Puru Pratap Singh, GNLU
Deepsea Chakraborty, Army Law College, Pune
Patent infringement in regard to a patented invention without a prior approval from the patent holder is a prohibited act. A patent infringement case not only includes a question of law but also a complex technical queries, which are central to be determined for a proper and just adjudication.
India amended the Patents Act in the year 2005 to allow grants of patent protection to pharmaceutical products, which were earlier limited to processes only. However, when the Patent Product Regime was presented in 2005, the domestic industry transformed into one of the biggest manufacturers of generic drugs which brought it in direct conflict with the innovator pharmaceutical companies. The trends observed in India concur with the global trends although the volume of patent litigation in India has seen a spike only after 2007. The Delhi High Court has been the busiest with patent litigation and has become a hub for patent law in India. Its judgements are getting noticed not only by other high courts but also at international forums.
Two such judgements to gain both national and international attention in the world of patent law are:-
F. HOFFMANN-LA ROCHE LTD. AND ANR. Vs. CIPLA LTD.
Over the years India has witnessed several patent disputes between foreign multinational Pharmaceutical companies and Indian generic drug companies. But then, the suit between Roche and Cipla has surely set the standards when it comes to a patent infringement suit. The case is the first Patent Litigation in India post India’s 2005 Product Patent Regime which included public interest and pricing issues in addition to Section 3(d) that prevents evergreening. The case was followed by Pharma giants globally.
The Roche vs. Cipla saga concerns the patent rights in the compound Erlotinib Hydrochloride (Patent IN ‘774), sold by Roche by the name of ‘Tarceva’, and introduced in India in April, 2006. Cipla began selling a polymorph of Erlotinib Hydrochloride in India under the name ‘Erlocip’ since late 2007, which provoked Roche to sue Cipla in 2008, beginning a chain of litigation.
Decade Long Litigation
a. Apart from adjudication of the core issues of validity and infringement of its patent, Roche filed for an interim relief against Cipla which was rejected by a Single Judge Bench of the Delhi HC. Though the judge ruled that Roche had a prima facie case against Cipla, he cited ‘public interest’ as the reason for holding against Roche, remarking that a month’s dosage of Tarceva cost around 1.4 lakhs whereas the equivalent cost of Elrocip was only Rs. 48,000. The balance of convenience was held in Cipla’s favor.
b. Roche then appealed against this decision which the Divisional bench of Delhi HC upheld. The bench ruled that Roche lacked a prima facie case and not only was Cipla’s infringement unclear, serious doubt appeared over Roche’s very patent. Roche then appealed to the Supreme Court against this order in the form of an SLP, which proved unsuccessful.
c. The central issues were put before another single judge bench of the Delhi HC, who held that though Roche had a valid patent, Cipla could not be held for infringing it. This was challenged by both Cipla and Roche, resulting in the 2015 Delhi HC division bench decision. The division bench had ruled in favor of Roche, upholding not only the validity of its patent IN ‘774, but also that Cipla had infringed it by manufacturing Erlocip, imposing a cost of Rs. 5 Lakhs on the latter.
e. After a spate of legal proceedings, on 30th May 2017 both the pharma majors finally came to an agreement and reached a settlement. In June 2017, Cipla moved the SC seeking to withdraw the SLP.
This was a surprising progress, considering it was one of the biggest cases where mediation was initially advised by the Delhi HC and had failed. The settlement marked the end of the first pharma patent case in India in the post TRIPS era, bringing a monumental chapter of India’s patent law to a full stop.
NOVARTIS A.G. VS. UNION OF INDIA
In the year 1997, Novartis a Swiss pharmaceutical, filed a patent application as per the TRIPS Agreement for the drug Glivec renowned for its capability to cure Chronic Myeloid Leukaemia and Gastrointestinal Tumours, before the Chennai Patent Office, on the grounds that it was made out of a new form of the chemical ‘imatinib mesylate’. The patent was filed at time when Section 5 of the Patent Act, 1970 only recognised processes and methods and not the product itself. When the application came under review in the year 2005, the section had been repealed to also include products within its ambit. The patent application was rejected by the Madras Office on the grounds that it did not qualify the test laid down by Section 3(d) of the Patent Act, which reads as follows-
“(d) 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. Explanation. -For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”
It was alleged that there was no considerable change in the efficacy of the drug over the pre-existing form. The order was challenged in the Madras HC through a petition under Article 226 of the Constitution, pleading that Section 3(d) was unconstitutional due to its non-compliance with the TRIPS agreement and its violation of Article 14. It was decided that by the Intellectual Property Appellate Tribunal to which the case was transferred that the drug has to satisfy the test laid down by the section which is not unconstitutional in nature for it has been laid down to tackle exploitation and to provide easy access to life saving drugs to the citizens of India.
Post this a Special Leave Petition under Article 136 was filed at the Supreme Court of India.
Key Issues Framed
1. Whether the invention is consistent with Section 3(d) of the Patent Act?
2. What is the meaning of efficacy?
3. Whether the new form of imatinib mesylate is more efficacious than the existing form?
For the first issue the Supreme Court recognised that the new beta crystalline form of the chemical is one whose efficacy is well-known. For the second issue it was held that efficacy for the purpose of Section 3(d) is strictly restricted to therapeutic efficacy and recognised that all properties of the chemical are not relevant when it comes to determining therapeutic efficacy. In the third issue it was ruled that even though there is a 30% increase in the bio-availability of the new form of the chemical and other improvements that the drug brings with it, none of them qualifies as an increase in therapeutic efficacy. Therefore the SLP filed by Novartis was rejected.
Inspired by the Indian Supreme Court Judgement in this case, South Africa in its draft IP rights policy proposed stricter patent criteria.
“The fact that Section 3(d) of India’s Patents Act withstood a challenge in the Indian Supreme Court when Novartis failed to patent cancer medicine Glivec, shows our government that you can stand up to pharma pressure and use these safeguards to protect your people,” Lotti Rutter, advocacy & campaign manager of South Africa’s Treatment Action Campaign (TAC), told Intellectual Property Watch. “The fact that Novartis threatened to withdraw their pharmaceutical operations from India during the case, only to expand their investment after the judgment, also tells our government that Big Pharma’s threat that using TRIPS flexibilities will lead to less foreign investment is a lie. TAC joined in global protests in solidarity with Indian activists against Novartis.”
Several activists in Thailand and Argentina too are using this judgement to pursue their respective governments to revisit the restrictions on patents especially when it comes to evergreening patents i.e. patents which are filed for the sole purpose of earning royalties without many changes. This move comes with a special emphasis on essentials such as medicine.
 https://www.mondaq.com> Patent Laws in India, (2017).  The Patents (Amendment) Act, 2005, No. 15 Sec. 3, Acts of Parliament, 2005 (India).  148 (2008) DLT 598, MIPR 2008 (2) 35.  Indian Patents Act, 1970.  2013 6 SCC 1.  Section 3(d), Patents Act, 1970.  ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict/