module 1-6 Flashcards
history of IPR (international)
The first international deveopment in the field of IPR was held in the empire of Austria- Hungary which invited other countries to participate in an international exhibition of inventions held in 1873 at Vienna, where participation was hampered by the fact that foriegn visitors were apprehensive of exhibiting their invention due to inadequate legal protection.
this led to two developments- a special austrian law secured temporary protections to their exhibitors for their invention, trademarks and industrial design
the Congress of vienna for patent reform was convened in the same year as a follow up to the same an International Congress on Industrial Property was convened at Paris in 1878. and the conference adopted a draft convention which are still main features of Paris Convention-
Principle Provisions of the Paris convention:
1. Right of national treatment to each of the member countries
2. Right of priority ( of filing for patents)
3.. Rights and Obligations of natural persons and legal entitiies
4. Administrative framework to implement the convention
plus add WTO HISTORY
History of IPR in india
India Act fo VI of 1856 was enacted “Protection of Inventions” exclusive privileges were granted to inventors of new manufacturers for a period of 14 years from the date of filing specification. privileges included: making, selling, and using inventions in India and authorising others to do so.
this lead to the “patents and designs protections act, 1872- then the Protections of Inventions Act,1883”
then these were consolidated to the Inventions and designs act,1888
Ayyanagrs Report and Patents Act, 1970
a Bill based on the UKs Patents act was introduced to the Lok Sabha but lapsed after the dissolution of the Lok Sabha,
then, Justice Ayyanagard was appointed to review patent law and advise the GOI
he submitted a comprehensive report. eventually the Patents bill was introduced and sucessfully passed in the parliament
and came into force in 1972.
scope of protection
A patent grants an inventor the exclusive right to prevent others from making, using, selling, or distributing the patented invention without permission for a specified period (generally 20 years). The protection applies to:
Product patents – Protects the physical invention (e.g., a new drug, machine, or device).
Process patents – Protects the method or process of manufacturing a product (e.g., a new method of producing steel).
For an invention to be patentable, it must fulfill the following conditions:
Novelty – The invention must be new and not previously disclosed anywhere in the world.
Inventive Step (Non-Obviousness) The invention must not be an obvious improvement over existing technology.
Capable of Industrial Applicability – It must have practical use in any industry (not just a theoretical concept).
Patentable Subject Matter – The invention must not fall under the exclusions (e.g., laws of nature, abstract ideas, or mathematical formulas
patentability criteria:
- Industrial Applicability (Utility)
- Novelty
- Inventive Step (non obviousness)
- patentable subject matterr
explain the patentability criteria- industrial applicability and novelty
1. Industrial Applicability (Utility)- must be of a kind which can be applied for practical purposes, not be purely theoretical. if the invention is intended to be a process or part of a process, it should be possible to carry that process out or “use” it.
mere usefullness is not enought to qualify patent, it must have commercial use or manifesation
2. Novelty- It must be emphasized, however, that novelty is not something which can be proved or established; only its absence can be proved
An invention is new if it is not anticipated by the prior art “Prior art” is, in general, all the knowledge that existed prior to the relevant filing or priority date of a patent application, whether it existed by way of written or oral disclosure.
3 ways for something to be classified as prior art:
1. by a description of the invention in a published writing or publication in other form;
2. verbal or oral disclosure uttered in public
3. use of the invention in public or putting the public in a position wherein any member of the public s anabled to use it (Disclosure by use)
inventive step and non obviousness
3. INVENTIVE STEP
Novelty and inventive step are different- Novelty exists if there is any difference between the invention and the prior art. The question, “is there inventive step?” only arises if there is novelty.
inventive step must be a technical step beyond what is already available in state fo the art-
- firstly, it must be result of a creative idea and a step ahead which must be noticeable. so a clearly identified difference between state of the art and the claimed invention.
