ROCHE VS CIPLA

PATENT
INFRINGEMENT
CASE
INTRODUCTION OF THE CASE

 There was a significant legal case involving two big companies: Hoffman-La Roche
Ltd., which is a Swiss multinational healthcare company (we'll call it Roche), and
Pfizer, a US-based company. They were on one side, and on the other side was Cipla
Ltd., which is a big Indian pharmaceutical company (we'll call it Cipla).
 Pfizer and Pfizer Items, Inc. jointly received a patent (a legal protection for their
invention) for a medicine called 'Erlotinib,' with the patent number 196774.
 Roche introduced this patented medicine in India in 2006, selling it under the brand
name 'Tarceva.' At the same time, Cipla wanted to sell a generic version of 'Erlotinib'
under the brand name 'Erlocip.' This disagreement led to a legal dispute between these
companies.
OVERVIEW OF PATENT INFRINGEMENT

 A patent is like a special permission given by the government to the person who
invents something new. This permission allows them to be the only ones who can use or
sell their invention for a certain time. It's a bit like having a special right to do
something that no one else can.
Breaking this rule and using or selling someone else's invention without permission is
illegal. It's important for people and companies to know about these rules and what
happens if they break them. You should protect your own inventions and make sure
you're not using someone else's without permission.
 In today's fast-moving world, it's even more important to understand these rules
because they can impact how new things are created and how things progress.
OVERVIEW OF PATENT INFRINGEMENT

 There are two main types of breaking these rules:

 Direct Infringement: This happens when someone makes, uses, sells, or tries to sell
an invention that's already patented without getting permission.
 Indirect Infringement: This is when someone indirectly helps or encourages others to
break the patent rules. For example, if they know someone is using a patented invention
without permission and they help them do it, they're also breaking the rules.
HOW THE CASE REACHED THE COURT

 Patented Drug Ownership: Hoffman-La Roche and Pfizer, collectively referred to as "the Plaintiffs," held
the patent for a ground breaking cancer treatment drug known as Erlotinib. This drug was recognized for its
ability to target cancer cells while sparing healthy ones from harm.
 Indian Patent Grant: The Plaintiffs were granted exclusive patents for Erlotinib in India on July 6, 2007.
 Generic Drug Production: Cipla, an Indian pharmaceutical company and "the Defendant" in this case, took
steps to manufacture and market a generic version of Erlotinib.
 Legal Action Initiation:
 On January 15, 2008, The Plaintiffs responded by initiating a lawsuit against the Defendant, alleging patent
infringement. Their legal action aimed to secure a permanent injunction to prevent the Defendant from
selling the generic drug and to seek damages for the alleged infringement
 The plaintiff contended that Erlotinib, a drug developed after extensive research and significant financial
investment, was legally protected.
 KEY ARGUMENT FROM CIPLA

 Cipla argued that they sold the generic version of Erlotinib, Erlocip, from October 2007. They pointed out
that the patentee's rights accrue from the patent's grant date, and the certificate Roche obtained was dated
February 2007, but the pre-grant opposition was resolved in July 2007.
 Cipla contended that Erlotinib's patent was invalid as it was a derivative of a known patent, 'Quinazoline.'
They argued that Erlotinib's composition was similar to Quinazoline, with an obvious substitution. They
invoked Section 2(1)(ta) of the Patents Act 1970, emphasizing the lack of inventive steps.
 Cipla also argued that for a drug to qualify for a patent under Section 3(d), it must demonstrate an improved
efficacy, which Erlotinib lacked.
 They highlighted that Erlotinib was merely a derivative of Gefitinib by Astrazeneca, for which India had
rejected a patent application.
 Cipla emphasized public interest, citing a substantial price difference between Roche's and their drug. They
stressed the drug's life-saving nature, urging consideration of the public interest in granting an interim
injunction.
 Lastly, Cipla contended that the plaintiff had withheld vital information about the drug, alleging it was a
mixture of polymorphs and unsuitable for pharmaceuticals.
 COURT RULINGS – SINGLE JUDGE

