In this article, Dr.V.Ramprasath Manohar who is currently pursuing M.A. IN BUSINESS LAWS, from NUJS, Kolkata, discusses Lawsuits on Patent Infringements In India And Pharma Patents.

Introduction

Patent gives exclusive rights to the owner to treat his intellectual property well by protecting it from others. Therefore enforcement of patent right is the major function of Indian Patent Act 1970. Whenever any patent applicant or patent right holder is aggrieved in enforcing his patent right under Indian patent act, he can approach the appropriate judicial authority to enforce his patent rights by way of filing law suits for infringement. This essay illustrates the patent jurisprudence in India with various case studies on law suits on patents infringement and pharma patents.

Patent Jurisprudence in India

• The Indian Patent Act 1970 is an act which covers the patent jurisprudence in India. This act was amended in 1999, 2002 and 2005 to adhere to the WIPO and TRIP guidelines on Patents. With these amendments, there is a paradoxical change in patent regime in India.
• The process patent of Indian patent regime is extended to product patent regime and the drugs, agriculture, and pharmaceutical sectors also being covered in new patent regime. Since 2005 amendments, there are many litigations on patent right infringements and therefore patent jurisprudence is evolving with various judgements on many patent related cases by High court and Supreme court.
• Indian patent law protects both product patent and process patent.
• In case of process patent infringement, the burden of proof lies on the defendant and in case of product patent infringement the burden lies on the patentee. It is important to have a strong IP regime in order to promote innovation and also to attract new investments in India. Further strong IP regime also promotes research and development in India and consumer will also be benefitted with new innovative products.

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Law suits on Patent Infringements

Patent infringement is not defined in Indian patent Act, but patent rights are described in the act. Patent right includes making, distributing, mortgaging, or selling the invention in India. Therefore, anything which interferes such patent rights may be considered as infringement of patent rights.  Hence, unauthorized making, using, offering for sale, selling any patented invention, or importing into India of patented invention during the live term of a patent may be considered as patent right infringement. In the initial phase, law suits of patent infringement were dealt with the tradition of civil suits of Indian court and civil remedies were awarded. Over the years, patent jurisprudence evolved and judgements on patent suits are centered on enforcement of rights of patent holder.

Over last 2-3 years number and nature of patent litigation has evolved dramatically. Innovators have not restricted themselves to mere gaining patent protection for their invention, but also aggressively protecting their patent right from being infringed upon by their competitors. Therefore, in recent years, protection and enforcement of patent right are the major points of patent litigation. Further, patent holders are also aggressively litigating to challenge the claim of new patent by their rivals.

Case studies on law suits on patent infringements and pharmaceutical patents in India

Gleevec case of Novartis case

• In this case, Novartis , a swizz based pharma company applied for patent right of its beta crystalline form of Imatinib mesylate( Gleevec). The patent claim was objected by CIPLA and other generic drug producers. The patent claim was rejected by Indian patent office and a writ petition was filed in Hon.
• Madras high court. Novartis has questioned the constitutional validity of 3(d) section of the patent act. Novartis contended that the term ‘efficacy’ in section 3(d) is vague and ambiguous and against article 14 of the Constitution of India. However, Hon. Madras High court dismissed writ petition and upheld the constitutional validity of section 3(d).
• Second appeal was filed by Novartis in Intellectual Property Appellate Board (IPAB) and IPAB has upheld the novel and invention aspect of Novartis claim, but rejected the claim of patentability under section 3(d). This order of IPAB was challenged in the Hon. Supreme court of India by filing an SLP.
• However, in 2013, the Hon. Supreme court of India has dismissed SLP and upheld that the Novartis claim was failing on both the test of invention and patentability as per the provisions of section 2(j), (ja ) (l) and section 3(d) of the patent act.
• The landmark judgement in patent litigation is epitome of patent jurisprudence in India. Because, the judgement of the Hon. Supreme court of India is illustration of balancing between the patent holder right and public right. It was clearly stated that evergreening of patent by patent holder and exploitation of general public and prohibition of competition of rivals are not the intention of the patent act.
• Indeed, the Hon. Supreme court upheld in paragraph 191 of the said judgement clearly stated that section 3(d) is valid and it does not disallow any right to patent on incremental innovation provided that the said incremental innovation fits into test of patentability.