-Secondly, it is required that this advance or progress be significant and essential to the invention.
it can be evaluated in 3 aspects:
1. the problem to be solved
2. the solution to the problem
3. the advatageous effects
Requirement for inventive step is either technical advancment or economic significance or both
4. NON OBVIOUSNESS?
there must be an element of non obviousness. even if it has comercial value or technical step, if a person of skill in the field on going through the specification can complete the product- non obviousness would be not be seen and thus patent cannot be granted.
graham v John Deere co Kansas city
obviousness can be determined by looking at:
1. scope and content of prior art
2. level of ordniary skill in prior art
3. differences between claimed inventiona nd prior art
4. objective evidence of non-obviousness such as solution of unsolved need, comercial success, failure of others.
disclosure of invention
4. Disclosure of the InventionAn additional requirement of patentability is whether or not the invention is sufficiently
disclosed in the application. - must be sufficiently clear, done in terms of examples, drawings etc
So that oppositions may be filed, the public must be informed of the content of the application, and this is done by the Patent Office by publication of a notice in an official journal or gazette to the effect that: - -
- the application is open to public inspection; and/or
- the Patent Office will, unless opposition is filed within a prescribed period, grant a patent;
or
- a patent has been granted on the application.
non- patentibility criteria
under section 3 of the patents act, non patentable things are:
1. frivolous inventions
2. invention contrary to public order or morality such as inventions assisting in crime such as a machine for counterfeiting currency or even genetic modification procedures for humans such as cloning of humans
- discovery of a scientific principle/thoery or living thing
4. mere discovery of new form of known subsance- if it doesnt enhance the efficacy of the substance s. 3(d)
5. substance obtained by mere admixture/aggregation
6. duplication of known devices functioning independently, 3(f)
7. method of agriculture and horticulture
8. surgical and medicinal treatment process for human and animals
9. Plants and Animals OTHER THEN MICROORGANISMS (cause if there is sufficient human interference and is not discovered from nature then microorg can be patented)
10. mathematical or business method
11. literary, dramatic musical artistic work etc- covered under copyright not patent
12. TRADITIONAL KNOWLEGDGE - s 3(p)
in F. Hoffmann-La Roche ltd vs Cipla Ltd
Court observed that under section 3(d), salts, esters, matabolites, mixtures of isomers and complexes and other derivates are to be considered as same substance. if there is no proven enhancement of efficacy - there will be no patent. the section 3(d) assumes that structurally similar derivatives of a “known substance” will also be functionally similar and thus not typically patentable, HOWEVER this DOES NOT bar subject matter from patentability.
if substance is found to be a new form of known substance with structural similarity and yet demonstrates a better functionality - ENHANCEMENT IN EFFICACY then under section 2(1)(j) it would qualify for assessment
Novartis AG v UOI
after india agreed to enter Wto and abide by TRIPS in 1998, it made changes to the standards and patent laws to align w trips- The most significant change was in patent protection for pharmaceuticals and agrochemicals, where India initially granted only process patents but not product patents once product patents were allowed- Novartis filed for patent for “Gleevec- a form of imatinib mesylate”
prior to when india didnt allow product patents- novartis had patented Imatinib with salts “vaguely specified” and could not patent in india
per TRIPS- novartis filed for Exclusive Marketing Rights for gleevec and priced it it at nearly 10x the price of generic verios.
under examination of patent in 2005- it was found that generic versions of gleevec were already being sold ind idnia and the patent was rejected using section 3(d)
Section 3(d) of the amended Act, specified that such inventions are patentable only if “they differ significantly in properties with regard to efficacy.” At one point, Novartis went to court to try to invalidate section 3(d); it argued that the provision was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal. it did appeal the patent offices decision to the Indian SC and was rejected again== on the basis that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib,
Had Novartis won and got its patent issued, it could not have prevented generics companies in India from continuing to sell generic Gleevec, but it could have obligated them to pay a reasonable royalty under a grandfather clause included in India’s patent law
Eli Lilly & Companys application
claim for novel manner of use of OLD chemical compounds for treatment of human disease was not patentable it was a process of purifying blood by dialysis
Dhanpath Seth v Nil Kamal Plastics
Kilta being a traditional product which has been used since time immemorial for carrying produce in hill areas of himachal pradesh, traditionally made of bamboo. the technical design of the kilta and the “device” developed by plaintiff and defendant was virtually the same.
a visual comparison of dhanpaths, nil kamals and traditional Kilta established prima facie that they were virtual copies of each other.
only real difference between plaint and def was that they used different types of plastics. further the only visible diffence was detachable straps with buckles.
this lead to the court concluding that the “device” developed was just a result of traditional knowledge and aggregation and duplication of known products and thus NOT an Invention
Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries (AIR 1982 SC 1444)
case revolved around patentability and the concept of “inventive step” under Indian patent law. the petioner was using an existing model of utensil manufacturing machine and HMI stated that biswanth was infringing on their patent which included a piece for holding and turning the utensils during the manufacturing process. the HMI patent was challenged:
3 questions:
- Was the patented invention truly novel and inventive, or was it just a minor improvement over existing designs?
