Merry Christmas!

To everyone who has read this blog, and to those who have participated in constructive discussions and debates, thank you for your continuous support. Patent Circle wishes you all a merry Christmas and best of holidays.

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Dr. Uday, Varun & Seema

Dr. Reddy's Settle Clarinex Patent Lawsuits

After Lupin, Dr. Reddy’s Laboratories has reported to settle all pending patent infringement lawsuits with Schering and Sepracor relating anti-allergic drug Clarinex (desloratadine). Under the settlement agreement, Dr. Reddy’s will be able to sell generic versions Clarinex-D12 and Clarinex-D24 with six-months marketing exclusivity, and Clarinex Reditabs with six-months marketing co-exclusivity starting from 2012. Earlier, Schering and Sepracor have similar settlement agreements with generic manufacturers including Ranbaxy, Perrigo Co. and Watson Pharmaceuticals Inc.

Ranbaxy to Continue with Generic Business Strategy

Leading Indian newspaper Times of India (TOI) run an interesting piece of news about Ranbaxy business strategy to retain generic focus after being acquired by the Japanese Daiichi Sankyo. As rightly pointed by TOI most in industry believed that Ranbaxy will likely dilute its aggressive generic strategy, particularly paragraph IV challenges after being part of pharmaceutical drug innovator Daiichi but in an interview given to TOI, Daiichi Sankyo president and CEO Takashi Shoda told that “the company will follow a unique business model, focusing not only on innovation but also on generics”. He further added that “in developed markets like US and Japan, Ranbaxy will expand its generic business”. Further elaborating on the strategy, Ranbaxy MD Malvinder Singh said, “Our business model will continue in the US, and so will out strategy in generics. We will continue to file and evaluate First-to-file patent opportunities. We will together create a new model, where we will maintain and leverage each other strengths to benefit both (companies)”.

Considering that Daiichi has or had been in business collaborations with many innovators including Roche, Novartis, Eli Lilly and Forest Laboratories, it would be really interesting to watch how Daiichi take Ranbaxy’s business model forward in the US, in particular paragraph IV opportunities.

CitePatents.Com

Popular patent search portal FreePatentsOnline.com (FPO) has launched an informational site, www.citepatents.com, particularly to help bloggers, journalists and others to easily reference to patent information, and to provide a free patent search box for adding to websites with a single mouse click. Anyone interested in placing FPO SearchBox on their website or blog may visit CitePatents.com for the html code. Just few months FPO also launched free patent search service SumoBrain with a powerful new feature of bulk PDF downloading from a database of tens of millions of records including US patents and published applications, European patents and published applications, and WO publications. This feature obviously came handy to us, particularly in patent searches. SumoBrain also features basic and advanced search capabilities including field search, word stemming, proximity search and search term weighting. We would sincerely recommend our readers to include SumoBrain in their search tool basket.

Patent Circle Not to Report on Granted Patents

After Mint’s misleading reporting, Patent Circle has decided not to report anymore about granted pharmaceutical patents in India. Some of our readers has humbly suggested that it would be in better interest that Patent Circle must stop tracking and reporting on granted pharmaceutical patents in India and should focus writing more on general topics and various aspect of India patent laws. We sincerely appreciate our readers’ suggestion and will definitely stay away from reporting on Indian patents.

Lupin Settles Clarinex Patent Lawsuit

Lupin Ltd. has reported to settle all patent infringement lawsuits with Schering-Plough Corp. and Sepracor, Inc. relating anti-allergic drug Clarinex tablets, generically known as desloratadine. Under the terms of the settlement, Lupin will be licensed Clarinex OB listed patents and will be able to commercialize its generic Clarinex tablets on July 01, 2012 or earlier in certain circumstances. Earlier in November 2007, Sepracor and University of Massachusetts filed an infringement lawsuit against Lupin for alleged infringement of the US Patent Nos. 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent).

Mint Baseless Reporting Continues

In last few days I received fair number of phone calls and emails from my readers and friends including couple of concerned Indian patent examiners commenting about Mint latest news that India has granted at least 10 patents in the past 12 months for what would appear to be mere modifications or new forms of known drugs and further cementing with inconsistency and lack of transparency in the functioning of Indian patent offices. Even some readers strongly pointed out that list of selective patents used by Mint is obtained from Patent Circle (see here and here) and more sadly accused Patent Circle for putting posts on granted patents in past and giving newspaper media ground for baseless reporting. I do accept that there had been instances where our posts are been negatively used by newspaper media but as an author I would like to clarify that our intention for carrying such posts was to send a constructive and positive message to our readers, particularly overseas readers which include foreign patent attorneys and pharmaceutical in-house counsels about Indian patent system and to remove misapprehension that Indian patent law do not merit incremental innovation. There are many newspaper journalists who not only used our post constructively but also doing a great job in building patent awareness.

