Roche Spearheads Changing Indian Pharma Landscape

Post 2005 the changing landscape of Indian Pharma Market from No Frills Generic Space to Competitive Patent Space is surely not going to be the same golden days for Indian Pharma companies which are often labelled as the Pirates of the Global Pharma Industry. Giving a careful glance over the weekly published Official Gazettes by the Indian Patent Office, the soaring numbers of patent applications filed by and patents granted to global pharma companies has apparently started reflecting that the time has already phased out to learn and question the rules of the game instead it is high time to start playing the game, otherwise it will take no time to be left out in the competitive race or may be wiped out. Fortunately for Indian companies, section 3(d) as amended by the Patents Amendment Act 2005 was formulated and brought into force in 2005 rather in 1995 which left global pharma companies with no option to re-strategize their patent applications filed between 1995 to 2005 in line to section 3(d) requiring additional condition of enhanced efficacy. Even though Indian pharma companies and NGOs has been fighting tooth and nail to oppose a handful of mail-box patent applications for drugs already or recently been introduced in Indian market, but still will not be able to slow down the rising phenomenon of patented drugs in domestic pharma market. Global drug major Roche trigged and spearhead the changing scenario of domestic pharma market by crediting the first product patent for its biotech drug Pegasys for the treatment of hepatitis C followed by some known marketed drug products including its antiviral drug Valganciclovir and revolutionary anticancer drug Tarceva. Pfizer too joined the race by receiving the patent for globally marketed antiretroviral drug Selzentry and oral suspension antipsychotic drug Geodon.

Patentee	Drug Name/Generic name	Patent Number	Application
Roche	Tarceva/Erlonitib Hydrochloride	IN 196 774	537/DEL/1996
Roche	Pegasys/Peginterfero alfa-2a	IN 198 952	1032/MAS/1997
Pfizer	Geodon/Ziprasidon Oral Suspension	IN 201 982	472/MUM/2000
Pfizer	Selzentry/Maraviroc	IN 204 132	885/BOM/1999
Roche	Valcyte/Valganciclovir	IN 207 232	959/MAS/1995

Patent Circle in News

Hindustan Times, one of the leading Indian newspapers has quoted Patent Circle in its Business News column. Read Here – Pharma Patents Swell in 2007.

Wockhardt Seems to have Lost Humalog Pre-Grant Opposition Against Lilly

Although not confirmed, the Mumbai-based Biotechnology Company Wockhardt has apparently lost the pre-grant opposition filed against Eli Lilly & Co. following Kolkata Patent Office rejection in July last year for Indian Patent Application No. 675/CAL/1995 covering recombinant DNA engineered fast acting insulin analogue Insulin Lispro, globally marketed as Humalog Injection and also as Humalog 50/50 and Humalog 75/25 in combination with recombinant engineered intermediate acting Insulin Lispro Protamine. Just added to that Pharmabiz recently published an article by Ashwini Sandu and Raju Kumar (Patent Attorneys working with S. Majumdar & Co.) referring that the Application was under pre-grant opposition where one of the contested issues was the application of Problem-Solution approach, where the Controller held that a correct application of the problem solution approach rules out an inadvertent application of an impermissible ex post facto analysis and this has been one of the guiding principles of the Patent Offices in the assessment of inventive step. Considering the hidden nature of pre-grant oppositions and dearth of information available, it seems to be that S. Majumdar & Co. was one of the Law Firm involved in the opposition, but the article does not talk about the outcome of the pre-grant opposition. Even not sure the Application filed June 14, 1995 claiming priority from the US Application No. 08/260,634 against which US Patent No. 5,474,978 is issued on December 12, 1995 has matured into a valid Indian Patent or not.

Happy New Year

Dear Readers,

Wishing all the readers very happy and prosperous celebrations and blessing for the New Year. Let's welcome 2008 with new hopes, challenges, and celebrations in building a more successful and memorable year ahead. Also, thanking all our readers for all their appreciations and support provided to keep Patent Circle motivated and getting famous across the globe. 2007 finished with high note for Patent Circle, which received appreciation from the leading business newspaper Business Standard for shaping Indian IPR scenario. We commit our readers to keep our good work continue this and coming years … With Warm Regards, Varun & Seema Mumbai, India

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.

