Author: ashwin

– By Apoorva Mishra

The plaintiffs entered into an Agreement dated 9th April, 2000 with Balaji Telefilms Pvt. Ltd., in order to create, compose and produce 262 episodes of a television serial entitled “KYUNKI SAAS BHI KABHI BAHU THI”.  Since then Balaji has produced episodes of the serial and their services were engaged by way of contract of service and as such the plaintiffs are the first copyright owners under Section 17 of the Copyright Act. Balaji has devised the original artistic work depicting inter alia the logo and the title in a peculiar stylized font and containing as its essential features the words “KYUN KI SAAS BHI KABHI BAHU THI” and as per the agreement plaintiffs have become the owner of the said artistic work. The serial had acquired immense goodwill and reputation so much so that the public associate the said serial with plaintiffs and plaintiffs alone. Plaintiffs started endorsing the serial and the characters in form of products and services for a fee. In February 2002, the defendants came up with the commercial for a consumer product “TIDE DETERGENT” telecasting it with a title, “KYONKI BAHU BHI KABHI SAAS BANEGI” and characters of a grandmother, mother-in-law and daughter-in-law, similar to the characters of J.D., Savita, Tulsi as in the serial of the plaintiff. The plaintiffs contended that there has been an infringement of copyright because an average viewer will have an impression that the plaintiffs are endorsing the defendant’s product and there is a connection between plaintiffs in the said serial and the defendants and their product. It is contended that the defendants are not entitled to do so without obtaining the prior consent and/or the permission from the plaintiffs and they have misrepresented the public at large and on account of this plaintiffs have suffered loss due to continuous act of infringement of copyright and passing off of the copy to the defendants.  The matter was brought before the Hon’ble Bombay High Court raising several issues:

First, Have the defendants by making the commercial film, violated and/or infringed the plaintiffs’ copyright in the T.V. serial “KYUN KI SAAS BHI KABHI BAHU THI”?

The court ruled that anything which is not a substantial copy of the film shall not be held liable for copyright infringement. Therefore, defendants by making the commercial film have not violated and/or infringed the plaintiffs’ copyright.

The court has rightly dealt with the above issue, for the second film to infringe the copyright of the first film it has to be the exact copy of that film which is not the case here. The plaintiff’s film is a work of 262 episodes whereas defendant’s advertisement is a work of 30 seconds in which only for 8 to 10 seconds the characters appear as a prelude to the tide detergent. The major and substantial part consists of tide detergent. Nothing is common between the two scripts. The defendants have put in their own independent skill and labour in making of the advertisement whole sole purpose is to promote the Tide detergent. The models are same in both the film. These models are professional and free to contract. There cannot be, therefore, any act which would amount to infringement by using the same models. Even if the idea is borrowed there, can be no copyright in the idea.

Second, Have the plaintiffs’ proved the defendants have infringed the plaintiffs’ artistic work?

The court denying the contentions of the plaintiffs coined the term Originality. Originality merely means effort expanded or that it involves skill, labour and judgment in its creation. Under Section 17 of the Copyright Act, the Author of a work is the owner of the copyright therein. The defendants have contended that the logo consisting of the two hands is a symbol in common use and in the public domain and open to anyone to use. The holding hands well known form of representing the handing over of something from one to another and are a commonly used symbol and they denied on the fact that the plaintiffs have put any skill, labour or some sort of judgement in its creation but has merely taken the lettering style from a source easily available in public domain. Hence, there is no originality, therefore no copyright.

Third, Have the plaintiff’s proved that the defendants are guilty of passing off their reputation and goodwill in the T.V. serial?

The court held that the defendants are not guilty of passing off as they do not satisfy the essentials of passing off per se. Plaintiffs’ serial is shown on Star Plus Channel which is not owned by the plaintiffs. Goodwill does not accrue to the plaintiffs. The plaintiffs have no goodwill or reputation. It is the case of the plaintiffs that their serial/film is associated exclusively with the Star Plus Channel by the public and public is well aware that it can be seen only on Star Plus. Also, the T.V. commercial will not cause any harm to the plaintiffs’ serial or their reputation because the field which the plaintiffs’ serial occupies as a film/soap opera is different from the field of defendants’ commercial that of an advertisement of detergent Tide. Even the activity area is also not in common, therefore there is no misrepresentation.

