Roche's Patent Rejection: A Numerical Quantifier for Section 3(d)?

Rajiv Choudhry, who'd already featured on this blog earlier for having taken the pains to give us a terrific statistical preview of the results of the patent agent exam, now explores the Roche Valcyte patent decision. Incidentally, Rajiv, a qualified US patent agent working with a leading American patent law firm took the Indian exam this year and cleared it. After his exam, this is what he wrote to me in an email:

"I took the Indian patent office exam today at New Delhi. I think it was a most welcome break from the pattern of previous years exams. A friend of mine expected to answer the objective type question by simply regurgitating the sections, fees/form number etc., but found that he had to now analyse the provisions and think through the nuances of each question.

As regards Paper II, the mechanical question was a bit difficult, but the chemical question balanced the difficulty in the mechanical question."

We're very lucky that an accomplished patent expert such as Rajiv has begun taking an active interest in Indian patent issues. Clearly, with more such commentators, we're likely to have more informed and insightful discussions, as will enable us to devise a more optimal patent regime for India.

In so far as the Valcyte patent decision is concerned, Rajiv takes issue with the section 3(d) analysis. Readers may recall that in an earlier post, I had stated that while the "inventive step" reasoning was logically coherent, the section 3(d) analysis was a bit fuzzy.

Rajiv recommends a numerical quantifier to make for a more determinate interpretation of section 3(d). I'm not entirely sure if we can have precise mathematical formula here--but to the extent that he recommends clarity on section 3(d) through guidelines of some sort, I think he is spot on. In fact, in a rather long and dull piece, Prashant Reddy and I make some very specific suggestions for clarifying the scope and ambit of section 3(d). For those interested, please see page 258 of the paper which proposes a very detailed amendment to section 3(d) to make it clearer and more coherent (the paper can be downloaded for free on SSRN).

Should there be a numerical quantifier for Section 3(d)?
By Rajiv Choudhry

Claim 1 of patent 207232 provides: The compound 2-(2-amino-l,6-dihydro-6-oxo-purin-9-yl) methoxy-3-hydroxy-l-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R)- or (S)-diastereomers, or in the form of mixtures of the two diastereomers.

The reasoning for §3(d) is based upon an obviousness analysis (§§ 2(1)(j), 2(1)(ja) inventive step). But the decision cannot substitute an obviousness analysis for the analysis required under § 3(d), because § 3(d) sets a higher bar than the inventive step analysis.

In this case, the mono ester was demonstrated to have more bio-availability compared to that of bis ester of ganciclovir. But the patent office did not consider it to be efficacy. The decision stressed that efficacy and bio-availability are two different concepts and are not the same. The decision discussed the definition of efficacy as therapeutic effect being independent of property (i.e. bio-availability) but did not provide any further detail. The decision then concluded that Claim 4 ( A compound according to Claim 1 in crystalline form) is not particularly described and in the absence of any improved effect the crystalline form considered as another form of known substance u/s 3(d) of the Act.

The decision refers to §3(d) under heading 6, ‘Not an invention’ and states that an “[e]ster of the known substance prima facie will get a patent only if it shows significant enhancement of efficacy.” The Chennai High Court in the case of Novartis A.G. v Union of Indiahad stated that “efficacy means therapeutic efficacy.”

In the judgment, the High Court had observed that the patent applicant is expected to be aware of the difference between the therapeutic effect of the patented drug and the drug in respect of which patent is asked for.

The High Court also made a requirement for providing comparative details showing that the discovery of a new form of a known substance had resulted in the enhancement of the known efficacy of the original substance and the derivatives so derived will not be the same substance, since the properties of the derivatives differ significantly with regard to efficacy. (Novartis AG v. Union of India W.P. 24760/2006).

The High Court decision does not contain a quantification/minimis requirement for efficacy. All it states is that there should a comparison between the new substance and the original substance. The draft Manual of Patent Practice and Procedure, 2008 (MPPP) does provide a specific statement regarding quantification of efficacy. The MPPP states that the efficacy need not be quantified in terms of numerical value to determine whether the product is efficacious because it is not possible to have a standard numerical value for efficacy for all products including pharmaceutical products.

There are two problems with this statement. First the law regarding the ‘quantification of efficacy’ is vague because it is not reasonably possible to comply with the requirements. Second it leaves great scope for discretion of the Patent Office while considering applicability of §3(d).

There is a heavy burden imposed upon the applicant to disclose a comparison between the new form of a substance and an existing form. Once the Applicant has provided the necessary details in the form of a comparison, the Patent Office cannot post-facto object to the comparison and substitute its own judgment of what kind of comparison is required (as has been done in this case). Hence the term ‘therapeutic efficacy’ requires that it be quantified in terms of a numerical value as there is unfettered discretion with the Patent Office.

The application and the declarations discussed in the decision clearly state the beneficial effects of the claimed invention are because of increased bio-availability, side-effect profile, and drug-interactions.

Paragraph 57 of the order states that improved bio-availability may increase the clinical efficacy in turn it may influence the therapeutic efficacy for which there is no support provided in the specification. It concludes that the claimed compound does not fulfill the requirement under the provision of the Act because it is obvious that the pro-drug of compound exhibit improved solubility, low resistance, no mutations, system exposure and avoidance of the drawbacks of the intravenous treatment which are inherent and expected properties of the prodrug.

The patentee tried to show a causal connection between increased bio-availability, and therapeutic efficacy but the Order took an extremely narrow view of the term therapeutic efficacy by concluding that increased bio-availability cannot be equated with therapeutic efficacy.

This decision of the Controller highlights the reason why the Courts need to provide more clarity in interpreting §3d as regards the term efficacy and provide a numerical quantifier to it.

