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.