Suven Stepped into Indian ‘NCE’ Patent Wagon, Joins Glenmark

Hyderabad-based drug manufacturing company Suven Life Sciences lately stepped into Indian 'NCE' Patent Wagon joining Mumbai-based drug Research Company Glenmark for receiving Indian patent for New Chemical Entity (NCE) indigenously researched and developed by the Indian company. The Chennai Patent Office issued Indian Patent No. 209540 to Suven for substituted 3-aminoalkoxyindoles as 5-HT (Serotonin) receptors against the mail-box Application No. 883/MAS/2002 filed November 28, 2002. Suven has also made a corresponding US patent filing via PCT National Phase published as US20060173193 dated August 03, 2006. According to the '193 publication, the compounds are suggested to have reach through indication over the treatment of certain CNS disorders such as, anxiety, depression, convulsive disorders, obsessive-compulsive disorders, migraine headache, cognitive memory disorders e.g. Alzheimer's disease and age-related cognitive decline, ADHD (Attention Deficient Disorder/Hyperactivity Syndrome), personality disorders, psychosis, paraphrenia, psychotic depression, mania, schizophrenia, schizophreniform disorders, withdrawal from drug abuse such as cocaine, ethanol, nicotine and benzodiazepines, panic attacks, chronobiological abnormalities, circadian rhythms, anxiolytic, osteoporosis, ischemic stroke, lower the risk of SIDS in young infants with low endogenous melatonin levels, reproduction, glaucoma, sleep disorders (including disturbances of Circadian rhythm) and also disorders associated with spinal trauma and/or head injury such as hydrocephalus. Compounds are further expected to be of use in the treatment of mild cognitive impairment and other neurodegenerative disorders like Alzheimer's disease, Parkinsonism and Huntington's chorea. The compounds are also expected to be of use in the treatment of certain GI (Gastrointestinal) disorders such as IBS (Irritable bowel syndrome) or chemotherapy induced emesis.

Read This: Gody Powers!

Go through the abstract of the US Publication No. 20070035812A1 which states “Christopher Anthony Roller is a godly entity. "Granters" had been given my powers (acquired my powers) (via God probably). These "granters" have been receiving financial gain from godly powers. These "granters" may be using their powers without morals. Chris Roller wants exclusive right to the ethical use and financial gain in the use of godly powers on planet Earth. The design of godly-products have no constraints, just like any other invention, but the ethnic consideration of it's use will likely be based on a majority vote of a group, similar to law creation. The commission I require could range from 0-100% of product price, depending on the product's value and use.” Any idea what this inventor up to, but am sure that if granted (LOL) this would be the broadest patent ever issued by any of the Patent Office.

Roche Need to Defend Post-Grant Opposition

Indian Patent No. 198952 covering Roche’s biotech drug Pegasys (pegylated interferon alfa-2a) for the treatment of hepatitis C has been opposed by the Mumbai-based biotech drug manufacturer Wockhardt within the statutory period of post-grant opposition under section 25(2) of the Patents Act, 1970. The post-grant opposition is likely to take place at the Chennai Patent Office where the patent was issued against the mail-box Application No. 1032/MAS/1997 claiming earliest priority from the US provisional application No. 60/018,834 filed May 31, 1996 for which US Patent No. 7,201,897 issued on April 10, 2007. This would probably the first post-grant opposition under the amended Patents Act, 1970. The patent is also opposed by the Mumbai-based NGO Sankalp, which challenged the patentability hindsight stating that Pegasys is a mere admixture of known substances and new form of a known substance. Wow all NGOs in India are scientifically backed by such research knowledge that every single patent application filed or patent granted in India for pharmaceutical compound is either mere a new form or mere a combination/ an admixture of known substances. Just thinking when scientists and research scholars working in R&D and research laboratories technically hesitate to quote say statements then how come NGOs gather such technical confidence. I believe if there would have been a patent application for Graphite (polymorphic form of carbon) and diamond (other known polymorphic form of carbon) would already known in India, then NGOs would definitely have filed a pre or post-grant opposition for such application stating that Graphite patent application is a new form of a known substance …

