PLANT VARITIES AND FARMERS’ RIGHTS

PLANT GENETIC RESOURCES (PGRs) are the foundation for the development of a food and nutritionally secure society. In addition, plants have many uses, including feed, fibre, medicine and industrial applications. PGRs were treated as the ‘heritage of mankind’ and were shared freely among nations, till the concerns for conservation of biological diversity were raised by the Convention on Biological Diversity (CBD), which came into force in 1993.

The conservation and sustainable utilization and access to biological diversity were considered as national sovereignty by CBD. Consequently, many issues regarding the rights of the conservers, users, breeders, farmers and intellectual property have emerged. 

During 2001, significant developments have taken place with respect to the realization of the rights of breeders, farmers and local communities. The Indian Government passed the Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPVFR). It was an outcome of India’s obligations which arose from the TRIPs (Trade Related Intellectual Property Rights) agreement which obligates members to protect plant varieties either by patents or by effective sui generis (unique) system or by any combination thereof. 

Objectives

The objectives of the Act are as follows: 

1.     To provide for the establishment of an effective system for protection of plant varieties. 

2.     To provide for the rights of farmers and plant breeders. 

3.     To stimulate investment for research and development and to facilitate growth of the seed industry. 

4.     To ensure availability of high quality seeds and planting materials of improved varieties to farmers.

Definitions

·      Variety 

According to section 2(za) of the Act, ‘variety’ means a plant grouping except microorganisms within a single botanical taxon of the lowest known rank, which can be: 

i)     Defined by the expression of the characteristics resulting from a given genotype of a plant of that plant grouping; 

ii)    Distinguished from any other plant grouping by expression of at least one of the said characteristics; and 

iii)  Considered as a unit with regard to its suitability for being propagated, which remains unchanged after such propagation and includes propagating material of such variety, extant variety, transgenic variety, farmers’ variety and essentially derived variety. 

·      Extant variety 

According to section 2(r) of the Act,  ‘extant variety’ means a variety available in India which is:

i)     Notified under section 5 of Seeds Act, 1966, or 

ii)    Farmers’ variety, or 

iii)  A variety about which there is common knowledge, or 

iv)  Any other variety which is in public domain. 

(Section 5 of Seeds Act, 1966 - If the Central Government, after consultation with the Committee, is of opinion that it is necessary or expedient to regulate the quality of seed of any kind or variety to be sold for purposes of agriculture, it may, by notification in the Official Gazette, declare such kind or variety to be a notified kind or variety for the purposes of this Act and different kinds or varieties may be notified for different States or for different areas thereof.)

·      Essentially derived variety 

According to section 2(i) of the Act, ‘essentially derived variety’ in respect of a variety (the initial variety) shall be said to be essentially derived when it: 

i)     Is predominantly derived from such initial variety, or from a variety that itself is predominantly derived from such initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of such initial variety; 

ii)    Is clearly distinguishable from such initial variety, and 

iii)  Conforms (excepting for the differences which result from the act of derivation) to such initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of such initial variety

·      Farmer 

According to section 2(k) of the Act, ‘farmer’ means any person who:

i)     Cultivates crops by cultivating the land himself, or 

ii)    Cultivates crops by directly supervising the cultivation of land through any other person, or 

iii)  Conserves and preserves, severally or jointly, with any person any wild species or traditional varieties, or adds value to such wild species or traditional varieties through selection and identification of their useful properties. 

·      Farmers’ variety 

According to section 2(l) of the Act, ‘farmers’ variety’ means a variety which:

i)     Has been traditionally cultivated and evolved by the farmers in their fields, or 

ii)    Is a wild relative or land race of a variety about which the farmers possess common knowledge.

·      Authority

The Central Government shall establish an Authority to be known as the Protection of Plant Varieties and Farmers’ Rights Authority. It shall consist of a chairperson and fifteen members as representatives of different concerned ministries and departments, seed industry, farmers organizations, tribal communities and State-level women’s organization, etc.

Criteria for Registration of a Variety:

Novel: if at the date of filing an application for registration for protection, the propagating or harvested material of such variety has not been sold or otherwise disposed of in India earlier than one year or outside India, in the case of trees or vines earlier than six years, or in any other case earlier than four years, before the date of filing such application.

Distinct: A variety is said to be distinct if it is clearly distinguishable by at least one essential characteristic from any other variety whose existence is a matter of common knowledge in any country at the time of filing an application.

Uniform: A variety is said to be uniform, if subject to the variation that may be expected from the particular features of its propagation it is sufficiently uniform in its essential characteristics.

Stable: A variety is said to be stable if its essential characteristics remain unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end of each such cycle.

Persons who can apply for the  Registration of Plant Variety

Application for registration of a variety can be made by:

1. Any person claiming to be the breeder of the variety;
2. Any successor of the breeder of the variety;
3. Any person being the assignee or the breeder of the variety in respect of the right to make such application;
4. Any farmer or group of farmers or community of farmers claiming to be breeder of the variety;
5. Any person authorized to make application on behalf of farmers and
6. Any University or publicly funded agricultural institution claiming to be breeder of the variety.

