Saturday, October 29, 2011

Patent professionals work in companies, state and federal governments, private institutes, and nongovernmental organizations.!!!


A Patent is a legal monopoly, which is granted for a limited time by a country to the owner of an invention. Merely to have a patent does not give the owner the rights to use or exploit the patented invention. That right may still be affected by other laws such as health and safety regulation, or the food and drugs regulation or even by other patents. The patent, in the eyes of the law, is a property right and it can be given away, inherited, sold, licensed and can even be abandoned. As it is conferred by the government, the government, in certain cases even after grant or even if it has been, in the meantime, sold or licensed, can revoke it.
Beginning a career in patent application would be based on the research reported in Graduation and Post graduation. During this process, we have to learn the scientific standards for peer review (on the one hand) and patenting (on the other) were different, and that the two writing tasks -- a scientific paper and a patent application -- required different approaches. Also learn the analytical skills from scientific training applicable to assessing whether an invention wouldbe patentable.
A patent law career offer' practical advantages, career in academia. In academic science, funds for conducting research were -- and continue to be -- very limited, and the requirements for obtaining funding are exceptionally high. Capable and qualified scientists were not being funded, and many talented postdoctoral scientists were ahead of me in the long line for an academic position. Meanwhile, there would be a shortage of people qualified, in science and in law, to work in patent law, and in the biotech industry the need for new patent expertise was -- and is -- increasing.
Yet, making a transition into patent law didn't require blazing a new trail, since patent law is a well-established career path for scientists. I was not aware of it at the time, but nearly , most attorneys working in biotechnology patent law have science Ph.D.s, and many have impressive postdoctoral experience.
Developments in bioscience occur frequently, making the work dynamic and unpredictable. Patent attorneys are exposed to many new discoveries well before they are available to the public, providing a rare glimpse into our future.
The legal aspect, too, is dynamic. Congress and the courts are still sorting out the legal framework for biotech patents. Recently, the courts decided a controversial case that asked a fundamental question: Are isolated genes patentable? The judges relied extensively on scientific findings to reach their much anticipated decision: Isolated genes are indeed patentable, at least for now.
That decision -- and its tenuousness -- directly impacts those working in (and depending on) patent law. The future of many biotech companies depends on the gene patents they own and the strength of those patents. The potential for a dramatic revision of patent law makes it essential for biotechnology attorneys to stay abreast of developments in the law so that they may advise their clients appropriately.
Another example of the need to keep up with the law is the recent establishment of a new law related to “biosimilars.” The Food and Drug Administration (FDA) has not yet issued guidelines for licensing biosimilar products in the United States; biotechnology patent attorneys must nevertheless be prepared to review information from FDA and USPTO and to advise clients without these guidelines. Skills in the biological sciences and the law help attorneys understand what the new U.S. biosimilar law means and how it is likely to be applied. I recently organized a conference and wrote a treatise on the new biosimilar law, which shows that a career as a patent attorney offers opportunities similar to those offered by a career in academic science.
Biotechnology patent law requires the communication of complex scientific ideas, so excellence in writing and speaking is essential. While conducting postdoctoral studies to identify and modulate the activity of the NPM-ALKoncogene, I practiced and developed the skills necessary to explain the relevance of my work to lay people and nonspecialist scientists. Some grant-review panels -- such as those for cancer research grants -- include a layperson whose opinions must be considered when preparing an application.

