MEENAKSHY V

BBA LLB , 5^TH YEAR

KRISTU JAYANTI COLLEGE OF LAW

Citation: 148 (2008) DLT 598

Judgment Delivered on :November 27, 2015

One of the most well-known incidents in India’s pharmaceutical sector is the patent dispute between Roche and Cipla over the cancer medication Erlotinib, which is sold as Tarceva by Roche and Erlocip by Cipla. In addition to highlighting the conflict between patent protection and the public’s access to reasonably priced life-saving medications, this legal case also sheds light on how India’s patent laws—specifically, Section 3(d) of the Indian Patent Act, 1970, which attempts to stop patents from “evergreening”—are interpreted.

Facts of the case

In February 2007, Roche and Pfizer asserted that they had received a patent on Erlotinib, which is sold in India under the Tarceva brand. The medication erlotinib is used to treat cancer.

In January 2008, Cipla declared its intention to introduce Erlotinib in generic form under the Erlocip brand.

In response, Roche filed a lawsuit alleging patent infringement against Cipla, claiming that the drug’s formulation infringed upon its patents.

Issues

Several legal problems were at the center of the lawsuit, including:

1.Did Indian patent law recognize Roche’s Erlotinib patent?

2.Was Roche’s patent violated by Cipla’s generic Erlotinib?

3.the use of Indian Patent Act Section 3(d), which limits the patentability of novel formulations of well-known compounds without improved efficacy.

4.Should patent protection be superseded by public interest factors like the accessibility and price of life-saving medications?

Contentions of the Petitioner (Roche)

According to Roche:

Erlotinib is a novel unique substance, and Indian law recognizes its patent. Erlotinib, according to Roche, is a unique invention rather than a simple derivation or little alteration of an already-approved drug.
Section 3(d): In this instance, the Indian Patent Act’s rules prohibiting the patenting of novel versions of well-known compounds without improved efficacy did not apply. Erlotinib, according to Roche, is more than just a derivative or polymorph of a well-known drug.
No Injunction: Despite claiming that Cipla’s Erlocip was being marketed for less, which would violate their patent rights, Roche maintained that the medication should be kept accessible because it is accessible to the general population.

Contentions of the Respondent (Cipla)

Among Cipla’s arguments were:
Cipla contended that Roche’s Erlotinib patent was invalid under Section 3(d) of the Indian Patent Act because Erlotinib is a known compound that is a derivative of Quinazolin and does not significantly improve its efficacy.
Cipla further contended that Roche’s innovation lacked an inventive step and was clear to a person with expertise in the field.
population Interest: Given that erlotinib has the potential to save lives, Cipla underlined the need of making it accessible to the general population. Many more cancer patients in India would benefit from Cipla’s generic version of the medication because it was much less expensive than Roche’s.

Relevant legal provisions
The Indian Patents Act of 1970’s Section 2(1) outlines the requirements for patentability, which include utility, innovation, and non-obviousness (inventive step).
The Indian Patents Act’s Section 3(d) prohibits the patenting of novel shapes of well-known compounds without demonstrating increased effectiveness. This clause is essential for stopping patents from “evergreening.”

In situations involving public health and access to necessary medications, Section 304 of the IPC—which deals with culpable homicide that does not amount to murder—becomes pertinent.

The Court’s ruling

Roche’s allegations of patent infringement were dismissed by the Single Bench Judgment, which decided in favor of Cipla. Among the decision’s main components were:

Public Interest: The court recognized that Erlocip was more affordable for cancer patients thanks to Cipla’s reduced price. Given that the medication was necessary for patients to survive, the judge gave public health precedence over Roche’s exclusive patent rights.

No Injunction: Roche’s request for an injunction was turned down by the court, which reasoned that it would hurt the public by making it harder to get reasonably priced medicine.

Invalidity of Patent: The court denied the injunction after dismissing Cipla’s claim of obviousness and finding that the drug’s cost and availability were more important factors.

But the Division Bench ruling overturned the ruling:

The court determined that Roche’s patent covered Cipla’s Erlocip, which was a polymorph B version of Erlotinib.The court further ruled that Cipla’s medication violated Section 3(d) of the Indian Patent Act by failing to demonstrate improved therapeutic efficacy.

According to the ruling, Cipla’s medication violated Roche’s patent because it was not appreciably more effective. Despite this, the court recognized the public interest and Cipla’s contribution to the drug’s affordability by refusing to issue a permanent injunction.

 Ratio decidendi

The reasoning behind the decision to reject an injunction was

according to the public interest premise. The court acknowledged the need of providing the people with affordable and accessible vital medications. The court considered the cost of Cipla’s generic version, which was much less expensive and would help more cancer patients, even though Roche’s patent was maintained.

Establishment of a New Legal Principle

The decision upheld the Indian Patent Act’s Section 3(d) applicability, especially with regard to barring patents from “evergreening.” The decision made it clear that little changes, such as polymorphs, that don’t improve therapeutic efficacy aren’t eligible for patent protection. This ruling established a significant precedent for how Indian patent law interprets what qualifies as a legitimate innovation.

Effects and Importance

There are important ramifications of this case for the

India’s pharmaceutical sector, especially for producers of generic medications. It emphasizes how crucial it is to strike a balance between the need for cheap healthcare and intellectual property rights, particularly when it comes to life-saving medications. Multinational pharmaceutical corporations were also strongly reminded by the ruling of India’s patent protection limitations, particularly with regard to small changes made to already-approved medications.

Critical Evaluation

The ongoing conflict in India between public interest and intellectual rights is exemplified by the Roche v. Cipla case. Although the ruling maintained Roche’s patent, it also put public health first by lowering the cost of a life-saving medication. The case is a crucial illustration of how Indian patent law might be applied to achieve a balance between promoting innovation and guaranteeing that people have access to reasonably priced healthcare. How Section 3(d) is applied

played a key role in dismissing Roche’s allegations, indicating India’s dedication to using environmentally friendly methods to stop intellectual rights exploitation.

In summary, this case illustrates India’s changing position on patent law and how it affects the availability of necessary medications. It also emphasizes how important it is for multinational pharmaceutical corporations to take into account how accessible and affordable their goods are in poor nations, especially when it comes to life-saving therapies.