On the facts of this case, there is no fictional character involved like ‘Superman’, ‘Shaktiman’ Teletubbies’. In the serial there are ordinary people in common life who plays the role of some character or the other. At least from the material on record there is nothing special in any, of the characters of which it can be said that they have gained any public recognition for itself with an independent life outside the serial. This, the plaintiffs have failed to establish. It is also not a case of one film against another film and further the defendants are not merchandising any character from the serial by means of their T.V. commercial. There should be in actual character merchandising and not mere potential of character merchandising.

The court, after analysis the entire case, rightly pronounced the judgement in favour the defendants. The defendants are just promoting their consumer product “Tide” via a T.V. commercial which in no way is connected. The field of activity of the plaintiff and defendant are totally different. No likelihood of damage has been caused to the plaintiff. The characters of which the plaintiff claims to be copied are simple general roles of our Indian society and the defendants are simply targeting the audiences of India who will relate easily to these household roles and nothing special that the plaintiffs have done with these characters for which they claim a copyright on them. This isn’t a case of misrepresentation or fraud and no real damage has been caused. No prudent person will confuse the advertisement with plaintiffs’ serial. Moreover, for character merchandising the plaintiffs should prove that the public would look at the character and consider it to represent the plaintiffs or to consider the product in relation in which it is used as has been made with the plaintiffs’ approval. But the plaintiffs have failed to establish this. In my opinion, the defendants have rightly pleaded that they are a major consumer goods Company, well known in their own right and their products including Tide have their own reputation amongst the public; Tide will be associated with the defendants and not with the plaintiffs.

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– By Apoorva Mishra

Compulsory licensing is an involuntary licensing where the licensor is unwilling to grant the license to the willing licensee, but this entire agreement of compulsory licensing is enforced by the state, by which the licensor has to transfer the rightful authorization of the patent to the licensee, against all his wishes. Government is basically the protector and acts as a guardian for the public at large. Therefore, for the benefit of nation, it has the right to grant the patent and next moment take away the patent and patentee’s monopoly over it. The requirements of the society at large supersedes against the rights of the patent holder to answer the pressing public requirements. Following situations may attract compulsory licensing where IP holder:

• Charges unfair and discriminatory prices; or
• Limits production of goods and services; or
• Restricts technical or scientific development of goods and services; or
• Desecrates consumer welfare.

Internationally, compulsory licensing has been supported saying that it helps in catering to the needs of the public at large and development of developing and underdeveloped countries. Compulsory Licensing has been mandated by several agreements like WIPO (World Intellectual Property Organization), Paris Convention for the promotion of industrial property. TRIPS has envisaged several conditions for issuance of compulsory licensing:

1. The person or company should apply for licensing after 3 years to the grant of patent.
2. Before applying for compulsory licensing, the person or company should make an attempt for voluntary licensing.
3. The person or company then should apply to the board for compulsory licensing if the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time.

In India, we have seen a growth of many foreign companies reason being they hold knowledge and they rule the terms.  Therefore, there exists a chance that these companies can abuse their positions. Compulsory licensing of IPRs in cases of such abuses would be an apt remedy that will deter these companies from abusing their dominant positions. Keeping in mind Indian conditions compulsory licensing will spur growth and development in Indian industrial sectors. Keeping in mind the size of Indian market the incentive for innovation will not erode to the extent that might deter companies from entering in to innovative endeavours as courts have granted reasonable royalties in cases where compulsory licensing has been awarded. Compulsory licensing will make the products more accessible to public and it will be beneficial for public welfare.

The developing and the under developed countries are not much concerned about protection of patent laws as much as developed countries are because they don’t have resources to spend on development of costly mechanism to ensure protection of patents.