Ericsson vs. Xiaomi case

• In this law suit, Ericsson filed a suit against Xiaomi in India in December 2014 to protect its patent right on the 8 standard-essential patents. An ex-parte injunction on the sale, manufacture, advertisement and import of Xiaomi’s devices was imposed by the Hon. Delhi High court.
• The Hon. Delhi high court injunction order was challenged by Xiaomi before a Division Bench of the Delhi High Court. A temporary order was issued by division bench to allow Xiaomi to resume the sale, import, manufacture, and advertisement of its mobile devices subject to the condition that Xiaomi would only sell devices having Qualcomm chips and royalty of Rs 100 per device would be deposited by Xiaomi.
• In this case, patent right infringement is averted by issuing injunction order against Xiomi to exploit patent rights of Ericcson and also remedies are provided to balance the right of patent holder as well as the user of patent.

Merck vs. Glenmark case

In this case, the Hon. Delhi High court passed injunction against Glenmark for manufacturing the generic drug Sitagliptin and using patented product of Merck Sharp. In this case, the Hon. Delhi High court upheld that there was Prima facie infringement of patent rights of Merck over its patented product sitagliptin and irreparable injury was also found to be caused to patent holder. Hence, balance of convenience is in favour of patent holder ie. Merck. and therefore the Hon. Delhi High court passed injunction order against Glenmark from manufacturing and selling of Zita and Zitamet. There by, patent rights of  Merck was protected and enforced.

Novartis vs. Cipla case

In another patent suit, Novartis filed suit against Indian generic drug maker Cipla from making or selling generic copy of Novartis’s “Onbrez”. In this case, temporary injunction was issued by Hon. Delhi High court against Cipla to protect the patent right of Novartis. The Hon. Delhi High court has cited Roche vs Cipla case, and observed that a strong prima facia case was established and validity of the patent of Novartis was not strongly disputed by Cipla. Further, Cipla’s counter arguments on the basis of “epidemic” or a “public health crisis”, unable to manufacture the same in India by Patentee and high cost of patented drug were not accepted by the Hon. Delhi High court. Therefore, claim of “urgent unmet need” for the drug in India was rejected by Hon. Delhi High court. Hence, the court granted injunction against Cipla to prevent patent infringement of Novartis.

This case is a classic illustration of patent jurisprudence in India to enforce the patent rights in a fair manner and to prevent inappropriate application of exemption clauses under patent act with a vested interest to infringe the patent rights of patentee. Further, the apprehension about the possibility of discrimination between MNC and Indian company in Indian patent regime was proved to be wrong.

SYMED Labs vs. Glenmark Pharmaceuticals case

In another case of SYMED Labs vs. Glenmark Pharmaceuticals, Glenmark Pharmaceuticals Laboratories was allegedly infringing two of SYMED patents: IN213062 & 213063. SYMED filed suit against Glenmerck in Delhi high court.

The court observed that there was a prima facie case in favour of SYMED. Further, the court also observed that protection to the patent processes ought to be granted to the SYMED as damages will not be an effective remedy. Thus, there will be irreparable loss and injury due to the misuse of patents by Glenmerck. Further, the balance of convenience was also found to be in favour of SYMED. Thus the court granted an ad interim injunction restraining Glenmark from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the production of Linezolid. Thus, infringement of the SYMED’s registered Patents was effectively remedied by the court.

Vringo vs. ZTE case

• In this case, Vringo and Vringo Infrastructure alleged that ZTE has infringed patent rights of Vringo patent IN200572. A suit was filed by Vringo against ZTE against infringement of patent in the Hon.
• Delhi High court in 2014. In this case an ad interim ex-parte injunction was granted to restrain ZTE from importing, selling, and advertising, installing or operating devices that comprise the infringing components of Vringo. However, ZTE has contested innovativeness of Vringo patent and Hon. High court has appointed commission to look into the technical aspects of patent.
• This case is illustration that the post grant patent objection is also being considered by the Indian patent jurisprudence during the hearing of patent infringement cases. Therefore, patentability and innovativeness of patent may also be tested after grant of patent. This ensures that patent is not only under scrutiny during grant of patent, but also during its enforcement.

