2. Practical Aspects of Patent Maintenance
Working of patent to be filed every year
Periodic renewal
Restoration of Lapse Patent
Enforcement of patent
3. Patent Infringement
Infringement of a patent consists of the unauthorized making, using, offering for sale or selling of any
patented invention
Violation of monopoly rights constitutes an infringement
Claim to claim analysis is done for essential elements
Legal status to be checked
Eg: A+B= C (one process)
X+Y=C (another process)
Since the components used in both the process to obtain C are different, there is no infringement
Eg: A formulation contains A+B+C for treating fever is patented by company X
Other Formulation contains A+B+C+D for treating fever is patented by company Y.
Y is infringing X’s patent
4. Types of Infringement:
1) Direct infringement
when the infringing device or process may be similar or equivalent to the claimed invention (performs
substantially the same function, in substantially the same way and to achieve substantially the same
result.
2)Indirect infringement: a) Induced infringement b) Contributory infringement
Person assisting or helping other person to use patented product/process
Contributory infringement is triggered when a seller provides a part or component that, while not
itself infringing any patent, has a particular use as part of some other machine or composition that is
covered by a patent.
3) Willful infringement:
Person is aware about the existing patent but intentionally uses the same product/process.
Once proved, have to pay substantial penalties
5. Patent Infringement: Exceptions
Government Use
Research Purpose
Supply of patented drugs to government run health institutions
Jurisdiction
District or High court
Who can apply for infringement?
Patentee
Co-owner
Assignee
Exclusive licensee
Remedies:
Temporary Injunction
Permanent Injunction
Damages
6. Novartis vs. Cipla
•Novartis had 5 patents for the drug Onbrez ( used to treat chronic obstructive pulmonary
disease)
•In 2014, the Defendant launched a generic version of Onbrez and in the process petitioned to
have the Plaintiff’s patents revoked. It contended that the disease has reached an ‘epidemic’
stage and the monopoly of the Plaintiff was limiting the extent of the drug.
•In light of that requested the Central Government to revoke the patent under Section 92 (3)
(compulsory license under special circumstances) and Section 66 (patents which are prejudicial
to public) of the Patents Act.
•Defendant contended that the Plaintiff was not manufacturing the drug locally and imported
only limited quantities through a licensee.
•Plaintiff then filed a case before the Delhi HC claiming patent infringement and damages.
7. •Delhi High court barred the Defendant from making or selling generic copy of the Plaintiffs drug
by granting temporary injunction to the Plaintiff.
•Defendant had previously also stated that there was a shortage of the drug and inadequacy
thereof. However, the HC observed that the Defendant failed to provide any proof or figures for
such claims.
•In 2017, Cipla filed an appeal against this order. However, the appeal was dismissed on similar
grounds. The 2017 Appeal further divided into the implications of a drug being imported and
whether the extent of imports was sufficient to meet the demands in India.
•Novartis also sort damages from Cipla
9. TECHNOLOGY TRANSFER
Technology transfer supports the
life cycle of technology, from seed
level to market sale and
commercialization
Collaborative process that allows
scientific findings, knowledge and
intellectual property to flow from
creators, such as universities and
research institutions, to public
and private users
Its goal is to transform inventions
and scientific researches into new
products and services that are
beneficial to society
Also known as knowledge transfer
10. Modes & Benefits
For universities it can bring revenues that
can be plowed back into research, as well
as recognition of its scientists and their
innovations – which in turn can help with
faculty recruitment and grant funding.
For companies, benefits include the
ability to tap into research advances
without spending on internal R&D, and
introducing new products that can drive
the success of their businesses forward
01 02 04
03 05
publications (technical
journals, scientific
magazines, etc).
contract research,
sponsored research
and R&D
collaborations with
firms
assignment and
licensing of
technology
presentations and
personal contacts
(conferences, courses,
professional
organizations, etc.).
patent documents.
11. TT in Pharmaceutical Industry
01
02
03
04
Drug discovery
Product Development
Clinical trials
Commercialization
12. Facets of TT
• Formulation with its development
• Analytical method for formulation development
• Packaging development
• Manufacturing Process
•Quality Control
• Quality Assurance
• Experts from Eng. Dept
14. IP Policy at research level
Rules for the management of IP resulting from research
•ownership of IP and research results;
•the person or department responsible for the protection and management of IP;
•responsibilities of the institution, staff and students;
•rules of engagement with third parties;
•management of conflicts of interest;
•incentives to reward researchers for their engagement with technology transfer and
commercialization;
•distribution of benefits.