There are few reasons behind this:

• by allowing piracy, developing and underdeveloped countries can ensure availability of needed goods and services to their citizens at affordable prices
• The local industries which produce counterfeit goods employee thousands of workers and therefore reduce unemployment.
• In order to advance in science and technology, they need maximum access to intellectual property of advanced nations.

More than 80% patents in developing and underdeveloped countries are owned by citizens of technologically advanced countries. Consequently, their governments are not willing to spend huge amounts in developing effective administrative mechanism to enforce IPRs of citizens of advanced states.

The Government will, however, pay royalty to the patent holder for using his patent without his permission, but this will in turn discourage the patent holder from making any further inventions or innovations. The discouraged Research & Development shall lead to deteriorating economic growth. The developing or under-developed countries shall refrain from investing in R & D, indirectly affecting the economy, and will settle for generic goods. This might increase the risk of goods turning into inferior quality. Ultimately, as a result of weak intellectual property regime, a country becomes less competitive, and brain drain is an obvious result.

Compulsory licensing becomes inevitable to deal with the situations of “patent suppression”. By incorporating an effective mechanism of compulsory licensing, governments of developing countries may pressurize the patent holders to work the patent to maximum national advantage. The threat of non-voluntary licensing may be helpful in negotiating a reasonable price of the needed drug acceptable to both the patent owner and the government. Compulsory licensing might be necessary in situations where its refusal may prevent utilization of another important invention which can be significant for technological advancement or economic growth.

Compulsory licensing ensures that a good number of producers or manufacturers are there to cater to the needs of society; it spurs competition and consumer welfare. Those who argue against it saying that it leads to erosion in incentive for innovation forget that a right is always accompanied by a corresponding duty, and failure to perform that duty might have its implications in law.

The abuse of patents is a very likely to occur where the patentee has its rights protected under Patent laws. The patent holder has monopoly rights but they are more likely to abuse. The patent holders are often tempted to indulge in to anti-competitive practices and they try to extend their monopoly into areas where they do not have rights protected by IPRs. Software companies like Microsoft, several pharmaceutical companies, as discussed above, are protected under the patent laws and most of the time they are the sole manufacturer. So this gives them an opportunity where they can dictate their terms over the entire market which might lead to exploitation of others right in the market. In such a scenario, compulsory licensing comes into play, which acts as a remedy to abuse of patents, where government intervention leads to increase in the versatility of the market leading to a monopolistic market rather than a monopoly, the consumers have a choice and the product will be easily available, where the opponents have argued that compulsory licensing will lead to discouragement for innovations, but this also true that this will lead to a heated competition, which will in return lead to a peer pressure over the patent holder to work more over his product, get distributers, improve his research and product and make it available to the public at large. This will lead to an increase in the economy. There are reasonable apprehensions that FDI may dry up if compulsory licensing is granted as a remedy, to that essential facility doctrine must be adopted, so that only what is essential and necessary should prevail.

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– By Apoorva Mishra

FACTS

• The writ petitioner in the case was Bayer Corporation. The second respondent in the case was the DCGI and the third respondent was Cipla.
• The Indian Patent Office had granted the petitioner, patent number 215758 on 3 March 2008. Therefore, by virtue of Section 48 (rights of a patentee) of the Patents Act, Bayer got the exclusive right to prevent third parties, from the acts of making, using, offering for sale, selling or importing the patented product in India, without its consent.
• Cipla then introduced a drug “Soranib” which was a substitute of its patented drug. Subsequently, on 31st July 2008 Bayer wrote to the DCGI requesting that marketing approval be not granted to Cipla for its drug “Soranib” as Bayer had the exclusive right to market the drug.
• It urged the DCGI to reject the representation of Cipla for grant of marketing approval for spurious adaptation of its patented drug “Sorafenib Tosylate”, as the same would contravene DCA.
• Also, Bayer wrote to Cipla asking it to confirm whether it had filed an application before DCGI for grant of marketing approval for a drug covering “sorafenib tosylate” but received no reply.
• Bayer filed the petition seeking directions to, inter alia, restrain grant of drug license in regard to an application by the third respondent for the license to manufacture, sell and distribute its drug ‘Soranib’. The petitioner claimed that the said drug was an imitation of, or substitute for, its patented drug.

