Madras High Court Judgment | Indian Network for People v. Union of India

Recent decision by the Madras High Court ordering the Chennai Patent Office to re-examine Valcyte patent can be found here.

Indian IP Laws: Troubled Waters

My latest article for Pharmabiz pull-out edition read here.

High Court Ordered Re-Examination for Valcyte Patent

The Madras High Court has ordered the Chennai Patent Office to re-examine Indian Patent No. 207232 issued to Roche in June 2007 for antiviral drug Valcyte, generically known as Valgancyclovir. The decision delivered by a bench comprising Chief Justice A.K. Ganguly and Justice Ibrahim Kalifulla is in response of petition filed by the Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS against the Chennai Patent Office decision to grant patent for Valgancyclovir without been given an opportunity for hearing (read earlier post). Recently, Roche also filed a lawsuit against Cipla for alleged infringement of the ‘232 patent (read earlier post). There is considerable likelihood that the decision may impact ongoing case in the Mumbai High Court between Roche and Cipla, possibly going in favor of Cipla. Girish Telang, Managing Director of Roche Scientific India said that “the court wants the patent granted on Valgancyclovir to be re-examined before January 31, 2009.”

Earlier in July 2006, Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS filed a pre-grant opposition before the Chennai Patent Office against the grant of a patent to Roche for Valgancyclovir and requested hearing under section 25 (1) of the Patents Act, 1970. Under the Indian patent law, an opponent may also request a hearing during pre-grant opposition. Also the Indian patent law seems to give the Controller a discretionary power to consider or not to consider the pre-grant opposition but if pre-grant opposition once considered by the Controller then section 25 (1) mandatory obligate the Patent Office to hear the opponent, if requested.

The Patent Office considered the pre-grant opposition and sent to Roche and later received a reply from Roche. Satisfied that the objections raised by pre-grant opposition had been met by Roche, the Chennai Patent Office went ahead and granted the ‘232 patent without hearing to the opponent. In October 2008, the opponent filed a petition in the Madras High Court alleging violation of the mandatory requirements of the patent law.

High Court Ordered Re-Examination for Valcyte Patent

The Madras High Court has ordered the Chennai Patent office to re-examine Indian Patent No. 207232 issued to Roche in June 2007 for antiviral drug Valcyte, generically known as Valgancyclovir. The court decision is made in response of petition filed by a Mumbai-based NGO Lawyers Collective on the behalf of Indian Network of Positive People and the Tamil Nadu Network of People with HIV/AIDS against the Chennai Patent Office decision to grant patent for Valgancyclovir without been given an opportunity for hearing (read earlier post). Recently, Roche also filed a lawsuit against Cipla for alleged infringement of the ‘232 patent (read earlier post). There is considerable likelihood that the decision may impact ongoing case in the Mumbai High Court between Roche and Cipla, possibly going into the favor of Cipla. Girish Telang, Managing Director of Roche Scientific India said that “the court wants the patent granted on Valgancyclovir to be re-examined before January 31, 2009.”

Feroz Ali Pen Down The Touchstone Effect: The Impact of Pre-grant Opposition on Patents

Leading IP advocate and author of a well-known book, The Law of Patents – With a Special Focus on Pharmaceuticals in India, Feroz Ali Hader has pen down his second book on patents and this time with special emphasis on pre-grant opposition. What really catches attention in this book is the unique amalgamation of law and business management in using pre-grant opposition for business edge. The book is titled The Touchstone Effect: The Impact of Pre-grant Opposition on Patents and is focused to deal with pre-grant opposition mechanism in India and how it can be triggered and framed for business advantage. Feroz has aptly portrayed the theme on his cover page – showing gold bars with a particular gold bar reveals to be a steel bar. A pre-grant opposition can be used to scan worthy inventions and differentiate them from trivial and frivolous patent applications.

As a companion to the book, Feroz also started a blog at www.thetouchstoneeffect.blogspot.com. You will find almost every decision referred in the book (with the relevant page and chapter numbers) here which can be searched and downloaded. The book as well as the blog starts off from a case study of the famous Bajaj-TVS patent dispute. Our readers may avail special benefit, Feroz and his Publishers have come up with a great offer:

The book can be purchased online for just Rs.295/- at www.lnbw.in or http://www.lexisnexis.in. As a special offer, the book will be shipped to anywhere in India for just one Rupee! The book is available for US$ 14.75 + shipping for readers/ professionals, outside India.

