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.