Combigan, product of Allergen, was patented under the Indian patent no. IN 219504. This patent is related to “combination
of brimonidine and timolol” for topical opthalmic use. Ajantha Pharma limited has filed petition for the revocation of this patent at IPAB and succeed yesterday in revoking the patent.
IPAB revoked the patent on the basis of Obviousness and Non
compliance of Sec. 8. However, opponent filed the application with several
grounds viz. Patent
was obtained on a false suggestion or representation, that it is not an
invention that it is obvious, that it does not sufficiently disclose and that
Section 8 of the Patents Act, 1970 was violated. The brief analysis of judgement
is as follows:
Section 8: First of all, Hon'ble Smt. Justice Prabha Sridevan provided the importance &
scope of section 8 of Indian Patent Act and this read as follows:
“The Inventors and the Challengers must remember that
- S 8 must be complied with.
- It must be pleaded and proved that the lapse was
with regarding applications in respect of the same or substantially the same
invention( vide ORA 17/2012/PT/KOl order no 162/2013)
- The documents to prove this must be filed at the
earliest if they are filed belatedly, costs may be imposed.
- The law does not say that the failure to furnish
the S.8 details must be deliberate and willful or that the failure must be in
regard to material particulars.
- It has been introduced to facilitate examinations
and therefore the patentee must be candid and fair.
- The Controller cannot deal with this ground
casually. They must adhere to the law nor can they dilute it. .
- The Patentee has a statutory duty under S.8, he
cannot say that the particulars are available on the website. Nor can the
Examiner condone the non-disclosure by saying the details are on the website.(
vide Sugen vs Cipla IPAB)
- It is not a penal provision and the object of the
law is clear disclosure and there can be no dilution.
- Rule 12(3) is part of the statute and indicates why
this provision has been introduced and reflects the sentiments of the Ayyangar
Committee report.
- The article “a” in the law cannot be understood to
mean only one. Once the S.8(1) detailed particulars are given, the Controller
may ask for the details relating to ‘a’ country. This means any. The Controller
May ask for the Rule 12(3) details regarding any application.
- It is repeated that S.8 must be complied with.”
IPAB held that the respondent withheld information that ought to have
been furnish under Section 8. In this case, EPO has rejected the patent and after
appeal USA has also rejected the patent. Respondent has only served the
controller with Canadian granted patent, which is in favour of him. This was
clear case of hiding out the material facts.
Sec 3(d)- This
ground was rejected and also provides
elaborate the term “combination” used in explanation part of sec 3(d) by
stating that
“The
combination mentioned in the Explanation can be only mean a combination of two
or more of the derivatives mentioned in the Explanation or combination of one
or more of the derivatives with the known substance which may result in a
significant difference with regard to the efficacy. A combination of two active
drugs like Brimonidine and Timolol cannot be considered derivatives of each
other”.
Obviousness: Here Justice referred to the decision of European
(rejected), USA (on appeal) and Canada (affirmed) counterpart. Justice, also referred the judgment of Justice
Pumfrey in (2004 EWHC 477 (Ch) Cipla Limited Vs. Glaxo Group Limited and
also provide a clear explanation with respect to each reference. The invention
was held obvious. The obviousness of the invention by the judgment is read as
follows:
“Ms. P. Sita
already knows from D1 and D2 that the serial combination has an additive effect
and therefore the closest prior art was this combination”.
“It held
that when viewed under a proper standard the evidence establishes a motivation
to combine since it was common at that time to provide Brimonidine and Timolol
sequentially and DeSantis taught fixed combination”.
Section 3(e):
As described
earlier, patent is liable to be revoked on the basis of sec 8 and obviousness
so IPAB has not taken sec 3 (e) in to consideration as they were not provided
with any comparison test to show that improvement in the concerned invention is
only additive or more
Final
Judgment: Petition is allowed and IN 219504
is revoked.
The above judgement
gives a clear warning to applicants regarding the importance of Sec. 8 and also
provides an explanation for the term “combination” referred in “Explanation”
part of “Sec 3(d)”. The whole judgement can be accessed here.