Particularly for overseas readers this book can be of great tool to understand how pre-grant opposition mechanism is exactly working in India and what do’s and don’ts need to be follow while filing patent applications in India, particularly for pharmaceutical inventions. Though I never had an opportunity to personally meet Feroz but have great regards for him and his writing. Patent Circle sincerely wishes him a great success for his second book.

Patent Office to Strengthen its Workforce

According to news reported by Economic Times, Indian Patent Office is likely to employ 1600 personnels in the next three-four years. N N Prasad, Joint Secretary Department of Industrial Policy and Promotion (DIPP) said that there would be more than 200 patent examiners and 1400 personnels to be added to the workforce in the next three to four years. He also added that the Centre is setting up a National Institute of Intellectual Property Management that will provide training and research in the international intellectual property regime, which is coming up at Nagpur. Speaking at a seminar organized by the DIPP and FICCI, Deputy Director General of the World Intellectual Property Organization (WIPO) Narendra Sabharwal said India has made rapid progress in the IPR.

This seems to be a good sign that the Indian Government want to strengthen workforce infrastructure but currently what is more important is particularly to pen-down a clear guidelines about the examining patentability of the inventions specifically for pharmaceutical inventions. As far as training is concerned, yes there is imperative need for root understanding of patents and examining merits of patentability particularly for patent examiners, who not only lack consensus among themselves about examining patentability but also decent understanding of technical jargons and know-how.

Kolkata Patent Office Issued Arzoxifene Polymorph Patent to Eli Lilly

Lately Kolkata Patent Office issued an Indian Patent No. 225209 to Eli Lilly & Co. for crystalline non-solvated anhydrous Arzoxifene. The ‘209 patent titled “A crystalline non-solvated anhydrous form 6-hydroxy-3-(4-[2-piperdin-1-yl) ethoxy] phenoxy)-2-(4-methoxyphenyl) benzo [b] thiophene hydrochloride” is published in Official Journal of the Patent Office (Issue no. 45/2008 dated 07/11/2008). Arzoxifene is a new molecule under clinical development in the family of selective oestrogen receptor modules (SERMs), estogren agonists/antagonists reported to be comparatively more potent and bioavaliable than raloxifene. Patent Circle interestingly noticed that Lilly had been fairly successful in prosecuting and convincing Indian Patent Office (IPO) for polymorph and salt patent applications. Last year Lilly got Indian Patent Nos. 208799 (for non-solvated crystalline raloxifene) and 220287 (for olanzapine pamoate salt and pharmaceutically acceptable solvate thereof).

Eli Lilly Filed Para IV Lawsuit Against Wockhardt

Wockhardt is lately been sued by Eli Lilly & Co. for alleged infringement of OB listed patent for antidepressant drug Cymbalta, generically Duloxetine. The lawsuit is result of Wockhardt’s submission of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking marketing approval for generic Cymbalta tablets before the expiration of the patent. Lilly also sued Sandoz Inc., Impax Laboratories Inc. and Cobalt Laboratories Inc. in separate lawsuits for seeking generic approval for Cymbalta tablets. Cymbalta is Lilly’s blockbuster drug which exceeded USD 2 billion global sales last year.

In separate development, Orion Corporation has filed a patent lawsuit (in the US District Court for the District of New Jersey) against Sun Pharmaceutical Industries Limited for alleged infringement of OB listed US Patent No. 5,446,194 (the ‘194 patent) for Stalevo, a combination drug (carbidopa, levodopa and entacapone) for the treatment of Parkinson disease. The lawsuit is result of Sun’s submission of an ANDA seeking marketing approval for generic Stalevo tablets before the expiration of the ‘194 patent. In November 2008, Orion also sued Wockhardt for alleged patent infringement for Stalevo OB listed patents.

Who Owns IN202354?