Practicing patent law requires managing a demanding schedule. Fortunately, my Post-graduation (and my graduate work) helped me learn this skill, too. As a Mater’s in Biotechnology , I also would like to  coordinated experiments, taking into account the availability of personnel, machines, viable reagents, and so on. Missing a time point could have set the research back for weeks, or longer. The requirements in patent law are similar: It's necessary to juggle several projects, each with several deadlines and many people involved. Failing to keep to a schedule can have a serious impact on the success of client companies.
We must have a law degree, but a law degree isn't required to work in patent law. Ph.D. scientists who move directly into patent-related careers may work as technology specialists or as agents. Typically, these jobs require passing an exam. To be eligible to take the exam, you simply must have formal training in a relevant science.
But many people who enter this field with Ph.D.s -- choose to become attorneys: attending law school, passing the patent bar examination, and gaining admission to a state bar association. A formal legal education is expensive and demanding and requires years to compete, but it will make you more marketable. Some firms will pay for law school tuition, but even if you can locate such an arrangement, your employer/sponsor will probably expect you to work as you study, which will delay the completion of your degree.
Patent law jobs exist in many settings, not just at law firms. Patent professionals work in companies, state and federal governments (including USPTO), private institutes, and nongovernmental organizations. Each organization has different objectives and functions.
Within a company, you're likely to specialize, since most companies are focused on a narrow area of science (i.e., therapeutic human monoclonal antibodies). The objective of patent attorneys working in companies is to protect and expand the intellectual property assets of the company by developing new patents and helping to protect existing ones.
Examiners at India, on the other hand, read patent applications, study the technology described in the applications, and assess the state of the art (i.e., the science) to determine whether a proposed invention is new and not obvious. Here, you may be called upon to evaluate a fairly wide range of technology, but you will still have a specialty.
Another option is working at an institution, such as a university. Here, you may work with an even wider range of technology, with patentable ideas emerging from disciplines as far apart as, say, physics and microbiology. In my work at SMS medical College and Hospital , Jaipur, I evaluated the potential of research and attempted to identify companies that might be interested in licensing the technology.
If you are considering biotechnology patent law as a career, talk to as many people as you can: to someone at USPTO about taking the patent examination, to admissions counselors about your law school options, and to attorneys about their day-to-day work. Professional associations, including the In India, a person registered to practice before Indian Patent Office is called a "Registered Patent Agent" or simply "Patent agent". The Indian Patent Law specifically does not mention the designation of "Patent Attorney". The Indian Patent Agent can thus be considered the counterpart of the Patent Attorney in Australia, EPO or Japan.
Indian Patent Office conducts a qualifying examination for patent agent registration yearly (earlier, it was twice a year). Indian Patent Law mandates a science or technical degree for person(s) to appear for the qualifying examination. Other criteria for eligibility include being an Indian Citizen, and 21 years of age. There are approximately 2000 registered patent agents in India as of April 1, 2010.
 www.wipo.org, and WIPO Index of Patent Systems  are outstanding sources of information and are usually happy to connect interested people with practitioners in the field.
Making the decision to switch to a career in patent law requires weighing and balancing many factors. But if you have the appropriate skills and enjoy analyzing and communicating about scientific innovations, patent law could be your ideal career.
·         A Patent gives an inventor the right for a limited period to stop others from making, using, selling or importing an invention without the permission of the inventor. That is why patent is called a "negative right"
·         Patents are generally concerned with functional and technical aspects of products and processes and must fulfill specific conditions to be granted.
·         Most patents are for incremental improvements in known technology - evolution rather than revolution. The technology does not have to be complex.
·         Patent rights are territorial; an Indian patent does not give rights outside of India.
·         Patent rights last for up to 20 years in India and in most countries outside India.
·         Depending on where you wish your patent to be in effect, you must apply to the appropriate body. In India, this is The Indian Patent Office. There are various Patent Offices around the world. Alternatively, a Patent Agent can apply on your behalf.

1. Legal Basis

 

·         The Patents Act 1970, as amended by The Patents (Amendment) Act 2005.
·         The Patents Rules, 2003, as amended by The (Amendment) Rules 2006.

Procedure for Filling Patent Application


2. Filing Application

 

Any person, even if he or she is a minor, may apply for a patent either alone or jointly with any other person. Such persons include the inventor, or his assignee or legal representative in the case of an ordinary application or, in the case of a priority application, the applicant in the convention country or his assignee or his legal representative. A corporate body cannot be named as an inventor. Foreigners and nationals not living in India need an address for service in India for this purpose. They may appoint a registered agent or representative whose address for service can be the address for service in India.