SpicyIP Tidbits: Anil Gupta @ TED talks

This is by way of a quick follow up to Shamnad's superlative post on romanticising innovation a couple of days ago. Here's a link to a very engaging talk by Prof Anil Gupta, the primum mobile behind the HoneyBee Network, from the TED Network. (Image from here)

It lasts for about 20 minutes, and I would urge all of you to take some time out to listen to this talk - the download link below the video gives you various options to listen to it as a podcast, etc as well. (If you have more time, browse around for other talks -- TED is a diamond mine that you'll never want to leave once you're hooked!)

During the talk, Prof Gupta is full of punchy one-liners, including a classic right at the beginning, "the minds on the margin are not marginal minds!". He brazenly dismisses Maslow's hierarchy of needs as an obstacle to innovation, which comment has set off a long discussion below the video. The talk may be a pitch for the Honeybee network, or at least, the concept behind the network, but it also prompts you to think about issues such as conventional endorsements of scalability, and the parochialism of communities that believe innovation will only emerge from certain spaces/conditions (hence Maslow).

Please do watch to learn more about how the grassroots to global (G2G) business model may just become the mantra of the century.

Roche-Natco update: Roche concludes arguments

The Roche-Natco proceedings continue in the Delhi High Court, which the SpicyIP team has been following closely. This is an extremely delayed update, and entirely due to myself -- Apologies for the same. For those who are new to the case, please read our previous posts on this, here and here.

Roche has now officially wrapped up arguments on the interim injunction. It essentially tied together loose ends of its previous arguments.

Readers will recall that the Court had thought that it might be bound by the Division Bench judgement in the Roche-Cipla case, while deciding on the injunction here (Recall that the DB had refused the injunction. Read current status of Roche-Cipla here).

Roche used Supreme Court cases to argue that interim orders have no finality and cannot be considered precedents, and therefore the Roche-Cipla judgment on the interim injunction could not be considered here. Previously, the Court had enquired of the counsel as to how Roche-Natco was different from Roche-Cipla, and why the decison in the latter could not be applied here, since the pharmaceutical composition in question in both the matters is the same.

Roche then went into the issue of Natco's attempt at getting a compulsory license for the drug in issue. It essentially returned to the principal requirements of grant of temporary injunction, including the establishment of a prima facie case, and the balance of convenience. Specifically, Roche argued that where there is an admission of rights of the patent by the Defendant, a temporary injunction will follow.

Roche also did some preemptive arguments, in preparation for the impending selection patent issue that Natco is likely to bring up in its arguments in re polymorph derivatives. Towards this, Senior Counsel CS Vaidyanathan ran through some cases and extracts from commentaries about what a selection patent is, and how every selection patent if invented/ selected by a different patentee will always infringe the genus patent unless a specific license is given to state otherwise. (NB: the last selection patent issue I recall making note of was in the Novartis Gleevec decision, but I will admit to my lack of understanding on the issue, and leave it to our learned commentators to pursue discussion on.)

So, Roche's days behind the lectern are over - for now. Natco is expected to take over. They attempted to seek an extension till July 2010 for their counter-arguments, citing the illness of their Senior Counsel, and the INTA Conference in Boston where the briefing counsel was attending. Justice VK Shali, however, who is hearing the case, was fairly determined to hear the matter earlier, and noted this was a case that had caught his interest, and a longer break could interrupt the flow of arguments in the case. A-ha. Good for us, in any case. Arguments continue on June 2. The SpicyIP team shall be ever vigilant, and try to bring you as timely an update on that as possible.

Laawaris -Housefull Controversy : Interim Order by Cal HC

Following from the earlier Orders in the Laawaris-Housefull matter this year, the interim Order by the Calcutta HC was passed on May 13,2010.The Court speaking through CJ Mohit Shah has now listed the matter for final hearing  on June 21,2010 when the Court resumes after the summer vacation. The Court pondered over the 1981 Agreement between film production house Prakash Mehra Productions and Saregama relating to the right of the soundtrack in the film Laawaris,to ascertain whether the rights in sound recording which were transferred by Prakash Mehra in 1981 included only the right to reproduce the song in the form of records as has been contended by the Mehras or if it also included a right to synchronize the lyrics and music of the songs in the film Laawaris along with other lyrics and embody them as a song as a part of the cinematography.

The Order referred to the impugned judgment and Order of April 29,2010 (granting an injunction in favour of Mehras against NGE and others) stating that the views expressed by Justice Pathreya would require a reconsideration in the view of the arguments advanced in the present matter. In particular, the Court stated that the impugned Order had not taken into consideration clause 4 of the 1981 Agreement.

Eros International (DISTRIBUTORS of Housefull) challenging the impugned Order of April 29,2010 submitted that Justice Pathreya had completely overlooked the question of balance of convenience while granting the injunction in favour of Mehras. Since Housefull was already slated to release all over India and abroad on April 30,2010, a large number of prints were already distributed. Eros also submitted that it had purchased the right to distribute and exhibit  the film from Nadiadwala after paying a substantial amount of money which ran into crores and thus Justice Pathreya could not have restrained the exhibition of the film by the impugned Order.

Saregama,Eros and NGE also submitted that the impugned Order should not have granted injunction in favour of the Mehras owing to the delay in moving to Court. Newspaper reports stating the similarity of the songs in Laawaris and Housefull was made public much before Mehras sought an injunction. Further,para 5 (d) of the plaint of Mehras in CS 1338/2010 was challenged. As per this, Mehras claimed that during his lifetime,Prakash Mehra had not transferred/licensed the copyright in literary work and sound recording in favour of any third person.

However, by a letter dated March 4,2010, Mehras wrote to Saregama stating that NGE had not approached Mehras to purchase the song for the item number in Housefull and would like to know if they had approached Saregama for the same and under which clause of the agreement was the permission given and that "Mehras may be given the copyright to mark the same." Owing to such conduct, the claim of injunction should have been disgranted.

