Patents – Intellectual Property Rights Laws and Practices Important Questions

Patents – Intellectual Property Rights Laws and Practices Important Questions

Question 1.
Write a note on ‘patent co-operation treaty’.
Answer:
The Patent Co-operation Treaty (PCT) is a multilateral treaty that became effective in 1978. The PCT is administered by the International Bureau of the World Intellectual Property Organization (WIPO) whose headquarters is in Geneva, Switzerland. The member countries of the PCT are called the PCT Contracting States. As of August 1, 2006, there were 133 PCT Contracting States.

The PCT enables a patent application to file one “international” patent application to seek protection in any or all of the PCT Contracting States. Patents are granted or rejected by each PCT Contracting State or regional officer individually under their respective patent laws. Thus, an applicant must still prosecute a patent application in each country or regional officer in which he seeks protection and pays the national or regional fees.

The main advantage of filing a PCT application is the additional time gained before having to prosecute applications in other countries after the initial filing. Without the PCT the applicant generally has 12 months to file patent applications in other Paris Convention countries after filing the initial application, in contrast, by using the PCT the application has at least 30 months (and more in. many countries) from the date of initial filing to begin prosecuting his application in other countries effectively gaining 18 months. This delay provides time to obtain knowledge as to the patentability and commercial prospects of an invention. It also postpones the major costs of internationalizing a patent application such as paying national/regional fees, translating the patent application, and paying fees to local patent agents in various countries.

The PCT procedure consists of two main phases; the “international phase” and the “national phase”.

The international phase consists of:

1. Filing of the international application ether with a national/regional “Receiving Office” or the International Bureau of WIPO
2. Novelty search on the patentability of the invention (including an international search report and a written opinion on potential patentability)
3. Publication of both the PCT application and the international search report by WIPO, and
4. (Optional step) request for an international preliminary examination of the international application.

National Phase:
After the international phase, the application enters the “national” phase, which consists of processing the international application before each Contracting State that has been designated in the international application and in which the applicant wishes to pursue patent protection. Certain requirements must be fulfilled in order to enter the national phase. These requirements include paying national fees and if necessary, furnishing a translation of the application (as filed and/or amended). Note that the filing of the PCT request together with the application constitutes the designation of all Contracting States that are bound by the Treaty on the international filing date. In the national phase, the applicant selects the particular States in which he wishes to obtain protection for his invention.

A PCT application must contain the following elements: request* description, one or more claims, one or more drawings (where drawings are necessary for the understanding of the invention), and an abstract. A request is simply a form that is filed with the international application. Any national or resident of one of the PCT Contracting States may file an international patent application.

Question 2.
Does a patent obtained in India give protection worldwide? Is it possible to file an international application in India under the Patent Cooperation Treaty (PCT)?
Answer:

1. A patent obtained in India does not provide protection worldwide.
2. Patent protection is effective only within the territory of India.
3. Separate patents should be obtained in each country where the applicant requires protection of his invention in those countries.
4. It is possible to file an international application in India under the Patent Co-operation Treaty (PCT) in the patent offices located at Kolkata, Chennai, Mumbai & Delhi.

Question 3.
Read the Novartis case on patenting law of Gleevec and answer the questions that follow:
Novartis vs. Union of India & Others is a landmark decision by a two-judge bench of the Supreme Court of India on the issue of whether Novartis could Patent Gleevec in India, and was the culmination of seven-year-long litigation fought by Novartis. The Supreme Court upheld the Indian Patent Office’s rejection of the patent application.

The patent application claimed the final form of Gleevec (the beta crystalline form of imatinib mesylate). In 1993, during the time India did not allow patents on products, Novartis had patented imatinib, with salts vaguely specified, in many countries but could not patent it in India. The key differences between the two patent applications were that the 1998 patent application specified the counterion (Gleevec is a specific salt imatinib mesylate) while the 1993 patent application did not claim any specific salts nor did it mention mesylate, and the 1998 patent application specified the solid form of Gleevec the way the individual molecules are packed together into a solid when the drug itself is manufactured (this is. separate from processes by which the drug itself is formulated into pills or capsules) while the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta crystalline.