·         Place of filing:

An application for patent must be filed at the Patent Office branch within whose territorial jurisdiction the applicant resides or has his principal place of business or domicile. A foreign applicant must file in the Patent Office branch having jurisdiction over the place where his address for service is located.

·         Priority:

Priority can be claimed from the earliest corresponding application in a convention country, provided that the Indian application is filed within twelve months of the priority date. Multiple and partial priorities are allowed.

·         Specification:

A priority application must be filed with a complete specification in the first instance but a non-priority application may be filed with either a provisional specification or a complete specification. Where a provisional specification is filed in the first instance, a complete specification must be filed within twelve months. Where two or more provisional specifications have been filed, the specifications may be cognated and all the subject matter may be incorporated into a single complete specification to be lodged within twelve months of the date of the earliest filed provisional specification.

·         Naming of inventor(s):

As regards non-priority applications, the inventor(s) must be named in the application form. As regards priority applications, a declaration as to inventorship must be filed with the application or within a maximum period of six months.

·         Information of corresponding applications in other countries:

It is necessary at the time of filing a patent application in India, to inform the Controller of the details of all corresponding applications in other countries and to undertake to keep the Controller so informed up to the grant of the Indian application. Failure to do so could result in the refusal of the application in case it is opposed, or even revocation of a patent in proceedings before the High Court.

3. Patent Examination

 

·         Examination of application:

Both formal and substantive examinations are made by the Indian Patent Office. Examination is by request.

·         Procedure:

An applicant is required to meet all the objections and requirements of the Patent Office within a period of twelve months from the date of the first examination report (FER) issued by the Controller. No extension of time is permitted. If a patent application is not put in order in twelve months from the date of the FER it lapses.

·         Amendment of application:

An applicant may, of his own accord, apply to the Controller for amendment of his application or any document filed in respect thereof but such amendments must be filed by way of correction, explanation, or disclaimer. An applicant may also amend his application or specification at the instance of the examiner and file a separate divisional application(s) for the other invention(s) which will be accorded the date of filing of the complete specification of the original application or such later date as the Controller may fix. The divisional application must be filed prior to the grant of the parent application.

4. Patent Publication

 

Publication takes place 18 months from the date of the application. Urgent publication is possible on request on payment of fees. On and from the date of publication of application for patent and until the date of grant of a patent in respect of such application, the applicant will have the like privileges and rights as if a patent for the invention had been granted on the date of publication of the application. 11A[7]

·         Pre-Grant opposition of patent application:

After publication but before the date of grant by way of representation, anyone may file opposition to the grant of a patent.

·         Publication of subject matter:

The grant of an application is published in the official journal and is notified therein for post Grant opposition. A patent can be revoked within one year after grant by postgrant opposition proceedings before the Controller of Patents.

·         Revocation of a patent:

It is possible on the grounds of prior publication anywhere in the world, public use or knowledge in India, lack of novelty with regard to the subject matter, obviousness, lack of inventiveness, ambiguity, insufficiency of description of the invention, fraud, false suggestion or representation that the person named as the inventor is not the true inventor, lack of utility, non-patentability of subject matter (e.g. food, drug or medicine per se, atomic energy, mere admixture, mere arrangement of known devices, process of testing, method of agriculture or horticulture, process of medicinal treatment), failure to furnish or falsity in material particulars of information regarding corresponding applications in other countries supplied to the Controller or that the invention is contrary to law or morality.

·         Annuities:

Except in the case of a patent of addition, for which no annuities are payable, annual renewal fees must be paid during the life of an Indian patent, the first of such fees falling due at the end of the second year of the life of a patents granted. Renewal fees falling due during the pendency of the application are payable within a non-extendible period of three months from the date the patent is taken on record in the Register of Patents. Two or more year's renewal fees may be paid in advance if the patentee so desires. A maximum extension of six months may be obtained on payment of the prescribed penalty fees. If the renewal fee in question is not paid within the extended period available, the patent will lapse.