Mehras on the other hand submitted that the 1981 agreement was only for the purposes of sound recording and not for embodying any song of Laawaris for any cinematographic effect. They argued that the copyright in sound recording does not include the right to exploit the literary work and the music of the song in question  into a cinematographic film. In the light of the decisions in  Rama Naranga case [AIR 2007 SC 2029] and  Pushpa Devi v. Rajinder Singh [(2006) 5 SCC 566] they also questioned the maintainability of the appeal in light of the Order of April 29,2010.

Counsels of Kalyanji-Anandji who were the music directors in Laawaris brought foward another interesting angle stating:

"Prakash Mehra had copyright only in .... the sound recording of the songs in the said film, but Prakash Mehra had no right in the musical work in the said songs of LAWAARIS .... it was Kalyanji Anandji who had composed the music of the songs in the film LAWAARIS and that Kalyanji Anandji were not employees of Prakash Mehra. Kalyanji Anandji had the rights in the musical work of the songs in the film LAWAARIS as recognized by Section 57 of the Copyright Act, 1957. .... there has never been any assignment of Kalyanji Anandji's rights in the musical works of the songs in LAWAARIS and, therefore, Kalyanji Anandji are entitled to get an interim injunction against the exhibition of the film HOUSEFULL with the song in question." 

 (We have analyzed this issue earlier here.)

They further submittted that makers of Housefull had mutilated and modified the song in question and thus Kalyanji-Anandji also have a right to restrain the exhibition of Housefull. Saregama however opposing this stated that although Kalyanji-Anandji were the composers, for the last 30 years,they had claimed no rights of their own with respect to the songs.It was only the producer Prakash Mehra who held the copyright had subsequently assigned it to Saregama by the 1981 Agreement.Relying on the judgment of  Anandji Shah v. Ritesh Sidhwani (2006),  Kalyanji-Anandji should be treated to have entered into a contract of service with producer Prakash Mehra who had the copyright over the works.Therefore, Kalyanji-Anandji cannot seek an injunction with respect to the exhibition of Housefull.

Justice Shah opined that since the ramification of interpreting these complex questions of law will be on the entire film industry, a detailed hearing can take place only after the vacations.The Court however considered the necessity of an interim arrangement during the pendency of the appeals. Taking into account the question of balance of convenience, the Court considered the issue of delay on part of Mehras in moving the Court quite seriously.The fact that Mehras were aware of the fact of inclusion of the disputed song in Housefull around March 4,2010 and approached the Court only on April 19,2010 in the opinion of the Court was very crucial. Also,Mehras were aware of the music release of Housefull on March 15,2010. This factor too was not appreciated by the learned Judge in the impugned Order of 29 April,2010. 

Granting an injunction on the exhibition of the film on April 30,2010 when the movie was slated to be released on April 30 was done without due consideration to the question of balance of convenience. To go ahead with the injunction requiring the distributors to recall the 1400 prints and delete portions from the movie would cause immense hardship to the producers,distributors and the music recording company.On the other hand, the suit filed by Mehras in Bombay High Court on wherein they claimed damages of Rs.50 lakhs (this suit was subsequently withdrawn in the Calcutta suit on April 29,2010) served the interests of justice in a far better manner.

The Court finally granted an interim stay of the injunction as per the impugned Order of April 29,2010 with a bank guarantee of Rs.50 Lakks to be furnished by Saregama,Eros and NGE. With regards to the issue raised by Kalyanji-Anandji, the Court didnot express a specific opinion but ordered a bank guarantee of Rs.25 Lakhs to be furnished either by Saregama,Eros and NGE jointly or NGE individually.It further restrained the producer of Housefull release any new prints of the movie till the final disposal of the matter.

We thank Frequent Anon  and Kruttika Vijay for bringing this Order to our notice.We will keep an eye on the final Order to be passed June 21 and consider the finer issues emerging from the present Order.

PS-Image from here.

Off topic :MJ Akbar and the Gandhi Pen Controversy

Slightly off beat,but our readers who have been keenly following the MontBlanc Gandhi pen controversy may find this piece by M.J.Akbar insightful. Akbar tries to explore the issue from a non-legal (especially, a non IP angle) aspect to debunk into the politics behind the manufacture of such branded pens.

Hope you all enjoy the read.

In ACTA India does (not) trust

(Image taken from here)

Recent developments indicate that India’s desire to strive to build a united front against the Anti-counterfeiting Trade Agreement (ACTA) (for previous posts, see here) being negotiated by some developed countries remains unabated with time. The said agreement can have harmful repercussions on exports of genuine off-patent drugs, information technology and other products from emerging markets. Proposed between the EU, the US, Australia, Canada, Japan, Korea, New Zealand and Switzerland, the purpose of ACTA is to enhance the scope of protection and elevate the enforcement standard of intellectual property rights beyond the existing TRIPS provisions.

In a report by The Economic Times, a government official who wished to remain unnamed was quoted to have said, “We will hold talks with like-minded countries (read Brazil, China, Egypt etc) and may oppose the ACTA proposal jointly as well as individually by holding talks with countries involved.” Besides posing a potential threat to the exports from emerging markets, the agreement may also empower member countries to seize and destroy exports while in transit to other countries, which is certainly not a desirable outcome by any stretch of imagination! Morocco, Singapore and Mexico have recently agreed to become members of the proposed agreement.

Signs of India’s continuing efforts seeking to hamstring the agreement were exhibited in a seminar organized by FICCI on May 28, wherein Amarendra Khatua, joint secretary at the commerce & industry ministry, said, “We are looking at the issue and preparing a negotiating brief.” The panellists at the seminar included names such as V.K Topa (Advisor, FICCI), T.C James (Consultant, FICCI), Leena Menghaney (Campaign Co-ordinator (INDIA), Medecins Sans Frontiers Campaign for Access to Essential Medicines), Dr. Mira Shiva (Director, Initiative for health Equity and Society) and Raghu Cidambi (Advisor- IPR & Regulatory matters, Indian Pharma Alliance).