Last month Delhi Patent Office issued an Indian Patent No. 202354 (the ‘354) to Council of Scientific and Industrial Research (CSIR) for a process for the preparation of fluid catalytic cracking catalyst. The ‘354 patent is classified in the area of catalytic cracking of hydrocarbon oils (C10G 11/00). Accidentally while searching Indian Patent Office official patent database, Patent Circle came across information that Chennai Patent Office too had issued a patent to Roche for carbamic acid derivatives and their use as metabotropic glutamate receptor ligands having same patent number i.e. 202354. That mean we are having substantially two different patented inventions having same patent number in India. In case, if this is because of some typographical error while entering patent data into database then it raises serious questions about the creditability of official patent database which is though under the process of verification and testing. If in case it is not a typographical error, then such incident raises serious doubt about coordination between various offices of Indian Patent Office located in Chennai, Delhi, Kolkata and Mumbai in assigning patent numbers.

US Appeals Court's Ruling Delays Generic Prevacid

Japanese drug major, Takeda Pharmaceuticals Co. has won a US appeals court ruling that delays Teva Pharmaceutical Industries Ltd. from selling a generic version of the heartburn drug Prevacid, generically Lansoprazole until next year. The US Court of Appeals for the Federal Circuit, without issuing an opinion upheld a district court’s decision that US Patent No. 4,628,098 is both valid and enforceable. Post ruling, Teva said it will launch its generic versions no later than November 10, 2009.

Earlier in March 2008, the US District Court for the District of Delaware in its opinion ruled that Takeda’s patents on Prevacid are valid and that Teva’s ANDA for a generic version of Prevacid capsules infringes one of the patents. During litigation Takeda asserted US Patent Nos. 4,628,098 and 5,045,321 against Teva. Teva conceded that its ANDA product infringes the ‘098 patent but still contested infringement of the ‘321 patent. Moreover, Teva argued that ‘098 and ‘321 patents are invalid for obviousness and unenforceable due to inequitable conduct.

During trial, the district court rejected Teva’s arguments that ‘098 and ‘321 patents would have been obvious but found that Teva’s ANDA product does not infringe the ‘321 patent. The court also found Teva’s inequitable conduct arguments to be meritless. Teva subsequently appealed the district court decision. Prevacid is a blockbuster drug with US annual sales more than USD 2.5 billion.

FICCI to organize Two Day Forum on the Role of IP

Federation of Indian Chambers of Commerce and Industry (FICCI) in association with World Intellectual Property Organization (WIPO) and Department of Industrial Policy and Promotion (DIPP) is organizing two day’s inter-regional forum on “Role of Intellectual Property in the Innovation Economy” on 26^th – 27^th November 2008 at ITC Sheraton New Delhi Hotel, District Centre, Saket, New Delhi. The forum will provide an opportunity to discuss –

(I) the latest international trends and developments in planning of a strategy for development of intellectual property;

(II) the appropriate policy approaches, strategic framework and institutional mechanisms for utilizing intellectual property as a powerful tool for an innovative economy;

(III) Intellectual property as a common language for government and markets in the promotion of competitiveness, innovation and creativity; and

(IV) Intellectual property rights policies to foster innovation and diffusion of technology in emerging areas of the economy.

The programme copy, brochure and response proforma can be downloaded from the following link. For further details you may get in touch with Sheetal Chopra, Senior Assistant Director sheetal.chopra@ficci.com) and faaiz.dijoo@ficci.com (Ph: 23738760 (ext: 368), 23766930, 9810144466, Fax No. 91-11-23765333, 23721504).

The Indian and International speakers will deliberate upon eight very important themes as given in the programme copy. Beside Indian delegates approx. 50 International Delegate will be participating in the conference representing China, Korea, Japan, Malaysia, Switzerland, Philippines, Singapore, Thailand, Vietnam etc.

FICCI lately organized a conference in Goa in association with WIPO and DIPP on 1-3^rd September ’08. There were many important points which were pointed out by the delegates which were really thought provoking such as whether 2^nd tier protection (utility model) for incremental innovations has really helped the growth of countries; patenting of method of use claims etc. The conference came to be a big success. May be this is the reason that WIPO seems to have again joined hands with FICCI to organize yet another conference on 26-27^th November ’08 with a new theme.

