ISSUE (Volume)

23 (2)
MONTH

Ap r i l
YEAR

A monthly Newsletter on issues relating to Intellectual Property Rights

Origiin Newsletter

2013

In this issue Patentability of Micro-organisms ............P.1 Patent Talk: Dr S Singh ........................... P.4 Interesting patent of the month ............P.5 IP News Bulletin ..................... ......P.6 News from Indian Patent Office...............P.7 Indian Patent Agent Examination ........... P.7

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Patentability of Micro-organisms
Dr. Swaranjit Singh Cameotra Deputy Director in Institute of Microbial Technology, Chandigarh Bindu Sharma Founder and CEO Origiin IP Solutions LLP, Bangalore Email: bindu@origiin.com

Blogs
http://origiinipae.blogspot.com http://inventorshub.blogspot.com

Editors
Anita Kalia Athira A

Email: ssc@imtech.res.in

Contact us

A patent is a form of
intellectual property, consisting of a set of exclusive rights granted

invention non-obvious to a person skilled in the art. The micro organisms as a subject matter of a patent have always been fascinating, primarily for their being a living form. Conventionally a micro-organism is considered as an organism that is microscopic or too small to be seen by the naked human eye though there are various algae and fungi that are visible by naked eye. Micro-organisms include bacteria, fungi, virus, protists and other prokaryotes as well as some microscopic plants (phytoplankton) and animals (zooplankton). In order to understand patentability of micro organism, it is important to know that Article 27(3) (b) of TRIPS Agreement, that allows member states to exclude from patentability plants and animals, other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. This clearly indicates that TRIPS makes it obligatory for all its member states to extend patents for micro-organisms, non-biological, and

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No amount of experimentation can ever prove me right; a single experiment can prove me wrong.

Albert Einstein

by a Government to an inventor or its assignee for a limited period of time in exchange for the public disclosure of an invention. In order to get patent rights, the invention must fulfil three fundamental statutory conditions of patentability, such as, novelty, inventiveness and industrial applicability. Often, subject matter of a patent to be claimed is either a product or a process to prepare a product or both. However, more precisely, as per Indian Patents Act, 1970, the invention means a new product or process involving an inventive step and capable of industrial application. Further, the inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the

All rights reserved (c) Origiin IP Solutions LLP 2013 microbiological processes. However, the plant

all its member states to extend patent protection for micro-organisms, non-biological, and microbiological processes. However, the plant and animals have clearly been indicated to be not patentable. As far as Indian patent laws are concerned, in order to be compliant with TRIPS agreement, the third amendment to the Patents Act, 1970 was introduced through the Patents (Amendment) Ordinance, 2004 w.e.f. 1st January, 2005 that extended product patents to all fields of technology including food, drugs, chemicals and micro organisms provided such inventions fulfil statutory conditions of patentability. It is worth noting here that micro organism that exists in nature is products of nature and mere identification of micro organisms cannot amount to invention but a discovery which is not patentable. Therefore, a naturally occurring micro organism fails to fulfil the critical conditions of patentability, i.e., novelty and inventive step. What differentiates an invention from a discovery is human intervention, thereby, the most critical issue regarding patentability of micro organisms is assessment of human intervention that draws line between discovery and invention. However, Genetically Modified Micro organisms (GEMs), creation of which involves human effort, resulting in enhancement of its known efficacies compared to state of the art, are patentable. Section 3 (j) of Indian patent act 1970 states that micro organisms are patentable but it doesnt categorically mention that only GEMs are patentable. However, relating patentability of micro organism to the statutory definition of an invention depicts that micro organism shall be a new product that involves an inventive step and is capable of industrial application. The most discussed and landmark case on micro organism is Diamond vs Chakrabarty. A genetic engineer Ananda Mohan Chakrabarty, working for General Electric, developed a bacterium (derived from the Pseudomonas genus) that is capable of breaking down crude oil and hence was used in treating oil spills.