- Did the patent meet the criteria of “inventive step” under Indian patent law?
- Could a mere mechanical improvement qualify for patent protection?
the court held that it was mere workshop improvememtn and there was no substantial advancememtn in technology
The Supreme Court of India revoked the patent, ruling that the invention was not new and had already been anticipated by earlier devices.
** The invention, according to the court, was a normal development of an existing manner of manufacture not involving something novel which would be outside the probable capacity of a craftsman .**
also discusses invention, revocation, rule of anticipation
APPLIED DOCTRINE OF ANTICIPATION
who can apply for patent
a person- defined as individual, company body of individuals, association incorporated or not and the govt as well
- true and first inventor - this does not include the first importer of an invention into india or a person to whom an outside invention is communicated to
- employer employee relationship
- if an invention was made by an employee during course of employment using the employers time and materials then its the employers invention.
- but if its made in absence of any positive contract, the employee may have initial rights to own invention per Worthington v Moore - asignee of the true and first inventor
- legal representative of the deceased
form of application
each application for a patent can be for one invention only under section 7
territorial jurisdiction of patent office basis:
1. place of residence of the applicant
2. place from where the invention originated
application ot name of teh true and first inventor
The application must include a provisional or complete specification (details of the invention).
read more on this from vk ahuja
right of patentee
The rights of patentees in India are governed by Section 48 of the Patents Act, 1970. These rights allow the patent holder to exclude others from using their invention without permission.
Rights of a Patentee:
1. Exclusive Right to Make, Use, and Sell – The patentee has the sole right to make, use, sell, or distribute the patented invention.
2. Right to License or Assign – The patentee can grant licenses or assign the patent to others in exchange for royalties or fees.
3. Right to Seek Remedies for Infringement – If someone uses the invention without permission, the patentee can take legal action to stop them and claim damages.
4. Right to Surrender – The patentee can voluntarily surrender the patent if they no longer wish to hold it.
These rights apply for 20 years from the date of filing, after which the patent expires and the invention enters the public domain.
Patent filing flow chart
FILING of patent
- Provisional specification- after 12 months of provisional specificatio, has to file complete specification - IF NOT- then patent application deemed to be abandoned
- once complete specification is filed- publication under section 11A
- then Pre-grant opposition under section 25 can be filed
4.request for examination / expedited examination and then examination is to be done to check for patentability,
5.FER- First Examination Report IS ISSUED - Application to be put in order by applicant within 6 months- (can be extended by 3 months)from issuance of FER
- Reexamination of amended document is done
- controller offers hearing to the applicant if objections are outstanding
9.** objections to be met within 6/9 months - then there will be GRANT OF PATENT !!!! WOHOOO**
Publication of application section 11A
no patent application shall ordinarily be open to the public for 18 months from date of filing or date of priority whichever is earlier.
the applicant can request for earlier publication to the controller and controller will publish ASAP
every application will be made public after 18 months UNLESS;
1. secrecy direction has been imposed
2. application has been abandoned
3. application has been withdrawn before the end of 15th month out of 18 month period
once it has been published, on and fromthe date of publication of application- the applicant will have rights and privileges like the patent has been granted however, they cannot institute any proceedings for infringement until patent is granted
request for examination
no application for patent will be examined unless applicant or any other interested party makes a request for such examination
- if no request for examinaton is made within 48 months then application is to be treaed as withdrawn.
