The patent law of India

1. Patent Case laws

2. BASMATI
Originally from India and Pakistan, Basmati became a
controversial ‘issue’ after RiceTec, a Texas-based company, in
1997, patented some types of rice they developed as “American
basmati”. ü RiceTec Inc, had been trying to enter the international
Basmati market with brands like “Kasmati” and “Texmati”.
Ultimately, the company claimed to have developed a new strain
of aromatic rice by interbreeding basmati with another variety.
They sought to call the allegedly new variety as Texmati or
American Basmati. ü RiceTec Inc, was issued the Patent number
5663484 on Basmati rice lines and grains on September 2, 1997. ü
This was objected to by two Indian nongovernmental
organizations (NGOs) — Centre for Food Safety, an international
NGO that campaigns against biopiracy, and the Research
Foundation for Science, Technology and Ecology, an Indian
environmental NGO who filed

3. RiceTec has got a patent for three things:
growing rice plants with certain characteristics
identical to Basmati, the grain produced by such
plants, and the method of selecting rice based on
a starch index (SI) test devised by RiceTec, Inc.
The patent was challenged on the fact that the
plant varieties and grains already exist as a
staple in India. 75 percent of U.S. rice imports
are from Thailand and that the remainder is
from India and Pakistan and both varieties are
rice that cannot be grown in the United States.

4. The legal theory is that the patent is not novel
and for an invention that is obvious, being based
on rice that is already being imported in the
United States, therefore it should not have been
granted in the first place.
India’s attorneys also seek to challenge the use of
the term ‘basmati’ in conjunction with the patent
and in marketing of the rice.
Such use of the term creates confusion as to
geographic origin and usurps the goodwill and
recognition established with basmati rice grown
and sold from India.

5. As a result of the re-examination application
filed by the Indian government, RiceTec
agreed to withdraw several of the claims. In
January 29, 2002, the United States Patent and
Trademark Office issued a Reexamination
Certificate canceling claims 1-7, 10, and 14-20
(the broad claims covering the rice plant) out
of 24 claims and entered amendments to claims
12- 13 on the definition of chalkiness of the rice
grains7

6. Turmeric is a tropical herb grown in East India, and the
powdered product made from the rhizomes of its flowers has
several popular uses worldwide. Turmeric powder, which
has a distinctive deep yellow color and bitter taste, is used as
a dye, a cooking ingredient, and a litmus in a chemical test,
and has medicinal uses as well. A U.S. patent on turmeric
was awarded to the University of Mississippi Medical
Center in 1995, specifically for the "use of turmeric in
wound healing." This patent also granted them the
exclusive right to sell and distribute turmeric.
Two years later, a complaint was filed by India's Council of
Scientific and Industrial Research, which challenged the
novelty of the University's "discovery," and the U.S. patent
office investigated the validity of this patent.

7. In India, where turmeric has been used medicinally
for thousands of years, concerns grew about the
economically and socially damaging impact of this
legal "biopiracy."
In 1997, the patent was revoked. But for two years
the patent on turmeric had stood, although the
process was non-novel and had in fact been
traditionally practiced in India for thousands of
years, as was eventually proven by ancient Sanskrit
writings that documented turmeric's extensive and
varied use throughout India's history.

8. Roche Vs. Cipla
Delhi High Court has been the battleground for a
pharmaceutical war between Roche and Cipla, over
Roche’s patent for anticancer drug ‘Erlotinib’, sold
by Roche as TARCEVA.
Both Roche and Cipla drugs are based on a
compound that goes by the name of ‘Erlotinib
Hydrochloride.’
This case is regarded as a very important case in a
series of high profile patent battles between
multinational pharmaceutical companies and
Indian generic drug companies.

9. In February 2007,Roche along with Pfizer (as a joint
applicant), claimed that it had been granted a patent
for “erlotinib” The patented product, which Roche
introduced onto the Indian market was marketed
under the brand name TARCEVA.
In December 2007 and January 2008, Indian
newspapers reported Cipla’s plan to launch a generic
version of ‘erlotinib’
Soon after that, Roche commenced patent
infringement proceedings.