Pseudomonas genus) that is capable of breaking down crude oil and hence was used in treating oil spills. Chakrabarty filed for a patent for the bacterium in the United States. There were three main claims in the patent specification that related to inoculums, bacterium itself and the process to prepare the genetically modified bacterium. Examiner had no problems granting rights over claims related to inoculums and the process but as the law dictated that living things were not patentable, rights were refused for the bacterium as a product. The Board of Patent Appeals and Interferences agreed with the original decision of patent examiner.

Drawing line between discovery and invention is extremely critical to assess patentability in case of micro organisms. Extent of human intervention is one of the most critical factors to determine

patentability.
However, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, stating that "the fact that micro organisms are alive is without legal significance for purposes of the patent law." Sidney A. Diamond, Commissioner of Patents and Trademarks, appealed to the Supreme Court. The Supreme Court case was argued on March 17, 1980 and decided on June 16, 1980. Drawing line between discovery and invention is extremely critical to assess patentability in case of micro organisms. Extent of human intervention is one of the most critical factors to determine patentability of microorganisms. In Dimminaco A.G v. Controller of Patents & Designs, the issue was the patenting of the process for preparation of infectious bursitis vaccine, which was invented for protecting poultry against infectious bursitis. The Controller held that the process of separation of the vaccine which has living entity cannot

be considered a manufacture All rights reserved (c) Origiin IP Solutions LLP 2013 and hence not patentable.

manufacture and hence not patentable. He also held that since the vaccine contains living organism, it cannot be patented. The court held that the matter involved is of a new process of preparation of vaccine under specific scientific conditions and the said vaccine is useful for protecting poultry against contagious bursitis infection and there is no statuary bar to accept a manner of manufacture as a patentable even if the end products contain living organism.

under Article-7 of the Budapest Treaty and accessibility of that micro-organism from the depositories. As per section 10(4) (d) (ii) of the Indian Patents Act, 1970, the microorganism if not being described fully and is not available to public, it to be deposited before the IDA under the Budapest Treaty before filing of application in India. All the characteristics of the micro-organisms and details of depositary institutions along with accession number shall be mentioned in specification for correctly identifying the same. Due to short life cycle, rapid growth, easy to culture, micro organisms have been used widely in industry today for producing high value compounds such as enzymes, hormones, polymers, organic acids etc. Various industries like brewery, dairy products are primarily based on various micro organisms. However, microbes are also well known for their vital role in degradation of toxic compounds by

Figure 1: Essential requirements for patents on microorganisms

transforming them into less toxic forms. It is interesting to note that more than half of the worlds oxygen is produced by the activity of the micro-organisms. Many algae and cyanobacterial strains produce and release oxygen in the atmosphere by means of oxygenic photosynthesis. Thus, there is a changing trend in the research on the microbial world around the globe and many more new ways to use the power of the single celled micro-organisms will come up in different fields like medicine, drugs, high value compounds production and in removal of toxic pollutants from the environment. In India, we have an IDA in IMTECH, Chandigarh and good progress is made in the conservation of microbial diversity. The IDA also has a Patent Depository where the facility can be availed as per the norms. In India there are two Hotspots of Biodiversity, the Western Ghats and the seven states in the Indo-Burma

Apart from basic criteria of patentability, i.e., novelty, inventiveness and industrial use, sufficiency of disclosure of the invention is extremely important and the subjectmatter of the invention shall be described in a manner sufficiently clear and complete to be carried out by the person skilled in the art. In case of an invention, claiming micro organism as a product, completely describing the invention in the description to enable a person skilled in the art to carry it out is usually impossible. This is why, in the particular case of inventions involving microorganisms, where such micro organism is not available in public, a deposition of such micro organism material has been made necessary in the institute recognised by Budapest Treaty. In India, an essential requirement for filing an application for patent wherein the invention is based on a microorganism, deposition of microbial sample is necessary in the International Depository Authorities (Institute of Microbial Technology, Chandigarh) formed

Region. Thus, it is all the more important to have a well defined system for the conservation of the important biodiversity. In Pune a culture collection and an IDA (MCC: Microbial Culture Collection) has been set up so that the rich and new microbial diversity that is isolated is properly

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maintained. The strains are identified for supply to users in academic institutes and industries. The MCC was recognized by the World Intellectual Property Organization (WIPO), Geneva, Switzerland as an International Depository Authority (IDA) on April, 2011. Setting up of two IDAs in India demonstrates that conservation of microbial diversity isolated from different environmental niches and its detailed study for products and processes is a very important activity.