In 2000, the United States Food and Drug Administration (FDA) approved imatinib mesylate in its beta crystalline form, sold by Novartis as Gleevec (U.S.) or Glivec (Europe/Australia/Latin America). TIME magazine hailed Gleevec in 2001 as the ‘magic bullet’ to cure cancer. Both Novartis patents on the freebase form of imatinib, and on the beta crystalline form of imatinib mesylate are listed by Novartis in the FDA’s Orange Book entry for Gleevec. As provided under the TRIPS agreement, Novartis applied for exclusive marketing rights (EMR) for Gleevec from the Indian Patent Office and the EMR was granted in November 2003. Novartis made use of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in India. Novartis set the price of Gleevec at USD 2,666 per patient per month; while the generic companies were selling their versions at USD 177 to 266 per patient per month. Novartis also initiated a program to assist patients who could not afford its version of the drug, concurrent with its product launch.

The Intellectual Property Appellate Board (IPAB) was formed and in 2007 the case was transferred before the IPAB in line with section 117G of the Patents Act, 1970. The IPAB on 26th June 2009 modified the decision of the Assistant Controller of Patents and Designs stating that ingredients for grant of patent novelty and nonobviousness to person skilled in the art were present in the application but rejected the application on the ground that the drug is not a new substance but an amended version of a known compound and that Novartis was unable to show any significant increase in the efficacy of the drug and it, therefore, failed the test laid down by section 3(d) of the Patents Act, 1970.

When examination of Novartis’ patent application began in 2005, it came under immediate attack from oppositions initiated by generic companies that were already selling Gleevec in India and by advocacy groups. The application was rejected by the Patent Office and by an Appeal Board. The key basis for the rejection was the part of Indian patent law that was created by an amendment in 2005, describing the patentability of new uses for known drugs and modifications of known drugs. That section, Paragraph 3d, 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 Paragraph 3d; it argued that the provision was unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal. However, Novartis did appeal the rejection by the Patent Office to India’s Supreme Court, which took the case.

The Supreme Court case hinged on the interpretation of Paragraph 3d. The Supreme Court decided that the substance that Novartis sought to patent was indeed a modification of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was properly rejected by the patent office and lower courts.

Although the court ruled narrowly and took care to note that the subject application was filed during a time of transition in Indian patent law, the decision generated widespread global news coverage and reignited debates on balancing public good with monopolistic pricing and innovation with affordability. Had Novartis won and gotten 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.
Question:
(a) Why did Novartis file the case in Supreme Court only after India signed TRIPS?
(b) Gleevec patent is already granted in 45 other countries including China. What will the Indian industry gain/lose in the rejection of the patent in India?
(c) What is your opinion on Novartis’ claim that the beta crystalline packing in solid form is a novelty and is thus patentable?
(d) What do you understand by the ‘grandfather clause’ of the Novartis patent developed when India did not have product patents?
Answer:
(a) India accepted products patents as part of the World Trade Organisation (WTO) deal hence Gleevec patent could be registered and enforced by the Indian Courts.

1. The patent application at the center of the case was filed by Novartis { in India in 1998 after India had agreed to enter the World Trade Organization and to abide by worldwide intellectual property standards under the TRIPS agreement.
2. As part of this agreement, India made changes to its patent law; the biggest of which was that prior to these changes, patents on products were not allowed, while afterward, they were, albeit with restrictions.
3. These changes came into effect in 2005, so Novartis patent application waited in a “mailbox” with others until then, under procedures that India Instituted to manage the transition.
4. India also passed certain amendments to its Patent Law in 2005, just before the laws came into effect, which played a key role in the rejection of the patent application.

(b) (A) Indian industry gains in the rejection of the patents:

• Savings in, outward remittance of foreign exchange
• Dumping shall be restricted
• Generic Medicines shall be available at cheaper rates
• Growth of Indian Pharma Companies
• Enhancement of innovation by Indian Pharma Companies

(B) Indian industry losses in the rejection of the patents:

• Multinational Companies will invest less money in research in India
• Hinders Medical progress
• Indian Industry will lose credibility
• Multinational Companies will not do R&D in India
• Better Technology transfer from outside is not possible

(c) A novel invention is one, which has not been disclosed, in the prior art t where prior art means everything that has been published, presented, or otherwise disclosed to the public includes documents in foreign languages disclosed in any format in any country of the world on the date of the patent. For an invention to be judged as the novel, the disclosed information should not be available in the ‘prior art.