ISA and IPEA Status for Indian Patent Office

Geneva-based World Intellectual Property Organization (WIPO) has granted the Indian Patent Office the status of International Search Authority (ISA) and International Preliminary Examining Authority (IPEA) joining in line of Austrian Patent Office, Australian Patent Office, Canadian Intellectual Property Office, State Intellectual Property Office of the People’s Republic of China, European Patent Office, Spanish Patent and Trademark Office, National Board of Patents and Registration of Finland, Japan Patent Office, Korean Intellectual Property Office, Federal Service for Intellectual Property, Patents and Trademarks (Russian Federation), Swedish Patent and Registration Office and United States Patent and Trademark Office. Following the development, the Indian Patent Office will now be entering into an agreement with the International Bureau of WIPO relating to the functioning as International Searching and International Preliminary Examination Authorities under the PCT which include conducting prior art search and preliminary examination, and preparing written opinions. Even the Nordic Patent Institute, an intergovernmental organization established by the governments of Denmark, Iceland and Norway will also join as International Searching Authority and International Preliminary Examining Authority from January 01, 2008 onwards.

IN/PCT/2002/00785/DEL: Pipeline Anticancer Drug Patent Application

Pfizer’s breakthrough anticancer drug Sunitinib Malate, which got marketing approval in January 26, 2006 by the Food and Drug Administration for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST) has been a subject of pending mail-box Application No IN/PCT/2002/00785/DEL (the Application) filed at Delhi Patent Office. Marketed as Sutent, Sunitinib has worldwide sales of US $ 219 million in the first year of its marketing launch (source: Pfizer Annual Report 2006). The Application is filed on August 09, 2002 and subsequently published by the Patent Office on January 19, 2007 claiming earliest priority from US provisional application No. 60/182,710 filed February 15, 2000 against which Orange Book listed US Patent No. 6,573,293 and 7,125,905 are issued on June 03, 2003 and October 24, 2006 respectively.

Eli Lilly Joins Glaxo, Withdraws Application for Osteoporosis Drug

Eli Lilly & Co. has voluntarily withdrawn its Application No. IN/PCT/00/00118 filed July 05, 2000 at Kolkata Patent Office for a stable crystalline form of osteoporosis drug Teriparatide (rDNA origin), globally marketed as Forteo with worldwide annual sales of US $ 600 million. According to the Patent Office, Lilly has withdrawn its application under section 11B (4) of the Patents Act, 1970. The Application claims earliest priority from US provisional application No. 60/069,875 filed December 18, 1997 against which US Patent No. 6,590,081 is issued on July 08, 2003. Earlier in August 2007, Kolkata Patent Office rejected Lilly’s Application for same drug following a pre-grant opposition from a Mumbai-based generic drug manufacturer USV Ltd. The rejection was made on the grounds of prior knowledge, incremental innovation and failure to establish enhancement of known efficacy. Teriparatide is a parathyroid hormone (PTH (1-34) (SEQ. ID NO:2)), a secreted 84-amino acid product of the mammalian parathyroid gland that controls serum calcium levels through its action on various tissues, including bone. Although not very sure about the Application number which got rejected by the Patent Office, but I guess it would be the Application No. IN/PCT/00/00119 filed July 26, 2000 for stabilized parenteral composition of Teriparatide (rDNA origin) claiming earliest priority from US provisional application No. 60/069,075 filed December 09, 1997 against which Orange Book listed US Patent Nos. 6,770,623 and 7,144,861 are issued. There is one more Application No. IN/PCT/00/00336 filed January 09, 2003 which is pending with the Patent Office which claims earliest priority from US provisional application Nos. 60/097,151 and 60/099, 746 filed November 08, 1998 and October 09, 1998 respectively and against which Orange Book listed US Patent Nos. 6,977,077 and 7,163,684 are issued. The Application IN/PCT/00/00336 seems to cover a method for increasing the toughness and/or stiffness of bone and/or reducing the likelihood and/or severity of bone fracture using Teriparatide, which is unlikely to receive a patent in India, as indication and method of treatment are excluded from patentability under section 3(e) of the Patents Act, 1970. So, most likely either Lilly will too withdraw the third application or it would be humbly rejected by the Patent Office.

