/s Prentice Hall of India Pvt. Ltd., who claimed that the export of the said goods by any other person is violation of their right and, therefore, they requested detention of the books attempted to be exported. Subsequently, a Show Cause Notice was issued by the Customs Authority to M/s Ami International proposing confiscation of the goods in question and also proposing imposition of the penalty, on the grounds that M/s Ami were in violation of Sections 51(a) and (b) of the Indian Copyright Act, 1957 and therefore, export of said photocopies were prohibited by Sections 11(2)(n) and 11(2)(u) of the Customs Act, 1962 and hence the said consignment ought to be confiscated under Section 113(d) of the 1962 Act. The Commissioner adjudicated in accordance with this view, following which an appeal was lodged by M/s Ami before the Customs, Excise and Service Tax Appellate Tribunal. The appellants raised several contentions, not all of which were without merit, viz.

(a) that the Customs Act cannot apply to violation of Section 51 of the Copyright Act,

(b) that under the Copyright Act, only violation of Section 53 has been extended as a prohibition under Section 11 of the Customs Act,

(c) that there is no provision prohibiting alleged illegal export of infringing works in the Copyright Act similar to Section 53 thereof that prohibits importation of infringing work,

(d) that before invoking Section 51, the Commissioner ought to have framed issue and recorded finding whether Copyright subsist or exist in the impugned works, for which Sections 13, 16, Chapters V & IX etc of the Copyright Act are required to be considered,

(e) that the Commissioner is not an authority to adjudicate either violation of Section 51 or the issue whether Copyright exist or subsist in the work and that a Custom Officer has only the power to confiscate goods, which are declared prohibited goods and not adjudicate and declare prohibition and

(f) that there is no violation of the Section 51 of the Copyright Act, 1957, as Reprography does not constitute infringement.

In support of their contentions, the appellants relied on cases like B.K. Dani v. State of M.P. reported in 2005 -Crlj-0-876, 2005 (TLS) 1404631, Commissioner of Central Excise, Jaipur v. Pukharaj Moondra MANU/CE/0236/2001 and Penguin Books Ltd. England v. India Book Distribution MANU/DE/0402/1984 as well as commentaries such as "Law Relating to Intellectual Property" by Dr. B.L. Wadhera, Fourth Edition (page 320).

A.K. Srivastava, Member of the Tribunal, held that the Commissioner should make comprehensive reference to the competent authority in the Copyright Act giving full facts of the case and details of all the 23 photocopied books in question and take appropriate action as per law on receipt of the clarification from him in this regard. Regarding the legal issues raised, he held that since said issues had not been raised by the appellants before the Commissioner, in the absence of any finding of the Commissioner, he cannot reach at a conclusion regarding the same and hence remanded the matter to the Commissioner for de novo decision.

As has been said, the points raised by the appellants do not seem entirely devoid of merit. The question as to the jurisdictional capacity of the Commissioner in particular is one of considerable importance. One can also wonder as to whether the Commissioner can adjudicate issues regarding his own jurisdiction, as the Tribunal has obviously directed him to do in an extension of the well-known kompetenz-kompetenz principle prevalent in arbitration. Having said that, it is obviously an event to bring hope to the advocates of stronger intellectual property regime, since it paves the way for better enforcement of copyright law in particular with the invaluable help of an agency that has hereinbefore remained neutral about the same.

p.s. The author is grateful to Ashly Vasu of Manupatra and thanks the same on behalf of Spicy IP members for drawing attention to this interesting (but neglected so far) case.

Part II: Novartis feels the heat of the Indian Summer. What is the fate of similar applications filed by Indian Manufacturers?

Following the concerns raised over allegations of lack of uniform standards of the Indian Patent Office in part I of this post series, this post attempts to put forth details of the various patent applications made by Indian companies (claiming patent for variants of imatinib mesylate). The aim is to get readers familiar with this area to comment on the possible outcome of these applications given the rigorous Section 3(d) standards as introduced applied in the Novartis case.