Filing Requirements For The Registration Of A Plant Variety

• Name, address and Nationality of Applicants as well as the address of service of their agent.
• Denomination assigned to such variety.
• Accompanied by an affidavit that variety does not contain any gene or gene sequences involving terminator technology.
• Complete passport data of parental lines with its geographical location in India And all such information relating to the contribution if any, of any farmer (s), village, community, institution or organization etc in breeding, evolving or developing the variety.
• Characteristics of variety with description for Novelty, Distinctiveness, Uniformity and Stability.
• A declaration that the genetic material used for breeding of such variety has been lawfully acquired. 

Certificate of Registration

The maximum time taken for issuing certificate of registration is three years from the date of filing of the application for registration of a plant variety.

Duration of Registration

·       For trees and vines (Perennials)- 18 years from the date of registration of the variety.

·       For other crops (Annuals) – 15 years from the date of registration of the variety.

·       For extant varieties – 15 years from the date of notification of that variety by the Central Government under section 5 of the Seeds Act, 1966.

Payment of annual fee

The Authority may, with the prior approval of the Central Government, by notification in the Official Gazette, impose a fee to be paid annually, by every breeder of a variety, agent and licensee thereof registered under this Act determined on the basis of benefit or royalty gained by such breeder, agent or licensee, as the case may be, in respect of the variety, for the retention of their registration under this Act

Breeders’ rights

Section 28 confers exclusive right on the breeder of a registered variety or his successor, his agent or licensee to produce, sell, market, distribute, import or export the variety.  The rights are subject to other provisions of the Act.

A breeder may authorise any person to produce, sell, market or otherwise deal with the registered variety subject to such limitations and conditions as may be specified in the regulations. Such authorisation is to be in such form as may be specified by the regulations made by the authority.

The agent or licensee shall apply to the registrar to register his title.

In the case of extant variety, unless a breeder or his successor establishes his right, the Central Government, and in cases where such extant variety is notified for a state under section 5 of the Seeds Act, 1966, the State Government is deemed to be the owner of such right.

Researchers’ right

Section 30 of the Act, allows the following uses:

a)    The use of any variety registered under this Act by any person using such variety for conducting experiments or research; and 

b)   The use of a variety by any person as an initial source of a variety for the purpose of creating other varieties.

However, the authorization of the breeder of a registered variety is required where the repeated use of such variety as a parental line is necessary for commercial production of such other newly developed variety’. 

Farmers’ rights

Section 39 provides that -
i)     A farmer who has bred or developed a new variety shall be entitled for registration and other protection in like manner as a breeder of a variety;
ii)    The farmers’ variety shall be entitled for registration if the application contains declarations as specified in clause (h) of sub-section (1) of section 18; 
iii)  A farmer who is engaged in the conservation of genetic resources of land races and wild relatives of economic plants and their improvement through selection and preservation shall be entitled in the prescribed manner for recognition and reward from the Gene Fund subject to the condition that material so selected and preserved has been used as donors of genes in varieties registrable under this Act; 
iv)  A farmer shall be deemed to be entitled to save, use, sow resow, exchange, share or sell his farm produce including seed of a variety protected However, the farmer shall not be entitled to sell branded seed of a variety protected under this Act. 

(For the purpose of clause (iv), “branded seed” means any seed put in a package or any other container and labeled in a manner indicating that such seed is of a variety protected under this Act.)

Where any propagating material of a variety registered under this Act has been sold to a farmer or a group of farmers or any organisation of farmers, the breeder of such variety shall disclose to the farmer or the group of farmers or the organisation of farmers, as the case may be, the expected performance under given conditions. If such propagating material fails to provide such performance under such given conditions, the farmer or the group of farmers or the organisation of farmers, the case may be, may claim compensation in the prescribed manner before the Authority. The Authority, after giving notice to the breeder of the variety and after providing him an opportunity to file opposition in the prescribed manner and after hearing the parties, may direct the breeder of the variety to pay such compensation as it deems fit, to the farmer or the group of farmers or the organisation of farmers, as the case may be.

Exemptions provided by the Act

·       Farmers' Exemption: 

Farmer shall be entitled to produce, save, use, sow, resow, exchange, share or sell his farm produce including seed of a variety protected under this Act.

·       Researcher's Exemption: 

i)     The use of registered variety for conducting experiment. 

ii)    The use of variety as an initial source of variety for the purpose of creating other varieties.

National Gene Fund

The Central Government is to constitute ‘The National Gene Fund’ under section 45 of the Act.  Following amounts are to be credited to the Fund:
i)     The benefit sharing from the breeder. 
ii)    The annual fee payable to the authority by way of royalties. 
iii)  By the compensation provided to the communities as defined under Section 41(1). 
iv)  Contribution from any national and international organization and other sources. 

The fund will be applied for disbursing shares to benefit claimers, either individuals or organization, and for compensation to village communities. The fund will also be used for supporting conservation and sustainable use of genetic resources, including in situ (in the original place or in the appropriate position) and ex situ (outside an ecological niche) collection and for strengthening the capabilities of the panchayat in carrying out such conservation and sustainable use.