- then there will be an investigation to search for anticipation- checking if these claims have been anticipated by publication before date of filing of application or in any other complete specification published
opposition to patent section 25
- Invention obtained wrongfully (burden on proff on opposition to show it has been obtained wrongfully but per Ivor Perretts application - if the complete specification of patent was communicated by opponent to applicant in a LETTER- then the applicant has to prove they they invented the subject independently
- Publication of invention before priority date
- prior claiming of invention in other specification which has earlier priority date
- invention publicly known and used in india (Per= Bristol Myers Co Appln- held that prior use which defeats patent need not be habitual, one single instance is enough)
- obviousness of invention and lack of inventive step= dhanpath seth case
- invention not sufficiently or clearly described
- failure to disclose information regarding foreign application
- invention based on local indeginous community
- specification doesnt disclose geographical source of bioogical material
public display section 31
and anticipation
invention not deemed to be anticipated if:
1. the display of the invention was with consent of true and first inventor or person deriving title form him at an industrialor other exhibition for the purpose of exhibiting
2. any publication regariding invention as a consequence of the said exhibition
3. the use of invention by a person without the consent of inventor AFTER display at the said exhibition
4. description of the invention in a paper read by or published with the inventors consent in transaction of such society
the application of the patent must be made but the true and first inventor within 12 months of such exhibition
further under section 29 - aticipation by previous publication - if the publication was made by obtaining information from the applicant or anyone whom derives title WITHOUT their permission then it will not be considered anticipation by publication
Section32 Anticipation by public working.—An invention claimed in a complete specification shall not be deemed to have been anticipated by reason only that at any time within one year before the priority date of the relevant claim of the specification, the
invention was publicly worked in India—
(a) by the patentee or applicant for the patent or any person from whom he derives title; or
(b) by any other person with the consent of the patentee or applicant
33. Anticipation by use and publication after provisional Specification- controller cannot deny patent + applies to convention patents as well
section 47 - grant of patent subject to certain condition
Section 47 – Conditions on Grant of Patents (Indian Patent Act) in Simple Words
When a patent is granted under the Indian Patent Act, it comes with certain conditions that limit the patent holder’s exclusive rights. These conditions allow the government and others to use the patented invention in specific cases without the patent holder’s permission.
Key Conditions Under Section 47:
1️⃣ Government Use of Patented Products (Sub-section 1 & 2)
- The Government can ithe patentable subject matter for its own use.
- If the patent is for a process, the Government can use it for its own purposes.
- Example: If a company holds a patent for a new water filtration device, the Government can produce or import it for its own use.
2️⃣ Use of Patents for Research & Education (Sub-section 3)
- Anyone can use a patented invention for experiments, research, or teaching without needing permission.
- Example: A university can study, test, or demonstrate a patented chemical process for students without infringing the patent.
3️⃣ Government Use of Patented Medicines (Sub-section 4)
- If a patent relates to a medicine or drug, the Government can import it for its own use.
- The Government can also distribute the drug to public hospitals, dispensaries, or other medical institutions providing public healthcare.
- Example: If a patented life-saving drug is too expensive, the Government can import and distribute it in government hospitals for public benefit.
Why is Section 47 Important?
✅ Balances patent rights with public interest.
✅ Ensures the Government can use patents for public services.
✅ Supports education and scientific research without legal barriers.
✅ Allows the Government to distribute essential medicines affordably.
Conclusion:
Section 47 limits absolute patent rights to ensure public welfare, research, and government use are not restricted by patent monopolies.
section 48
(a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering
for sale, selling or importing for those purposes that product in India;
(b) where the subject matter of the patent is a process, the exclusive right to prevenhird parties, who do not have his consent, from the act of using that process, and
from the act of using, offering for sale, selling or importing for those purposes the
product obtained directly by that process in India
section 84
- Compulsory licences.—(1) At any time after the expiration of three years from the date of
the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely=
(a) that the reasonable requirements of the public with respect to the patented
invention have not been satisfied,or
(b) that the patented invention is not available to the public at a reasonably affordable price, or
(c) that the patented invention is not worked in the territory of India
Who Grants the Compulsory License?
The Controller of Patents decides whether to grant a CL based on public interest.
The patent holder still gets royalties (fair compensation).
Why is Section 84 Important?
✅ Ensures essential products (like medicines) remain accessible.
✅ Prevents patent monopolies from restricting public access.
✅ Encourages local manufacturing instead of only imports
section 83
general principles applicable to working of patents=
1. patents are granted so that inventions are worked in indi ato the fullest extent of commercial scale
2. it is not granted merely to enable patentees to enjoy a monopoly
3. patents granted should act as instrument for promoting public interest
4. patent granted does not in any way prohibit central govt from taking measures to protect public health
5.
Bayer Corporation Vs. Union of India and Others
(Bayer v. Natco)
indias first compulsory licensing case
- “Sorafenib”, an active pharmaceutical compound used for the treatment of liver and kidney cancer was patented by Bayer Corporation an Sold under the brand name Nexavar.
