module 1-6 Flashcards

Question

section 84

Answer 1

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

Answer 2

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.

Answer 3

1. **"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**. 2. 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** 3. Bayer charged = 280k rupees/per month approx 4. CIPLA charged= 27K rupees/ Per month for same amt of tablets 5. *Dehi HC refused to grant injunction against CIPLA but asked them to maintain account fo sales from the infringing product* 6. 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** 7. Bayer Appealed 8. the appelate body stated that three things could not be overlooked: 1. The grant of patents shall not impede protection of public health; 2. The grant of patents must balance the patentees’ rights and obligations; 3. **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 2. 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%**

Answer 4

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.

Answer 5

- 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 -

Answer 6

1. 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 2. 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.** 5. 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.

Answer 7

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.

Answer 8

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.**

Answer 9

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.**

Answer 10

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.

Answer 11

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. **

Answer 12

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.

Answer 13

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.*

Answer 14

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.

Answer 15

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**.

Answer 16

**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.

Answer 17

--- **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**. 🚀

Answer 18

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).

Answer 19

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.

Answer 20

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)

Answer 21

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.

Answer 22

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.