A FICCI paper has in fact, referred to an EU study on ACTA, which opined that there would be an infringement, if a medicine or product is made for which a company holds a patent in any country irrespective of the lack of clarity involved in the scope and validity of the said patent. Following the same line of argument, production of spare parts may also violate an unexamined design right with unclear scope and validity.

T.C. James, one of the panellists in the FICCI seminar, who is also a consultant with FICCI, went on to say, “The stringent norms being proposed will extend to import, export, in-transit and other situations when goods are under customs supervision.” A logical corollary of the same will be that the existing problem of wrongful seizures that the Indian generic drug exporters to Latin America and Africa are struggling to cope with especially at European airports will get complicated further, since all products and a considerably large number of nations fall within the purview of ACTA.

India has already lodged a formal complaint at the WTO against an EU customs legislation. The said legislation empowers officials to seize consignments of medicines that are off patent in both India and the countries where they are being exported to, provided there are companies holding patents to it in the EU. In fact, in the opinion of Raghu Cidambi, advisor in IPR and regulatory matters at Indian Pharmaceutical Alliance and another panellist at the FICCI seminar, the ACTA members are in effect seeking to undermine the WTO and WIPO processes. Such actions are certainly open to challenge at the WTO, said Leena Menghaney, the Indian campaign coordinator, Medicines Sans Frontiers. According to her, if ACTA comes into effect, it would certainly have an adverse impact on exports of several goods, especially medicines and IT products from developing countries. Nonetheless, the fact remains that such measures can be contested only following their implementation and until the same takes places, India would be better advised to try to form an alliance with other concerned developing countries and lobby and pressurize against the implementation of ACTA.

The Spicy IP team thanks Shashwat Purohit, Research Fellow at the Franklin Pierce Law Centre, for making available valuable details regarding the FICCI seminar, including the identity of the panellists.

Non-Conventional Trademarks in India by Dev Gangjee

Those of you looking for that extra spicy bite in law of trademarks,here is a treat.

Dev Gangjee of London School of Economics has recently penned his thoughts on Non-Conventional Trade Marks in India  [22 (1) National Law School of India Review 67 (2010)] on the accommodation of non conventional trade marks within Indian trade mark law. Its written with trade mark examiners, IP practitioners and adjudicators in mind and considers relevant provisions of the Draft Manual of Trade Mark Practice and Procedure.

The abstract of the article reads :

In recent years, trade mark registries and courts have grappled with trade mark applications for silhouettes, shapes, scents, textures and tastes, as well as short cartoons, single colours, body movements and Tarzan's yell.This invasion of the unconventional is due to the open ended definition of a trade mark. On the one hand, trade mark law has embraced a definition that emphasizes the functional, rather than the ontological, status of a sign.Anything which does the communicative work of a trade mark, by distinguishing goods on the basis of trade origin, can be registered as one. On the other hand registration systems have historically developed around paradigmatic subject matter: a conventional or traditional trade mark that is visual and consists of words and/or figurative devices. The need to reconcile these conflicting imperatives - the system is open to all categories of signs and it's apparently 'business as usual,' yet the registration system was designed with only words and figurative devices in mind - requires a careful reconsideration of certain basic assumptions in this area. The Indian Trade Mark Registry's Draft Manual of Trade Mark Practice and Procedure provides the contextual framework for this reappraisal and this article evaluates to the approaches it has adopted to accommodate such signs.

This brilliant read is also available here.

We hope it tickles your tastebuds!

Laawaris and Poetic Justice

Sumathi blogged extensively and eruditely on the Laawaris controversy. The appellate judgment (albeit an interim one) by Justice Shah and Justice Sengupta of the Kolkata High Court is out now and Shayonee will bring you a detailed post on this soon.

In the meantime, here is an interesting issue. Kalyanji Anandji's lawyers claim as below:

".... Prakash Mehra had copyright only in .... the sound recording of the songs in the said film, but Prakash Mehra had no right in the musical work in the said songs of LAWAARIS .... it was Kalyanji Anandji who had composed the music of the songs in the film LAWAARIS and that Kalyanji Anandji were not employees of Prakash Mehra. Kalyanji Anandji had the rights in the musical work of the songs in the film LAWAARIS as recognized by Section 57 of the Copyright Act, 1957. .... there has never been any assignment of Kalyanji Anandji's rights in the musical works of the songs in LAWAARIS and, therefore, Kalyanji Anandji are entitled to get an interim injunction against the exhibition of the film HOUSEFULL with the song in question".

It is easy to see that the Kalyanji Anandji duo are indeed the"authors" of the musical compositions. But does this necessarily make them the copyright owners in respect of such compositions? (Note that there is a distinction between copyright ownership and copyright authorship, as Nikhil Krishnamurthy aptly points out in his very thoughtful post here).

Not so, said the Supreme Court (Justice Jaswant Singh and Justice Krishna Iyer) in a landmark 1977 judgment (IPRS vs Eastern India Motion Pictures). The Supremes, in a conceptually flawed, albeit flowery judgment, held that under section 17(b), the ownership of all underlying words that were incorporated into a movie vest with the film producer (the commissioner of the work), unless a contract provided otherwise.

In other words, what might have been a logically and legally obvious proposition to many of us (that copyright continues vesting in favour of authors of underlying works, unless a contract provides otherwise) was flipped around by the Learned judges.