Glenmark Received Indian Patent for PDE IV Inhibitors

Mumbai-based Glenmark has lately received an Indian Patent No. 201170 for novel heterocyclic compounds as Phosphodiesterase type IV (PDV IV) inhibitors of the Formula I against the mail-box Application No. 363/MUM/2003 filed April 11, 2003 with the Mumbai Patent Office. Possibly this could be Glenmark’s first drug compound patent to be granted patent protection in India, which already has been granted US Patent No. 7,223,789. According to the ‘789 patent disclosure, the compounds are suggested to have reach through indication over the treatment of variety of allergic and inflammatory diseases including asthma, chronic bronchitis, atopic dermatitis, urticaria, allergic rhinitis, allergic conjunctivitis, vernal conjuctivitis, eosinophilic granuloma, psoriasis, rheumatoid arthritis, septic shock, ulcerative colitis, Crohn's disease, reperfusion injury of the myocardium and reperfusion injury of the brain, chronic glomerulonephritis, endotoxic shock and adult respiratory distress syndrome, particularly for the treatment of asthma or chronic obstructive pulmonary disease (COPD).

Roche’s Valganciclovir Patented in India

Chennai Patent Office lately granted an Indian Patent No. 207232 to Hoffman-La-Roche for antiviral drug Valganciclovir against the mail-box Application No. 959/MAS/1995 filed July 27, 1995 under section 5(2) of the Patents Act, 1970. Interestingly, the application claims its earliest priority dated July 28, 1994 (pre-1995) probably making Valganciclovir the first pre-1995 drug compound to be patented in India. Generally, there is an unanimous understanding among the Indian pharma patent practitioners and generic companies that only post-1995 drug molecules are eligible for patent protection in India although it is not explicitly been mentioned anywhere in the Patents Act, 1970. This would, in fact, definitely going to be an interesting case, let see what Indian pharma patent experts has to say about this? Coming back to Great Indian Patent Show, Valganciclovir patent application, like most of the antiviral drug applications was opposed during the pre-grant opposition, this time by the Mumbai-based NGO Lawyers Collective, but surprisingly the Chennai Patent Office decided not giving the opponent an opportunity for hearing and proceeded with the examination and grant of a patent. Lawyers Collective has already expressed their dismay over the issue and is planning moving to the Chennai High Court against the discriminatory decision of the Chennai Patent Office. But the Chennai Patent Office firmly stated that the patent is granted looking at the merits in the application and statutorily the Patent Offices are not bound to hear pre-grant opposition. Although I do want to comment over the whole episode, but I do appreciate the bold initiative taken by the Chennai Patent Office to proceed with the application. I believe it would be better that we should leave such issues to our learned Judges to decide what Patent Offices are supposed or not supposed to do, particularly during pre-grant opposition period?

Sanofi Sued Glenmark for Patent Infringement

Reacting over the regulatory development of Glenmark’s submission of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market generic Tarka prior to the expiration of the Orange Book listed patents, Sanofi-Aventis jointly with Abbott Laboratories has filed a civil action for the infringement of patent in the US District Court of New Jersey alleging that the proposed generic product will infringe one or more claims of Orange Book listed US Patent No. 5,721,244. Tarka is a combination extended release antihypertension oral tablet containing Trandolapril and Verapamil Hydrochloride having US $ 100 million sales in the US. It is believed that Glenmark is a First-to-File generic challenger and will be entitled to 180-day exclusivity period.