Patent Circle believes it would be an important forum to learn about the policies being adopted by different countries to foster the growth the Intellectual Property thereby strengthening the innovative economy. Recently, FICCI has submitted draft Innovation Act to the Ministry of Science and Technology with an aim to create an enabling environment for more innovations to take place. The text of this Act is also available on DST’s website. During the forum, possibly discussions might take place on this front as well.

Gleevec Update: Hearing to start from November 17

In a latest update, the Intellectual Property Appellate Board (IPAB) comprising Z. S. Negi (Judicial Member) and P.C. Chakraborty (special Technical Member) convened in Chennai yesterday to issue directions. As per directions, the hearings of the appeals will commence on 17 November 2008. The hearings are expected to continue on a day-to-day basis and spill over into the next week. The hearings are to decide appeal filed by Novartis AG challenging the Indian Patent Controller’s decision to reject its patent application for the beta-crystalline form of Imatinib Mesylate (Gleevec).

On a lighter note, we have restarted Drug Patent Expiry after receiving innumerous requests from our readers.

Happy Diwali 2008

Patent Circle wishes all its readers a very happy, prosperous and peaceful diwali.

Novartis to Defend Mylan’s Paragraph IV for Fluvastatin

Swiss-drug major Novartis has filed a lawsuit in the US District Court for the District of New Jersey against Mylan Pharmaceuticals Inc. for infringement of Orange Book listed US Patent No. 5,354,772 (the ‘772 patent) for Lescol capsules, generically known as Fluvastatin Sodium. The infringement suit is result of Mylan’s submission of an abbreviated new drug application (ANDA) with paragraph IV certification for the Lescol capsules earlier in June 2008. Mylan believes that it is first to file ANDA for the product. Fluvastatin is indicated for the treatment of high cholesterol and had US market sales of approximately USD 60 million for the twelve months ending June 20, 2008 according to IMS Health.

Absent Innovation Culture, Disowning and Other Dangerous Things

If you remember Prof. George Lakoff, by reading this title, you are right. This renowned linguist wrote a book entitled “Women, Fire and other dangerous things” where he addressed interesting aspects of categorisation. I wouldn’t elaborate on it here. The book must be read in original though. This I mentioned since I borrowed Prof. Lakoff’s style.

Present text is about the attendant hue & cry about so called corruption in Indian patent office. This tempest was set in by a small butterfly article fluttering its wings in the Mint.

What is on record is that about 130 patent examiners in Indian Patent office helped grant about 15000 patents in one year (2007-08). This has been compared to EPO statistics where 4000 examiners helped grant 54000 patents in a year. An inference is drawn without any evidence on record that the system is greased with money which makes so many applications go through smoothly.

One wonders if this is fair to so many serious examiners who might be doing their jobs right without ‘extra cash’ as a carrot. I am not saying that all is well in Indian patent offices. In fact a couple of months back, I almost fainted after receiving an answer from a guy in Patent office’s library whom I asked if Dr. Mashelkar visited there in recent past. He coolly told me to leaf through the visitor’s register there kept in a corner in which all library visitors wrote their names. He just didn’t know who Dr. Mashelkar was. But by quoting this example I wouldn’t generalise that whole office staff is absolutely ignorant.

Likewise for a few examiners who might be part of dangerous liaisons during some part of grant process, I would not condemn the whole system. It ain’t cricket!

India might be having patent protection mechanism since 1911 but patent awareness is of recent times. If Britons are to be credited for installing this system, they may not shrug off the dire failure in teaching technocrats patentese and for failure in sowing the seeds of innovation culture.

The innovation culture is just absent here. Indians traditionally are just not into observing, documenting and using the surroundings for their material well being. If I write that science culture itself is absent, I might invite an avalanche of criticism. But I will tell you something. Although I have used the word ‘canary yellow precipitate’ several times while describing an outcome of certain chemical test, I have not seen Canary till now. I even didn’t know for quite long that this was name of a bird found in western countries and not sighted at all in India. Indians get science educated in a setting where the teachings are not internalised. Above example can be contrasted with my own experience when I was TA'ing in North America. There I came across a stunning visual description of a chemical reaction product which ‘looked like a rotten beer” to an undergrad in my lab. The product really looked like a rotten beer. The pragmatic thinking of west didn’t grow overnight. West has had a long tradition since renaissance period. Indian renaissance may be dated to 1947 the year of freedom.

