1. L.Hoffmann- La Roche ltd., Switzerland
2. Osi Pharmaceuticals, New York
Defendants – Cipla Ltd, Mumbai Central
Court – High Court of Delhi : New Delhi
Decided by – Hon’ble Justice Manmohan Singh
Decided on – 07.09.2012
Topics Covered in this article
The Indian pharmaceutical company had led to major developments and reached recognition after the recommendations made by the Ayyanayar report. Hence, if these have been introduced then it would also have to face the consequences, i.e., disputes at the national and international arena.
The case of L.Hoffmann- La Roche ltd. v. Cipla Ltd, Mumbai Central is a landmark case in the history of patents, as this was a case of a dispute between the Foreign Multinational Company and the Indian generic drug companies, and the dispute set standards in the field of patent infringement and the tests necessary for the patentability of an invention.
L. Hoffman Ltd is one of the world’s best pharmaceutical and diagnostic companies in respect of research mechanisms, with healthcare of the individuals as a primary concern. The plaintiffs L. Hoffman and Osi Pharmaceuticals manufactured a drug named ‘Erlotinib ‘through the compound Erlotinib Hydrochloride, which marked a major effective breakthrough and invention in the treatment of cancer cells i.e., to cure cancer. There were various tests conducted on the drug, which showed its positive effectiveness on public health. These tests finally made it possible to get the drug administered in the form of a tablet.
As a partnership, L.Hoffman and Osi Pharmaceuticals entered into a Development Collaboration and licensing agreement in January, 2001 ,which gave Hoffman the right to use, sell and offer for sale the licensed products including ‘Erlotinib’ ,which made the company the licensor of the drug. The tablet formulation of the drug ‘erlotinib’ was sold by the plaintiff (L.Hoffman) under the trademark of ‘Tarceval’, which made L.Hoffman, the original proprietor of the drug and its formulation and was also approved by the U.S Food and Drug Administration in 2004 and the European Union in 2005. The drug was also granted a patent by the Controller General of Patents, Trademarks and Designs, New Delhi in 2007.
The plaintiff (Hoffmen ) after receiving the patent for the drug, and also because of its claimed right to sell, manufacture and sale the drug Tarceva in various countries, finally introduced the drug ‘Tarceva’ in the year 2006 in India by Roche Scientific Company (India) pvt ltd, which was a subsidiary of the of the Roche Group in India, and gained a wide publicity by the media, for its effective treatment for cancer.
The dispute arose when L.Hoffman – Roche ltd came under notice that the defendants Cipla Ltd were also engaged in the manufacturing and marketing of healthcare products, and learnt from a publication in the newspaper in Delhi- The Hindustan Times that the defendants were engaged in the manufacturing of the generic version of the drug ‘Tarceva’ not only in India, but would also export it to other foreign countries. The Plaintiffs held this action of the defendants as to the violation of their Intellectual Property Rights, and filed a plaint against the defendants in the Delhi High Court, claiming damages and compensation.
- Whether the manufacturing and selling of Erlocip by the defendants has infringed the rights of the plaintiffs
- Whether the Indian Patent Act is revoked on the grounds of counterclaim?
- Are the plaintiffs liable to seek permanent injunction from the defendants?
- Whether the defendants counter claim stating that the suit patent is a mixture of two polymorph compounds and are need to be separated
- Is there infringement of the patent against the plaintiffs? (Relief)
- The plaintiff claimed that as per in accordance with Section – 48 of the Patents Act, 1970, it has been complied that the patentee being the original registered owner has an exclusive right to prevent any third parties from using the product or the process i.e., Cipla Ltd should be restrained from manufacturing the process; and under Section- 68 has complied that when the license agreement has been signed between the companies, there was compulsory licensing provided to the plaintiff, which embodied all the terms and conditions.
- The plaintiff then claimed that being the registered owner of the patented drug ‘Tarceva’ which has been developed with a long and substantial research are liable to get protection of the invention and also that no other person is liable to use the product other than the authorized owner.
- They contended that by using the invention in the unlawful manner, had also infringed the legal rights of the plaintiff.
- The plaintiffs stated that the defendants should be directed to render all accounts in relation to such infringing activities as well as to give damages to the plaintiffs for the violation of their legal rights.
- The plaintiff filed an interim application under Order XXXXIX, Rule 1 & 2 of the code of civil procedure stating that the defendant has been selling and marketing the disputed product in the market for three weeks, for profits.