Further reading: 1. Indian Patents Act 1970 2. Manual of Indian Patent Office, 2008

3. Preservation of micro-organisms as deposits in Patent Applications. Swaranjit Singh Cameotra. BBRC 353(4): 849-850, 2007. 4. Can Microbes be patented? Swaranjit Singh Cameotra. BBRC, Online November 2012.

PATENTALK: DR. SWARANJIT SINGH CAMEOTRA On deposition of microbial samples at IMTECH Chandigarh
Dr Swaranjit Singh is Deputy Director at Institute of Microbial Technology, Chandigarh. He is an active scientist who has made significant contributions in the field of Environmental Biotechnology and Biosurfactant production. He is Adviser to the Himachal Pradesh Government for starting Biotechnology, Environmental Science and Microbiology in the colleges and Dental Colleges of the State. Consortium Member of the ICAR NAIP Project- Development of non-destructive systems for evaluation of microbial and physico-chemical quality parameters of mango. Organizing Committee Member of many National/International Conferences. Currently in the Scientific Committee constituted for the International Biotechnology Symposium - IBS 2009 to be held in Italy.

Origiin: Please tell us something about Budapest treaty. What is purpose of this treaty? Dr Singh: The Budapest Treaty on the international recognition of the deposit of microorganisms for the purpose of
patent procedure. It recognizes International Depositary Authorities (IDA) for microorganism, sets out the minimum standards for such collecting authorities, and also sets out the guidelines for the deposit of microorganisms. It started on August 9, 1980. The treaty was amended on September 26, 1980. Budapest treaty is administered by the World Intellectual Property Organization (WIPO). The purpose of this treaty is to deposit the microorganism in order to satisfy the terms required for the patenting the modified microbes/processes/products. Deposit of the biological material is needed only at one recognized institution, and this deposit is acceptable and recognized in all the countries that follow the Budapest Treaty.

Origiin: As micro organisms are living organisms, are they patentable in India? Dr Singh: The answer is no, in their native or original form. However, if the microbe is genetically modified it is
ready to be accepted as a Patent deposit, it may be patentable. Even though one has to patent a microbial process or a product, the respective microbe has to be deposited in a Patent depository.

Origiin: What is the procedure of deposition of micro organism? Dr Singh: The procedure for the deposition of cultures can be made in four categories;

1. General Deposits: There is no fee for deposit of cultures in the general category. The details of the culture need

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1. General Deposits: There is no fee for deposit of cultures in the general category. The details of the culture need to fill in a culture data sheet. 2. Safe Deposits: These cultures are handled with confidentiality and are kept under security. Only the depositor has access to these cultures. There is an annual fee for such a deposit. An agreement needs to be signed between the depositor and the Collection. 3. Patent Deposits: These cultures are not listed in the catalogue / database. Since a depositor needs to declare accession number in the patent application, the information about the culture is also in public domain. These cultures are handled with confidentiality and kept under security and are given to the depositors or authorized persons as per patent regulations. There is one time fee for such a deposit. 4. The Patent Deposits under the Budapest Treaty (IDA): One can deposit cultures under the Budapest Treaty (IDA) for filing international patents or for filing patents in India.

Origiin: Is the applicant required to deposit samples in hand or there are other modes of delivery? Dr Singh: After getting the go ahead signal from the Collection, the samples can be deposited by hand or through
Registered Post/Courier.

