Tuesday, October 28, 2008

Happy Diwali 2008

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

Friday, October 24, 2008

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.

Tuesday, October 21, 2008

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 na├»ve 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.

Friday, October 17, 2008

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.

Tuesday, October 14, 2008

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.

Friday, October 10, 2008

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).