Generic Medicine and its

Protection
► India is known as the ‘pharmacy of the developing world.’ Medicines produced by
generics companies in India are among the most affordable in the world.
► A generic drug is a pharmaceutical drug that contains the same chemical substance as
a drug that was originally protected by chemical patents.
► Before 2005, India did not grant product patents on medicines. This allowed for the
production of low-cost generic versions of medicines that were patented in other
countries. Competition among generic producers in India has brought the price of
medicines to treat diseases such as HIV, hepatitis and cancer down by more than 90
percent.
► India thus became a key source of essential medicines at an affordable price, such as
antiretroviral medicines (ARVs) to treat HIV. Over 96 percent – and growing – of all HIV
medicines purchased by donors for use in developing country treatment programmes
come from India.
► As a member of the World Trade Organization (WTO), India was obliged to
start granting pharmaceutical patents in 2005, and has since granted
thousands of patents for medicines.

► However, when amending their patent law to comply with the new WTO
rules, Indian lawmakers decided to set the bar high for what does and does
not merit a patent, in the interest of public health.

► India awards patents for new pharmaceutical compounds. But the

amended patent law was specifically designed to limit ‘evergreening.’
► Evergreening is when companies try to extend their patent monopolies by
additional years by making modifications to existing medicines (e.g.
combining multiple existing medicines into one pill).

► ‘Evergreening’ or ‘secondary’ patents are routinely granted in wealthy

countries, but India chose to prioritise public health over pharmaceutical
industry interests. This public health approach to setting strict patent standards
is in line with international trade rules and better provides for the robust
generic competition that keeps medicine prices low.
 Relationship between
Generic(affordable) medicine and IP
► When a pharmaceutical company is awarded a monopoly in a specific country, the company
gains a right to block generic competition in that country for a specific period of time.
► The patent prevents other companies from easily registering and/or selling the medicine in that
country for the duration of the patent term, which is a minimum of 20 years for pharmaceutical
patents. Companies can thus charge high prices because there are no competitors in the market.
► When the patent terms expires, multiple generic producers can then produce medicines, thereby
driving the price down. Competition among multiple producers is the best way to bring prices
down.
► Competition among generic manufacturers in India helped bring the cost of HIV treatment down
from over US$10,000 per patient per year in 2000 to around $100 today. With the availability of low-
cost affordable generic drugs from India, nearly 14 million people living with HIV today receive
treatment.
► Due to India’s obligation under WTO and TRIPS Agreement Indian generic manufacturers are not
able to automatically produce cheaper generic versions of these medicines.
 NOVARTIS AG AND ORS V. UOI AND
ORS (2015)

► Discussed the meaning of efficacy in detail.

► Efficiency means the ability to produce a desired or intended result.

► The test of efficiency in the context of S.3(d) would be different depending upon the result
of the product unless consideration is desired or intended to produce

► It would depend upon function, utility or purpose of the product under consideration.
► Eg. If it is a medicine if it claims to cure the disease, the test of efficiency
can only be therapeutic efficiency.
 FACTS

► Novartis AG developed drug which cured blood cancer called Gleevec on which patent was
claimed.

► Novartis claimed grant of patent on imatinib mesylate in beta crystalline form.

► In India prior to this case product patent was not granted.

► A mailbox application for grant of patent was made by Novartis AG.

► Novartis had EMR which was granted in the year 2003 and thereby the application made
for grant of patent was scrutinized in 2005.

► IPO rejected the patent application on the ground that the application claimed patent
on an already known substance without any change in the efficiency as required under
S.3(d).

► Novartis then file a Writ Petition before the Madras High Court against the decision of IPO of
rejecting the application
 CONTENTIONS - NOVARTIS

The Patent Controller has erred in rejecting the patent application.

► S.3 (d) is vague, ambiguous and contrary to the requirements of the TRIPS Agreement therefore it
is violates of right to equality.

► India has failed to comply with the mandate to amend the domestic laws as required under the
TRIPS Agreement.

► There is ambiguity in reference to what constitutes increase in the efficiency and significant
enhancement as required under S.3(d).
 CONTENTIONS OF THE GOVT

High Court is not the appropriate forum to decide Novartis’s claim of the domestic laws not
being compliant with the TRIPS Agreement. (the same was held by the Madras High Court).
 JUDGMENT

► The controversy in relation to evergreening of pharmaceutical patent is thereby settled by the

landmark judgment.

► The Honorable Supreme Court upheld the decision of rejection of the patent application by IPO
as the substance on which Novartis claimed patent did not qualify the efficiency test laid down
under S. 2(1)(j) and Section 2(1)(ja) of the Patent Act,1970.

