In an order (No. 161/2013) dated July 27, 2013,
IPAB-India has revoked the patent of Lapatinib Ditosylate Salt. Fresenius Kabi
Oncology Ltd had filed the revocation petition against Patent No.IN221171
entitled “Quinazoline Ditosylate Salt Compounds”, the said patent belongs to Glaxo. In
a decision main arguments were focussed on obviousness, S.3(d) and S. 8 in IPAB
decision.
Below is the gist of decision and few important
clarifications by IPAB on some points.
Section 3(d):
Citing the recent Novartis
case judgement by Hon’ble Supreme Court, IPAB stated that efficacy
relates to “therapeutic efficacy” and not all advantageous or beneficial
properties. More importantly considering the genesis of S.3(d) the words
“therapeutic efficacy” must receive a
narrow and strict interpretation.
Patentee argued that
ditosylate salt absorb much lower amounts of water when exposed to a broad
range of humidities and can be prepared in a stable crystal form. And that “Due
to the improved moisture sorption properties of these compounds and increase in
stability they exhibit enhanced efficacy in their use as a medicament following
storage when compared with the di-HCL salts disclosed in the prior art
reference. But IPAB dismissed the argument and said improved moisture
absorption property and hence stability of ditosylate salt cannot be considered
as enhanced efficacy as per recent supreme case judgement.
Obviousness:
By citing F.
Hoffman-La Roche Ltd v. Cipla Ltd IPAB stated it was obvious to try for
person skilled in the art to choose from different salts disclosed in Exhibit B
ie. substance patent of Lapatinib. Out of 19 salts disclosed in Exhibit B, two
sulphonyl salts include ditosylate salts. It was submitted that when the
problem to be solved was hygroscopicity, it was obvious for a person skilled in
the art to try the salts disclosed in Exhibit B which would give the desired
result.
Exhibit C teaches the
salt of a different active ingredient which is analgesic. Once there is a
suggestion that tosylate salt would solve the problem of hygroscopicity, there
is definitely an encouragement to try it.
IPAB further explained
that in the present case there is a clear indication in Ex.B of the tosylate
compound. There is no doubt that zooming in on a correct salt is not easy, if
the choice could only have been made by testing each compound one after the
other with no clue available. But Ex.C gives a clue. It was reasonable to hope
it might, it would not have been a blindman’s buff choice. So we are of the
opinion that to the Person Skilled in The Art taught by Exhibits B and C the
invention was obvious.
S.8 disclosure and non-compliance:
IPAB gave elaborated
explanation for the section 8 requirement and stated that one must carefully
apply the provision. S.8 of the Act is not intended to be a bonanza for all
those who want an inconvenient patent removed.
The Ayyangar Report
makes it clear that the purpose for introducing this provision was to ensure
that it would be an advantage for our Patent Office to know the objections
raised by the patent offices outside India regarding the patentablity of the
invention and the amendment if any made or to be made. It also says that it
would be of great use for the proper examination to know if the invention was
anticipated.
IPAB also remanded patent office and said that It is unfortunate that the office has failed to understand
the importance of the S.8 requirement and leaves it to the Patentee to decide
what he will give. IPAB also requested patent office and Controller General to
educate and instruct the officers regarding the requirements of law.
Finally IPAB rejected
S. 8 ground and stated that In the present case we are rejecting the S.8
objection only because the applicant has not made out the grounds of attack by
stating the facts. In this case in the Revocation application, the
applicant has merely stated that S.8 has not been complied with and foreign
filing particulars have not been given. Nothing more is stated. In the petition
filed for receiving additional documents, the affidavit filed by the applicant
merely lists the documents were downloaded. We do not think that is sufficient.
If you wish to see the
whole decision, you can access the same on IPAB site at http://www.ipab.tn.nic.in/
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