RICHA PANDEY

Trademark – Brand Names (Crocin) Design – Shape/packaging Copyright – labels (look & feel) Patents

o India became a member of WTO/TRIPS Agreement effective, January 01, 1995 o India was given ten years’ transition period to fully comply with TRIPS o This was done in three stages effective: o January 01, 1995 Filing of Black-Box applications Provision for Exclusive Marketing Rights o May 20, 2003 Uniform patent term of 20 years o January 01, 2005 Grant of product patents in all fields of technology including drugs, food and chemical substances. 3

(c) the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature. Funk Bros. Seed Co Vs Kalo Inoculants Co. 75 USPQ 280 (1948) Mixture of six strains of bacteria packaged to be used to inoculate leguminous plants. The Supreme Court held that the mixture of the already existing bacteria is not patentable but a mere discovery of nature 4

Section 3(d): Mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or mere discovery of any new property or new use for a known substance or of mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. 5 KNOWN SUBSTANCE SAME SUBSTANCE Unless they differ significantly in properties with regard to efficacy

The Apex court observed – “In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of section 3(d) of the Act, since these properties have nothing to do with therapeutic efficacy”. 6KRISHNA & SAURASTRI ASSOCIATES

Section 3(e) “A substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substances.” How to overcome: - By establishing synergism; - By incorporating a broad range of the quantity of the ingredients in the main claim, preferably as ratio/percentages (w/w); - Technical affidavit having comparative data establishing synergism, if necessary. 7

(h) a method of agriculture or horticulture. (i) any process for the medicinal, surgical, curative, prophylactic [diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products; 8

(j) plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; 9

What if your invention falls within these boundaries???

The biological material shall be deposited at a Depository Authority under Budapest Treaty if it is not commonly available to the public. The source and geographical origin of the biological material is to be disclosed in the specification. Necessary permission is to be sought from National Biodiversity Authority if a biological material is used from India. 11

Buruli Ulcer Chagas disease (American trypanosomiasis) Cysticercosis or Taeniasis Dengue/dengue hemorrhagic fever Dracunculiasis or guinea-worm disease Echinococcosis Endemic treponematoses (Yaws) Foodborne trematode infections Clonorchiasis Opistorchiasis Fascioliasis Paragonimiasis Human African trypanosomiasis Leishmaniasis Leprosy Lymphatic filariasis Onchocerciasis Rabies Schistosomiasis Soil transmitted helminthiasis Trachoma Podoconiosis Snakebite Hydatid disease or Echinococcosis African Sleeping Sickness

Leprosy Dengue Japanese encephalitis Chikungunya Soil transmitted helminthiasis Lymphatic Filariasis Amebiasis Rabies Leishmaniasis

The above three charts depict patent filings relating to neglected tropical diseases and the comparative analysis of the same worldwide vis-a- vis India. It is seen that, w.r.t worldwide filings, there is more research focus on diseases like Dengue Leprosy, Japanese encephalitis, Leishmaniasis Trachoma, Chagas disease, Schistosomiasis Rabies, and Trypanosomiasis. In reference to the Indian filings, more focus is on diseases like Dengue, Leishmaniasis, Japanese encephalitis, Rabies and Chikungunya.

Overall patenting trend shows that maximum no. of patent applications in the area of neglected tropical diseases have been filed between worldwide.

Patenting trend in India also shows that maximum no. of patent applications have been filed between the same decade i.e in India.

The patenting activity in the area of compositions and methods for treating neglected tropical diseases has shown a drastic rise after 1991 onwards. The patenting trend for the same has increased to about 55% after year 2000.

In the worldwide priority country distribution, United States tops the chart depicting around 58% priority filings in the areas of Tropical diseases, followed by China.

In the priority country distribution for India, United States tops the chart, followed by European Union countries.

With reference to the Application country analysis, is can be depicted that around 22% applications show United States as the Application country, followed by around 16% applications having PCT filings and China respectively.

Patent applications classified under IPC A61K003900, A61P and A61P are maximum in number.

A61K Medicinal preparations containing antigens or antibodies (materials for immunoassay) A61P003500Antineoplastic agents A61P003112Antivirals A61K Medicinal preparations containing antigens or antibodies (materials for immunoassay - Lipids; Lipoproteins A61P Non-central analgesic, antipyretic or Anti-inflammatory agents

Merck & Co Inc., Sanofi- Aventis, Glaxo Smithkline Beecham Biologicals, Pasteur Institute and Pfizer Products Inc. are the most prolific Assignees working in the area of Neglected Tropical Diseases.

Merck Inc and Pfizer Inc are seen active in the area of neglected tropical diseases since 1961 onwards. Comparative activity however dropped over the last decade. Patenting activity of Glaxo Smithkline and Sanofi-Aventis has increased during the last 15 years i.e after 2000 onwards.

Most of the Assignees have United States as their priority country. Country coverage of Sanofi-Aventis appears to be wide spread even though their filings are comparatively lesser than Merck Inc.

The patenting trend has increased to about 55% post Indian Pharmaceuticals can focus more on neglected diseases like: Leprosy Chagas disease Amebiasis Hookworm infection Helminthiasis Leptospirosis Trematodiasis Trachoma Trypanosomiasis Schistosomiasis Lymphatic filariasis, etc

United States tops in priority country as well as application country wise filings. IPC- A61K relating to Medicinal preparations containing antigens or antibodies (materials for immunoassay holds more no. of patents. Merck & Co Inc., Sanofi- Aventis, Glaxo Smithkline Beecham Biologicals, Pasteur Institute and Pfizer Products Inc. are the most prolific Assignees working in the area of Neglected Tropical Diseases.

The above findings suggest that the Indian generic companies can find out the grey areas relating to various neglected diseases. Identify prevalence of such diseases in India and worldwide and focus their research on compositions and methods of treating these neglected diseases.

DrugCompanyAcquired/Licensed from AtorvastatinPfizerParke Davis InfliximabJ & J, Merck,Mitsubishi Tanabe Pharma New York University School of Medicine and developed by Centocor (Jansenn) RituximabRoche & others IDEC Pharmaceuticals Oxaliplatinoutlicensed to Sanofi Aventisinlicensed by Debiopharm from Nagoya City University Fasudil HCLCoTherixInlicensed from Asahi Kasei CarisbamateJohnson & Johnson in-licensed from SK Corp

ProductOriginatorLicenseeSub-Licensee QuadGilead Sciences Inc. MPP - sublicensed to Shasun Pharmaceuticals Ltd. Shilpa Medicare Ltd., Hetero Labs Ltd., Aurobindo Pharma Ltd. Huperzine- A Debiopharm GroupShasun Pharma (commercialization) GBR 500GlenmarkSanofi (Co development) SITAGLIPTI N MerckSun- (commercialization) AbacavirViiV HealthcareMPP- sublicensed to Aurobindo Pharma Ltd. MPP- Medicines Patent Pool

DISCLAIMER: We have taken utmost care and diligent effort to keep the search conducted thorough amongst the leading databases, which however is non-exhaustive. The landscape report is based on the available bibliographic data amongst the leading patent databases and no technical analysis is involved in this report.

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