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
Thursday, December 18, 2008
Lupin Settles Clarinex Patent Lawsuit
Wednesday, December 17, 2008
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
In past
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).
Tuesday, December 16, 2008
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 26th, 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
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.
Friday, December 12, 2008
Q Corner | Minimum Period for Patent Grant
What is the minimum period in which patent can be granted in
As such there is no exact rule for calculating minimum period in which patent can be granted in
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.
Thursday, December 11, 2008
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
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
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.
Friday, December 05, 2008
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
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 (
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.
Thursday, December 04, 2008
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.
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
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.
Wednesday, December 03, 2008
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
Monday, December 01, 2008
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
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
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.
Saturday, November 29, 2008
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
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.
Saturday, November 22, 2008
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).
Wednesday, November 19, 2008
Eli Lilly Filed Para IV Lawsuit Against Wockhardt
Wockhardt is lately been sued by Eli Lilly & Co. for alleged infringement of
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.
Wednesday, November 12, 2008
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,
Saturday, November 08, 2008
US Appeals Court's Ruling Delays Generic Prevacid
Japanese drug major, Takeda Pharmaceuticals Co. has won a
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.
Thursday, November 06, 2008
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 26th – 27th November 2008 at ITC Sheraton New Delhi Hotel, District Centre, Saket,
(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
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
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.
Tuesday, November 04, 2008
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.