To reiterate, there are several patent applications by domestic pharmaceutical companies relating to different forms of imatinib mesylate pending before the Indian Patent Office. The concern is whether the Patent Office will apply the rigorous standards it applied in Novartis’s case to the applications made by the Indian companies.

A blog post on the IAM blog puts forth the concerns which arise from differential treatment are clearly outlined as follows:
“The Indian authorities need to make sure that they act and, crucially, that they are seen to act, as disinterested participants in the patenting process. Any reputation for partiality would cause a lot of potential inward investors a lot of trouble.”

The list of the Indian applications and brief details of the same is provided below, please note that the italicized text relates to specific definitions or improvements that are claimed by the applicant in the patent application. As stated in the earlier post, the fate of none of these applications is traceable. It would be interesting if our readers could comment on the possible outcome of these applications against the ‘efficacy’ requirement of Section 3(d) of the Indian Patent Act as interpreted by the Madras High Court and the Indian Patent Office in Novartis’s case.

1. Application no. 500/CHE/2004 (dated 02/06/2004) filed by Hetero Drugs Ltd. for novel polymorphs of imatinib mesylate.

The claimed invention is defined as follows:
The invention relates to novel polymorphs of imatinib mesylate, to processes for their preparation and to pharmaceutical compositions containing them.

The background of the invention is as follows:
“Imatinib and its salts are anti-tumor agents, which were disclosed in US 5,521, 184. Two crystalline modifications (a-form and (3-form) of imatinib mesylate were mentioned in WO 99/03854. WO 99/03854 mentioned amorphous imatinib mesylate, but it did not make any reference to hydrate of imatinib mesylate….

We have discovered a stable novel crystalline form of imatinib mesylate. The novel form is at least as stable as the reported forms, a-and p-forms. The novel crystalline form is stable over the time and has good flow properties and so, the novel crystalline form is suitable for formulating imatinib mesylate…

Amorphous forms of pharmaceutical products are usually known to have better dissolution properties than their crystalline forms. If amorphous form of a pharmaceutical product is stable enough, it can be formulated to a pharmaceutical composition having good dissolution properties.

We have discovered hydrate of imatinib mesylate. We have also discovered a sufficiently stable non-hygroscopic amorphous form of imatinib mesylate hydrate. So, amorphous form of imatinib mesylate hydrate can be utilized to prepare stable pharmaceutical dosage forms having good dissolution properties.”

Spicy IP dealt with Hetero’s patent application in an earlier post relating to analyzing the possibility of solving the problem of ‘access’ to medicines by inventing around granted patents.

2. Application no. 105/CHE/2004 (dated 11/02/2004) filed by Natco Pharma Ltd. for a polymorphic form of imatinib mesylate.

The claimed invention is defined as follows:
“The invention relates to improved processes for the preparation of imatinib mesylagte, beta form suitable for industrial operations. This stable a2 form of imatinib Mesylate is not hither to known and is a novel polymorphic form. This form prepared by us now is also suitable for developing a pharmaceutical composition. Such a pharmaceutical composition containing a2 form is also not known and is novel.

The main objective of the present invention is to provide a novel au crystalline form of Imatinib Mesylate which is stable at room temperature and even at higher temperatures like 120°C and accelerated stress conditions, freely soluble in water… Another objective of the present invention is to provide a process for the preparation of novel a2 form of Imatinib Mesylate which is stable and less hygroscopic and water soluble… Yet another objective of the present invention is to provide a pharmaceutical composition useful for the treatment of Chronic Myeloid Leukemia containing the novel aa form of Imatinib Mesylate which is stable and less hygroscopic and water soluble …. Still another objective of the present invention is to provide an improved process for the preparation of P-polymorphic Imatinib mesylate.

Accordingly, the present invention provides a novel a2 crystalline form of Imatinib Mesylate which is stable at room temperature and even at higher temperatures upto 120°C and accelerated stress conditions, freely soluble in water having the XRD characteristics ….”