ARGUMENTS BY BAYER

• The Petitioner contends that in the absence of an overriding provision in the Drugs Act, reinforces the intention of the legislature that its provisions of the Drugs Act are to be read in addition to the Patent laws and not to the contrary. Therefore, Section 2 of the Drugs Act have to be read in conformity with the Section 48 of the Patents Act which establishes a concept of “Patent Linkage” which imposes a burden on the Drug Controller to make sure that any of his decisions of granting market approval for a drug do not violate any law for the time being in force.

 

• The petitioner relies on Section 18 and Form 44 of the Drugs Act, which talks about mentioning of patent status of the drug. While making an application before the Drug Controller, CIPLA ought to have mentioned the subject Patent of Bayer. Therefore, by a mere reading of Form 44, and also by virtue of publication of grant of the subject patent, it would be well within the knowledge of the Drug Controller that the subject patent exists in relation to the product for which CIPLA has applied for consequently, if the marketing approval is granted, it will contravene the provisions of Section 17B of the Drugs Act, as well as the provisions of Section 48 of the Patent Act.
• The petitioner contends that the application of Cipla is for the license to manufacture, sell and distribute its drug “Soranib” which is an imitation of the Petitioners’ patented drug. The drug “Soranib”, being “spurious drug” as defined in Section 17B of the Drugs Act, the DCGI would not only be exceeding his jurisdiction but also give a decision which would be ultra vires Chapter IV of the Drugs Act.

ARGUMENTS BY CIPLA

• Cipla contends that Bayer’s claim for patent linkage, based on an interpretation of Section 2 of the Drugs Act is misleading, because the grant of drug regulatory approval by the DCGI cannot, by itself amount to a patent infringement.
• The existence of patent infringement cannot be assumed merely because the patentee states so, but has to be clearly established before a court of law in accordance with the infringement provisions mentioned under the Patents Act, 1970. Such an assessment is beyond the statutory powers of the DCGI, which is institutionally incapable of dealing with complex issues of patent scope, validity and infringement.
• Cipla states that Section 107A of the Patents Act, clearly exempts from patent infringement any of acts of making, using or even selling a patented invention, in so far as such acts are necessary to obtain information for the filing of a drug regulatory application before the DCGI.
• Cipla relied on the concept of “Bolar Provision” under Section 107A of the Patents Act which permits any drug manufacturer to experiment with any patented drug and is aimed at speeding up generic entry into the market and the availability of low cost drugs to the consumer.
• Cipla states that Section 19 of the Patents Act provides limited powers to the Controller. It may at its best only direct that a reference to the earlier patent be inserted but does not authorise the controller to deny the grant of the patent itself to the applicant. Hence, DCGI cannot assess the possibility of patent infringement and dent drug regulatory approval on such grounds.
• Cipla argued that the terms ‘limitation’ and ‘substitute’ in Section 17 B (b) cannot be read in isolation to the remainder of the sub-clause. The words ‘substitute for’ were to be read along with ‘in a manner likely to deceive’. The text of the said sub clause reveals that the same covers a situation where an individual is passing off his drug as that of another by way of using deceptive marks get-up or packaging and this did not include patents.

 

ISSUES RAISED

(1) Whether a combined reading of the Drugs Act and the Patents Act lead to the conclusion that no marketing approval can be granted to applicants for drugs or formulations, of which others are patent owners, by reason of Section 2 of the Drugs Act, read with Sections 48 and 156 of the Patents Act?

(2) Whether drugs or formulations which infringe patents are “spurious drugs” under the Drugs Act?

APPLICATION AND ANALYSIS

ISSUE 1 : Whether a combined reading of the Drugs Act and the Patents Act lead to the conclusion that no marketing approval can be granted to applicants for drugs or formulations, of which others are patent owners, by reason of Section 2 of the Drugs Act, read with Sections 48 and 156 of the Patents Act?

What is Patent Linkage?