In past Patent Circle exclusively brought in notice couple of patents issued to Cipla for new forms of known drugs, namely, esomeprazole and alendronate and accused Cipla of practicing double standards on patenting so-called trivial improvements. Our basis of raising fingers on such patents was our years of understanding and expertise in technical domain and Indian patent practice. Now coming back to Mint news, the reporter has accused the Indian Patent Office of oversighting Section 3 (d) of the Patents Act, 1970 and issuing patents for mere modifications or new forms of known drugs. The reporter’s allegation is based on selective 10 patents which include Cipla’s esomeprazole inclusion complex (IN219034) and alendronate monohydrate (IN219022) patents. The other patents are –

1. IN204325 titled “An eletriptan hydrobromide monohydrate and a process for the preparation of the same”

2. IN204343 titled “Polymorph of (2R, 3S, 4R, 5R, 8R,10R, 11R, 12S, 13S,14R)- 13- [[2,6-dideoxy-3-cmethyl-3-0-methyl-4-(-[(propylamino)methyl]-a-l- ribohexopryanosyl] -2-ethyl-3,4,10- trihydroxy-3,5,8,10,12,14 -hexamethyl -11- [[3,4,6-trideoxy-3-(dimethylamino)-b-D-xylohexopyranosyl] oxa]-1-oxa-6-azacycopentadecan-15-one diphosphate”

3. IN204126 titled “4-(Diarylmethyl)-1-piperazinyl derivatives”

4. IN204151 titled “Substituted oxazoles and thiazoles derivatives as HPPAR ALPHA Activators”

5. IN204158 titled “Imidazo Pyridine Derivatives which inhibit Gastric Acid Secretion”

6. IN202128 titled “Stable crystalline polymorph Form I of (-)-4-[4-[4-[4-[[(2R-cis)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-tri azol-1-ylmethyl)furan-3-yl]methoxy]phenyl]-1-piperazinyl]phenyl-2,4-dihydro -2-[(S)-1-ethyl-2(S)-hydroxylpropyl]-3H-1,2,4-triazol-3-one”

7. IN201649 titled “Novel succinate salt of O-desmethyl-venlafaxine”

8. IN201140 titled “Novel crystalline forms of a macrolide antibiotic CP-472,295”

Apart from four patents - IN219034 (esomeprazole inclusion complex), IN219022 (alendronate monosodium salt), IN204325 (eletriptan hydrobromide monohydrate) and IN201649 (Desvenlafaxine succinate salt) – which fortunately have drug substance generic name included in the title, the reporter seems to be not sure about what drug substances are covered by remaining six patents. In fact, the reporter seems to be not even sure whether such patents are related to human drugs or they relate to agro-chemicals/veterinary drugs. To identify such information one need to be more than an average organic chemist or patent specialist in chemistry (what the reporter referred to be so-called patent agent). For instance, IN201140 and IN204343 both issued to Pfizer are covering crystalline forms of anti-bacterial veterinary drug Tulathromycin marketed as Draxxin for the treatment of bovine respiratory disease (BRD) in cattle and swine respiratory disease in pigs. Obviously the reporter seems to be not aware of this fact because these two patent was not mentioned anywhere in public domain except one of them reported by Sandeep’s blog. I personally believe that efficacy requirement in Section 3(d) of the Patents Act, 1970 is restricted to efficacy intended for human subject not for pig, dog, cow and other animals. I hope the reporter is not weighing interests of human and pigs in same basket.

IN202128 covers polymorphic form of antifungal drug posaconazole. Remaining three patents – IN204126 issued to Sun Pharmaceutical industries Ltd. covers 4-(diarylmethyl)-1-piperazinyl derivatives having base structure similar to cetirizine, IN204151 issued to Glaxo covers substituted oxazoles and thiazoles derivatives, and IN204158 issued to AstraZeneca covers imidazo pyridine derivatives having base structure similar to structure disclosed in the US4920129 – are related to novel compounds. Obviously it is well known to a person skilled in the art that most of the new compound or group of compounds synthesized in a laboratory are chemically derived from some known chemical structure (basic chemistry concept) and by mere reading term ‘derivative’ in title or abstract of a patent no one (not even veteran chemist) would have concluded that these patents are mere derivative or modification of known substances. I am completely perplexed how a newspaper journalist came to such a conclusion, which even for me is a challenging task, and requires high-end research (not to forget complex structure search).