- indian generic manufacturer CIPLA started producing and marketing generic version of the drug under name “‘Sorafenib Tablets 200mg” without license and Bayer filed for infringement
- Bayer charged = 280k rupees/per month approx
- CIPLA charged= 27K rupees/ Per month for same amt of tablets
- Dehi HC refused to grant injunction against CIPLA but asked them to maintain account fo sales from the infringing product
- During the ongoing dispute between CIPLA and Bayer, another generic manufacturer,
Natco Pharma Limited, filed a request for compulsory license against Bayer’s patent
as the 3 year expiration date on grant of patent had passed and per section 84, the other requirements were fulfilled, the controller granted compulsory license to NATCO with 6% royalty to Bayer - Bayer Appealed
- the appelate body stated that three things could not be overlooked:
- The grant of patents shall not impede protection of public health;
- The grant of patents must balance the patentees’ rights and obligations;
- patentee must make the benefits of a patented invention available at a reasonably affordable price to the public
and since bayer was not fulfilling these requirements, the compulsory licence shall be granted.
Bayer contended:
1. that the provisions under section 84 were not fulfilled as it requires the applicant for a compulsory license to first seek out a voluntary license from the patentee and bayer contended NATCO had failed to do so.
= to this it was found that bayer had rejected the offer made by NATCO initially and the board stated that there was no need for NATCO to make another effort as the law does not require subsequent efforts
- further, BAYER stated that the sale by CIPLA + bayer itself meets the publics requirement under section 84 and thus there is no need for compulsory requirement
= to this the board held that section 84 discusses that the invention that must be made available to the public by the patentee, the IPAB stated that public demand must be met by the patent holder or its licensee, not by an infringer.
so the court held in favour of granting the license on few main points:
1. Reasonable Requirements of the Public = if the price is not reasonably affordable the reasonable requirement is not satisfied
that the public could neither access nor afford the drug
2. it found a need to balance the publics right to affordable healthcare vs the private right of a patent holder who had not made efforts to make the product accessible.
3. Patent Working Requirement
Bayer was only importing the drug, not manufacturing it in India.
The IPAB held that merely importing a drug is not sufficient unless it is done on a commercial scale and at an affordable price.
further, CIPLA’s sale showed the demand of the public and the possibility of manufacturing the product at a cheaper price.
the court decided to incerease royalty from 6% to 7%
what was the adequate extent test in bayer v uoi
under section 84= we have to check if the reasonable requirement of the public was satisfied. we must see if the demand of the patented article has been met to an adequate extent. here as it is a medicine and lifesaving drug, the “adequate extent” has to be 100%. it is not a luxury item, it is a necessity.
medicine has to be made available to every patient and thsi cannot be sacrificed at the altar of rights of patent holder.
conditions and terms compulsory licencing- section 90
- royalty or remuneration must be reserved for patentee or their beneficiary
- the patent has to be worked to the fullest extent by the person with the comp. license
- patented article is to be made affordable to the general public
- license is non-exclusive
- license is non transferrable
- license is for balance of patent term unless a shorter term is in line with public interest
- ## predominent purpose has to be for supply to indian public. but it can export if need be
Types of Infringement in patent
- deliberate infringement= by a third party without any attempt to avoid
the infringement. This will either be straight copying of the invention or else involve minor
variations or modifications thereof - where the infringement is deliberate, but some attempt has been made to avoid the appearance of infringement.
indirect infrigment -
Involves a third party encouraging or inducing someone else to infringe a patent. - CONTRIBUTORY INFRINGEMENT: A type of indirect infringement where a party supplies a component or part that has no substantial use except in an infringing product or process.
This is narrower than indirect infringement and applies when the supplied part is specifically designed for infringement.
section 104-106 infringement
Section 104 – Jurisdiction for Patent Infringement Suits= A patent infringement lawsuit can only be filed in a District Court or High Court with jurisdiction over the defendant’s location or where infringement occurred.
Section 105 – Defense of “Innocent Infringement
roves they were unaware of the patent at the time of infringement, the court may limit or reduce damages.
However, ignorance is not a full defense and must stop using patent once notified
Section 106 – Groundless Threats of Infringement Suits
alsely accused of patent infringement through unjustified legal threats, they can sue the accuser for relief.
The court can issue an injunction (to stop threats) and award damages.
this does not apply if the threat is based on a legitimate lawsuit.
Doctrine of Exhaustion in Patents
The patent holder only controls the first sale.
After the first sale, the buyer can freely use, resell, or distribute the product without needing further permission from the patent owner.
However, this does not allow the buyer to replicate or manufacture the patented product.
Samsung Electronics Co. Ltd. v. Kapil Wadhwa & Others (2012, Delhi High Court)
Samsung alleged that parallel imports (genuine Samsung printers imported and sold without Samsung India’s authorization) violated its patent rights.