1. The “beta crystalline form” of the molecule is a specific polymorph of imatinib mesylate; a specific way that the individual molecules pack together to form a solid.
2. This is the actual form of the drug sold as Gleevec; a salt (imatinib mesylate) as opposed to a free base, and the beta crystalline form as opposed to the alpha or other form.
3. So, by going through the concept of novelty, the process of “beta crystalline packing in solid form” passes the test of novelty, since, this process is not disclosed anywhere in the prior art.
4. But, if anything to be patentable, then the sole test of novelty is not sufficient. By the virtue of Section 3 (d) (as amended), we also have to test that whether the same is differ significantly in properties with regard to efficacy.

Note:
Section 3 (d) of Indian Patent Act, 1970 (as amended) reads as follows: ‘The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

As the beta crystalline form of Imatinib Mesylate being a pharmaceutical substance and moreover a polymorph of Imatinib Mesylate, it directly runs into explanation to Section 3 (d) of the Act. As Novartis was unable to show any significant increase in the efficacy of the drugs, hence it failed in the test laid down by explanation to Section 3 (d) of the Act. So, the same is not patentable under Indian Patent Act, 1970.

(d) Section 11A (7) of The Patents Act, 1970 provides that on or from the date of publication of the application for patent and until the date of grant of a patent in respect of such application, the applicant shall have the like privileges and rights as if a patent for invention had been granted on the date of publication of the application.

However, the applicant shall have no right to institute any proceeding for infringement until the patent has been granted. Additionally, the rights of a patentee in respect of applications made under section 5 (2) of the Patents Act before January 1,200.5 shall accrue from the date of grant of patent.

Moreover, after the patent is granted in respect of applications made under section 5 (2), the patent holder shall only be entitled to receive reasonable royalty from such enterprises which have made significant investments and were producing and marketing concerning product prior to January 1, 2005, and which continue to manufacture the product covered by the patent on the date of grant of the patent and no infringement proceedings shall be instituted against such enterprises. The above provision is termed as the “grandfather clause” in common parlance.

The above grandfather clause created “a special regime for generic versions of medicines if the initial patent application was made between the 1st of January, 1995 and the 31st of December, 2004 and if these medicines were already on the Indian market before the 1st of January, 2005. Generics that enter into this category can stay on the Indian market even if their pharmaceutical substance is patented. However, Indian Law requires that the producers of those generics then pay a “reasonable royalty” to the patent holder.

If Novartis won the case and got the patent, then also the Indian Companies could have continued to sell generic Gleevec, but they have to enter a grandfather clause with Novartis and shall be obligated to pay a reasonable royalty to the patent holder.

Question 4.
Briefly discusses the Paris Convention for the Protection of Industrial Property.
Answer:
Paris Convention for the Protection of Industrial Property: The Paris Union, established by the Convention, has an Assembly and an Executive Committee. Every State member of the Union who has adhered to at least the administrative and final provisions of the Stockholm Act (1967) is a member of the Assembly. The members of the Executive Committee are elected from among the members of the Union, except for Switzerland, which is a member ex officio. The Paris Convention, concluded in 1883, was revised at Brussels in 1900, at Washington in 1911, at The Hague in 1925, at London in 1934, at Lisbon in 1958, and at Stockholm in 1967, and it was amended in 1979.

The Convention applies to industrial property in the widest sense, including patents, marks, industrial designs, utility models, trade names, geographical indications, and the repression of unfair competition. The substantive provisions of the Convention may be divided into three main categories namely national treatment, right of priority, common rules.

Question 5.
What are the advantages of PCT filing?
Answer:
Advantages of PCT Filing:
The advantages of PCT filing for the applicant, the patent offices, and the general public are given below:

1. The applicant has up to 18 months more than in a procedure outside the PCT to reflect on the desirability of seeking protection in foreign countries
2. To appoint local patent agents in each foreign country
3. To prepare the necessary translations and to pay the national fees. The PCT filing assures the applicant that if his international application is in the form prescribed by the PCT, it cannot be rejected on formal grounds by any designated Office during the national phase of the processing of the application. On the basis of the international search report, the applicant can evaluate with reasonable probability the chances of his invention being patented. On the basis of the international preliminary examination report, that probability is even stronger; the applicant has the possibility to amend the international application to put it in order before processing by the designated Offices.