- The plaintiffs contended to the plaint and stated that there was no filing of the copy of the specification, and the patent has been granted under suspicious circumstances to the plaintiff.
- The patent in the question was likely to be revoked, because the Quinazoline compound inhibits growth and is used to treat cancer cells and are easily available in the market. Thus, it being a derivative of a compound is not liable to be patented under Section-3(d) of the Patents Act.
- The alleged patent product is a derivative from Gefitnib of AstraZeneca for which a patent was refused in India on the ground that it was already in use and in public domain, and the patent office should not have granted a patent because erlotinib was a derivative of Gefitinib, and the plaintiff was actually trying to establish ever-greening.
- The defendant also affirmed that the drug was actually a life saving drug, made in the public interest of the public use to cure cancer, and also the former was selling the drug at Rs. 4,600 while the latter was selling the drug at Rs.1,600 and thus cannot be granted injunction.
- The defendants stated that the plaintiffs had failed to place a copy of the licensing agreement. They also stated that they have been granted approval by the Government of Goa to sell the medicines, and were selling them since December, 2008 and denied the propositions filed by the plaintiff.
- The defendant also filed a counterclaim on various grounds under Section- 64 of the Patents Act, 1908.
- The Plaintiffs filed an interim order application before the division bench for claiming injunctions from the defendants but was rejected by the Division Bench. The defendants then challenged the order of the division bench and filed a special leave petition under the Supreme Court and the court also dismissed the same.
- The court on deciding the revocation of a patent stated that there was no lack of inventive step in the patent in the suit, and the defendant’s plea was rejected. The court stated that as the issue is raised in the Jurisdiction of the Indian Courts so it’s necessary to discuss the Indian Patents Act, 1970 to determine the obviousness and inventive step in the patent.
This has been laid under Section – 2(1) (ja) defining the inventive step.
The Supreme Court has discussed the test of obviousness and novelty in the case of Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries, 1982 and held that it depends on the facts and circumstances of the case and is to be seen from the technological advancement as well as obviousness of a skilled person of art, and the decision was thus based on the following judgment.
The court rejected the defendants’ plea on the basis of weak evidence, was not able to show the appropriate selection of the compound and was held to be arbitrary in nature. Thus, no ground of obviousness and or lack of inventive step under Section – 64(1)(f) of the Indian patents Act, is made out due to the inability of the defendant.
The court also held that the plaintiff did not violate the provisions of Section -3(d) and rejected the claim filed by the defendants.
- The court also held that the plaintiff had violated section-8 read with Section-64, but there was a discretion to revoke or not to revoke, and thus stated that on the ground of non-compliance of Section -8 of the act by the plaintiffs, the suit patent cannot be revoked. Thus, it was decided in favour of the plaintiff.
- The defendants counter claim by the defendant as that mixture of two polymorph compounds needs to be separated was decided in the case of defendants.
- The plaintiff’s plea to grant an injunction was also rejected by the court because the defendants making and manufacturing the medicines was also in the interest of the public domain.
The case was thus decided in the favor of Roche ltd and cipla was made liable to render accounts on the manufacturing and selling of the medicines and decreed costs in favour of Roche of Rs.5, 00,000.
The court had dealt with the issues with utmost due diligence, and also in a very concrete way have given justice to both the parties i.e., the plaintiff and the defendant. It had also laid down the guidelines for the test of infringement and test to determine the novelty of an invention.
However there are few points like, the court did not specify the patentability of an invention, and also should have determined the patentability in accordance with the US and European Union patent office.
Thus it can be concluded by stating that before a patent is granted, the patentee has to describe in the patent application, the invention with such clarity and completeness of all the technical details that anyone having ordinary skill in the art should after merely reading the description, be able to carry out the invention. In other words, before a patent is granted the invention has to be disclosed. The disclosure of the invention provides useful information to the public, which helps in avoiding wasteful duplication of effort and the multiplication of costs that research aimed at finding solutions to technical problems can entail.
If the patent is inappropriately used by the party it may lead to the infringement of that particular patent and invention, which would lead to injunction and compensation and awarding of relief. The case of Roche v .Cipla has been a landmark case in the terms of Patent rights and infringement and the court has rightfully acted in the case, providing justice to the parties and laying the tests provided for infringement.
 Cs (Os) No.89/2008 And C.C. 52/2008.
 The Patents Act, 1970, s.48.
 Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries, 13 December, 1978.