Compulsory License

Under Section 47 of the Act, the authority can grant compulsory license, in case of any complaints about the availability of the seeds of any registered variety to public at a reasonable price. The license can be granted to any person interested to take up such activities after the expiry of a period of three years from the date of issue of certificate of registration to undertake production, distribution and sale of the seed or other propagating material of the variety. The Authority is to determine the duration of the compulsory license.

As on March 8^th 2018, 147 Crop species are open for registration under New/Extant/Farmers Variety.

SEMICONDUCTOR INTEGRATED CIRCUITS LAYOUT-DESIGN

"Semiconductor Integrated circuits Layout- Design Act 2000" is a supplement act to designs.

With the growing technological development in the field of information technology, a new branch in the field of intellectual property flourished, called as the Layout-Design and the semiconductor integrated circuits.

The semiconductor integrated circuit is an integral part of every computer chip. The fifth generation computers were using Very Large Scale Integration (VLSI) where numerous transistors are accommodated on a single chip, cutting down the size of the chip and at the same time increasing it’s processing power significantly. This ultimately translates into smaller and more powerful computers. Hence, the development of the layout-design on a semiconductor integrated circuit as an intellectual property is quite significant.

Therefore, a step was taken by various organizations to pass regulations regarding this issue. One such was the World Trade Organization, and the result was the TRIPS agreement addressing the intellectual property related issues. India being a signatory of the WTO also passed an Act in conformity with the TRIPS agreement called the Semiconductor Integrated Circuits Layout-Design Act (SICLDA) passed in the year 2000.

Definitions

·      "Semiconductor integrated circuit"

According to section 2 (r) of the Act, ‘Semiconductor integrated circuit’ means a product having transistors or other circuitry elements, which are inseparably formed on a semiconductor material or an insulating material or inside the semiconductor material and designed to perform an electronic circuitry function.

·      "Layout-design" 

According to section 2 (h) of the Act, ‘Layout-design’ means a layout of transistors, and other circuitry elements and includes lead wires connecting such elements and expressed in any manner in a semiconductor integrated circuit. Section 2 (n) of the Act defines ‘registered layout-design’ to mean a layout-design which is actually on the register.

·      "Commercial exploitation" 

According to section 2 (e) of the Act, ‘commercial exploitation’ in relation to the SICLD means to sell, lease, offer or exhibit for sale or otherwise distribute such semiconductor integrated circuit for any commercial purpose.

·      “Registered Proprietor”

According to section 2(o) of the Act, ‘registered proprietor’ in relation to a layout-design, means the person for the time being entered in the register as proprietor of the layout-design.

·      “Registered User”

According to section 2(p) of the Act, ‘registered user’ in relation to a layout-design means a person who is for the time being registered as such under section 25.

(According to section 25, a person may be registered as a registered user of the layout design when the registered proprietor and the proposed registered user apply jointly in writing to the Registrar. The application shall accompany the agreement in writing or its authenticated copy, entered between the registered proprietor and registered user. The registered proprietor also has to submit an affidavit to the satisfaction of the Registrar.)

Need for Protection of IC designs:

Product life cycles in many industries are shortening. The length of time and amount of investment required, to obtain intellectual property rights, especially patents, can be disproportionate to the life of such product. Requirements such as the need to mark products with "patent pending" also become impracticable when products have short life cycles and use many different technologies subject to different patents, especially when these products are miniaturized.

Protection under Patent or other IP Laws:

·      Integrated circuits comprises of numerous building blocks, each block being patentable. Since an integrated circuit contains hundreds or thousands of semiconductor devices, a claim to an integrated circuit would have to cover hundreds or thousands of individual elements. Consequently, a patent claim that attempts to describe an entire integrated circuit may be hundreds of pages long. Clearly, such a narrow claim would provide almost no protection. 

·      Even if one sought such narrow protection, writing a patent application supporting a claim with thousands of elements would be extremely complex, cumbersome, and expensive. Obviously, integrated circuits are not easily describable in a patent specification or the claims. 

·      Also, it may take several years to obtain an integrated circuit patent from most patent offices worldwide. This is unacceptable given that an integrated circuit’s useful commercial life may be less than one year. The cumbersome, time-consuming nature of filing combined with extremely narrow protection often makes patent law an insufficient form of protection for integrated circuits.

·      Other forms of existing intellectual property protection are also inapplicable to integrated circuit layouts. Design patents protect the ornamental, but not the functional, aspects of an article of manufacture described in its drawings. Since integrated circuit layout is more functional than ornamental, design patent protection is generally inapplicable to integrated circuits.

·      Finally, trade secret law cannot be used to protect most integrated circuits because an integrated circuit layout may be reverse-engineered.

·      The layout of transistors on the semiconductor integrated circuit or topography of transistors on the integrated circuit determines the size of the integrated circuit as well as its processing power. That is why the layout design of transistors constitutes such an important and unique form of intellectual property fundamentally different from other forms of intellectual property like copyrights, trademarks, patents and industrial designs.

·      Given that patent, copyright, and trade secret law cannot adequately protect integrated circuit design, hence an exclusive protection for semiconductor integrated circuits layout-design has became necessary to the semiconductor industry.