·         Restoration:

A lapsed patent may be restored if an application for restoration is made within one year of the date of lapsing of the patent, provided it can be shown that the lapsing of the patent was unintentional and that there was no undue delay in making the application for restoration.

·         Working of patents:

Every patentee and every licensee is required to furnish within three months from the end of the calendar year in which the patent is granted, a statement as to the extent to which the invention has been worked in India on a commercial scale in the preceding year. Non filing of this statement is a criminal offence.

·         Compulsory licenses:

After three years from the date of sealing of a patent, an interested party may apply to the Controller for the grant of a compulsory license alleging that the reasonable requirements of the public with respect to the invention have not been satisfied or that the invention is not available at reasonable price. If the Controller is satisfied that a prima facie case for an applicant for compulsory license has been made out, he shall serve notice on the patentees who, if they so desire, may oppose the application for compulsory license.

·         Marking:

It is not compulsory but advisable as otherwise damages may be difficult to recover in cases of infringement. The invention may be marked with the word “Patented” or “Patent” accompanied by the number and year of the patent.

·         Infringement:

An infringement suit may be instituted by a patentee or his exclusive licensee. Every ground for revocation is available as a defense and revocation can be counter claimed in infringement proceedings. The Court may grant relief in respect of a valid claim or claims even though one or more other claims in the suit may be held to be invalid. Relief may include damages and costs as awarded by the court. A suit for injunction may be instituted and damages recovered in cases where there have been groundless threats. Any person may institute a suit for declaration as to non-infringement of a patent. Onus of proof of non-infringement lies with the defendant.

 

5. Patents and Computer Software

 

It is possible to patent programs for computers which, when run on a computer produce a "technical effect or includes hardware" . However, if a program does not produce a technical effect when run on a computer it is unlikely to be patentable. A technical effect is generally an improvement in technology and needs to be in an area of technology, which is patentable. For instance, an improved program for translating between Japanese and English is not patentable because linguistics is a mental process, not a technical field. On the other hand, a program, which speeds up image enhancement, may be patentable because it produces a technical improvement in a technical area.
Some countries, such as the USA, which may be a large potential market for your software, have a more liberal approach to software patenting and often grant patents for software, which would be excluded in India and other countries.

Deciding whether or not a particular computer program is patentable is a complex issue and advice from a Patent Agent may help to determine which is the most effective form of protection available.

William Simmons is a patent attorney in Washington, D.C., working in all aspects of patent law, with a focus on biotechnology and biopharmaceuticals. He is currently preparing a legal treatise, Biologic Patenting and Regulation, to be published in 2012 by BNA and AIPLA.

The relevant provisions in the Patent Act and Rules are quoted below :-
PATENTS ACT , 1970
CHAPTER XXI- PATENT AGENTS
125. Register of patent agents :- (1) The controller shall maintain a registered to be called the register of patent agents in which shall be entered the names, addresses and other relevant particulars, as may be prescribed , of all persons qualified to have their names so entered under section 126.
(2) Notwithstanding anything contained in sub-section (1), it shall be lawful for the Controller to keep the register of patent Agents in computer floppies , diskettes or any other electronic form subject to such safeguards as may be prescribed.
126. Qualifications for registration as patent agents :- (1) A person shall be qualified to have his name entered in the register of patent agents in he fulfils the following conditions, namely :-
(a) he is a citizen of India;
(b) he has completed the age of 21 years
(c) he has obtained a [degree in science , engineering or technology from any university established under law for the time being the force] in the territory of India or possesses such other equivalent qualifications as the Central Government may specify in this behalf , and, in addition,-
(d) he has paid such fee as may be prescribed.
127. Rights of Patent Agents :- Subject to the provisions contained in this Act and in any rules made there under, every patent agent whose name is entered in the register shall be entitled.
(a) to practice before the controller ; and
(b) to prepare all documents, transact all business and discharge such other functions as may be prescribed in connection with any proceedings before the Controller under this Act.
128. Subscription and verifications of certain documents by patent agents :- All applications and communications to the Controller under this Act may be signed by a patent agent authorized in writing in this behalf by the person concerned.
129. Restriction on practice as patent agents :- (1) No person, either along or in partnership with any other person , shall practice, describe or hold himself out as a patent agent , or permit himself to be so described or held out, unless he is registered as a patent agent or, as the case may be , unless he and all his partners are so registered.
(2) No company or other body corporate shall practice, describe itself or hold itself out as patent agents or permit itself to be so described or held out.
Explanation :- For the purpose of this section, practice as a patent agent includes any of the following acts, namely:-
(a) applying for or obtaining patents in India or elsewhere.
(b) Preparing specifications or other documents for the purpose of this Act or of the patent law of any other country.
(c) Giving advice other than of a scientific or technical nature as to the validity of patents or their infringement.
130. Removal from register of patent agents and restoration :- (1) The controller may removes the name of any person from the register when he is satisfied, after giving that person a reasonable opportunity of being heard and after such further enquiry if any , as it thinks fit to make-
(i) That his name has been entered in the register by error or on account of misrepresentation or suppression of material fact;
(ii) That he has been convicted of any offence and sentenced to a term of imprisonment or has been guilty of misconduct in his professional capacity which in the opinion of the Controller renders his unfit to kept in the register.
(2) The Controller may, on application and on sufficient cause being shown, restore to the register the name of any person removed therefrom.