 In the judgment dated March 19, 2008, the single judge highlighted two critical issues related to Roche's
patent:
 The claim made by Cipla that the patent should be deemed invalid due to its apparent obviousness, as
Erlotinib was a derivative of a known compound.
 According to Section 3(d) of the Patents Act, Cipla argued that the "increased efficiency" criteria were
not met. However, the single judge bench outrightly rejected this argument and held that it was not
obvious for a skilled person in the same field to replace methyl with ethynyl.
 Cipla's second claim, centered around public interest, was accepted by the single judge bench. They
argued that Cipla's generic version of Erlotinib, being available at a significantly lower price, was
crucial, especially considering the drug's life-saving nature. Cipla's drugs were also manufactured in
India, not imported.
 The court faced a choice between ensuring affordable access to life-saving drugs and issuing an
injunction during the trial.
 The single judge rightly prioritized the former, rejecting the injunction plea, as it would unnecessarily
harm many innocent individuals who are not even party to the suit
SECTION 3(D) OF THE INDIAN PATENTS ACT

 Section 3(d) of the Indian Patents Act is a crucial provision that deals with the patentability criteria for pharmaceutical
substances and related inventions.
 It was introduced as an amendment to the Indian Patents Act in 2005 and is primarily aimed at preventing the
"evergreening" of patents.
 Evergreening refers to the practice of extending the life of a patent by making minor changes to an existing drug or
invention, without substantially improving its therapeutic efficacy.
 It promotes genuine innovation in the pharmaceutical industry while preventing the misuse of patent rights to prolong
monopolies on essential medicines.
 It ensures that patents are granted only to inventions that provide a real and significant therapeutic benefit over existing
knowledge.
 This provision has been important in facilitating access to affordable medicines in India and has been a subject of debate
and litigation in several high-profile pharmaceutical patent cases.
 COURT RULINGS - DIVISION BENCH

Roche filed an appeal against he order of the single Judge arguing that a failure to protect the right of patentee that
would discourage research in pharmaceutical field
 Non Infringement: The division bench conclusively ruled that there was no patent infringement. The core
issue revolved around the patent in question, which combined Polymorphs A and B, while the Tarceva drug
contained only Polymorph B.
 Roche’s Patent Rejection: Roche had previously sought a patent exclusively for Polymorph B, but the
Indian Patent Office rejected this request. The rejection stemmed from the failure to meet the criteria set forth
in Section 3(d) of the Indian Patent Act and the broader patentability assessment.
 Consideration of Legislative Intent: The court took into account the legislative intent that underpinned the
creation of Section 3(d) and related anti-evergreening provisions. In this regard, the court prioritized the
broader public interest.
 Recognition of Life-Saving Drug: The court recognized the critical nature of the case, given that it involved
a life-saving medication. Consequently, the drug made available by Cipla was priced at a fraction of Roche's
product, ensuring broader accessibility and affordability.
 Thus the court dismissed Roche’s appeal & upheld the order of the single judge.
COURT BATTLES – FURTHER APPEALS

 Roche subsequently appealed the Supreme Court against this order in the form of an SLP, but this appeal
was unsuccessful.
 The key issues were then brought before another single judge bench of the DHC, who ruled that although
Roche had a valid patent, Cipla could not be held responsible for infringing it. This inconsistent decision
was challenged by both Cipla and Roche, ultimately leading to the 2015 DHC division bench decision.
 In this decision, the DHC division bench sided with Roche, affirming the validity of its patent IN ‘774 and
ruling that Cipla had infringed it by manufacturing Erlocip.
 They imposed a cost of Rs. 5 Lakhs on Cipla.
 Cipla then filed an SLP against this decision, which was accepted by the Apex Court in 2016. The court
heard arguments about appointing a technical expert, after which the matter was adjourned.
FINAL SETTLEMENT

Following a series of legal proceedings, in 2017 the prominent pharmaceutical companies

ultimately come to a settlement, thereby withdrawing all ongoing litigation against each
other.
This marked the end of a decade long battle – a first of its kind patent case in Indian Pharma
sector
IMPACT ON THE PHARMACEUTICAL
INDUSTRY:

 The case underscored the importance of public access to essential medicines.

 It discouraged pharmaceutical companies from attempting patent evergreening.
 It highlighted the courts' role in considering public benefit while granting or denying
patents.
 The case potentially set a precedent for other patent disputes in the pharmaceutical
industry, favouring public interest over strict patent protection.