Glochem Vs Cadila

• Hyderabad-based pharmaceutical company Glochem Industries filed a

pre-grant opposition to Cadila's Patent Application Number
413/MUM/2003A under Section 25(1) of the Patents Act, alleging that
the invention was not novel and was covered under prior art, and did not
pass the test of Section 3(d) of the Patents Act.

• Petitioner's claims (Glochem)

The invention related to Clopidogrel besylate, a salt of Clopidogrel.

– Already been patented by Sanofi Aventis through its Patent Numbers 4529596 and
4847265. 
– Glochem further alleged that on the date of the invention, the therapeutic efficacies
of Clopidogrel and Clopidogrel bisulfate (Plavix) in treating heart ailments were well
known.
After hearing both parties at length, the assistant controller of patents
ruled in favour of Cadila.
Contd…

• Glochem objected to the assistant controller's order .

• Filed a writ petition before the Bombay High Court under
Article 226 of the Constitution.
• Glochemmade the following objections:
– Cadila had failed to produce any legal or admissible evidence of its
claim
– Cadila had not shown that the invention resulted in the enhancement
of the known therapeutic efficacy as prescribed under Section 3(d);
and
– The assistant controller had failed to examine the above issues.
Contd…

Respondent's grounds (Cadila)

• Cadila, on the other hand, stated that the assistant controller's
grant of the patent was correct.
• Cadila objected to the writ petition on the grounds that the
Bombay High Court cannot sit in appeal over an assistant controller
decision on technical issues.
• Cadila submitted that the writ petition was not good in law
because Glochem had had efficacious and fair opportunity to
pursue its objections by way of:
– Filing a post-grant opposition under Section 25(2) of the Patents Act;
– Seeking suo moto (on its own motion) revocation of the patent under Section
64 of the act;
or
– Filing a counterclaim for revocation or invalidation of the patent in a suit
which may be filed by the patentee under Section 104 of the act.
Cadila further clarified that when the patent application was made in
2003 the present Section 3(d) did not exist.
Contd…
Judgment
• After considering the rival submissions and answering Cadila's
objection, the Bombay High Court held that:
• "Although the Petitioners may have remedy of post grant
opposition or of seeking suo moto revocation as well as filing
of a counter claim as is suggested by the Respondents, that by
itself can be no basis to non-suit the Petitioners, if the
Petitioners were right in their grievance that the authority has
committed manifest or jurisdictional error while considering
the representation by way of opposition or for that matter
decided the objections on palpable misreading and
misapplication of the relevant provisions of law."
Contd…

• The Ahmedabad-based Cadila Healthcare will approach the

Supreme Court seeking interpretation of the controversial
Section 3(d) of the Indian Patent Act.

“The company has lost its case against the Hyderabad-based

Glochem Industries Ltd to retain patent protection for its
antiplatelet drug, Clopidogrel besylate.”
 Slimona (Rimonabant)

• Anti Obesity drug.

• Invented by French drug major Sanofi Aventis
• Launched in India on Dec’08
• Drug Technical Advisory Board (DTAB) or DCGI has asked
the Health ministry to ban the drug immediately
• Banned on Dec’09.
• Reason for ban -> Causes suicidal tendencies in consumers.