History and Genesis of protection:

Ever since the early 1970s, chip pirates have quickly produced copies of semiconductor chips at vastly reduced prices by copying chip designs and avoiding the expensive research and development phase. This problem was particularly prevalent in the US where, until 1984, there was virtually no intellectual property protection for the IC layout, which cost millions of dollars to design and develop. As a result, the manufacturers of ICs sought some sui generis (Unique) form of intellectual property protection for this backbone of modern technology.

Need For Sui Generis Protection:

The need for a sui generis form of protection developed primarily as a result of chip piracy, which threatened to undercut the vitality of the semiconductor industry. Chip pirates could sell identical chips for lower prices than could the companies that originally designed them. This caused legitimate companies that engaged in chip research and development to cut prices to compete with pirated chips, which deprived legitimate companies of the funds needed to carry out further research and development to build the next generation of chips. Legitimate companies could not get adequate chip protection under patent, copyright, or trade secret law, so a sui generis form of protection was provided.

What is protected?

A layout design expressed in any manner, which is original, which has not been commercially exploited for more than 2 years from the date of application for the registration, which is inherently distinctive and capable of being distinguishable from any other registered layout design, is protected or registered under the Act.

Who can apply?

·      The application for the protection of layout design can be made by the person who claims to be the creator of the layout design, his legal representative, a person registered in the prescribed manner as a layout design agent or a person in the sole and regular employment of the principal, in writing to the registrar in the prescribed manner.

·      The application can be filed either alone or jointly. The application has to be filed within the territorial limits that is a principal place of business in India of the applicant.

Procedure for registration

·      Filing of application in writing to the registrar in the office of SICLD registry in a prescribed form along with 3 sets of drawings produced to the plotter which describes the layout design and 3 sets of photograph of masks used for the fabrication of the semiconductor integrated circuits by using of the layout design or drawings which describes the pattern of such masks.

·      Acceptance of the application with acknowledgement by way of returning one copy of the application. The registrar can also withdraw the acceptance if the application is found to be prohibited for registration.*

·      The application is advertised in a prescribed manner within 14 days of acceptance of layout design application. If any opposition is found to the registration, then a notice is sent to the registrar in the prescribed manner within 3 months from the date of advertisement. The registrar can call for evidences to be produced by both the parties and finally give his decision.

·      If the application is not opposed or the opposition has been decided in favor of the applicant, the registrar shall register the said layout design in the register of layout design and also issue a certificate sealed with the seal of the SICLD Registry.

*Grounds for Prohibition of Registration

Section 7 of the Act lays down grounds for prohibition of layout-design. It provides that a layout-design shall not be registered -

a.     Which is not original; or 

b.     Which has been commercially exploited anywhere in India or in a convention country; or 

c.      Which is not inherently distinctive; or 

d.     Which is not inherently capable of being distinguishable from any other registered layout-design, 

Provided that a layout-design which has been commercially exploited for not more than two years from the date on which an application for its registration has been filed either in India or in a convention country shall be treated as not having been commercially exploited for the purposes of this sub-section. 

Original Layout-Design

According to Section 7(2), a layout-design shall be considered to be original if it is the result of its creator's own intellectual efforts and is not commonly known to the creators of layout-designs and manufacturers of semiconductor integrated circuits at the time of its creation. Hoever, a layout-design consisting of such combination of elements and interconnections that are commonly known among creators of layout-designs and manufacturers of semiconductor integrated circuits shall be considered as original if such combination taken as a whole is the result of its creator's own intellectual efforts. 

According to section 7 (3), where an original layout-design has been created in execution of a commission or a contract of employment, the right of registration to such layout-design under this Act shall belong, in the absence of any contractual provision to the contrary, to the person who commissioned the work or to the employer.

Duration of Registration

The registration of the layout design shall be only for the period of 10 years counted from the date of filing an application for registration or from the date of first commercial exploitation anywhere in any country, whichever is earlier.

Exclusive Right to the Registered Proprietor

The registration of the layout design gives to the registered proprietor of the layout design the exclusive right to the use of the layout design and to obtain relief in respect of infringement. This right shall be available to the registered proprietor of that layout design irrespective of the fact as to whether the layout design is incorporated in an article or not.

Assignment and Transmission

A person who becomes entitled by assignment (in writing) or transmission (operation of law) to a registered layout design shall apply to the Registrar in the prescribed manner to register his title. The Registrar, on the proof of the title being to his satisfaction, will register him as the proprietor of the layout design.

Protection against Infringement

The act of reproducing, selling, importing and distributing of integrated circuit layout design for commercial purposes constitutes infringement. Where such act is performed for the purposes of scientific evaluation, analysis, research or teaching it shall not constitute the act of infringement.

Any person who commits infringement shall be punishable with imprisonment for a term, which may extend to 3 years, or with fine which shall not be less than fifty thousand rupees but which may extend to ten lakh rupees, or with both.

Adjudicating Authority

·      The Government of India appoints a person to be known as a registrar of the SICLD. He has both administrative and legal powers.