Be that as it may, the opponents in the Lawaris case claim that Kalyanji Anandji were employees of the producer, Prakash Mehra (under a contract of service) and therefore any musical work created by them belonged to Prakash Mehra. If this contractual relationship is proved true (and I doubt it will), the argument that Mehra owns the musical compositions as well will indeed be a valid one. For our copyright act provides in section 17(1)(c), that any work created under a contract of service will belong to the employer.

The appellate court in Laawaris did not make any ruling on this count at this stage, preferring to leave it to more detailed hearings to come up in July.

All of this throws up a larger issue:

A number of early commissions, where music composers were asked to compose music for films were not done through proper written contracts or through agreements that would have helped establish a "contract of service". Would this mean that music composers could have stopped the screening of movies (despite being commissioned to create the music for the movie), since the Indian copyright act does not provide for implied licenses in favour of such screening?

And while you ponder this issue, let me leave you with some musings from the ever verse-atile Justice Krishna Iyer, who despite a conceptually flawed judgment, manages to advocate for a separate copyright in favour of Bollywood singers in rather flowery language. A judge who epitomises poetic justice, one might say!

"A cinematograph is a felicitous blend, a beautiful totality, a constellation of stars, if I may use these lovely imageries to drive home my point, slurring over the rule against mixed metaphor. Cinema is more than long strips of celluloid, more than miracles in photography, more than song, dance and dialogue and indeed, more than dramatic story, exciting plot, gripping situations and marvellous acting.

....In 'a cosmic perspective, a thing of beauty has no boundary and is humanity's property, but in the materialist plane on which artists thrive, private and exclusive estate in art subsists. Man, the noblest work of the Infinite Artist, strangely enough, battles for the finite products of his art and the secular law, operating on the temporal level, guarding material works possessing spiritual values. The enigmatic smile of Mona Lisa is the timeless heritage of mankind but till liberated by the prescribed passage of time, the private copyright of the human maker says, 'hands off'.

The creative intelligence of man is displayed in multiform ways of aesthetic expression, but it often happens that economic systems so operate that the priceless divinity which we call artistic or literary creativity in man is exploited and masters, whose works are invaluable, are victims of piffling payments.

....copyrighted music is not the soulful tune, the superb singing, the glorious voice or the wonderful rendering. It is the melody or harmony reduced to print, writing or graphic form. The Indian music lovers throng to listen and be enthralled or enchanted by the nada brahma, the sweet concord of sounds, the rags, the bhava, the lava and the sublime or exciting singing.

Printed music is not the glamour or glory of it, by and large, although the content of the poem or the lyric or the song does have appeal. Strangely enough, 'author', as defined in s.2(d), in relation to a musical work, is only the composer and s. 16 confines 'copyright' to those works which are recognised by the Act. This means that the composer alone has copyright in a musical work. The singer has none. This disentitlement of the musician or group of musical artists to copyright is un-Indian, because the major attraction which lends monetary value to a musical performance is not the music maker, so much as the musician. Perhaps, both deserve to be recognised by the copyright law."

Welcoming the India Law Journal

Just came across a wonderful initiative by two enterprising students, Vikrant and Naina Pachnanda of GNLU and NUJS respectively.

They have put together an online law journal called the "India Law Journal" that boasts a wide assortment of articles on a variety of legal themes. In particular, they have some interesting IP articles including one on nanotechnology and patents.

Please join me in congratulating these proactive siblings on this laudable venture.

Vacancy at FICCI-IPR Division

Intellectual Property Rights Division at FICCI is intensively involved in issues pertaining to protection and enforcement of Intellectual Property Rights. It has taken a lead role in raising awareness on Intellectual Property Rights amongst the citizens of India along with various capacity building and training programmes for the industry, judiciary and enforcement agencies. Further, the IPR division is a platform for continuous interaction between the industry and the Government with a view to provide an interface for the businesses to resolve their various issues pertaining to IPRs. Most importantly, it also provides constructive inputs and feedback to the Government on policy related matters.

FICCI-IPR Division is currently looking for a dynamic, mature and experienced (3-5 yrs) IP professional, having excellent writing skills, for handling various tasks as provided below:

Job description:

1. Liaisoning with senior Government officials in various Ministries
2. Business Development, Planning, Resource allocation and Management of Industrial Intellectual Property related projects.
3. Preparing comments on various IPR policy issues being discussed at national and International fora
4. Acting as a face of Indian industry and lobbying for their concerns with the govt.
5. Managing various Task Force/Advisory Boards for Examination and analysis of IPR issues followed by facilitating in bringing pro-active solutions to address those issues.
6. Preparing post conference reports besides preparing speeches for Govt. officials and press release for media coverage
7. Preparing the contents for FICCI’s quarterly newsletter “IPR Spotlight”

Interested candidate may like to send their resume to Ms. Sheetal Chopra, Deputy Director, FICCI-IPR Division at sheetal.chopra@ficci.com

“Person Interested”: How is an Inclusive Definition to be interpreted?

In an earlier post, Kruttika initiated a thought-provoking discussion on certain lesser discussed aspects of Justice Murlidhar’s decision on appealability of pre-grant decisions. In the comments, the discussion ultimately veered towards the distinction between “any person” under Section 25(1) of the Patents Act and “a person interested” under Section 25(2) with the former referring to pre-grant opposition and the latter, post-grant.

 The questions raised as part of the comments were:

1.      1. Is “any person” under s.25(1) the same as a “person interested” under s.25(2)?

2.      2. Are all pre-grant opponents entitled to challenge the patent as post-grant opponents?

To answer this, we must first circumscribe the identity of a “person interested”. Section 2(t) of the Patents Act defines a “person interested” as follows:

“person interested includes a person engaged in, or in promoting, research in the same field as that to which the invention relates”

The definition of a “person interested” (let’s call him PI for short...it’s probably an apt nickname because he is recurring (in our posts) and may turn out to be irrational) is inclusive. But how are inclusive definitions to be interpreted? There are quite a few decisions of the Supreme Court on inclusive definitions. 