Indian Patent Office Launches National IPR Campaign in association with FICCI

It is well realized now that with increased relevance of Intellectual Property (IP) in this era of globalization, it is inevitable to recognize the role which IP systems play in the growth of Indian Industries. However, there is still a need to create larger public awareness about the pivotal role of IPR in globalized knowledge economy.

To meet this objective, Secretary, Department of Industrial Policy and Promotion (DIPP) announced National IPR Campaign” on World IP Day, the April 26^th, 2008. To transform this vision into reality, Office of the Controller General of Patents, Designs and Trademarks (CGPDTM) and Department of Industrial Policy and Promotion (DIPP) under Ministry of Commerce and Industry in association with Federation of Indian Chambers of Commerce and Industry (FICCI), other institutions and industry associations are jointly conducting seminars, workshops and specialized training programmes in industrially important cities across India.

The seminars in association with FICCI will be held in eight cities all over India namely Jaipur, Kanpur, Ludhiana, Delhi, Ranchi, Surat, Bhopal and Agra during December, January, February and March. The programs are highly specialized and specially oriented for the IP users, industries, innovators, and entrepreneurs and alike

At the end of the conference a quiz contest shall be held to map the success rate of the programme. The winners shall be awarded cash prize on the spot.

At the end of each seminar, the Certificate shall be issued directly by Controller General, Indian Patent Office to all the participants.

For respective dates, places, and further information Click here.

Q Corner | Minimum Period for Patent Grant

What is the minimum period in which patent can be granted in India? --- Dr. Ashwin K. Gupta, Delhi

As such there is no exact rule for calculating minimum period in which patent can be granted in India as the Indian Patent Office (IPO) has its own right to reserve timeframe for processing procedural formalities under the Patent Rules, 2003. However, if we consider that IPO effectively process its procedural formalities and the applicant promptly reply objections made by the examiner and comply with other procedural formalities within shortest possible time then a patent may be issued within 9-10 months from the date of filing of application. Obviously while calculating I am generously considering that there is no pre-grant opposition made by any concern party against grant of the patent. My basis of calculation primarily rely on the following Rules –

Rule 24 and 24A – Considering that the Applicant has made request for early publication which the Controller will publish ordinarily in one month from the date of request for publication.

Rule 24B – Considering that the applicant has requested for examination at the earliest, possibly along with the request for early publication.

Rule 24B (3) – This is the standard time period (six months) in which a First Examination Report (FER) will be dispatched to the applicant or his authorized agent from the date of the request for examination or from the date of publication whichever is later.

Rule 24B (4) – Applicant has maximum twelve months to reply the objections made by the examiner. We are considering that the applicant provide reply within shortest possible time and accepted by IPO for patent grant.

Rule 55 (1A) – Importantly, a patent cannot be granted before the expiry of a period of six months from the date of publication of the application.

The above Rules ordinarily place an application for patent a minimum of 9-10 months to grant.

Q Corner | Paragraph IV

What is Para IV and how to file Para IV? --- Dr. Jitendra Koundinya, Mumbai

This is the first question asked by our reader in our new section Q Corner. Para IV (or paragraph IV) is a statutory concept related to the US drug regulatory and patent system brought by the Drug Price Competition and Patent Term Restoration Act, 1984 also referred as “Hatch-Waxman Act.” Hatch-Waxman Act amended the Food, Drug and Cosmetic Act remarkably balancing the business interests of pioneers and generic drug manufactures, and is primarily credited for the development of the US generic drug industry. Title I of the Hatch-Waxman Act contains the drug price competition part, specifically authorizing generic drug manufactures to file Abbreviated New Drug Applications (ANDAs) along with bioavailability studies. The Act also required one of four certifications to be made when someone files an ANDA: 1) that the drug has not been patented; 2) that the patent has already expired; 3) the date on which the patent will expire, and the generic drug will not go on the market until that date passes; and 4) that the patent is not infringed or is invalid. Those certifications are now referred to as the paragraphs I, II, III and IV certifications. Title II of the Hatch-Waxman Act contains the patent term restoration part, specifically authorizing pioneers to receive an extension in patent term lost during the FDA approval process.