Granted Indian Patents for Pharmaceuticals (Journal Issue No. 50/2007)

Continued below is list of few Indian patents issued by the Mumbai Patent Office for pharmaceutical inventions published dated December 14, 2007 vide Official Journal Issue No. 50/2007. These patents are currently open for post-grant opposition under section 25(2) of the Patents Act, 1970 for a period of one year from the date of the publication. This journal has published 245 patents issued by the Mumbai Patent Office. I have included a column for foreign equivalent of the Indian Patent, if available.

Indian Patent Number	Foreign Equivalent	Title of the Invention
Application Number
Patentee/Inventors
IN204777	US6552227 US6809221	Novel Process for preparing (+)-cis Sertraline
IN/PCT/2002/01250/MUM
Teva Pharmaceutical
IN204778	US6329564 US6822133 US6831205	Bandage for Wound or Incision Closure
IN/PCT/2002/00664/MUM
Clozex, LLC
IN204783	US20070099899	Heterocyclic Dihydroxypyrimidine Compounds ff Formula I
IN/PCT/2002/00584/MUM
Bristol-Myers Squibb
IN204791	US20060173214	A process for the Manufacture of Optically pure (r) or (s) -5-(2-Aminopropyl) -2-Methoxybenzenes Ulfonamide
1153/MUM/2002
Cadila Healthcare Ltd.
IN204820	US6573386 US6884895	Process for the Preparation of Spiro[(4- Cyclohexanone)- [3h]indo]-2' [1 'h]-One derivatives
IN/PCT/2001/01625/MUM
Sanofi-Synthelabo
IN204952	US6890924	Substituted Bicyclic Derivatives for the treatment of Abnormal cell Growth
IN/PCT/2002/01600/MUM
Pfizer
IN204969	---	An improved Process for Preparing a Composition Containing Carotenoids & Nutrients rich Extract from Carrots
133/MUM/2001
Ajanta Pharma Ltd.
IN204971	US6967188	A Composition
366/MUM/2001
Bayer Aktiengesellschaft

Source: Official Journal, The Patent Office Issue No. 50/2007

Granted Indian Patents for Pharmaceuticals (Journal Issue No. 50/2007)

Below is provided the list of few Indian patents issued by the Mumbai Patent Office for pharmaceutical inventions published dated December 14, 2007 vide Official Journal Issue No. 50/2007. These patents are currently open for post-grant opposition under section 25(2) of the Patents Act, 1970 for a period of one year from the date of the publication. This journal has published 245 patents issued by the Mumbai Patent Office. I have included a column for foreign equivalent of the Indian Patent, if available.

Indian Patent Number	Foreign Equivalent	Title of the Invention
Application Number
Patentee/Inventor
IN204725	US20070259902	Farnesyl Transferase Inhibiting 1, 2-Annelated Quinoline Enantiomer
IN/PCT/2002/01545/MUM
Janssen Pharmaceuticals
IN204727	WO2001047920	Process for Preparing Benzazole Derivatives
IN/PCT/2002/00731/MUM
Applied Research Systems ARS Holding NV
IN204729	US20070207214	Oral Pharmaceutical Composition with Controlled Release and Prolonged Absorption
IN/PCT/2002/01874/MUM
Flamel Technologies
IN204739	US20050119492	New Process for the Synthesis of Perindopril and Pharmaceutical Acceptable Salts thereof
598/MUM/2002
LES Laboratories Servier
IN204758	US6579640	Compounds Benzisoxazoles and Phenones of Formula I and Process of Preparation thereof
IN/PCT/2001/00443/MUM
Janssen Pharmaceuticals
IN204761	WO2000050045	Injection Solution for the Treatment of Arthroses
IN/PCT/2001/00979/MUM
Dr. Medadusumalli Chakravarty
IN204765	US7056512 US7070784	A GDF-8 Analogue comprising the Natural GDF-8 Amino Acid Sequence and a Composition thereof
IN/PCT/2001/01600/MUM
Pharmexa A/S
IN204775	WO2001054662	A Method of Preparing Pharmaceutical Implant for Controllably Releasing a Drug in a Subject
IN/PCT/2002/00981/MUM
Ardana Bioscience Ltd.

Source: Official Journal, The Patent Office Issue No. 50/2007.

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.