One of the most cited observations found in SC decisions on inclusive definitions is the observation of Lord Watson in Dilworth v. Commissioner of Stamps (1899AC99), which is as follows:

"The word "include" is very generally used in interpretation clauses in order to enlarge the meaning of words or phrases occurring in the body of the statute; and when it is so used these words or phrases must be construed as comprehending, not only such things as they signify according to their natural import, but also those things which the interpretation clause declares that they shall include. But the word "include" is susceptible of another construction, which may become imperative, if the context of the Act is sufficient to show that it was not merely employed for the purpose of adding to the natural significance of the words or expressions defined. It may be equivalent to "mean and include", and in that case it may afford an exhaustive explanation of the meaning which, for the purposes of the Act, must invariably be attached to these words or expressions."

It is possible that the first portion (underlined) of this observation may apply to the definition of PI because it may include entities which are commonly and naturally understood as PIs, in addition to the ones specifically included. However, this kind of interpretation of an inclusive definition is applicable only where the entities included specifically would not be commonly understood as falling within the definition.

This is not the case with the definition of PI under the Patents Act, because persons/entities engaged or promoting research in the same field to which the invention relates would qualify as PIs by default, even if they had not been expressly mentioned/included.

If this is so, we must analyse if the second portion (emboldened) of this observation applies to the definition of PI. The import of the second portion is that, although a definition may appear to be inclusive on the face of it because it states “includes”, in reality it could and should be construed as “includes and means” thereby making the definition exhaustive. For one to reach such a conclusion, the use of the term/phrase in question in all places in the Act must be looked into.

In our case, a PI also figures prominently in compulsory licensing provisions of the Patents Act. Only a person interested may invoke a compulsory licensing provision and such a PI has to be a person/an entity who/which is capable of stepping into the shoes of the patentee/licensee of the impugned patent to cater to the demands of the Act with regard to the working of the patent.

This means he must be someone who practices or promotes/engages in research in the same field to which the invention relates. What this could mean is that an NGO, which cannot fulfil the obligations of a patentee/licensee imposed by and under the Act, cannot invoke a compulsory licensing mechanism under the Indian Act (whether this situation needs to be changed is a topic for another post because that would be a policy argument and not a statutory argument).

Therefore coming back to our discussion, since a PI, as used in compulsory licensing provisions, has to necessarily be a person/entity who can suitably replace a patentee/licensee, his identity is clearer than we think it to be. Therefore, one might say that only a pre-grant opponent who satisfies these requirements is legitimately entitled to agitate the validity of the patent as a post-grant opponent.

Further, in Dilworth, the Court held that an inclusive definition is used by the Legislature to:

1. to enlarge the meaning of words or phrases so as to take in the ordinary, popular and natural sense of the words and also the sense which the statute wishes to attribute to it; or

2. to include meaning about which there might be some dispute; or

3. to bring under one nomenclature all transactions possessing certain similar features but going under different names.

The first and third situations seem to apply equally to the instant discussion on “person interested”; however, obviously both cannot apply. So which situation does a PI fall under? First or the third?

The argument that it falls within the third category has already been made out above, but let’s test the possibility of it falling within the first category i.e. to enlarge the meaning of words or phrases so as to take in the ordinary, popular and natural sense of the words and also the sense which the statute wishes to attribute to it.

For this, we must look at other statutes to understand the popular meaning attributed to an inclusively defined “person interested”. Of course, it can be argued that the sense and scope in which a PI has been used in the Patents Act may be entirely different given that it is a niche legislation and addresses a techno-legal field of endeavour. Be that as it may, I don’t see the harm in arriving at the same conclusion after having considered a meaningful cross-section of meanings imputed to a PI.

In U.P Awas Ekam v. Gyan Devi (2004), the SC discussed the inclusive definition of a PI under Section 29 of the Land Acquisition Act (LAA) of 1894 and held that the definition must be construed liberally. This interpretation seems to have been relied upon in cases which concern social/welfare legislations such as the LAA. But can the same approach be used to define PI in the Patents Act? Is the context and the nature of the proceeding (post-grant opposition) the same? The answers to these questions are crucial.

And the answers can be found in this report of the Standing Committee on the Law of Patents of the World Intellectual Property Organization (WIPO), and even from our Act. The primary distinction between a pre-grant opposition and a post-grant opposition is that the former is not a proceeding inter partes. This means that it is not a proceeding between the pre-grant opponent and the applicant for a patent.

As stated in the report and as clarified by the Delhi High Court in the UCB Farchim v. Cipla, a pre-grant opponent merely aids the process of examination of the patent application. This is not so in the case of post-grant opposition. A post-grant opposition is a proceeding inter-partes i.e. it is a proceeding between the post-grant opponent and the patentee with the Opposition Board playing the judge. This also explains why a post-grant opposition is neither equal to a pre-grant opposition nor is it a provision for appeal from a pre-grant proceeding.

The primary respondent in an appeal to the IPAB from the rejection of a patent application in a pre-grant opposition is the Controller or the Assistant Controller and not the pre-grant opponent, whereas the primary respondent in an appeal from a post-grant proceeding is the post-grant opponent.

How are all these points relevant? These points are relevant because every proceeding which is a proceeding inter-partes has to involve affected parties i.e. the parties to the proceeding must be in direct conflict and any outcome is binding on both of them. Stated otherwise, “a person interested” is equal to an “interested party”/necessary party and this explains why the definition of a “person interested” refers to those engaged in or promoting research in the same field to which the invention relates. Further, if the decision in a post-grant opposition were to be deemed as binding not just on the parties to the opposition  but to everyone else, then it forecloses the possibility of a second post-grant opposition. Since this cannot be so, such an interpretation is not tenable.