PATENT RULES 2003
CHAPTER XV - PATENT AGENTS

108. Particulars to be contained in the register of patent agents :- (1) The register of patent agents maintained under section 125 shall contain the name , nationality , address of the principal place of business, address of branch offices, if any , the qualification and the date of registration of every registered patent agent.
(2) Where the register of patent agents is in computer floppies,diskettes or any other electronic form, it shall be maintained and accessed only by the person who is duly authorized by the Controller and no entry or alteration of any entry or rectification of any entry in the said register shall be made by any person who is not so authorized by the Controller.
(3) (i) Copies of register of patent agents shall be maintained in each of the branch offices;
(ii) The register of patent agents shall also contain specimen signatures and photographs of the person registered as patent agents.
109. Application for registration of patent agents :- (1) Every person who desires to be registered as a patent agent shall make an application in Form 22.
(2) The applicant shall furnish such other information as may be required by the Controller.
(3) A person desirous to appear in the qualifying examination under rule 110 shall make a request to the Controller along with the fee as specified in the first schedule.
110. Particulars of the qualifying examination for patent agents :- (1)The qualifying examination referred to in clause (c)(ii) of sub-section (1) of section 126 shall consists of a written test and a viva voce examination.
(2) The qualifying examination shall consist of the following papers and marks, namely:-
Paper I – Patent Act and Rules 100
Paper II- Drafting and interpretation of
Patent specification and other documents 100
Viva Voce 100
(3) The qualifying marks for each written paper and for the viva voce examination shall be fifty per cent each , of total marks and a candidate shall be declared to have passed the examination only if he obtains an aggregate of sixty per cent of total marks.
111. Registration of patent agents :- After a candidate passes the qualifying examination specified in Rule 110 and after obtaining any further information which the controller considers necessary he shall, on receipt of the fee specified therefore in the first schedule, enter the candidate’s name in the register of patent agents and issue to him a certificate of registration as a patent agent.
112. Details to be included in an application for the registration of a patent agent :-An application by a person entitled to be registered as a patent agent under sub-section (2) of section 126 shall also be made in Form 22.
113. Registration of patent agents under section126(2) :- On receipt of an application for the registration of a person as a patent agent under rule 112, the Controller may if he is satisfied that the said person fulfils the conditions specified in sub-section (2) of section 126 enter his name in the register of patent agents.
114. Disqualification for registration as a patent agent :- A person shall not be eligible to be registered as patent agent, if he-
(i) has been adjudged by a competent court to be unsound mind ;
(ii) is an undischarged insolvent.
(iii) Being a discharged insolvent, has not obtained from the Court a certificate to the effect that his insolvency was caused by misfortune without any misconduct on his part.
(iv) Has been convicted by a competent Court, whether within or outside India of an offence to undergo a term of imprisonment , unless the offence of which he has been convicted has been pardoned or unless on an application made by him, the Central Government has, by order in this behalf , removed the disability.
(v) Being a legal practitioner has been guilty of professional misconduct.
(vi) Being a chartered accountant, has been guilty or negligence or misconduct.