The defendants argued that once Samsung sold the printers, it exhausted its rights, allowing resale under the doctrine of international exhaustion.
🔹 Ruling:
The Delhi High Court upheld the doctrine of exhaustion but clarified that India follows the doctrine of National Exhaustion, meaning patent rights are only exhausted for products first sold within India (not abroad).
Impact:
Parallel imports remain restricted in India unless explicitly permitted.
Reinforced that patent rights end after the first sale in the domestic market.
Doctrine of Equivalence
Doctrine of Equivalence in Patents
The Doctrine of Equivalence allows a patent holder to claim infringement even if the accused product or process does not literally copy the patented invention but performs the same function in a substantially similar way.
🔹 Key Principle:
Even if an infringing product does not exactly match the patent claims, it can still be considered infringing if:
1. It performs the same function.
2. It operates in the same way.
3. It produces the same result.
🔹 Purpose:
Prevents infringers from making small, insubstantial modifications to evade patent claims.
F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. (Delhi High Court, 2015)
Roche held a patent for Erlotinib Hydrochloride, an anti-cancer drug.
Cipla manufactured a similar drug (Erlocip) but argued that it had a slightly different molecular structure and was therefore not infringing.
🔹 Ruling:
The Delhi High Court applied the Doctrine of Equivalence and ruled in favor of Roche, holding that Cipla’s drug was structurally and functionally similar to Roche’s patented drug.
🔹 Impact:
Strengthened patent protection in India against minor modifications.
**Reinforced that substantial similarity in function, operation, and result is enough for infringement.
**
- Revocation of patents by the Controller for non-working- section 85
If a compulsory license has been granted, the Central Government or any interested person can apply for revocation of the patent after two years if:
* The patented invention is still not worked in India.
* The public’s reasonable requirements are not met.
* The patented invention is not available at an affordable price.
If the Controller finds any of these grounds valid, the patent may be revoked.
The application for revocation must be decided within one year.
section 86
Section 86 – Adjournment of Compulsory License Applications
If the Controller believes that not enough time has passed for the patent to be worked commercially in India, they can delay hearing the compulsory license application for up to 12 months.
However, this is allowed only if the patentee proves they are making genuine efforts to start working the invention in India.
If external reasons (like government restrictions) prevented working of the patent, the adjournment period starts after those restrictions end.
Section 87 – Procedure for Compulsory License Applications
if a prima facie case for a compulsory license is established under Sections 84 or 85, the Controller must:
* Notify the patentee and interested parties.
* Publish the application in the official journal.
* Allow the patentee or any opposing party to file objections and present their case.
section 88-
4️⃣ Section 88 – Powers of the Controller in Granting Compulsory Licenses
If a patent holder imposes unfair conditions on licenses, the Controller can force the patentee to grant compulsory licenses to applicants and their customers.
If a licensee applies for a compulsory license, the Controller can:
* Cancel the existing license and grant a new one.
* Modify the existing license instead of granting a new one.
* If a company needs multiple patents owned by the same patentee to work an invention, the Controller can force the grant of licenses for additional patents if they are technically and economically linked.
If a licensee works the invention for at least 12 months and proves that the license terms are too burdensome, they can apply for a revision of terms—but only once.
sec 92
Summary of Sections 92 & 92A of the Indian Patent Act
These sections deal with compulsory licensing in cases of national emergency, public health needs, and for exporting medicines to countries lacking manufacturing capacity.
1️⃣ Section 92 – Compulsory License in Case of National Emergency & Public Interest
- The Central Government can declare a national emergency, extreme urgency, or public non-commercial use for certain patented products or processes.
- Once such a declaration is made, the Controller of Patents can grant compulsory licenses to any applicant without following the normal procedure under Section 84.
- Situations where this applies:
1. National emergency (e.g., a pandemic).
2. Extreme urgency (e.g., rapid outbreak of diseases needing immediate drug access).
3. Public non-commercial use (e.g., government schemes distributing medicines at subsidized rates).
- The license terms (like royalty) are decided by the Controller.
🔹 Example: During the COVID-19 pandemic, the government could have used Section 92 to issue compulsory licenses for vaccines or treatments if they were not made available affordably.
section 92A
2️⃣ Section 92A – Compulsory License for Exporting Medicines to Countries with No Manufacturing Capacity
- This section allows Indian companies to manufacture and export patented pharmaceutical products to countries that lack manufacturing capabilities to produce those medicines themselves.