3. Application no. 1188/MUM/2004 (dated 04/11/2004) filed by Sun Pharmaceutical Industries Ltd. for a crystal form of imatinib mesylate and process for preparation thereof.

The abstract of the claimed invention reads as follows:
“The present invention provides crystalline imatinib mesylate in a non-needle shaped a-crystalline form. In one aspect the present invention provides crystalline form of imatinib mesylate, characterized in that the difference between the tapped and untapped density is less than 0.15 gm/ml. The present invention also provides a novel, simple viable process for preparation of crystalline imatinib mesylate.”

The background of the invention reads as follows:
“United States Patent No. 5521184 discloses N-phenyl-2-pyrimidine amine compounds including the compound of formula 1.

United States Patent No. 6894051 (equivalent of WO 99/03854) discloses that the methanesulfonic acid addition salt of imatinib (imatinib mesylate) can exist in needle - shaped α-crystalline form or non-needle-shaped β-crystalline form. It is reported that the α-crystalline form of imatinib mesylate is characterized by needle-shaped crystals, is hygroscopic and not particularly well suited to pharmaceutical formulation as solid dosage forms because of its physical properties, for example its flow characteristics are unfavourable. The patent application discloses a method for preparation of the α-crystalline form of imatinib mesylate wherein a hot solution of imatinib mesylate in aqueous ethanol is cooled. However, we have found that this process for preparation of the α-crystalline form is inconsistent, non-reproducible…

We have found surprising results when we prepared crystalline imatinib mesylate by the process of thin film drying. We found that the process resulted in a crystalline imatinib mesylate in a non-needle shaped form. The process resulted in a crystalline form that has a bulk density, which is relatively insensitive to tapping and which is non-hygroscopic. This crystalline imatinib mesylate is easy to handle and convenient to process into a dosage forms, for example it can be conveniently formulated and processed into tablets by dry granulation and direct compression methods.

We have also found a process for preparation of imatinib mesyalte in α-crystalline form in a reproducible manner, which is convenient for industrial use to provide α-crystalline form of imatinib mesylate reproducibly.”

4. Application no. 1209/MUM/2003 (dated 24/11/2003) filed by Sun Pharmaceutical Industries Ltd. for a substantially amorphous form of an anticancer agent, commonly known as imatinib mesylate and process for preparation thereof.

5. Application no. 4745/KOLNP/2007 (dated 06/12/2007) filed by Elan Pharma International Ltd. for nanoparticulate imatinib mesylate formulations, or a salt or derivative thereof, having improved pharmacokinetic profiles and reduced fed/fasted variability.

In the application, the claimed invention is defined as follows:
“The present invention is directed to a nanoparticulate compositions of imatinib mesylate, or a salt or derivative thereof, having improved pharmacokinetic profiles and reduced fed/fasted variability. The nanoparticulate imatinib mesylate particles of the composition have an effective average particle size of less than about 2000 nm and are useful in the treatment of chronic myeloid leukemia, gastrointestinal stromal tumors and related diseases.”

In brief the benefit of this form of imatinib mesylate formulations is that, “Imatinib mesylate has high therapeutic value in the treatment of chronic myeloid leukemia, gastrointestinal stromal tumors, and related diseases. However, because conventional, non-nanoparticulate imatinib mesylate tablets are only very slightly soluble in water at 370C, the dissolution of conventional imatinib mesylate tablets is reduced in the fasting state as compared to the fed state. Thus, imatinib mesylate has limited bioavailability in the fasting state as compared to the fed state, which limits the therapeutic outcome for all treatments requiring imatinib mesylate. There is a need in the art for imatinib mesylate formulations which overcome the fed/fasted absorption variability, along with other problems, observed with conventional imatinib mesylate dosage forms. The present invention, which overcomes such problems, relates to a nanoparticulate composition comprising imatinib mesylate, or a salt or derivative thereof for the treatment of chronic myeloid leukemia, gastrointestinal stromal tumors and related diseases.”