It must be clarified that when I say that a PI, as defined in the Act, must be an "interested party", I mean that he must be someone who is affected by the patent, not as a member of the public, but as someone who is a practitioner of the field of technology to which the invention relates.

Therefore, in my humble opinion, not every pre-grant opponent can qualify as a “person interested” under Section 25(2).

We welcome the opinion of our better-informed readers on this issue.

(A review of the WIPO Standing Committee Report on Opposition Systems shall follow shortly)                                                                                                                        

“Informal” India and the Romanticisation of Innovation

FICCI's latest newsletter carried an article of mine dealing with grassroots innovation and the need to romanticise innovation. For those interested, here is the text:

“Informal” India and the Romanticisation of Innovation

3 idiots, one of the most tasteful Bollywood flicks this year, was embroiled in a “copyright” controversy involving credits to Chetan Bhagat, the author of the book on which the movie was allegedly based. What has been largely missed, however, is the ‘patent’ significance of the movie. The mysterious Phunsuk Wangdu, played by the inimitable Amir Khan, innovates in his open-air Ladakhi lab and owns over 400 patents!

This imagery will no doubt give patents and innovation a tremendous face lift in India. Particularly so, when most media projections of intellectual property have been far from graceful. Newspaper headlines routinely juxtapose the term “patents” with "murder", "kill" and "exploitation". Yusuf Hamied, the maverick head of Cipla, celebrated as a modern day Robin Hood, claimed in a television interview in 2005 that the introduction of pharmaceutical product patents was sure to cause genocide in India! Bollywood isn’t far behind either: in a flick titled ‘Laaga Chunri Mein Daag’, Rani Mukherjee plays the role of a high class escort and defines patents as an extortionist instrument devised by the West to milk developing countries.[2]

Given that ‘3 Idiots’ boasts a more intelligent script and better performances, Wangdu’s character is more likely to resonate in the minds of the average Indian viewer than a sizzling hooker with strong views on intellectual property. It also helps that Wangdu’s inventions did not involve pharmaceutical patents, a species of patents that are highly contentious owing to their innate potential to jack up drug prices and impact public health.

Since 2005, when India was forced to introduce pharmaceutical patents at the behest of TRIPS, most innovation debates in India have been framed primarily around drugs. Fortunately, Wangdu’s character helps in stripping innovation of its problematic drug centric focus. The inventions showcased in the movie did not stem from multinational corporations, but from poor grass-root innovators, as below:[3]

i) Remya Jose (20), a student from Kerala, created the exercycle-cum-washing-machine.
ii) Jehangir Painter (49), a painter from Maharashtra, put together a scooter-powered flour mill to escape the vagaries of Indian power cuts.
iii) Mohammed Idris (32), a fifth-standard dropout and a barber from Uttar Pradesh, invented a cycle-powered horse clipper.

Luckily for these inventors, their ideas were captured and leveraged by the National Innovation Foundation. This organization, the brainchild of Prof Anil Gupta and Dr R.A. Mashelkar, has already compiled more than 1,40,000 innovations belonging to the rural “informal” poor and virtually demolished the assumption that innovation is the preserve of the urban rich.[4]

Unfortunately for the NIF, the Indian legal regime that is meant to engender innovation continues to mainly favour only “formal” innovations emanating from the rich. This is despite the fact that almost 90% of India’s economy qualifies as “informal”![5] For one, the existing patent registration process is beset with considerable uncertainties and costs (including steep attorney fees), making it well-nigh impossible for a number of our informal creative minds to participate in India’s IP regime. Indeed, a number of such innovators have often found that applications drafted personally by them have failed time and again to meet the stringent requirements of Indian patent law.[6]

Not too surprising, given that India hiked up its patentability threshold considerably, owing to adverse perceptions against pharmaceutical patents. While this is laudable from the point of view of preventing pharmaceutical ever-greening and keeping drug costs down, it is a double edged sword, in that it impacts the patentability of a great number of grassroots innovations, many of which are “incremental” in nature.[7] Illustratively, consider the example of the inventor father son duo, the Appachans’, whose tree-climbing device was so attractive that even botanists from the US were interested.[8] Unfortunately, both father and son died within a week of each other in 2008. While the father held the “parent” patent over this device, the son obtained a patent over a slight improvement. The son’s improvement is generally thought to be a “weak” patent, which may perhaps explain the reluctance of the NIF to take on the Kerala state government that has been violating this patent with impunity.[9]

Owing to the rather severe standards that India’s patents regime now represents (at least on paper), a large number of grass-root innovation may find it difficult to make the cut, leading to a wide “patent” divide. Indeed, if “access” to patented goods is the key issue today, the problem of access to the patent system itself will be the issue of tomorrow!

A Proposed Utility Model System

One way out of this quagmire is to devise a patent like system with an easier registration threshold, a correspondingly weaker set of rights and most importantly, lower costs. Commonly known as the utility model system, this regime has found takers in several countries including a competitor that we in India watch very carefully, China. The latest figures reveal that of the 310,771 utility model applications filed in China in 2009, 99.4% were filed by domestic entities.[10] Contrast this with regular patents, where domestic entities accounted for only about 72.8% of the total number filed in that year.[11] The percentage of domestic patent filings when compared to foreign applications is considerably lower in the case of India[12], but a utility model system has the potential of helping reverse this trend.

However, there are variations amongst the various prevailing models and India must work towards a model that caters to the India milieu. The system must be an affordable and easy-to-use one, where grass-root innovators can participate without necessarily approaching expensive attorneys. Further, given that the low threshold for registration is likely to cause a spike in the number of applications, the corresponding set of rights associated with such registrations must be weaker than the patent system.