Now the inventors and patent examiners are also product of this culture where ‘innovation is not intrinsically respected’. Property is hated, owning something is just a matter of following grand design. ‘Disowning’ is great. “Obedience” has to be inculcated. These are the memes we in India have grown-up with.

Corruption if any (and it could be there) would be just a symptom of several dangerous & deep seated issues. Now Indians can’t claim monopoly on corruption. It will be very naïve to eliminate incidences of corrupt practices in patent offices of other countries.

If I were a Patent Examiner with a target of finishing at least 10 applications per month alongside attending several training sessions, I am better off going by what Assistant Controller allows. I won’t venture being a maverick. I wouldn’t see many mavericks upstairs too, so why set an example which will not benefit me? Moreover, why should I risk my career for the so called inventors who are busy in exploiting consumers? I am good in handling language, good in referring to the patent manual & have several applicants or their representatives eager to give me free ego trips. I wouldn’t do knit-picking what others afford to do sitting in easy-chairs ; I would just do my job because that’s my choice, last year when I visited Vaishnvi devi or Nasik an year before ; I thanked god for the bread & butter provided to me. I would rather carry on with this job, enjoy whatever ego gratification it provides without worrying about fancier pastures. I have done fairly well for my background. I am doing OK. Nothing earth shaking is happening around me. These big inventions and that entire publicised innovation news item are good as a read with a glass of fruit juice I have begun to afford these days. Nothing can be innovated, it is already with you; it is only resurrected. I cannot maintain few properties I have. Many times I think they are not mine, it is my luck that I am blessed with the material wealth I have. Things are fine the way they are. It is all pre decided.

I do not think quixotic expectations from Patent Examiners will lead to quality enhancements overnight. A person in the system is a part of the society he/she comes from. If managing more than one house, civil properties is difficult, one just can’t be expected to know the prowess of intellectual property & to know how wealth could be generated through it across the borders. It is not far stretched.

Where Innovation culture is absent & distributing something to everybody like ‘Prasad’ is commonplace, claiming ownership on the technological advances is difficult to digest. This again is not far stretched.

The persons who are not serious about respecting innovative activities, who do not respect ownership on intellectual property and who will not assert at right place on right time, will not be able to function properly as the facilitators of innovative culture.

One just can’t say - “I want these examiners to follow the Manual verbatim, if you can’t get the job done, clear the place”. The examiners are not robots.

One has to address this issue in holistic manner to attain desired goal of honest & transparent system. Smartly worded and ill founded criticism without deep analysis will only harm the system. There are better ways of catching attention than putting examiners/agents in a corner and squandering accusations.

Good structured training, adequate patience and empathy will help the examiners at various stages on the learning curve. It is surely understandable that we expect exquisitely drafted FER, a prudent application of law and overall a well home- worked boldness in performing on this extremely important position. But it is going to take time.

Patent examiner being part of the absent-innovation-culture will not feel the sanctity of patent law.

Dr. Uday Gokhale Joins Patent Circle Family

We’re happy to welcome Dr. Uday Gokhale to join Patent Circle family as a co-author. He is an organic chemistry with Ph.D. from University of Alberta. He has rich 20 years of professional experience in bioorganic and pharmaceutical field and has been involved in new product development activities with repute companies including Ciba-Giegy, Glaxo and Boots. He is presently been retained as an advisor by pharmaceutical companies for intellectual property issues, technology know-how and cGMP.

Roche Cuts Price of Tarceva in UK

After UK’s National Institute for Health and Clinical Excellence (NICE) agreed to pay for Roche’s anticancer drug Tarceva on the condition that Tarceva should matched the price of an older, less costly remedy Taxotere, Roche discounted Tarceva by about $ 1000 in order to bring the cost in line with Taxotere (Docetaxel) marketed by Sanofi-Aventis. Earlier, NICE ruled that four drugs used to treat kidney cancer – Roche’s Avastin, Bayer’s Nexavar, Pfizer’s Sutent and Wyeth’s Torisel – are not cost effective for treating advanced or metastatic kidney cancer and should not be prescribed to new patients. However, NICE decision caused outrage among charities and patients. Importantly, there are reports (link 1, link 2) that Tarceva is significantly improved medication in prolonging life and quality of life.