As a part of Para IV process, a generic applicant must do two things: 1) certify in its ANDA that the patent in question is invalid or is not infringed by the generic product and 2) notify the patent holder of the submission of the ANDA. Once the patent holder receives the ANDA notification, they have statutory discretion to file a patent infringement suit against the applicant within 45 days. If an infringement suit is filed within the 45-day period, FDA approval to market generic version is automatically stayed for 30 months. Notably, a Para IV certification can be triggered by a generic applicant for a drug product that has unexpired Orange Book (OB) listed patents and the generic applicant is seeking to market its generic equivalent before the expiration of OB patent(s).

Roche Challenged the Madras High Court's Decision

The Mumbai High Court has decided to consider Valycte patent infringement case only after eight weeks based on the order of the Madras High Court. Earlier, the Madras High Court ordered the Indian Patent Office to reexamine the patent granted to Valycte active ingredient, Valganciclovir before January 31, 2009. Roche later decided to challenge the Madras High Court’s decision and has filed a special leave petition before the Supreme Court of India. In another development, the Mumbai High Court restrained Cipla from using the trademark “Valcept” for its generic version of Valycte.

Lilly Patent Particulate Form of Tadalafil

Indian Patent Office (Chennai) has lately issued an Indian patent # 224314 (the ‘314 patent) to Lilly Icos LLC for Tadalafil particulate form and method of preparation thereof. The ‘314 patent is issued against the national phase application (PCT) # IN/PCT/2002/143/CHE claiming priority from US provisional application # 60/147,048 dated August 03, 1999 which later issued as US 6,821,975 and currently listed with the US FDA Orange Book. Marketed as Cialis by Eli Lilly, Tadalafil is one of the drug that was granted exclusive marketing right (EMR) in India against the application # 85/DEL/1995 (the 1995 application) which later got stayed by the Calcutta High Court after a petition made by Mumbai-based Ajanta Pharma.

The 1995 application covered claims for Tadalafil per se and process of preparation thereof. Considering [pre-grant opposition] filed by Ajanta Pharma, the Indian Patent Office (Delhi) last year on March 22 rejected product claims for Tadalafil per se but allowed process claims. The product claims were found obvious over the US 3,917,599 (the ‘599 patent) issued to Central Drug Research Institute (CDRI). The ‘599 patent exemplified 2-substituted-1, 2, 3, 4, 6, 7, 12, 12a-octahydropyrazino [2’, 1’:6, 1] pyrido [3, 4-b] indoles which is the base structure of Tadalafil but never suggested to be useful for treatment of erectile dysfunction.

Q Corner

Patent Circle is pleased to announce that we are starting an interesting section Q Corner where our readers can send their questions or queries related to patents and Indian patent laws, and we will try answering them within the shortest possible time. Though we will sincerely try our best responding all questions but may still drop some mostly repetitive or similar to what already been answered by us. Readers can send their questions/queries at varun@ipfeathers.com.

Disclaimer: Answer(s) provided in Q Corner nowhere constitute a legal advice and may still need to be double checked for their accuracy and current applicability.

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).

Mumbai High Court Ask Cipla to Reply in 2 Weeks

Mint has further reported that Justice Abhay Oka of Mumbai High Court has asked Cipla to reply in two weeks to the patent infringement suit filed by Swiss-major F Hoffmann-La-Roche over anti-infection drug Valganciclovir. The case is expected to come up for hearing in the third week of October. In parallel, Roche is also facing post-grant oppositions from Ranbaxy, Cipla and the Delhi Network of Positive People in the Chennai Patent Office. Though we are not able to go through the complete specification of Valganciclovir patent but according to reliable sources Roche’s patent has broadly issued claims which may likely invalidated on the grounds of obviousness (and possibly be challengeable under section 3(d) on the grounds of obvious variation of known compound ganciclovir).

Natco Withdraws Application for ‘Export’ Compulsory Licenses

Mint has reported that Natco requested Controller of Patents to withdraw its applications for compulsory licenses for export of generic anti-cancer drugs Sunitinib and Erlotinib, both patented in India. Earlier, Natco filed application for compulsory licenses of Erlotinib and Sunitinib to be exported to Nepal under section 92A of the Indian patent law. Though Natco’s move was unprecedented and shocked many but legal equations were never favorable for Natco because there was no official notification made by Nepal Government to allow importation of anti-cancer drugs from India (a litmus test for Indian Patent Office to evaluate compulsory license for export). Whatever may be the reasons for Natco to withdraw its application for compulsory license but what can be concluded from the whole episode that it was a bad patent-legal strategy yet was a good business strategy to keep Natco's script rolling on Bombay Stock Exchange?