·      Any person aggrieved by an order or decision of the Registrar may file an appeal to the Layout Design Appellate Board. The procedure and powers of the Appellate Board are that of a civil court as given under the Civil Procedure Code, 1908. 

·      If any person is not satisfied by any decision or order of the Appellate Board may file an appeal to the High Court within prescribed period and in a prescribed manner.

Compulsory Licences

Section 51, of the Act, empowers the Appellate Board to permit the use of registered layout-design by the Government or by any person authorised by the Government on an application made in the prescribed manner, and after providing an opportunity of being heard to the parties concerned. 

The permission shall, however, be given subject to any or all of the following conditions as the Board deems fit under the circumstances of such use. These conditions are:

a.     That the use of the layout-design shall be for non-commercial public purposes or for the purposes relating to national emergency or of extreme public urgency; 

b.     That the duration of the use of the layout-design shall be limited for a period specified by the Board. 

c.      That the use of the layout-design shall be non-assignable and non-transmissible; 

d.     That the use of the layout-design shall be to the extent which the Board deems necessary to remedy the anti-competitive practice; 

e.     That the use of the layout-design shall be predominantly for the supply of semiconductor integrated circuits or articles incorporating semiconductor integrated circuits in domestic market of India.

 It is obligatory for the person so authorised to first make efforts to enter into agreement with the registered proprietor of such layout-design on reasonable commercial terms and conditions for permitted use of such layout-design. It is only when such efforts have not been successful within prescribed period that the Board shall permit the use of such layout-design.

However, there shall be no such obligation for such person where he produces to the Board a certificate issued by the Government to the effect that such use is required due to national emergency or any other circumstances which the Government considers to be of extreme urgency or of public non-commercial use. 

The Appellate Board shall determine the amount of royalty to be paid by the Government or the person authorised by the Government, as the case may be, to the registered proprietor of such layout-design for such permitted use. 

The Appellate Board may, on the application of the registered proprietor of a layout-design referred to above, may review the permission granted and, after giving notice and opportunity of hearing to the parties concerned in the prescribed manner, cancel or amend such permission if the Board is satisfied that any of the conditions subject to which the permission was granted has not been observed or the circumstances which led to the granting of such permission has ceased to exist or substantially altered.

Convention Countries

Any country which accords to the citizens of India similar privileges and rights as granted to its own citizens, the Central Government may specify such country to be a convention country and provide the citizens of such convention countries the similar privileges as granted to citizens of India under the SICLD Act. Where any country does not accord to the citizen of India the same rights in respect of registration and protection of layout design as it accords to its own citizens, the citizens of such countries shall not be entitled to be registered as a proprietor of layout design, assignee of the proprietor of a registered layout design or to be registered as a registered user of a layout design.

Summary

·       There is protection of semiconductor integrated circuits layout and designs by a registration process.

·       There is a mechanism for distinguishing which layout designs can be protected.

·       There are rules to prohibit registration of layout designs which are not original or which have been commercially exploited.

·       Protection of 10 years period is provided to layout designs.

·       Provisions regarding infringement and evidence of validity are mentioned.

·       There are provisions for determining payment of royalty for registered layout designs in case of innocent or unintentional infringement.

·       Penalties in the form of imprisonment and fine are imposed for willful infringement and other offences in the Act.

·       The Registrar is appointed for the purpose of administration and the Appellate Board is established for facilitating the legal objective.

Conclusion

The SICLD Act fulfills India’s obligation under the TRIPS agreement as approved by the members of WTO. The intellectual property protection for Integrated Circuit layout design is a key factor throughout the world, and more so in India because it does not have a strong intellectual property protection policy in software. As integrated circuit layout designs is in its early years in India, it’s important that the country boosts of a strong protection policy right in the beginning itself and the SICLD Act provides such a strong protection policy.

The number of Indian companies focusing on integrated circuit design is beginning to grow and this would force major semiconductor companies to set up their offices and address the needs of the domestic market. This will encourage a lot more companies to base their operations in India.

The Indian legislation therefore provides a comprehensive protection to the layout designs of the semiconductor integrated circuits as recognized intellectual property and bundle of rights to the proprietor of the registered layout design.

PATENTS - Patent Litigation in India

5 COMMON QUESTIONS ABOUT GENERIC DRUGS

What are Generic Drugs?

•       A generic drug is a copy of a brand name drug. To be sold, a generic drug must be ‘bioidentical’ to the brand name drug. 

•       This means that the generic drug must be proven to be the same as the original brand name drug in the following ways:

•       dosage form (tablet, capsule, liquid, etc.)

•       strength (same amount of drug in both)

•       Safety

•       how it is taken (by mouth, injection, etc.)

•       quality

•       how the medicine gets into the bloodstream and works in the body

•       The manufacturer must prove that their generic drug meets these requirements before the Food and Drug Administration (FDA) will approve it and allow it to be sold to the public.

Why are Generic Drugs Cheaper Than Brand Name Drugs?

•       A brand name drug has to go through 10-15 years of research and testing in animals and people before it can be sold to the public. During this testing, the company making the drug must prove that it is safe and effective for people to use. All of this testing can cost over $1 billion. Once the new drug is approved, the company that made and tested it receives a patent. This means that no other company can make the drug until the end of the patent, which is usually 10-15 years after the drug is released.