Tarceva UK’s development is an example of fair negotiation between Health Agency and Innovator. Access to life-saving drugs at reasonable price can only be possible if there is constructive platform for mutual discussions between drug agencies and innovators. Not only innovators have resources to improve quality of life but also a moral responsibility that their drugs should reach across the globe to the patients who are in need of them. Reciprocally, Government should also make policies to safeguard business interests and provide incentives to innovators in brining effective and life-saving drugs.

Post-Approval Study Revealed Tarceva Causes Deaths

Last month the US Food and Drug Administration published a notification submitted by OSI and Genentech bringing in notice about severe cases of liver damage among patients who look cancer drug Tarceva, as part of a post-approval study designed for patients with moderate liver impairment and advanced tumors. According to the notification, one patient died from rapidly progressing liver failure and another died from a liver complication called hepatorenal syndrome. Genentech spokesperson said that the label information will now include a stronger warning about liver damage and fatalities. Erlotinib was approved by the US FDA, after priority review, in November 2004 and later received marketing approval in India on July 13, 2005.

In January, Cipla launched the generic copy of Tarceva and was sued by Roche for infringement of patent in the Delhi High Court. High Court is already done with the hearing and verdict will be announced in near future. However, the incident of deaths caused by Tarceva raises an important question about the generic approval of newly approved drugs for which post-approval study is still under progress. Do Indian drug regulators need to have strong guidelines for post-approval study for newly approved drugs, particularly life-threatening diseases before giving marketing approval for generic drugs? At least such initiative will minimize the risk of Vioxx-like debacle.

Invitation for Co-Authors

We are looking to expand Patent Circle family and in respect would like to invite people interested in joining Patent Circle as a co-author. We are particularly interested in people with keen and analytical understanding of patent and intellectual property issues and can blog on legal, technical or even business aspects of patents and intellectual property. We also invite co-author from other countries, particularly China, US, Australia, Europe, Germany and Brazil in contributing to make Patent Circle the first global patent law blog.

We are sincerely working to scale this blog to the global platform for reliable source of patent news and reporting. Patent Circle has a fairly wide readership in India and across the global and mostly read by patent practitioners, R&D scientists, students, in-house counsels and print media. So if you are interested to be part of Patent Circle family and contribute in building globally regarded patent law blog, please write to us @ chhonkar.varun@gmail.com.

FICCI to organize One Day Training Programme on Patent Litigation

FICCI-IPR division in association with Indian Patent Office (IPO) and European Patent Office (EPO) with a leading European Law firm Kilburn and Strode is organizing a one-day industry specific training program on “Prosecuting and Litigating Patents in Europe and India” at FICCI, New Delhi on 24th October 2008 with an aim to share with each other the best practices.

The focus of the workshop is to make Indian Industry aware about prosecuting/litigating patent applications in India/Europe and to learn about the best practices being adopted by each patent office. The programme will also help in understanding the legal landscape so as to learn the ways of enforcing one’s Intellectual Property against the infringer.

Patent Circle personally views that this programme would be of tremendous help to not only those who are IP professionals but also for those who intend to build their career in the IPR field. This is the right platform to get in touch with not only senior officials from Industry and Indian Patent Office but also with the officials from European Patent Office. We are particularly grateful to FICCI and Sheetal Chopra (Senior Assistant Director, FICCI) who has agreed to give 30% discount in fee for the readers of Patent Circle who would like to participate in this one day training programme. We request our readers interested for participation to mention “Patent Circle” as a source of programme information.

The invited speakers for the program are expert Patent Examiners, Controllers from Indian and European patent office; Patent Attorneys and Litigators from the leading Law Firms, who have extensive years of experience in their professional fields. This program will be attended by Legal practitioners, Industry professionals, academicians and IP outsourcing organizations.

The programme copy, brochure and response proforma can be downloaded from the following link. For further details you can get in touch with Ms. Harinder at harinder@ficci.com (Ph: 23738760 (ext: 368), 23766930, 9910734340, Fax No. 91-11-23765333, 23721504) or with Mr. P L Sharma (Ph: 23738760 (ext: 212), Fax No. 91-11-23765333, 23721504).