► It also upheld the decision of the Madras High Court that S.3(d) of the Patent Act,1970 is
constitutional.
► The judgment sought to draw a balance between public good with monopolistic pricing,
innovation with affordability.

► The Honorable Supreme Court wanted to ensure that generic drugs are available at a low cost so
that can be beneficial for the people at large, more specifically the poor population of India.

► The decision also gave boost to the generic drug industry.

 F. HOFFMANN LA ROCHE LTD AND ANR V. CIPLA LTD

► Roche, along with Pfizer as joint applicants, claimed that it had been granted a patent in February
2007 for, the molecule medically termed as a “Human Epidermal Growth Factor Type- 1/Epidermal
Growth Factor Receptor” (HER/EGFR) inhibitor, popularly known as Erlotinib.
► The said drug was a major breakthrough for the treatment of cancer. The drug was in the tablet
form and was sold under the Trademark name ‘Tarceva’.
► The said drug was approved by the U.S Food & Drug Administration and thereafter by the
European Union. The Controller General of Patents, New Delhi had also granted patent in respect of
Erlotinib with a certificated dated 23rd February, 2007.
► On the record as per the amendments of 2005 in the patents act Erlotinib stood patented.  The
patented product, which Roche introduced onto the Indian market in 2006, was marketed under
the brand name TARCEVA.
► Meanwhile Cipla Limited (Cipla) a Indian company incorporated under the Companies Act 1956
launched a generic version of Tarceva (Erlotinib). The news regarding this appeared in an English
Daily Mint.
► The plaintiff alleged that the drug Erlotinib had been developed after long years of research and enormous
expenditure had been incurred and moreover the innovation was protected by law. Henceforth the
defendant company had no right to opt to manufacture, sell or offer to sell any version of the drug Tarceva
(Erlotinib) and that such action of the defendant, as announced by it, would be in blatant violation of the
legal rights of the plaintiffs.

► The Roche filed a suit for infringement on the 15th January 2008 and an application for ad-interim injunction
was also filed. Two major points to be noted at this very stage was that :
► It was stated that the certificate of patent No. 196774 dated 23rd February, 2007 recorded in the Register of
Patents on 6th July, 2007 pertained to Erlotinib Hydrochloride which was marketed as Tarceva.
 
► In the plaint no details of the specification of the aforementioned patent or the X-ray diffraction of the
product (tablet) Tarceva or the defendants Erlocip was indicated
 
 RESPONSE OF CIPLA TO ROCHE

► In response of the claims made by Roche Cipla replied that the generic version of Erlotinib was sold
by Cipla under the name Erlocip from October 2007. Also according to the Patents Act, Section 5(2)
the right of the patentee accrues only from the date of grant of the patent. Though the certificate
gained by Roche Limited was dated February 2007, but the post grant opposition was disposed off
in July 2007 and hence the certificate granted was incorrect.
► Secondly Cipla said that patent granted to Erlotinib was invalid as Erlotinib was a derivative of a
known patent ‘Quinazoline’. Also that the composition of Erlotinib was same as that of Quinazoline
except for one substitution which was “obvious to any skilled person”. Under Section 2(1)(ta) of the
Patents Act 1970 pharmaceutical meant invloving one or more inventive steps and something
which had not been anticipated by any document or publication in any country . Meaning thereby
that  Roche’s invention, as disclosed in the complete specification and claims was obvious or did
not involve any inventive step, having regard to what was publicly known or publicly used in India,
or what had been published in India or elsewhere before the priority date
► Thirdly they pointed out that for any drug to be qualified as patentable under Section 3(d) it is essential
that one shows that there is “any improved efficacy of the said drug.

► Fourthly, it was specifically averred that “the alleged patented product is nothing but a derivative from
Gefitinib of Astrazeneca for which a patent was refused in India” by a decision dated 30th August 2007
of an application of Astrazeneca.
► Fifthly, what Cipla pleaded was public interest. It pointed out that the huge difference in price between
Roche’s drug (Rs.4,800 tablet (approx. US$ 100) and Cipla’s drug (Rs.1,600 (approx US$ 33) should be
taken into account when deciding whether or not to grant an interim injunction. Cipla strongly argued
that because the drug in question was a life saving drug, the public interest issue was an important
factor to be taken into account.
► Lastly Cipla contended that that the plaintiff has intently withheld important information regarding the
drug and that it is actually a mixture of polymorphs and which is useless for pharmaceuticals.