Patent linkage is the practice of linking drug marketing approval to the patent status of the originator’s product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term, unless consented to by the patent owner. This creates a duty in favour of the Drugs Controller to ensure that marketing approval is not granted to generic manufacturers in cases where the drug is already covered by an existing patent.

Difference between the objectives of the Statutes

The Drugs Act is a public regulatory measure, prescribing standards of safety and good manufacture practices which are to be followed by every pharmaceutical industry, or which are to be satisfied by the importer of a drug, to assure that what are marketed are safe. The provisions of the Act manifest Parliamentary concern with public health in ensuring standard practices, and that people do not fall prey to adulterated or spurious drugs. There is a general public policy interest in such regulation.[1]

The Patents Act on the other hand, puts in place a regime containing standards for conferring private monopoly rights in favour of inventors. It requires that processes or products, to claim patents, should involve steps that are “technical advance as compared to the existing knowledge or having economic significance or which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of the patent application.

Authority of the DCGI

The Controller of Patents and other officers are experts at judging whether claimed products or processes are patentable. This expertise is not only in respect of pharmaceutical products, but other specialized areas as well.

This expertise depends upon adjudging, on an objective basis, whether a product or process is novel, or contains an inventive step. Such expertise does not necessarily exist in the case of officials under the Drugs Act, who are required to test the safety of the product, and ensure that it conforms to the therapeutic claim put forward. Whether it involves an inventive step, or is novel, is not within the domain of the Drugs Act authorities and officials.

The existence of patent linkage standards in express legislation, in other parts of the world underscores that courts, in the absence of a Parliament mandated regime, should not blaze into an obviously legislative path. No doubt, courts can, through interpretive devices such as purposive interpretation, or for avoiding absurd results, at times “fill in” statutory gaps.[2]

Bayer relies on Section 2 of the Drugs Act and Section 156 (of the Patents Act) to contend that statutory intention is clear that Drugs authorities are bound by patents, granted under the Patent Act, by virtue of Section 156 and therefore, they cannot, by conferring drug or marketing approval permit violation of patents validly granted. However, Section 156 is a clarification, that the Government, and its officials, as grantors, are bound by the patents. This means that they have to respect patents, and cannot infringe them.

Patent Linkage in Grant of Market Authorisation

One of the important reasons to inferring Drug agencies role in patent policing or enforcement is unacceptable, is that some developed countries, and the European Union cautioned against patent linkages. [3]

The EU Directorate General for Competition noted that “Patent linkage refers to the practice of linking the granting of MA (market authorization), the pricing and reimbursement status or any regulatory approval for a generic medicinal product, to the status of a patent (application) for the originator reference product. Under EU law, it is not allowed to link marketing authorisation to the patent status of the originator reference product. Since the status of a patent (application) is not included in the grounds set out in the Regulation and in the Directive, it cannot be used as an argument for refusing, suspending or revoking Marketing approval (MA).[4]

The court also rejected the Bayer’s argument that Rule 122 B(1) (b) of the Drugs Rules, read with Form 44 and the data required (Appendix 1 to Schedule Y), gave an insight that patent linkage is intended by Parliament. The court stated a known principle of statutory construction, which said that the Parliament or the concerned legislature is deemed to be aware of existing laws when it enacts new legislative measures.[5]

Therefore, there is no patent linkage in the country and what the Petitioner wants to do is to legislate it through the interpretations, which is impermissible. The court should avoid from making any policy choices which are to be made by executive and then made by the law. The concept of patent linkage is controversial in nature, since:

(1) It clothes regulatory authorities, which are executive bodies solely concerned with scientific quality, efficacy and safety issues, with completely new powers, and into areas lack in expertise, i.e. patent rights policing.

(2) It transforms patent rights which are private property rights, that depend on the owners’ promptitude and desire to enforce them, into public rights, whose enforcement is dependent on statutory authorities, who are publicly funded.

(3) Such linkage potentially undermines the “Bolar/Early Working” exception that encourage quick access to the post patent markets for generic medicines. This is a major public policy consideration in India, which faces a host of public health challenges.