•       When a patent for a brand name drug expires, any other company can copy the drug and sell a generic version. These other companies must only prove that their product is the same as the brand name drug. This means that generic drug companies do not have to spend as much time and money because they do not have to invent or test the drug for safety and get FDA-approval. This is why generic drugs cost less.

•       When a patent for a brand name drug expires, there are usually a number of companies that begin to make a generic version of the drug. Since there is more than one company making the drug, the price is lowered even farther due to competition between all of the different generic drug makers.

Are Generic Drugs as Safe and Effective as Brand Name Drugs?

•       The short answer to this question is “usually yes”. A company must prove that its generic version of a drug is both safe and effective before it can be sold to the public. The company that made the original brand name drug proved during years of testing that the drug is both safe and effective.

•       A company that makes a generic drug must show that its version of the drug is 80%-125% ‘bioequivalent’ to the original brand name drug. For example: a brand name drug is taken and it is found that 100mg of medicine reaches the person’s bloodstream. For a generic version of the drug to be considered safe and effective, the active drug in the tablet or capsule must release between 80mg and 125mg to reach the bloodstream (80-125%). This means that some companies might make generic versions that have 80mg reach the bloodstream and other companies might make generic versions that have 125mg reach the bloodstream. This difference isn’t a problem in most drugs. 

If This Generic Drug is the Same as the Brand Name Drug, Why Do They Look Different?

•       Just because two versions of the drug do not look the same does not mean they act differently in the body.

•       There are laws in the United States that say that a generic version of a drug cannot look the same as a brand name version. The company that makes the generic version of the drug can make it whatever colour, shape, or flavour they want as long as the amount of active drug remains the same as the brand name drug.

How Do I Know if There is a Generic Version of the Drug that I Take?

•       There are a few different ways to find out if there is a generic version of the drugs you take.

•       The easiest way is to ask your pharmacist. They will be able to tell you if there is a generic version of a drug available or when a generic version will most likely become available. 

CIPLA Vs ROCHE  (Generic Industry Rejoices)

BACKGROUND

•       Delhi High Court has been the battleground for  a pharmaceutical war between Roche and Cipla, over Roche’s patent for anticancer drug ‘Erlotinib’, sold by Roche as TARCEVA. 

•        On 24 April 2009, the Division bench of the Delhi High Court dismissed Roche's appeal against the refusal of a single judge to grant an injunction restraining Cipla from manufacturing, offering for sale, selling and exporting its generic version of ‘erlotinib’. Both Roche and Cipla drugs are based on a compound that goes by the name of ’Erlotinib Hydrochloride.’  

•        This case is regarded as a very important case in a series of high profile patent battles between multinational pharmaceutical companies and Indian generic drug companies. 

FACTS OF THE CASE

•       In February 2007,Roche along with Pfizer (as a joint applicant), claimed that it had been granted a patent  for ‘erlotinib’  

•        The patented product, which Roche introduced onto the Indian market  was marketed under the brand name TARCEVA.  

•        In December 2007 and January 2008, Indian newspapers reported Cipla’s plan to launch a generic version of ‘erlotinib’

•        Soon after that, Roche commenced patent infringement proceedings. 

CIPLA’S DEFENCE AND COUNTERCLAIM

1. It had been selling its drug under the brand name ERLOCIP since December 2007.
2. Roche’s patent was invalid because ‘erlotinib’ was a derivative of Quinazolin, which had been used in cancer treatment. Pursuant to s.3(d) of the Indian Patents Act, a derivative of a known compound is not patentable.
3. Roche’s invention, as disclosed in the complete specification and claims was obvious or did not involve any inventive step, having regard to what was publicly known or publicly used in India, or what had been published in India or elsewhere before the priority date 

4.     The complete specification did not sufficiently and fairly describe the invention or the method by which it was to be performed 

5.     The huge difference in price between Roche’s drug (Rs.4,800 tablet (approx. US$ 100) and Cipla’s drug (Rs.1,600 (approx US$ 33) should be taken into account when deciding whether or not to grant an interim injunction. 

ü   Cipla strongly argued that because the drug in question was a life saving drug, the public interest issue was an important factor to be taken into account .

ROCHE’S SUBMISSION

1. Section 3 (d) of the Patents Act is not applicable as it prohibits only derivatives of ‘a known substance’. ‘Erlotinib’ is not ‘salts, esters, polymorphs, particle size, mixture of isomers, etc.’ of a ‘known substance’. It is a novel compound. 
2. The prior art argument was adequately dealt by the Patent Office during opposition proceedings. In any case, ‘erlotinib’ is a different compound; its properties differ from those of Astra Zeneca’s Gefatinib, which was cited as prior art.
3.  When determining where the balance of convenience lies, it is appropriate to consider the issue of ‘accessibility’ to, and use of, the invention in the territory. It is not, however, necessary that the drug should be manufactured in India. 