Delhi Patent Office Turn Down Gefitinib Patent Application

Following pre-grant opposition hearing by Indian drug companies Natco Pharma Ltd. and JM Pharmaceuticals Ltd. made last year, the Delhi Patent Office lately rejected AstraZeneca’s Patent Application No. 841/DEL/1996 for its anticancer drug Gefitinib on the ground of “known prior use.” Both Natco and JM opposed the patent application citing that the drug has been in the public domain before the patent application filed in India. Natco spokesperson and company secretary Adi Narayana said his company filed a pre-grant opposition since the drug was not a new drug under the Patents Act, 1970 and lack inventive step. Gefitinib, worldwide marketed as Iressa, is oral tablet medication approved by the US Food and Drug Administration having three Orange Book listed US Patent Nos. 5,457,105 (genus); 5,616,582 (indication) and 5,770,599 (species). The ‘841 patent is Indian equivalent of the species patent.

Abacavir and Trizivir Patent Applications Withdrawn by GlaxoSmithKline

GlaxoSmithKline lately dropped the patent claims for its antiretroviral drugs Abacavir and Trizivir in India, which was facing strong pre-grant opposition from the Non-profit Government Organizations over the patentability yardstick under section 3(d) of the Patents Act, 1970. According to various online sources, Glaxo voluntarily withdrew the Patent Application No. 872/CAL/98 for Abacavir, a second-line treatment for HIV often prescribed to patients who developed resistance against the first line drug therapies treatment and also requested Kolkata Patent Office not to examine the Patent Application No. IN/PCT/00/00521 for Trizivir, a fixed-dose combination therapy containing three drugs, Lamivudine, Zidovudine and Abacavir Sulfate. As far as the patentability of such combination and salt are concerned, it is almost difficult for Glaxo to procure patent protection for such combination and salt under section 3(d) without furnishing sufficient details about the enhancement in efficacy over the known form. In Company’s Official Statement, the Glaxo spokesperson said that the move to drop the patent applications is in public interest and is part of its policy of routine review of patent applications. Earlier this year in August, Glaxo withdrew the Patent Application No. 2044/CAL/1997 for Combivir, a combination therapy containing Lamivudine and Zidovudine.

Pfizer Patented First Antiretroviral Compound in India

Mumbai Patent Office lately granted an Indian Patent No. 204132 (the ‘132 patent) to Pfizer for newly approved antiretroviral drug Selzentry, a second-line treatment for HIV, often prescribed to patients who develop resistance to first-line drug therapies. The ‘132 patent is issued against the mail-box Application No. 885/BOM/1999 filed December 02, 1999 under section 5(2) of the Patents Act, 1970 claiming earliest priority from Great Britain applications dated October 23, 1998. Selzentry, worldwide marketed as Maraviroc is the first antiretroviral drug compound to be awarded patent protection in India, which obviously will cause a concern among the generic pharmaceutical companies in India and also the Non-profit Government Organizations advocating affordable drugs for poor patients. Not only Pfizer will be able to keep generic competitors out of the market, but also fueled its market share value on the Bombay Stock Exchange, which clearly indicates the building confidence of Indian market for patent portfolio. Earlier this year in August, the US Food and Drug Administration approved Selzentry oral tablet prescription for the treatment of patients infected with CCR5-TROPIC HIV-1 through an accelerated regulatory approval process, and subsequently listed two US patents with the Orange Book. US Patent No. 6,586,430 is the US equivalent of the ‘132 patent. Although patent is granted in India, Pfizer still need to overcome the post-grant opposition period under section 25(2) of the Patents Act, 1970 which will be valid till one year from the date of grant of patent to have the real taste of Indian market exclusivity. However, there were no pre-grant oppositions for Pfizer’s patent application because Indian generic industry did not find any (financial) market potential for this newly approved drug (which still need to achieve market acceptability and monetary success), which in fact a clear indication that Indian Generic companies are more concern about the profit margins rather than patients’ well-being in India or other least-developed countries, and even so the NGOs who keep targeting patent applications which cover drugs already achieved market success. Despite Selzentry is a critical drug therapy, NGOs and Indian Generics completely failed to spot Pfizer’s patent application for pre-grant opposition because they keep focusing around blockbuster and profitable drug products, which again raises a crucial question who come first profit or patient? Fishy …