Snippets of the summary of the application are as follows:
“The compositions disclosed herein typically include nanoparticulate imatinib mesylate, or a salt or derivative thereof, having an effective average particle size of less than about 2000 nm and at least one surface stabilizer. The surface stabilizer is typically adsorbed on or associated with the surface of the nanoparticulate imatinib mesylate particles. Optionally, the compositions may include a pharmaceutically acceptable carrier and any suitable excipients….

..One embodiment of the invention encompasses a nanoparticulate imatinib mesylate composition, wherein the pharmacokinetic profile of the nanoparticulate imatinib mesylate is not affected by the fed or fasted state of a subject ingesting the composition.

In yet another embodiment, the invention encompasses a nanoparticulate imatinib mesylate composition, wherein administration of the composition to a subject in a fasted state is bioequivalent to administration of the composition to a subject in a fed state….”


6. Application no. 951/MUM/2004 (dated 02/09/2004) filed by M/S. Cipla Ltd. for a stable crystal form of imatinib mesylate and process for the preparation thereof.

In the application, the abstract reads as follows:
“The invention relates to a stable, non hygroscopic alpha crystalline form of methane sulfonic acid addition salt of 4-(4-methyl piperazin-lyl methyl)-N-[4-methyl-3-(4-pyridin-3-yl) pyrimidin-2-yl amino) phenyl]-benzamide (imatinib mesylate). A process for the preparation of the crystalline form is also described.”

The background of the invention is as follows:
“Imatinib is the international non-proprietary name of 4-(4-methylpiperazin-l-yl methyl)-N-[4- methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl]-benzamide. Imatinib is currently used for the treatment of patients with certain types of leukaemia (most commonly chronic myeloid leukaemia) and a rare type of cancer known as gastro-intestinal stromal tumour (GIST).

EP564409 and US5521 184 first reported a process for preparation of 4-(4-methylpiperazin-l-yl methyl)-N-[4-methyl-3-(4-pyridin-3-yl) pyrimidin-2-yl amino) phenyl] benzamide of formula I and the use thereof, especially as an anti-tumor agent. However, it does not specify any crystal modifications. Patent Application WO 99/03854 disclosed two polymorphic forms of Methane sulfonic acid addition salt of imatinib (Imatinib Mesylate) viz: an (α) Alpha crystal form and a (β) Beta crystal form and the processes for their preparation. The process for the preparation of the alpha crystalline form comprises suspending imatinib base in ethanol, adding methane sulfonic acid dropwise to the said solution, heating the solution to reflux and filtering; evaporating the filtrate to 50 %, filtering off the residue; evaporating the mother liquor to dryness; suspending the residue and filtered material in ethanol; dissolving under reflux conditions by simultaneously adding water; cooling overnight, filtering and drying to obtain alpha crystalline form. The obtained alpha-crystalline form is not stable, is highly hygroscopic, is amorphous in nature and not useful for the preparation of pharmaceutical preparations.

The previously known method for producing the alpha-crystal form of methane sulfonic acid addition salt of the compound of formula (I) involves the precipitation of the salt from its solution in non-alcoholic solvents. It has also been acknowledged in the prior art that the α-crystal form obtained by such a process was inconsistent and hence had an undesirable property such as hygroscopic nature and unfavourable flow characteristics. It was thus an unstable crystal form and unsuited for pharmaceutical preparations.

The known process for preparing the beta-crystal form involves use of an alcoholic solvent such as methanol or ethanol, or a mixture of acetone and water or dimethyl formamide and crystallization is induced by seeding.