15. TT Agencies in India
APCTD : Asian and Pacific centre for technology transfer
• In Bangalore, moved to Delhi
• Implementation & Promotion of TT
• Improvisation of terms & conditions of Agreement
• Promotion of global TT in Asian Pacific region and cross
border relationship between different states for SMEs
NRDC: National Research Development Corporation
• transferred indigenous technologies to business
developers or industries
• commercialize the technology
• FUNGISOME, India's first Liposomal Amphotericin B
developed by employing DBT technology was transferred
to M/s. Lifecare Innovations Pvt. Ltd. by NRDC.
TIFAC: Technology Information Forecasting and
Assessment Council
• creating awareness and assisting in technology
development
BCIL: Biotech Consortium India Limited
• promoted by DBT and Govt. of India
• biotech related inventions commercialization
TBSE: Technology Bureau for Small Enterprises
• global level platform for technology acquisition or
developing business collaboration via social networking
• assists in complex tasks of negotiation and matching the
perceptions.
16. In 2016, Pfizer transferred their rights and technologies to NovaMedica (Russia) to produce 30
medicines in Russia. This gave Pfizer direct access into the Russian market, where the earlier
stringent regulations had made it difficult for them to enter.
In 2017, Otsuka Pharmaceutical (Japan) and R-Pharm Group (Russia) collaborated to
manufacture and market Deltyba, a drug for the treatment of pulmonary multidrug-resistant
tuberculosis, in Russia and the Commonwealth of Independent States.
Pfizer and BioNTech successfully developed a promising mRNA vaccine for use against COVID-19
in March 2020
Co-vaccine developed by ICMR & NIV was manufactured by Bharat Biotech
17. Ethics and values in IP
Positive Aspect of IP Rights
• Encourage individuals to come up with new ideas
• Exclusive right for limited period
• Monetary gain
• Monopoly to exploit the IP
• Pursue legal action
• Collateral to obtain financing
• Facilitating technology transfer
18. Negative Aspect of IP Rights
• denies access to medicines to patients in the developing world who are unable to afford the
high prices for patented drugs
• permission required for manufacturing drug by third parties
• negative effect on patient care and the practice of medicine
• pirating
Impact on world:
• Access to health-related technology in developing countries is a serious concern
• In Africa, the AIDS epidemic is causing alarm world-wide
22. Ethical Issues with respect to R&D
Intellectual property refers to patents, copyrights, trademarks and trade secrets, all of which are
legal means meant to protect unique ideas, inventions and other non-tangible property. Ethical
issues regarding intellectual property frequently arise in IPRO projects concerning how group
member's contributions should be measured and rewarded if the research project results in a
patent, how businesses, advisors and other institutions may have a claim to intellectual property
resulting from projects they sponsor and intellectual property and confidentiality agreements
companies may ask students to sign to protect the intellectual property rights of a company.
23. Societal responsibility: Avoiding unethical
practices
Unfair Trade Practice and Unfair Competition
-distribution of false or misleading information that is capable of harming the business interests
of another firm;
- distribution of false or misleading information to consumers, related to the price, character,
method or place of production, properties, and suitability for use, or quality of goods;
- false or misleading comparison of goods in the process of advertising;
- fraudulent use of another’s trademark, firm name, or product labelling or packaging;
- unauthorized receipt, use or dissemination of confidential scientific, technical, production,
business or trade information
24. Creation of original images thereby avoiding copyright infringement and also taking permission
from the person whose photo is being used for any purpose like literary work
Avoid purchasing pirated copies
Avoid taking screenshots of branded/trademarked products from the internet, third-party
catalogs, or another merchant’s listings for your product listing
Reducing the likelihood of counterfeiting of goods by not selling replicas, counterfeits or fake
versions of actual products.
Refrain from using a patented invention or design without the permission of the patent or
registered community design owner
Avoiding using images of celebrities or famous models to list your products without their
consent.