Origiin: How much time does it take to get accession number after microbial sample is submitted? Dr Singh: About 4-6 weeks. Origiin: What are the security requirements of a Patent depository? Dr Singh: As the strains are of very high value, care must be taken that the strains are not misused. Only authorized
people can enter the Patent depository by punch cards/thumb impressions. The location is under strict electronic surveillance with CCTV etc.

INTERESTING PATENT OF THE MONTH

Motorized ice cream cone Patent number: US 5971829 Filing date: Mar 6, 1998 Issue date: Mar 30, 1993 Abstract: A novelty amusement eating receptacle for supporting, rotating and sculpting a portion of ice cream or similarly malleable food while it is being consumed comprising: a hand-held housing, a cup rotatably supported by the hand-held housing and adapted to receive and contain a portion of ice cream or food product of similar consistency, and a drive mechanism in the hand-held housing for imparting rotation upon the cup and rotationally feeding its contents against a person's outstretched tongue

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Main claim of the patent 1. A novelty amusement eating device for supporting, containing, rotating and sculpting a food portion of malleable consistency during consumption comprising: a) a housing adapted to be grasped and supported by a person's hand, said housing being substantially coneshaped simulating the appearance of a common edible pastry cone; b) a cup rotatable supported by said housing, said cup being adapted to receive and contain a food portion of substantially malleable consistency, said food portion having a periphery or outer surface; and c) a drive mechanism supported by said housing, said drive mechanism including rotating means for imparting a rotary motion upon said cup, said rotary motion providing feeding means for rotationally feeding said periphery of said food portion against a person's outstretched tongue.

A bench of justices Aftab Alam and Ranjana Prakash Desai dismissed the claim of the Swiss firm for getting exclusive rights for manufacturing the cancer drug on the ground that a new substance has been used in the medicine. Section 3 (d) of Indian Patents Act states that inventions that are a mere discovery of a new form of a known substance and do not result in increased efficacy of that substance are not patentable. This effectively means that if there is an old molecule in a new substance you cannot patent it by making a minor modification, and passing it off as a completely new invention. The act reads as follows: the 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 the mere discovery of any new property or new use for a known substance or of the 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.

IP NEWS BULLETIN
Supreme Court rejects patent for cancer drug from pharma giant Novartis

Micromax sued by Ericsson for Rs. 100 crore over patent infringement

The Supreme Court finally dismissed Swiss drugmaker Novartis AG's attempt to win patent protection for its cancer drug Glivec. This long awaited judgement from the Supreme Court sets a benchmark for several intellectual property disputes in India, where many patented drugs are unaffordable for most of its billions of people, 40 percent of whom earn less than Rs. 70 a day. Novartis had applied for a patent for the beta-crystalline version of the drug, on the basis of increased safety due to the modifications in the chemical entity. However, on the basis of Section 3 (d) of the Indian Patent Act, it was initially rejected by the Controller of Patents in 2006, after hearing 5 pre-grant oppositions filed by various generic pharmaceutical companies including Ranbaxy, Cipla, Hetero and Cancer Patient Aid Association (CPAA). Novartis filed an appeal with the Madras High Court which subsequently transferred the appeal to the Intellectual Property Appellate Board (IPAB). In 2009, the IPAB upheld the rejection by the Controller and thereafter, Novartis appealed directly to the Supreme Court.

Micromax, an Indian handset manufacturer has been sued by Ericsson on charges of patent infringement, asking for 100 crore rupees in damages. The company also claims that it has been negotiating with Micromax for about three years now and has finally moved the Delhi High Court to seek legal remedy. The disputed devices are Micromax' Ninja series, Funbook Talk and the Canvas 2. Micromax is one of the most popular handset brands in India and the company has recently churned out Android-based smartphones like A110 Canvas 2 and A116 Canvas HD.