The summary of the invention is produced below:
“The present invention relates to a crystalline form of methanesulfonic acid addition salt of 4-(4- methylpiperazin-lylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)-pyrimidin-2-ylaminophenyl]- benzamide (imatinib mesylate). More specifically, the invention relates to the alpha crystalline form of imatinib mesylate. It is important to understand that the crystalline polymorphic form of imatinib mesylate according to the invention not the same material as is described in WO 99/03854. The alpha imatinib mesylate described in WO 99/03854 is not a stable compound, whereas the alpha imatinib mesylate according to the invention is stable.

The term "stable" as used in this specification preferably means that the imatinib mesylate retains polymorphic or chemical stability for at least three months, more preferably for at least six months, and most preferably for at least twelve months. More preferably, the term "stable" as used in this specification preferably means that the imatinib mesylate retains polymorphic and chemical stability for at least three months, more preferably for at least six months, and most preferably for at least twelve months.

The invention also relates to a process for the preparation of said crystalline form of imatinib mesylate. The process according to the invention makes it possible to produce a crystalline form of methanesulfonic acid addition salt of imatinib in a form which is stable and non-hygroscopic. We have found that the stable, non-hygroscopic crystalline form of methanesulfonic acid addition salt of imatinib has needle shaped crystals. The stable, non-hygroscopic crystalline form of methanesulfonic acid addition salt of imatinib can be produced in an essentially pure crystal form.

Thus, the invention relates to a process for preparing the alpha-crystalline form of methanesulfonic acid addition salt of imatinib and also to a stable, non-hygroscopic form of the salt itself. This salt is very suitable for the preparation of pharmaceutical formulations.”

It would be great if our readers could get back with their feedback on the possible fate of these applications in light of the Novartis standards.

Ramkumar Loses Case Before Indian Customs Authorities

Indian customs authorities recently held against Ramkumar in a legal saga involving a patented dual SIM technology. By way of background, Ramkumar asserted patent rights over dual SIM enabled cell phones against several importers including Hansum India, Samsung and Micromax. While many of the smaller importers caved in and paid Ramkumar to have their consignments released by customs authorities, bigger players such as Samsung refused to pay and challenged his claims before customs authorities.

As we'd noted several times on this blog, Ramkumar's patent is limited to dual SIM phones that carry multiple headphone jacks (or bluetooth facilities) in order to facilitate simultaneous calls through different SIM cards within the same phone. By claiming rights over all dual SIM phones, Ramkumar's actions smack of fraud and misrepresentation. The law is now slowly catching up with him and calling him on his bluff.

If Roche (in the Tarceva litigation) was hit with a cost of Rs 5 lakhs for alleged misrepresentations and inconsistent statements before the Indian patent office and the Delhi High Court, one wonders what kind of a "costs" figure is likely to befall poor Ramkumar at the end of this interesting legal saga that has already been tainted with one murder.

Mumbai Customs Order

After hearing the parties (Ramkumar and Samsung), the Mumbai Commissioner of Customs (imports), Mathew John, went to the extent of stating thus:

"From the foregoing facts, it is clear that the claim made by Mr Ramkumar is vexatious because the impugned goods are covered by Prior Art declared by him and are not infringing the patent granted to him. Demurrage and other warehousing charges arising due to suspension of clearance are liquidated amounts and are to be borne by the Patent Holder."

In particular, the Commissioner relied on the following points pleaded by Samsung:

i) Unity of Invention under Section 10(5) of the Indian Patents Act which mandates that the claims shall "relate to a single invention or to a group of inventions linked so as to form a single inventive concept.."

ii) The All Elements Rule: A claim will not cover any device unless that device contains all elements of the claim.

iii) Dependency of Claims: Claim 1 is the omnibus claim and all other claims depend on this first claim. Therefore if claim 1 is not infringed, none of the other claims are infringed.

iv) File Wrapper Estoppel: Ramkumar's first application filed in 2002 claimed dual SIM technology broadly. Owing to objections from the patent office, it was narrowed down to include only those dual SIM phones that also permitted simultaneous communication via multiple headsets (or bluetooth facility). Ramkumar now cannot claim what he had expressly given up to address concerns of novelty. (nb: The Commissioner relied on Chisum's patent treatise while ruling on this aspect).