Cipla Mocks Roche’s Patent for Valganciclovir

Mumbai-generic major Cipla has yet again made a mockery of Indian patent law by launching a generic version of Roche patented anti-infection drug Valganciclovir. This is the second instance of Cipla mocking Indian patent after it deliberately launched generic copy of Roche patented anti-cancer drug Erlotinib. Though we are not sure how much impact this will make on availability of drugs to Indian patients but surely it will deteriorate India’s image in global IP scenario. What is more pathetic is India’s legal state-of-affairs which is slowly becoming hand-puppet and regularly been twisted by politicians and strong businesses for their self-business interest. Politicians often used language and regionalism for their political gain but continue to ignore national interest and security for better growth and war against terrorism. Cipla too have mastered targeting high-pricing of innovators’ for their business interests but continue to ignore building healthcare infrastructure. Even after 60 years of independence only margin section of society have access to medicines with most even struggling for food and shelter. Post 1970 Indian generic companies including Cipla made phenomenal growth (in absence of patent protection for pharmaceutical drug products) to thousand crore plus company but still Indian healthcare scenario is struggling for better infrastructure. Over the years, Cipla has proudly publicized to provide cheap AIDS medicines to African countries when back here in India their own people are dying of common disease like tuberculosis, cholera and malaria. What can be more shameful when home grown pharma companies are more concern in exporting AIDS and cancer drugs rather than reaching to rural areas of India to provide medicines for common diseases which make more horror news than AIDS?

Drug Patent Expirations: 2009 – 2015

Patent Circle has compiled a list of more than 100 active pharmaceutical ingredients (APIs) going off-patent in the US from the year 2009 – 2015. At least 24 APIs will go off-patent in the year 2009 including Levetiracetam (more than USD 700 million US sales in 2007), Lamotrigine (USD 2.2 billion US sales for twelve months that ended March 2008), Sumatriptan (nearly USD 1 billion US sales in 2007), Valacyclovir (USD 1.3 billion US sales in 2007), Topiramate (USD 2.2 billion US sales for twelve months that ended March 2008) and Tamsulosin (USD 1.3 billion US sales for twelve months that ended September 2007). Moreover, two of the biggest blockbuster drugs Atorvastatin Calcium (USD 6 billion US sales in 2007) and Clopidogrel Bisulphate (USD 3 billion US sales in 2007) will finally reaching end of their patent protection in 2010 and 2011.

Undoubtedly, there is a big opportunity coming up for generic players with many drug compounds going off-patent in next 6 years and our list will keep generic players stay tuned with drug expiries. Readers may buy our report by writing to us at varun@ipfeathers.com. We are confident that our report will help to seize business opportunity in growing competitive generic space.

ANOTHER MILESTONE ACHEVIDED BY FICCI-DIPP CONSULTATIVE WORKING GROUP - PRE-GRANT OPPOSITION PROCESS SREAMLINED

This is further to the news item which appeared in the “The Hindu Business Line.” The non-uniformity in the practice being adopted by each patent office with regard to pre-grant opposition procedures is no more a worry for the opponents representing NGOs, Health care groups, industry, competitors, researchers and other stakeholders. As a result of the proposal made by FICCI-DIPP Consultative Working Group, the Controller General of Patents has issued administrative instructions to all patent offices in India to furnish a copy of the applicant’s reply to the opponent if he has made the request and has paid prescribed fee. This Order of the Controller General is timely and has come as a great sigh of relief for the stakeholders who were so far staggering under the weight of non-uniform practices. The problem underlying the procedural aspect are the uneven practices being followed by the officials at each patent office with regard to providing to the opponent an access to the patent applicant’s reply contesting pre-grant opposition. The reason behind this non-uniformity across and within the patent offices is that the Indian Patents Act is completely silent about this issue. FICCI and DIPP are working synergistically in bringing more consistency in the procedures being followed by the officials of patent office. For any further clarification on this matter you may contact Sheetal Chopra, Senior Assistant Director, FICCI-IPR Division at sheetal.chopra@ficci.com, 011-23766930.