Question 6.
Briefly discuss the Berne Convention for the protection of literary and artistic work.
Answer:
Berne Convention for the Protection of Literary and Artistic Works:
The Berne Union has an Assembly and an Executive Committee. Every country member of the Union which has adhered to at least the administrative and final provisions of the Stockholm Act is a member of the Assembly. The members of the Executive Committee are elected from among the members of the Union, except for Switzerland, which is a member ex officio.

The Berne Convention, concluded in 1886, was revised at Paris in 1896 and at Berlin in 1908, completed at Berne in 1914, revised at Rome in 1928, at Brussels in 1948, at Stockholm in 1967, and at Paris in 1971, and was amended in 1979. The Convention rests on three basic principles and contains a series of provisions determining the minimum protection to be granted, as well as special provisions available to developing countries.
Basic Principles
The three basic principles are the following:
1. Works originating in one of the contracting States must be given the same protection in each of the other contracting States as the latter grants to the works of its own nationals.

2. Such protection must not be conditional upon compliance with any formality.

3. Such protection is independent of the existence of protection in the country of origin of the work. If, however, a contracting State provides for a longer-term than the minimum prescribed by the Convention and the work ceases to be protected in the country of origin, protection may be denied once protection in the country of origin ceases.

The minimum standards of protection relate to the works and rights to be protected, and the duration of the protection:
1. As to works, the protection must include every production in the literary, scientific, and artistic domain, whatever may be the mode or form of its expression.

2. Subject to certain permitted reservations, limitations, or exceptions, the following are among the rights which must be recognized as exclusive rights of authorization:

• the right to translate
• the right to make adaptations and arrangements of the work,
• the right to perform in public dramatic, dramaticomusical and musical works
• the right to recite in public literary works
• the right to communicate to the public the performance of such works
• the right to broadcast (with the possibility of a contracting State to provide for a mere right to equitable remuneration instead of a right of authorization)
• the right to make reproductions in any manner or form
• the right to use the work as a basis for an audiovisual work, and the right to reproduce, distribute, perform in public or communicate to the public that audiovisual work.

Question 7.
Explain salient features of the Patents (Amendment) Act, 2002.
Answer:
The second phase of the amendment was brought in by the Patents (Amendment) Act, 2002 which came into force on 20th May 2003. The main features of the amendments included:

1. The term of the patent was extended from 14 to 20 years, wherein the date of patent was the date of filing of the complete specification.1 Also the difference in terms of a drug/food patent and other patent was removed.
2. The definition of “invention” was made in conformity with the provisions of the TRIPS Agreement by introducing the concept of inventive step, thereby enlarging the scope of the invention.
3. A deferred examination system was introduced.
4. Introduction of the provision of publication of application after 18 months from the date of filing thereby bringing India at par with the rest of the world.
5. Microorganisms became patentable, whereas inventions relating to traditional knowledge were included in the list of “what are not inventions”.
6. The concept of the unity of invention is in accordance with EPC and PCT.
7. Section 39 was reintroduced thereby prohibiting the Indian residents to apply abroad without prior permission or first filing in India.
8. Provisions of Appellate Board were brought in by inserting section 116. All appeals to the decision of the Controller would be appealable before the Appellate Board. The Head Quarter of the Appellate Board is to be in Chennai.
9. Section 117 provided for Bolar’s provision for the benefit of the agrochemical and pharmaceutical industry.

The third and final amendment to the Patents Act, 1970 came by way of Patents (Amendment) Ordinance, 2004, which was later replaced by The Patent (Amendment) Act, 2005, and Patents (Amendment) Rules, 2006 with retrospective effect from 1st January 2005. With the third amendment, India met with the international obligations under the TRIPS. Significant achievements of this amendment were:

Deletion of section 5, the opening of the mailbox, and grant of product patents. Thus this amendment led to the dawn of the “product patent regime” in India.

Abolition of Exclusive Marketing Rights (EMR).
The definition of “startup” under rule 2(FB) has been substituted with a new definition. A more liberal definition of startup has been incorporated that can allow domestic as well as foreign entities to claim benefits such as fast-track mechanisms and lower fees for filing patents.

According to the Patent (Amendment) Rules, 2017
“Startup” means

• an entity in India recognized as a startup by the competent authority under Startup India Initiative.
• In the case of a foreign entity, an entity fulfilling the criteria for turnover and period of incorporation/registration as per Startup India Initiative and submitting a declaration to that effect.

Explanation:
In calculating the turnover, reference rates of foreign currency of Reserve Bank of India shall prevail.