In pertinent part, the Commissioner notes:

"Though the advocate of the patent holder was present while these arguments were raised, he did not counter these arguments apart from just stating that each of the 20 claims made in his application is independent and infringement of any one would have the effect of infringing his rights under the Patent."

and later:

"..the idea of a mobile phone with dual SIM cards is not an original invention of the Patent Holder. He has just wrapped it up with some additional features and claiming that any mobile phone with dual SIM cards violates his rights."

Chennai Customs Order in Favour of Hansum

Samsung obtained a favourable order from the Chennai customs authorities as well. And so did Hansum India. Both the Mumbai and Chennai orders are quite detailed and well reasoned and once our SpicyIP website is up again (sadly some miscreants have hacked it), I will put this up for public consumption.

In an order favouring Hansum India, the Chennai Customs Commissioner held thus:

"From a plain reading of the above claim 1, it is seen that a provision for a plurality of SIM cards, a plurality of SIM sockets, a plurality of headphone/earphone jacks and a plurality of bluetooth devices should be present in the mobile phones. The reason for such a provision is also enlarged by the patentee that it is for the purpose of communicating simultaneously with the respective SIM cards. Therefore it boils down to the point that the sum and essence of the patent is for simultaneous communication by using the plurality of SIM cards".

The only slight mistake in the claim construction above is that it ought to have been "... a plurality of headphone/earphone jacks and/or a plurality of bluetooth devices...".

This however does not impact the merits of this case, as Hansum does not import phones that deploy either a "plurality of headphone/earphone" jacks OR "a plurality of bluetooth devices".

In an earlier post, I'd noted that the lawyer representing Ramkumar threatened defamatory action against me and referred to my analysis of the patent claim as "juvenile". It's interesting that two detailed orders from customs authorities interpret the claim in the same "juvenile" manner. It would appear that "juvenile" is a favourite term of Ramkumar's lawyers and they've used it in their submissions before the customs commissioner as well. I quote:

"Therefore the burden of proof lies with Samsung to establish that their goods do not infringe my patent right and they cannot escape their liability by putting forth juvenile contentions that my patent is part of prior art."

Incidentally, Ramkumar's lawyer reacted to my earlier post (documenting his threat to take defamatory action against me), insinuating that I was a "failed lawyer turned academic". Once again, let me exhort him to desist from resorting to ad hominem attacks. Rather, let us engage with the substantive merits of this dispute.

The tide is slowly turning against Ramkumar and his misrepresentations of the scope of his claims are now returning to haunt him. At the end of all these legal proceedings, it is likely that the importers will prevail over Ramkumar. The question then is: does our law provide for any penalties for such a fraudulent attempt at misrepresenting the scope of one's claims? More importantly, what of all the small importers that paid huge sums to Ramkumar to have their consignments released?

The bigger players like Samsung will walk away after winning this legal battle. But what of the smaller players: will they be able to recover moneys paid to a patentee who blatantly misrepresented the scope of his claims? Does our law provide for the return of such moneys under theories of unjust enrichment or restitution?

Part I: Novartis feels the heat of the Indian Summer. What is the fate of similar applications filed by Indian Manufacturers?

In an article titled “India rejects Patent to Glivec’s Second Variant,” the Business Standard reported that the Swiss drug manufacturing multinational, Novartis AG, had been dealt with another blow by the Indian Patent Office. The Patent Office, in its March 30 ruling, accepted the pre-grant oppositions filed by Indian drug firms Sun Pharma, Okasa and others against Novartis’s five-year-old patent application over the alpha crystal form of Novartis’s blockbuster cancer medicine, Glivec.