SINGLE JUDGE RULING

While hearing the case, the judge noted the following points: 

•       Public interest: The generic drug version of ‘erlotinib’ manufactured and marketed by Cipla is available at one-third the price of Roche’s drug, Tarceva.

•       Further, the Court noted that Tarceva is not manufactured in India, it is imported. The Court noted that the right to access to life-saving drugs, and the need for secure long term supplies, is a serious issue in India.

•       In such case, the injury that would be caused to the general public if the generic version of the drug were not available is a strong point in favour of a refusal to grant an injunction. 

THIS POINT COMPLETELY FAVOURED CIPLA’s DEFENCE

•       Validity of the patent: The doubts about the validity of the patent raised by Cipla on the ground of obviousness, and ‘erlotinib’ being a derivative of a known compound which did not meet the ‘increased efficacy’ requirement provided for in s.(d) of the Patents Act, were dismissed by the judge as having been adequately dealt by the Patent Office at the opposition stage.

•       The Court reviewed the observations that had been made by the Controller while granting the patent, and concluded that Cipla had not substantiated this objection. 

THIS POINT STIFLED CIPLA’s DEFENCE

   Overall, the judge was of the view that while Roche had established a strong case in support of its patent infringement claim, the 'public interest' and lower pricing of Cipla's drug tilted the balance in favour of Cipla.  

DIVISION BENCH RULING

•       Roche filed an appeal against the Order of the single judge, arguing that a failure to protect the rights of the patentee, is contrary to the public interest of encouraging further research in the pharmaceutical field. 

•        The division bench in its ruling observed: 

•        Non infringement: The bench was of the view that the patent in question related to a mixture of Polymorphs A and B, whereas Roche’s Tarceva drug consisted of only Polymorph B, for which a patent had not yet been granted. The division bench considered that this fact ought to have been disclosed by Roche both at the time of examination, and during the proceedings before the single judge. The bench gave weight to the fact that Polymorph B of ‘erlotinib hydrochloride’ was the subject of a later patent application, and that this had not been considered by the single judge. 

The bench criticised Roche for: 

1.     Its failure to provide a sufficient and fair description of the invention; and 

2.     For not having filed X-ray diffraction data for Tarceva and Erlocip that would have shown whether or not the crystalline structure of Cipla’s Erlocip tablets corresponded to Roche’s patented invention.

     The Court dismissed Roche’s appeal, and upheld the order of the single judge. It did not fully elaborate the public interest point relating to the pricing of the drugs, basing its judgment instead on the ground that Cipla had raised a credible challenge to the validity of the patent.

WHY WAS NOVARTIS DENIED A PATENT FOR GLIVEC IN INDIA?

'Novartis AG v. Union of India (UOI) and Ors.; Natco Pharma Ltd. v. UoI & Ors.; M/S Cancer Patients Aid Association v. UoI & Ors. Decided on 1.4.2013

•       From 1972 to 2003, India only allowed process patents, which meant that even a patented product could be produced by someone other than the patent-holder if they could find a different method to manufacturing it. However, in 2005 the law was amended retrospectively to allow for product patents so that India could be compliant with the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

•       But even before the law was amended, India agreed to invite applications for product patents under the TRIPS agreement. These "mailbox" applications were opened in 2005 when the law was finally enacted. Novartis filed an application for patent for Glivec, the blood cancer drug, under the mailbox provision.

•       The key issue revolved around whether Glivec was a "new product" under the terms of the law. In January 2006, the Indian patent office ruled that the drug was not substantially different from one for which patents had already been given in the US and Europe. Thus, it did not pass the novelty test. While moving to the new patent regime, Indian lawmakers had inserted a provision — section 3(d) in the Patents Act — to check against 'evergreening'.

•       (This is the term used to describe a practice under which firms slightly tweak an existing process or product to seek a fresh patent once the original protection expires. This helps them retain monopoly rights for a longer period. The patent office's ruling was upheld by the Intellectual Property Appellate Board (IPAB) and now by the Supreme Court.)

•       If Novartis had won the case, it would have been granted a monopoly on Glivec, and denied Indian companies the right to make the drug. This would obviously have allowed Novartis to sell the medicine at a much higher price. Already, there is a huge differential with generic versions by Indian companies costing Rs 5,000-9,000 for a month's treatment, compared to Glivec's cost of around Rs 1.2 lakh a month.

•       The order is also likely to encourage existing Indian manufacturers to step up production and perhaps new players to enter the market. This should lead to a further fall in prices.

•       What will be the impact on the drug industry?

•       The multinational drug companies are worried that this could be a trendsetter and are even threatening to block supplies of new patented medicines to India. But this is unlikely to deter Indian industry from developing "copycat" versions that would sell at a lower price.

•       In short, while this is bad news for Big Pharma, it is as much good news for domestic manufacturers as it is for consumers. Big Pharma could also be worried that the Indian example may be emulated by others.

MERCK VS. GLENMARK OVER “SITAGLIPTIN”

•       Anti-diabetes drugs are the top-selling therapy area in India, where about 65 million people live with the disease and that number is expected to reach 100 million by 2030.

•       Merck sued Glenmark in 2013 for infringing a patent it has on sitagliptin, the chemical compound in Januvia and Janumet, both of which the company has been selling in India since 2008.