The Hon’ble High Court rightly decreed the issue in favour of the Respondents, because Whenever there is a complaint on infringement it has to be challenged before the Intellectual Property Board and suits in the High Court. Before each such body, the patentee has to establish and prove infringement, wherever alleged, and may, in some cases, face challenges to the grant of its patent. Such crucial provisions, conceived in public interest, would be rendered a dead letter, if the Drugs authorities, on a representation of the patentee were to refuse licenses or approval, to applicants who otherwise satisfy the requirement of the Drugs Act and its provisions, or even be precluded from examining such applications, on assumed infringement. Also, under the Patents Act, infringement of a patent is not considered a criminal offence. On the other hand, under the Drugs Act, violation of any of its provisions constitutes a criminal offence. If patent linkage is directed, an act of infringement which is not an offence would indirectly be alleged to be an offence.

 

ISSUE 2: Whether drugs or formulations which infringe patents are “spurious drugs” under the Drugs Act?

Section 17-B of the Drugs Act defines spurious drugs as follows:

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

Bayer states that Cipla’s generic version of Sorafanib, which, it is contended, is sold under the brand name “Soranib” would amount to a “spurious drug”. If Bayer’s contention were to prevail, every generic drug would ipso facto amount to a “spurious drug”, since they are deemed substitutes of originator (patented) drugs. Such interpretation is facially untenable and contrary to the intent of the Drugs Act. The key elements of “spuriousness” are deception, in the manner of presentation of the drug concerned, in the sense that they imitate or represent themselves to be something that they are not.

The definition of “spurious drugs’ was introduced because of the problems of adulteration of drugs and production of spurious and sub-standard drugs, as posing a serious threat to the health of the community. A declaration by the drug agency entrusted with the task of deciding applications seeking marketing approval that someone not holding a patent is attempting to get clearance for a “spurious drug” would be pre-emptive, and would negate the provisions requiring that enforcers should follow certain mandatory procedures, and prosecute potential offenders.

When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can only be legally produced for drugs which are free of patent protection. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug for a fraction of the original cost of testing and developing that particular drug; in essence, says Bayer, this is a “generic” product.

 

Therefore it was rightly held by the court in favour of CIPLA because if Bayer’s contentions were accepted then every drug would be considered as spurious drug and generic drugs are nothing but the substitutes of patented drug, whereas the key element of determining the spurious drug is deception, in a manner, that they imitated themselves as something which they were not.

CONCLUSION

The court rightly dismissed the writ petition and pronounced the judgement in favour of the Respondents. Patent Linkage forces the regulatory authorities to perform a function which is completely in different domain altogether leading to changing the nature of patent right from a private right to a public right. If at all, patent linkage has to be adopted it should make sure that it does not come in the way of Compulsory Licensing. Even though such measures are good for the benefit of investing into Research and Development, but it still discourages generic competition in the market, leading to large monopoly of pharmaceutical company due to which the accessibility of the drug is difficult and if at all the drug is made available, it is at a very higher price which is unaffordable almost by the majority section of the people. Hence, whenever there is a need and it is in the benefit of public, market approval should be granted so that the drug can cater to the public, if the situation demands then, the generic drug manufacturer can be asked to pay royalty to the patent holder. This will also discourage monopoly of foreign pharmaceutical companies in the Indian market leading to rise in Indian economy as well.

 

[1] Robert  Galantucci,  Data  Protection  in  a  US-Malaysia free trade  agreement:  New  barriers  to  market  access  for generic  drug  manufacturers, Fordham  Intellectual  Property,  Media and Entertainment Law Journal, 17 (2007), 1083.

[2] Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Available at: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

 

[3] European  Generic  Medicines  Association,  New  strategy  on patent  linkage  is  contrary  to  EU  law  and  threatens access  to competitive generic medicines, 2 February 2006, http://www.egagenerics.com/pr-2006-02-02.htm

[4] European  Union  –  DG  Competition,  Pharmaceutical  Sector Enquiry:     Preliminary     Report,     28    November     2008,  http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf

[5] Syndicate Bank v  Prabha D Naik AIR 2001 SC 1968.

 

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