Maj. (Retd.) Sukesh Behl & Anr. vs Koninklijke Phillips case

In this case counterclaim for revocation of the suit under Section 64(1)(m) of the Patents Act, 1970 (for short “the Patents Act”) for non-compliance of the provisions of Section 8 was made by Sukesh Behl. In the original suit Koninklijke Phillips has sued for permanent injunction restraining Sukesh Behl from infringing its patent and for other incidental reliefs. However, the court examined counterclaim for revocation and observed that the failure to comply with the requirement of Section 8 of the Patents Act would invariably lead to the revocation of the suit patent under Section 64(1)(m) of the Patents Act. This is significant judgement in a complex patent jurisprudence to revocation of the suit on patent infringement.

Patent Revocation in Roche case

• In this case, a patent granted to Roche for Valganciclovir was revoked by controller of patents. The patent for Valganciclovir was granted to Roche in 2007 in India. The grant of the patent in India also looked as restrictions or a threat to cheaper generic versions of the drug that cannot enter the market. The principle ground for revocation of the patent was non patentability under section 3 (d) of the Indian Patent Act, 1970.
• Further, the drug formulation was alleged to exist before grant of patent and “efficacy” of patented drug over old drug was also questioned. The arguments were made stating that the drug was having improved bioavailability where whether the improvement of oral bioavailability constitutes enhancement of the known efficacy of that substance was discussed.
• By considering the thorough arguments The Controller ruled that the present patent was a ‘mere use of a known process’ which was not patentable under Section 3(d), Patents Act as well as known by the prior arts. Therefore on consideration of all the above arguments and evidences the patent granted to Valganciclovir was revoked. Thus, this case illustrates the evolution of Indian patent jurisprudence to revoke the patent claim during patent litigation.

Natco and Bristol Meyers Squibb case

• NATCO and BMS has made a settlement in the matter of drug named “Entecavir”. The drug is used in the treatment of hepatitis B infections and the dispute of the patent concerned the use of “Entecavir” oral composition once in a day. Prior to 1995, Indian Patent Act was not granting product patents and hence the drug did not process an Indian patent. Hence, many pharmaceutical companies infringed patent rights of patentee and launched their own generic product.
• Therefore, injunction was granted against Ranbaxy when they had launched the generic version of the same drug. When, the issue was raised against NATCO when they had launched their independent drug, X-Vir and challenged BMS in IPAB and settlement was entered with BMS. Thus, the alternative ways to protection of patent right through settlement among disputed patentee is an innovation of Indian patent jurisprudence.

Conclusion

• The patent regime in India is mainly governed by the Indian Patent Act 1970 which was amended in 1999, 2002 and 2005 to adhere to the WIPO and TRIP guidelines on Patents. Since 2005 amendments, there are many litigations on patent right infringements and therefore patent jurisprudence has evolved over the years with various judgements on many patent related cases by High court and Supreme court. The patent validity is being tested for innovativeness and patentability of patent.
• The claim of patent by the patentee during the law suits are being tested for the above two aspects. If the court is not convinced with these aspects, in many cases, the patent claim of patent applicant was dismissed by Indian judiciary.
• However, if the patent right is established by the patentee, by establishing three essential elements like prima facie case, irreparable injury and balance of convenience, in such cases, injunction orders were passed by the courts to prevent the infringement and suitable remedies to protect the patent right were also passed in various law suits of patent infringement.
• Post grant verification of patent during litigation, revoking of patent on counterclaim and settlement of claim among the disputed patentee are the other alternative innovation of Indian patent jurisprudence to protect and enforce patent rights without affecting public interest. Further, in few case, misuse of exemption clause of pharmaceutical patents was also injuncted by Indian judiciary.
• Non-discriminatory, fair, and innovative patent protection of patent rights and users of patent are the highlights of various patent case judgements in various law suits of patent infringements.

References:

1. Patent infringement suit by Dolby against oppo and vivo by Khurana and khurana
2. Pharma Patent Infringement Cases in India- Intellepedia
3. spicyip.com
4. http://www.thepharmaletter.com/article/plethora-of-pharma-patent-infringement-cases-in-india
5. Landmark pharma patent jurisprudence in India, vol 19 Journal of Intellectual property rights, March 2014.