This setback follows the steps of the erstwhile controversial Novartis decision wherein the Madras High Court rejected Novartis's challenge to the constitutional validity of Section 3(d) of the Patent Act, 1970 as amended by the Patents (Amendment) Act, 2005. The High Court's decision was one of the first instances of interpretation of Section 3(d) by the courts. Going back, the rejection of patent to alpha form of Glivec was on grounds similar to the grounds for rejection of the beta form by the Patent Office, i.e., the invention fell short of the standards laid out in Section 3(d). “If granted, it would have been a clear case of frivolous patenting. The different form of Glivec is in no way superior to the other form for which patent was not granted,” said an attorney involved in the pre-grant opposition. Interestingly, the rejection for patent over the alpha form comes when the apex complaint redressal forum, the Intellectual Property Appellate Board (IPAB), is about to give its verdict on Novartis’s appeal against the rejection of a patent to the beta crystal form of Glivec.

The Novartis litigation gave rise to a lot of negative publicity for the multinational and the main concern was access to Glivec at an affordable price. Presently, such access is ensured by the low-cost versions of Glivec is being sold by domestic companies in India. The patenting of the beta crystal form of Glivec was fervently opposed by NGOs and patient groups as it would lead to Novartis getting exclusive rights over the drug and drive out the cheaper Indian products. In fact, several groups had asked Novartis to drop the case against Indian patent law given the negative effect the challenge could have had on the access to medicines in developing countries.

SpicyIP has dealt extensively with the Novartis case and the Section 3(d) issue in several posts. Moreover, Shamnad and Prashant exhaustively analyze issues in an article titled, “The ‘Efficacy’ of Indian Patent Law: Ironing out the Creases in Section 3(d)”, available for download on SSRN <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1086254>.

More importantly, it is interesting to note that the Patent Office’s decision against the alpha variant comes when several Indian companies have also applied for patents over variants of imatinib mesylate. Some of these applications will be discussed in part II of this post. Unfortunately, the fate of the applications or any opposition proceedings filed against them is untraceable. The decisions in these applications become relevant because of the fact that there have been allegations in the past that the Indian Patent Office is more lenient to Indian pharmaceutical industry. Thus, the concern is whether the Patent Office will apply the same rigorous standards applied in the Novartis case to the Indian applicants, given the fact that if patents are granted to these variants the question of cheap access would be as relevant.

As far as Novartis is concerned, clearly the unfriendly Indian summer has caused a lot of heartburn to Novartis as it fails to reap monetary benefits for Glivec, its key blockbuster medicine. The official response came from Ranjit Shahani, vice-chairman and managing director, Novartis India and read as follows, “Novartis is disappointed that the patent for the alpha crystalline form of imatinib mesylate (chemical name of Glivec) has been rejected, even though the impact of the decision is low. We have 90 days to review the merits of the decision and to evaluate and decide our options.” In order to get out of the access to medicines debate, the company continues to lay claims on its philanthropy and says 99 per cent patients on Glivec in India get it for free and the others who pay for the drug are reimbursed. Further, according to Shahani, under the Glivec International Patient Assistance Program (GIPAP), Novartis has provided Glivec (beta form of imatinib mesylate) completely free of charge to more than 35,000 patients in 80 countries. “In India, around 11,000 patients currently receive Glivec absolutely free of charge through GIPAP. Since inception of GIPAP in India in late 2002, Novartis has distributed Glivec valued at more than Rs 2,900 crore free of charge to patients in need,” he said.

This claim to philanthropy is thwarted by groups like the Cancer Patients Aid Association (CPAA) which point out that the strings attached to the GIPAP make it an impossible option. For more on CPAA’s position read “CPAA responds to Novartis' Open Letter”. In fact, the discounted price claim made by Novartis was also rubbished by the Indian Government during the Novartis litigation, if the statement of the Indian Ambassador in Belgium at the Exchange of views on Novartis case organised by the European Parliament in Brussels is any indication.

Part II of this post will deal with the specific applications made by the Indian companies, their possible outcomes and the role to be played by the Indian Patent Office.