•       A month's dose of Merck's drugs costs about 1,300 Indian rupees ($20) and 1,900 Indian rupees ($30), respectively. Merck has licensed the drugs to Sun Pharmaceutical Industries Ltd (SUN.NS) for sale in India.

•       Glenmark sells the medicines under the brand names Zita and Zita-met at a nearly 30 percent discount to Merck's price.

•       The Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug* Sitagliptin till 28th April 2015. 

•       Merck Sharp & Dohme filed an application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals from using its patented product Sitagliptin (Indian Patent No. 209816) at Delhi High Court. 

•       The Delhi High Court conclusively held that all the three ingredients (Prima facie, Irreparable injury and balance of convenience) for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

•       On 15^th May 2015 India's Supreme Court has blocked Glenmark Pharmaceuticals Ltd from selling copies of U.S. drugmaker Merck & Co Inc's diabetes drugs Januvia and Janumet, sources with knowledge of the matter said after a court hearing.

•       The court has, however, allowed Glenmark to continue to sell existing inventory, the sources said.

ERICSSON VS. XIAOMI

What is the fuss about?

•       According to Ericsson, Xiaomi needed a licence from Ericsson for selling and marketing the phones imported to India and using Ericsson’s patents.

•       Ericsson alleged standard essential patents (SEPs) used in AMR, 2G, 3G and Edge technologies for mobile phones were being infringed upon by Xiaomi. 

•       An SEP is the patent for the core technology essential to create something of a particular technical standard. In this case, mobile phones cannot be made without the GSM, GPRS, EDGE and WCDMA technology, which are patented by Ericsson.

•       Xiaomi apparently uses 3G- and EDGE-compliant technologies on its smartphones in India. Ericsson said it had several patents on these connectivity standards, and that the Chinese manufacturer was required to acquire licences for those or pay royalties.

•       The Delhi High Court was satisfied that Ericsson had made out a prima facie case for grant of ad interim injunction in its favour, and directed Xiaomi to stop sale of all its handsets/devices in India. 

•       Xiaomi in its appeal against the injunction alleged that Ericsson, while obtaining the ex parte injunction order, did not inform the court that Xiaomi also made, imported and sold handsets having Qualcomm chipsets. It contended that it did not infringe Ericsson’s patents, as Qualcomm had obtained a licence from the Swedish company for this patented technology.

•       This implied that Xiaomi would be unable to sell 3G-variant of the Redmi Note (which features a MediaTek chipset) in India, while the Redmi Note 4G and all other sets running on Qualcomm-based chips would still be sold. 

•       Eventually, the court on December 16^th  2014 permitted Xiaomi to sell its Qualcomm chipset-based devices as a ‘pro tem’ (temporary) measure till the issue of patent infringement was heard and decided by a single-judge Bench of the high court.

•       Xiaomi can now sell other devices in India apart from the ones that feature Media Tek chipsets. Thus, from now, Xiaomi phones working on Qualcomm chipsets will be available for customers in India.

•       Redmi 1S, Mi 3, Mi 4 and Mi 4i, fitted with Qualcomm chips, are very popular Xiaomi handsets.

•       After landing in 2014 over patent infringement, Chinese handset maker Xiaomi, which was asked to stop the sale of some of its handsets by the Delhi High Court, has been allowed to send back its Redmi Note 3G handsets to Hong Kong.

•       A vacation Bench of high court judge Mukta Gupta permitted Xiaomi to return over 100,000 handsets to their point of origin, Hong Kong, after Swedish telecom firm Telefonaktiebolaget LM Ericsson agreed to the arrangement.

•       In December 2014, the court had barred Xiaomi from selling or importing phones into India, after a complaint from Ericsson alleging patent infringement. The move was seen as having dealt a severe blow to Xiaomi’s prospects in what was considered its most important international growth market.

•       Xiaomi, though, got a reprieve in a second ruling, which stated the company was forbidden only from importing and selling phones containing components linked to the Ericsson dispute. This referred specifically to parts made by MediaTek, a Taiwanese chipmaker.

•       The court had directed Xiaomi to maintain an inventory of handsets, currently lying unused with e-commerce site Flipkart, through which the Chinese company sells its phones under an exclusive arrangement.

NOVARTIS VS. CIPLA

•       Delhi High court barred Indian generic drugmaker Cipla from making or selling generic copy of Novartis’s “Onbrez” (for chronic obstructive pulmonary disease) by giving temporary injunction to Novartis. Citing famous Roche vs Cipla case, the court observed that Novartis has a strong prima facia case and as the validity of the patent is not seriously questioned, there is a clear way out to grant injunction. Further, the court observed that Cipla did not provide any figures about the “inadequacy or shortfall in the supply of the drug.” 

•       Earlier Cipla launched its generic version of Indacarterol in October 2014 claiming “urgent unmet need” for the drug in india.

•       Without going conventional way, Cipla, also approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol. Cipla argued on the basis of 3 main points i.e. “epidemic” or a “public health crisis” of COPD, unable to manufacture the same in India by Patentee and high cost of patented drug.