10. Cipla’s Defence and Counterclaim
It had been selling its drug under the brand name ERLOCIP since
December 2007.
Roche’s patent was invalid because ‘erlotinib’ was a derivative of
Quinazolin.
Roche’s invention, as disclosed in the complete specification and
claims was obvious or did not involve any inventive step.
The complete specification did not sufficiently and fairly describe
the invention or the method by which it was to be performed.
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 .

11. Roche’s Submission
Section 3 (d) of the Patents Act is not applicable as
it prohibits only derivatives of ‘a known substance’.
‘Erlotinib’ is not ‘salts, esters, polymorphs, particle
size, mixture of isomers, etc.’ of a ‘known
substance’. It is a novel compound
In any case, ‘erlotinib’ is a different compound; its
properties differ from those of Astra Zeneca’s
Gefatinib, which was cited as prior art.
When determining where the balance of
convenience lies, it is appropriate to consider the
issue of ‘accessibility’ to, and use of, the invention
in the territory. It is not, however, necessary that the
drug should be manufactured in India.

12. Single Judge Ruling While hearing the case, the
judge noted the following points:
Public interest: The generic drug version of
‘erlotinib’ manufactured and marketed by Cipla is
available at one-third the price of Roche’s drug,
Tarceva. Further, the Court noted that Tarceva is not
manufactured in India, it is imported. The Court
noted that the right to access to life- saving drugs,
and the need for secure long term supplies, is a
serious issue in India. In such case, the injury that
would be caused to the general public if the generic
version of the drug were not available is a strong
point in favour of a refusal to grant an injunction.
This point completely favoured Cipla's Defence.

13. Division Bench Ruling Roche filed an appeal against the
Order of the single judge, arguing that a failure to protect the
rights of the patentee, is contrary to the public interest of
encouraging further research in the pharmaceutical field. The
division bench in its ruling observed: Non infringement: The
bench was of the view that the patent in question related to a
mixture of Polymorphs A and B, whereas Roche’s Tarceva
drug consisted of only Polymorph B, for which a patent had
not yet been granted. The division bench considered that this
fact ought to have been disclosed by Roche both at the time of
examination, and during the proceedings before the single
judge. The bench gave weight to the fact that Polymorph B of
‘erlotinib hydrochloride’ was the subject of a later patent
application, and that this had not been considered by the
single judge.

14. The bench criticised Roche for: Its failure to provide
a sufficient and fair description of the invention; and
For not having filed X-ray diffraction data for
Tarceva and Erlocip that would have shown whether
or not the crystalline structure of Cipla’s Erlocip
tablets corresponded to Roche’s patented invention.
The Court dismissed Roche’s appeal, and upheld the
order of the single judge.
In sept 2012 Cipla Ltd won a landmark patent case
against Roche Ltd. It had been scientifically proven
that Cipla’s generic version was a polymorph b
variant of Roche’s patented drug and it didn’t
infringe any patent in India.

15. Novartis v. Union of India
Novartis filed an application for grant of patent for
chemical compound called Imatinib Mesylate
which is a therapeutic drug for chronic myeloid
leukemia and certain kinds of tumours and is
marketed under the names "Glivec" or "Gleevec" at
the Chennai Patent Office. In the application it
claimed that the invented product, the beta crystal
form of Imatinib Mesylate, has more beneficial
flow properties better thermodynamic stability and
lower hygroscopicity than the alpha crystal form of
Imatinib Mesylate and further claimed that the
aforesaid properties makes the invented product
novel.

16. The patent application had attracted five (5) pre-grant
oppositions. The Assistant Controller heard all the
parties, and rejected the appellant's (Novartis)
application for grant of patent to the subject by 5
(five) separate, though similar, orders passed the
opposition petitions. The Assistant Controller held
that the invention claimed by the appellant was
anticipated by prior publication, i.e., the
Zimmermann patent; that the invention claimed by
the appellant was obvious to a person skilled in the
art in view of the disclosure provided in the
Zimmermann patent specifications. The Supreme
Court of India rejected Novartis patent plea on April
1, 2013