DBT IPR & Biosafety Syllabus in M.Sc. Biotechnology
Unit I: Introduction to Intellectual Property
Types of IP: Patents, Trademarks, Copyright & Related Rights, Industrial Design, Traditional Knowledge, Geographical Indications, Protection of New GMOs; International framework for the protection of IP IP as a factor in R&D; IPs of relevance to Biotechnology and few Case Studies; Introduction to History of GATT, WTO, WIPO and TRIPS

Unit II: Concept of ‘prior art’
Invention in context of “prior art”; Patent databases; Searching International Databases; Country-wise patent searches (USPTO, EPO, India etc.); Analysis and report formation

Unit III: Basics of Patents
Types of patents; Indian Patent Act 1970; Recent Amendments; Filing of a patent application; Precautions before patenting-disclosure/non-disclosure; WIPO Treaties; Budapest Treaty; PCT and Implications; Role of a Country Patent Office; Procedure for filing a PCT application

Unit IV: Patent filing and Infringement
Patent application- forms and guidelines, fee structure, time frames; Types of patent applications: provisional and complete specifications; PCT and convention patent applications; International patenting-requirement, procedures and costs; Financial assistance for patenting-introduction to existing schemes; Publication of patents-gazette of India, status in Europe and US Patenting by research students, lecturers and scientists-University/organizational rules in India and abroad, credit sharing by workers, financial incentives Patent infringement- meaning, scope, litigation, case studies and examples

Unit V:Biosafety
Introduction; Historical Backround; Introduction to Biological Safety Cabinets; Primary Containment for Biohazards; Biosafety Levels; Biosafety Levels of Specific Microorganisms; Recommended Biosafety Levels for Infectious Agents and Infected Animals; Biosafety guidelines - Government of India; Definition of GMOs & LMOs; Roles of Institutional Biosafety Committee, RCGM, GEAC etc. for GMO applications in food and agriculture; Environmental release of GMOs; Risk Analysis; Risk Assessment; Risk management and communication; Overview of National Regulations and relevant International Agreements including Cartagena Protocol.
Important Links
http://www.w3.org/IPR/
http://www.wipo.int/portal/index.html.en
http://www.ipr.co.uk/IP_conventions/patent_cooperation_treaty.html www.patentoffice.nic.in
www.iprlawindia.org/ - 31k - Cached - Similar page
http://www.cbd.int/biosafety/background.shtml
http://www.cdc.gov/OD/ohs/symp5/jyrtext.htm
http://web.princeton.edu/sites/ehs/biosafety/biosafetypage/section3.html

PATENT AGENT EXAMINATION PPREPARATION SERIES

INTRODUCTION
Patent Agent Examination Preparation Series helps you prepare for the Indian Patent Agent
Examination conducted by Patent Office, Government of India.

ABOUT THE EXAMINATION
All science and technology graduates (B. Sc, M.Sc, B.Tech, M.tech etc.) are eligible to sit
the exam. You need to pass the India Patent Agent Examination to become a Registered
Patent  Agent in India. This Exam is conducted by Patent Office in the month of January every
year.

Pattern of Questions
-Paper I will have 40 objective type questions of one mark each and descriptive type questions
of 60 marks.

-Paper II will have a set of two questions (different sets for science and engineering) on drafting
of 30 marks each consisting of:
1. Drafting of specification from given claims and background.
2. Drafting of claims from given specification and the rest will be descriptive/interpretative type
questions of 40 marks.

• Viva-voce examination will be based only on domain knowledge.
This is a professional qualification and a life long qualification. The passing score is a minimum
of 50% in each and overall 60%.