The author proposes a tentative model in this regard, as below:

1. An easy to use and affordable registration system, where the only criterion for registration is that the applicant discloses a useful “new technical advance” (NTA).
2. A registered NTA is protected only for 5 years. If the said NTA is commercialized within the first 5 years of registration, the rights holder gains protection for another 5 years.
3. All NTA-s are subject to compulsory licenses and can be used by any third party that wishes to make a product based on this right. The third party would, however, have to pay reasonable royalties to the NTA holder, based on a percentage of sales from the product. These reasonable royalties depend on the value of contribution made by NTA to the final product. This way, the granted right does not have a “blocking” impact on future inventions, in the way that a patent allegedly does today.

One might even have an amended version of the above, whereby a prototype or model of the alleged invention is insisted upon before registering the NTA in question. The model is best explained through a hypothetical. Consider an improved water pump that is made by company “A”. Assume that there are 3 NTA’s that are implicated in the creation of this pump. The NTA’s are registered in the name of X, Y and Z, various “informal” innovators. Assume that X’s “inventive” contribution to the pump is 30%. Similarly Y contributes 30% and Z contributes 20%. A’s inventive contribution is 20%. Apart from this, it invests money and other resources in creating a commercialized version of the pump. Let us peg this investment and risk at 50% of the total value of the product. The relative contributions to the total product therefore would be:

i) A: 50% (+20% of 50%): .5x + .1x=.6x
ii) X: 30% of 50%: .3 x/2=.15x
iii) Y: 30% of 50%: .3 x/2=.15x
iv) Z: 20% of 50%: .2x/2=.1x

Assume that A now makes Rs 1,00,000 as its profits in the first year. The respective shares will be as under:
i) A: Rs 60,000
ii) X: Rs 15,O00
iii) Y: Rs 15,000
iv) Z: Rs 10,000

The advantage with such a model is that it not only creates more determinacy (as the validity of an NTA is easier to objectively ascertain) but also solves the problem with patent hold ups and thereby fosters greater commercialization of new and valuable ideas. It avoids things like patent trolls and other mystical and mythical problems now associated with the current patent regime. It must be borne in mind that utility model systems in other countries have not always been run-away successes.[13]

But we could at least begin to think along these lines and devise a system that would most appropriately address the Indian milieu. Once grassroots and other informal innovators become familiar with a utility model like system, it may perhaps make it easier for them to gain access to the tougher patent system. In other words, the utility model system has the potential to serve as a “stepping stone” of sorts for such informal innovators.

Romanticisation of Innovation

The Indian government must also take other steps to romanticize innovation and ensure that it becomes a mantra chanted by one and all. In particular, much like the US, a National Inventors’ Hall of Fame to celebrate India’s most well known inventors, would be an excellent start.

Similarly, we also ought to award national medals of innovation to our most promising innovators. Such awards are statutorily mandated in the US through the AMERICA Competes Act. Although the government appears to have drawn inspiration from this Act in framing a tentative Innovation bill, it surprisingly left out this important feature from the Bill.[14] Only a conscious effort at romanticising innovation will help us in leveraging the one advantage that we have over the rest of the world: a large and creative work force. Bollywood has already taken the first step in this direction by giving us a hero who makes innovation look cool. Can we now leverage this sentiment to ensure that life imitates art?

Footnotes:

[1] The author thanks Shouvik Guha for his valuable inputs on this piece.

[2] See Shamnad Basheer, Bollywood and Patents: A Hooker’s Narrative of “Exploitation”!, SpicyIP.

[3] See Samar Halarnkar, Top Grosser 3 Idiots to fund Real Life Inventors, Hindustan Times, Mumbai, December 31, 2009.

[4] For details about this organization, see http://www.nif.org.in/ (Last visited February 26, 2010). The objectives of the Foundation include, inter alia, to help India become an innovative and creative society.. and a global leader in sustainable technologies by scouting, spawning and sustaining grassroots innovations . See http://www.nif.org.in/. NIF has 140,000 inventions from 545 districts in its database, generating 220 patent applications in India and one in the US.. See Samar Halarnkar, Innovation Network plans Giant Leap on the Back of 3 Idiots.

[5] “The “informal” economy either lies outside the scope of state regulation, or is officially subject to state regulation but nevertheless does not operate according to the rules that state regulation officially prescribes. In the former sense it is also known as ‘unregistered’, and defined as consisting of firms with electricity but under 10 workers or without electricity and over 20 workers (very rare outside agriculture). See Barbara Harriss White, India’s Informal Economy – Facing the 21st Century, Paper for the Indian Economy Conference, Cornell University, 19th and 20th April, 2002. See also Shamnad Basheer, Creating ‘Informal’ IP Norms.

[6] Interview with P.H. Kurian, Controller-General of Patents, dated February 26, 2010.

[7] See see Shamnad Basheer, Patent Oppositions in India: The "Efficacy" of Section 3(d)

[8] See MG Radhakrishnan, Fruit of Labour , India Today, June 26, 2008.

[9] Personal interview in July 2008 with MJ Joseph Appachan’s wife and lawyers .

[10] See http://www.sipo.gov.cn/sipo_English/statistics/gnwsznb/2009/201001/t20100127_488773.html.

[11] Id.

[12] In the financial year 2007-08, 35, 218 applications had been filed in India, out of which, 6,296 had been filed by domestic applicants, which is about 18% of the total. See Patenting Landscape in India 2009, Evalueserve Whitepaper.

[13] See generally Uma Suthersanen, Utility Models and Innovation in Developing Countries, February 2006, UNCTAD-ICTSD Project on IPRs and Sustainable Development.

[14] For a draft version of the Bill, see http://dst.gov.in/draftinnovationlaw.pdf. Also see Shamnad Basheer, “Making India Innovative: An Indian Innovation Act”, SpicyIP.