Current Position
The present Indian position in respect of patent law is governed by the provisions of the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 (hereinafter referred to as the Act) and Patents (Amendment) Rules, 2017 (hereinafter referred to as the Rules) Department of Industrial Policy and Promotion (DIPP) has amended Patent Rules 2003 with effect from 1st December 2017 called as the Patent (Amendment) Rules, 2017. The Head Patent Office is located in Kolkata and its branch offices are located in Delhi, Mumbai, and Chennai. The patent system in India is administered by the Controller General of Patents, Designs, Trademarks, and Geographical Indications. Each office has its own territorial jurisdiction for receiving patent applications and is empowered to deal with all sections of the Patent Act.

Question 8.
Discuss the ways, through which CBD and TRIPs could be harmonized.
Answer:
Harmonization of CBD and TRIPs
The Convention on Biological Diversity (CBD) 1992: Opened for signature at the Earth Summit in Rio de Janeiro in 1992, and entering into force in December 1993, the Convention on Biological Diversity is an international treaty for the conservation of biodiversity, the sustainable use of the components of biodiversity and the equitable sharing of the benefits derived from the use of genetic resources. The interface between biodiversity and intellectual property is shaped at the international level by several treaties and processes, including at the WIPO, and the TRIPS Council of the WTO. With 193 Parties, the Convention has near-universal participation I among countries.

The Convention seeks to address all threats to biodiversity and ecosystem services, including threats from climate change, through scientific assessments, the development of tools, incentives, and processes, j the transfer of technologies and good practices, and the full and active involvement of relevant stakeholders including indigenous and local communities, youth, NGOs, women and the business community. The Cartagena Protocol on Biosafety is a subsidiary agreement to the Convention. It seeks to protect biological diversity from the potential risks posed by living modified organisms resulting from modern biotechnology.

The treaty defines biodiversity as “the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.” The Convention on Biological Diversity establishes important principles regarding the protection of biodiversity while recognizing the vast commercial value of the planet’s store of germplasm. However, the expansion of international trade agreements establishing a global regime of intellectual property rights creates incentives that may destroy biodiversity, while undercutting social and economic development opportunities as well as cultural diversity. The member countries were pressurized to change their IPR laws to conform to the TRIPS agreement.

While the TRIPS and the CBD both attempt to legislate some form of intellectual property and technology transfer, the Agreement appears to provide contradictory prescriptions for the control over genetic control over genetic resources and biodiversity. The two Agreements embody and promote conflicting objectives, systems of rights, and obligations. The core issues are that, in the area of patentable subject matter, benefit-sharing, protection of local knowledge, requirements of prior informed consent, and role of the state.

Major tension between the CBD and the TRIPS is related to the case of National Sovereignty and the Rights of IPR Holders. Through the CBD, countries have the right to regulate access of foreigners to biological resources and knowledge and to determine benefit-sharing arrangements.

The TRIPS enable persons or institutions to patent a country’s biological resources in countries outside the country of origin of the resources or knowledge. In this manner. TRIPS facilitates the conditions for ‘ misappropriation of ownership or rights over living organisms, knowledge and processes on the use of biodiversity.

In the benefit-sharing arrangements, a key aspect of the CBD is the one, which recognizes the sovereign rights of the states over their biodiversity and knowledge, and thus gives the State the right to regulate the access and this, in turn, enables the state to enforce its rights on arrangements for sharing benefits. Access where granted, shall be on mutually agreed terms (Art 15.4) and shall be subject to prior informed consent (Art 15.6). Most importantly, each country shall take legislative, administrative, or policy measures with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the contracting party providing such resources. Such sharing shall be upon mutually agreed terms.

The TRIPS is a device with an international intellectual property regime that maximizes the potential for both traditional knowledge and modern scientific innovations to contribute to economic progress. To achieve this goal, the TRIPS need to be reviewed incorporated further:

1. Establish the concept of community property rights with respect to Traditional Knowledge recognition;
2. Recognize communities’ rights over their resources and TK;
3. Recognizes safeguards and protect the TK, innovations, practices, and technologies of indigenous and local people and communities;
4. Mandate legal protection for TK;
5. Recognize the sovereign rights of states over their biodiversity and genetic resources;
6. Mandate the principles of prior informed consent and benefit-sharing when other countries access the biogenetic resources and local

CS Professional Intellectual Property Rights Laws and Practices Notes