However, too many startup and small technology companies have utilized IP an in ad-hoc basis without considering IP as a strategic part of their business model. This workshop will focus on the importance of protecting intellectual property (IP), several forms of IP protection available for startup and small technology companies, and practical IP strategies to develop an IP portfolio that can be aligned strategically with their business model and to avoid mistakes pertaining to IP that can be costly or fatal for a startup and small technology company..
M.S. University, Baroda
Post M.Sc Advanced Diploma in Intellectual Property Rights, Biosafety and Regulatory Affairs
Admission form and brochure for course will be available from the Biotechnology Centre Office, M.S. University, Baroda from April/May , by DD in favour of 'Coordinator, PG Diploma Course in IPR', payable at Baroda.
The one year course is being started with support from Department of Biotechnology, Ministry of Science & Technology, Govt. of India, New Delhi, with the aim of providing an ideal opportunity to train fresh students who would like to work in the field of IPR, filling of patents and regulatory affairs in public and private institutions.
Eligibility and Selection process
M.Sc with minimum 50% marks in Microbiology/Biotechnology/ Biochemistry/allied branches of biological sciences.  Selection to the course shall be based on an Entrance Test and Viva voce (interview) to be conducted at the Department of Microbiology and Biotechnology Centre, M.S.University.
Course outlines for Entrance Test
The question paper of 100 marks for entrance exam will have questions at the level of B.Sc/M.Sc from all or some of the areas in Microbiology/Biotechnology/Biochemistry and other related disciplines. 100 marks will be for interview/viva.
The Entrance test will be conducted in June/July every year.  Admission Forms will be available from the Department office from 25th May to 25th June every year (tentative dates).
Intake of Students, fees and Studentship
A maximum of ten students will be admitted.  Fees will be as prescribed by the University. Admitted students will be paid a studentship of Rs.5000/-p.m.  


Paper I:  Intellectual Property Rights
Introduction to intellectual property, History of patents, Indian Patent law, Patent laws in the US and European Union.
Patents :
Patentable subject matter and patent types
Patent requirements: technical specifications, novelty, and non-obviousness
Rights of patent holder
Patent protection for biological materials, biotechnological inventions, software, algorithms and methods
The patent application
Scope of amendments and claims
Conflict and infringement
Copyrights :
Copyrightable subject matter
Requirement, limitations, length and rights
Comparison with patents
Copyrights in the context of information technologies
Fair use doctrine and file sharing
Trade marks :
Types, trade dresses
Protecting trademark, industrial designs
Infringement
Trade secrets
Technology transfer and license agreements
Protocols, treaties and conventions related to IPR
Case studies of biotechnology patents
Role of NGOs in IP protection
Paper II   :   Regulatory Procedures
Good laboratory practice, Good manufacturing practice and FDA regulations
Pharmacopia standards
Regulations for recombinant DNA research and manufacturing process
Bio-safety and Bioethics
Regulations for clinical trials, Documentation and Compliance, in India and selected countries
Rules for import and export of biological materials
Paper III:  Biotechnology Processes and Products
Techniques used in Biotechnology, with special emphasis on molecular and recombinant DNA techniques
Cloning Strategies and Tissue culture procedures for plant cells, animal and stem cells
Transgenic plants, animals, genetically modified organisms (GMO) and GM food etc.
Large scale production of recombinant proteins, Processes for separation and purification
The Human Genome project and genomics of selected organisms
Medical Biotechnology: gene therapy, tissue engineering and xeno-transplantations
Biotechnology Products:
Health care products: Vaccines, Diagnostics, Recombinant therapeutic proteins
Agricultural : Hybrid and modified seeds, Bio-pesticides, Bio-fertilizers
For More info you are welcome. 
  1. www.sinapseblog.com
  2. www.onlineipcourses.com
  3. www.ipconvergence.im
  4. www.radisinapse.com
  5. www.ipracademy.org
  6. www.dipp.nic.in