- The importing country must:
1. Issue a compulsory license or confirm the need for importing.
2. Notify the WTO (if a TRIPS member) about the requirement.
- The compulsory license is only for export purposes and cannot be used for sale within India.
🔹 Example: If an African country suffering from a rare disease does not have the facilities to produce a patented drug, an Indian pharma company can get a compulsory license under Section 92A and export the drug to that country.
Conclusion
✅ Section 92 ensures that patents do not block access to essential goods in emergencies.
✅ Section 92A helps developing countries access life-saving drugs through Indian manufacturers.
✅ Both sections balance patent rights with public health needs while complying with international agreements like TRIPS. 🚀
1️⃣ TRIPS Minimum Guidelines on Patents
TRIPS requires all WTO members to provide:
✅ Patent protection for inventions (including pharmaceuticals) for at least 20 years from the filing date (Article 33).
✅ Patents must be available for all fields of technology without discrimination (Article 27).
✅ Patent rights must include the right to prevent others from making, using, selling, or importing the patented product (Article 28).
✅ Compulsory licensing is allowed in certain situations, but must meet TRIPS conditions (Article 31).
2️⃣ TRIPS Transitional Period for Developing Countries
TRIPS recognized that developing and least-developed countries needed time to adjust their IP laws. It granted:
🔹 Developed countries – No transition period; full TRIPS compliance from 1995.
🔹 Developing countries (like India) – 5+4+1 years
🔹 Least-developed countries (LDCs) – Initially given until 2006, but later extended several times (current extension until 2034 for pharmaceutical patents).
🔹 India’s Approach:
India delayed granting product patents on pharmaceuticals until 2005 under the transitional period (Article 65).
From 1995-2005, India followed a “mailbox system”, where pharma patent applications were filed but not examined until 2005.
3️⃣ TRIPS Flexibilities for Developing Countries
TRIPS allows countries to prioritize public health over strict patent enforcement. Flexibilities include:
✅ Compulsory Licensing (Article 31) – Governments can allow production of patented drugs without consent in cases of public health emergencies (e.g., India’s Natco-Bayer compulsory license for the cancer drug Nexavar in 2012).
✅ Parallel Importing (Article 6) – Countries can import cheaper patented drugs from other nations where they are sold at lower prices.
✅ Patentable Subject Matter Restrictions (Article 27) – Countries can define what is patentable, allowing India to introduce Section 3(d) of the Indian Patent Act, which prevents evergreening of pharma patents.
✅ Bolar Provision (Article 30) – Allows generic manufacturers to start testing patented drugs before expiry, so they can launch immediately after patent expiry (from Roche v Bolar case)
Doha Declaration (2001) – TRIPS & Public Health
4️⃣ Doha Declaration (2001) – TRIPS & Public Health
The Doha Declaration on TRIPS and Public Health clarified that:
✅ TRIPS should not block countries from protecting public health.
✅ Countries can freely use TRIPS flexibilities (like compulsory licensing) to access affordable medicines.
Article 31- countries to issue “compulsory licenses” under specific circumstances, essentially permitting them to produce a patented product without the patent holder’s consent, particularly in situations of national emergencies or to address public health concerns, while still requiring adequate remuneration to the patent holder;
allows parallel importing
🔹 Impact on India:
The Doha Declaration justified India’s strict patent laws, including compulsory licensing and Section 3(d).
India remains a global supplier of affordable generic medicines under these flexibilities.
Roche Products, Inc. v. Bolar Pharmaceutical
The Roche v. Bolar case is a significant U.S. patent law decision, but it is not related to parallel importing. Instead, it deals with the Bolar Exemption (Research Exemption), which allows generic manufacturers to conduct pre-market research on patented drugs before the patent expires.
Bolar argued: It needed to conduct clinical trials before the patent expired so that its generic version could be marketed immediately after expiration, benefiting the public
RULED Favor of Roche: The Court ruled against Bolar, stating that even experimental use for FDA approval was patent infringement unless explicitly allowed by law.
andmark Development – Creation of the Bolar Exemption
🚀 The U.S. Congress responded by passing the Hatch-Waxman Act (1984), which introduced the Bolar Exemption (35 U.S.C. § 271(e)(1)):
✅ Now, generic manufacturers can use patented drugs for FDA testing before the patent expires.
