Important Case Studies related to Pharmaceutical patents

1. Azithromycin:

Pliva is a Croatian pharmaceutical company headquartered in Zagreb, discovered an antibiotic named

Azithromycin. From early trials, Azithromycin proved to be extremely efficient and capable of remaining
in the body tissue of animals longer than other similar antibiotics. Pliva was a small player relative to the
leading global pharmaceutical firms and lacked the necessary capital to commercialize the product
internationally and reap the full benefit of its successful research. Pliva filed a patent application for
Azithromycin in the former Yugoslavia and subsequently patented it worldwide, including in the United
States when the drug was still undergoing trials before its final approval by the relevant health authorities.

Patenting proved to be the key to the commercial success of Azithromycin: scientists from pharmaceutical
multinational Pfizer Inc. came across Pliva's patent while searching the database of the US Patent and
Trademark Office (USPTO) and realized the enormous potential of the antibiotic. Pfizer offered Pliva an
ideal channel to commercialize its antibiotic. In 1986, the talks between the Pliva and Pfizer eventually
led to a licensing agreement through which both companies, as well as the general public, could benefit
from the commercialization of the powerful antibiotic. Under the agreement, Pfizer acquired the right to
sell Azithromycin worldwide. Pliva, however, maintained the right to sell the product in Central and
Eastern Europe and would earn royalties on Pfizers sales.

2. Cefadroxil:

Zenith Laboratories v. Bristol Myers Squibb, 19 F.3d 1418, 30 USPQ2d 1295 (CAFC 1994): Cefadroxil
hemihydrates converted in monohydrate form which was covered by patent of BMS. The decision is
taken based on advantages that is obtained, bioequivalence studies and the extent of information available
with litigants on the properties of such polymorphs.

3. Glivec and Imantinib Mesylate:

Novartis fought a seven-year, controversial battle to patent Gleevec in India, and took the case all the way
to the Indian Supreme Court. The patent application at the center of the case was filed by Novartis in
India in 1998, after India had agreed to enter the World Trade Organization and to abide by worldwide
intellectual property standards under the TRIPS agreement. As part of this agreement, India made changes
to its patent law, the biggest of which was that prior to these changes, patents on products were not
allowed, while afterwards they were, albeit with restrictions. These changes came into effect in 2005, so
Novartis' patent application waited in a "mailbox" with others until then, under procedures that India
instituted to manage the transition. India also passed certain amendments to its patent law in 2005, just
before the laws came into effect.

The patent application claimed the final form of Gleevec (the beta crystalline form of imatinib
mesylate).:3 In 1993, during the time India did not allow patents on products, Novartis had patented
imatinib, with salts vaguely specified, in many countries but could not patent it in India. The key
differences between the two patent applications, were that 1998 patent application specified the
counterion (Gleevec is a specific salt imatinib mesylate) while the 1993 patent application did not claim
any specific salts nor did it mention mesylate, and the 1998 patent application specified the solid form of
Gleevec the way the individual molecules are packed together into a solid when the drug itself is
manufactured (this is separate from processes by which the drug itself is formulated into pills or capsules)
while the 1993 patent application did not. The solid form of imatinib mesylate in Gleevec is beta
crystalline.
As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing Rights (EMR) for
Gleevec from the Indian Patent Office and the EMR was granted in November 2003. Novartis made use
of the EMR to obtain orders against some generic manufacturers who had already launched Gleevec in
India.

When examination of Novartis' patent application began in 2005, it came under immediate attack from
oppositions initiated by generic companies that were already selling Gleevec in India and by advocacy
groups. The application was rejected by the patent office and by an appeal board. The key basis for the
rejection was the part of Indian patent law that was created by amendment in 2005, describing the
patentability of new uses for known drugs and modifications of known drugs. That section, 3d, specified
that such inventions are patentable only if "they differ significantly in properties with regard to efficacy."
At one point, Novartis went to court to try to invalidate Section 3d; it argued that the provision was
unconstitutionally vague and that it violated TRIPS. Novartis lost that case and did not appeal. Novartis
did appeal the rejection by the patent office to India's Supreme Court, which took the case.

The Supreme Court case hinged on the interpretation of Section 3d. The Supreme Court issued its
decision in 2013, ruling that the substance that Novartis sought to patent was indeed a modification of a
known drug (the raw form of imatinib, which was publicly disclosed in the 1993 patent application and in
scientific articles), that Novartis did not present evidence of a difference in therapeutic efficacy between
the final form of Gleevec and the raw form of imatinib, and that therefore the patent application was
properly rejected by the patent office and lower courts.

4. Sorafenib (Nexavar): Bayer v/s Natco.

Bayer did not file Form 27 properly and hence invoking Compulsory Licencing addressing issues of
patent working.

5. CIPLA v/s Novartis :

Central Govt should exercise its powers under Section 92(3) (compulsory license in cases of extreme
emergency) and Section 66 (revocation of patents -generally prejudicial to the public) to revoke Novartis
Onbrez patents.