Apple Faces Siri Patent Lawsuit

Apple is facing a patent lawsuit in China over its Siri voice activated service, after Shanghai Zhi Zhen Internet Technology filed a lawsuit in Shanghai. The Chinese firm says that it filed its patent in 2004 and was granted it in 2006. Siri is man-machine interaction rather than speech recognition, and that is based on the word chat robot system xiaoi patented. Zhi Zhen filed a suit on June 21, 2012 seeking a declaration that patent infringement is taking place - it is leaving the issue of damages to a later action. Apple has in turn applied to have Xiaoi's patent invalidated

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IMPORTANT NEWS FROM INDIAN PATENT OFFICE MARCH 2013

Last date for PAE application extended
The last date for making online application for Patent Agent Examination 2013 has further been extended upto 15th March 2013 (5:00PM) Notification. All other deadlines will remain unaffected. In case of any technical

problem in accessing the service, kindly contact the system administrator at kamal.singh@nic.in For any other query kindly contact: patentagentexam.ipo@nic.in

Guidelines for biotech inventions

Controller General of Patents, Designs & Trade Marks launches GUIDELINES FOR EXAMINATION OF

BIOTECHNOLOGY APPLICATIONS FOR PATENT.

One day session of patent specification drafting (including claims)

Origiin IP Academy announces one day session of basics of patent specification drafting including formulation of claims. Exercises will be provided in the class for practice and tips to attempt specification drafting question in the examination. Duration: 5 hours (one day), Cost: 5,000 INR Date: 12th April 2013 Dictionary of Indian Patent Law authored by Bindu Sharma and Anita Kalia as well as assignments will be provided. Kindly note that the purpose of this session is only to enable candidates understand basics of specification drafting to attempt questions relating to drafting patent specifications or claims for Indian Patent Agent Examination. This is not a comprehensive course to learn patent specification drafting.

Two days session for revision of important questions

This session will provide complete revision of previous year question papers, tips for viva, group discussions and interactions, clarification of doubts and revision of important sections and rules. Duration: 10 hours (two day), Cost: 8,000 INR Date: 13th and 14th April 2013 Module III, Dictionary of Indian Patent Law authored by Bindu Sharma and Anita Kalia as well as assignments will be provided. For more info please mail at info@origiin.com or call at 9845693459.

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Certificate Courses on Patent Search

Certificate Course on Patentability/Novelty search Course Code: 1201

Patent filing is a tedious and expensive process and hence it is important to check patentability of invention on the scale of Novelty, Non-obviousness and Industrial utility before filing the patent application. During a patentability search, the invention is accessed and a report is produced on its patentability, based on which the client can decide whether to file a patent or not. Duration: Time period: Cost: Number of Seats: BATCH Batch P01 Batch P02 15 hr (contact class 8 hr, project 7 hr) 1 month 20,000 INR (all inclusive) 6-8 DATES FOR THE CLASS Theory classes will be held on 11th (Saturday), 12th May (Sunday) 2013 Theory classes will be held on 24th (Saturday), 25th Aug (Sunday) 2013 PROJECT SUBMISSION 8th June 2013 5th October 2013 EXAMINATION DATE 22nd June (Saturday) 2013 12th October (Saturday) 2013

Certificate Course on Freedom to Operate Search Course Code: 1202

Freedom-to-operate analysis or FTO analysis is used to determine whether a particular action, such as testing or commercializing a product, can be done without infringing valid intellectual property rights of others. Duration: Time period: Cost: Number of Seats: . BATCH Batch F01 Batch F02 25 hr (contact class 13 hr, project 12 hr) 1 month 33,000 INR (all inclusive) 6-8 DATES FOR THE CLASS PROJECT SUBMISSION 13th July 2013 26th Oct 2013 EXAMINATION DATE 20th July (Saturday) 2013 2nd Nov (Saturday) 2013

Theory classes will be held on 25th ( Saturday), 26th May (Sunday) 2013 Theory classes will be held on 7th (Saturday), 8th September (Sunday) 2013

HOW TO REGISTER?: Download the registration form from www.origiinipa.com and send us the filled form along with payment to register. For more info please mail at info@origiin.com

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