Intellectual Property Appellate Board revoked a GSK’s Patent related to Lapatinib
Ditosylate on Jul 27th, 2013. Revocation application for Patent No.IN221171 has been filed by
Fresenius Kabi Oncology Limited. The petition was attacked on the
grounds of 64(1)(f) and on the grounds of Sections 64(1)(k), 64(1)(d),
2(1)(ja), and 64(1)(h) of The Patents Act. But the arguments were
focussed on obviousness, S.3(d) and S. 8
IPAB pronounced the
judgment after having a clear analysis of the patent, grounds by the opponent (Fresenius
Kabi oncology Limited) and also the reply of the Patentee (GSK). The Decision
of the IPAB is based on the following Grounds:
Sec 3(d):
The reply of the
patentee of the examination report has been taken in to account wherein he
admitted the enhancement by using lapatinib ditosylate as compared to prior art
salts is the moisture sorbtion property and the increase in stability. It was held by IPAB after considering the interpretation
of efficacy in decision “ Novartis Ag
vs Union of India” that
“In whatever way therapeutic efficacy may be interpreted, this much is
absolutely clear: that the physico-chemical properties of beta crystalline form
of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better
thermodynamic stability, and (iii) lower hygroscopicity, may be otherwise
beneficial but these properties cannot even be taken into account for the
purpose of the test of section 3(d) of the Act, since these properties have
nothing to do with therapeutic efficacy.” Physico-chemical
properties have nothing to do with therapeutic efficacy.
Applying S.3(d) and
the decision of the Supreme Court in the Novartis case, IPAB held that the patent
deserves to be revoked.
Obviousness:
Firstly, IPAB states
that is necessary to understand who is the person Skilled in the Art, what is
the Common General Knowledge and so on for deciding obviousness. In earlier judgment
F.Hoffman la Roche v Cipla, it was
held that according to law, the obviousness test will be made against the Person
Skilled In the Art (Ms.P.Sita) and not a Person with Ordinary Skill In The Art.
This had earlier described this person in the IPAB Order No.250/2012 in OA/8/2009/PT/CH and M.P. NOs.85 & 111
of 2012 In OA/8/2009/PT/CH - Sankalp Rehabilitation Trust vs.
F.HOFFMANN-LA ROCHE AG and Others.
IPAB held
that there is no doubt that
selecting 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 references
provided by the opponent provide a clue. It was reasonable to hope it might, it
would not have been a blindman’s buff choice. So to the Person Skilled in The
Art taught by references provided by opponent, the invention was obvious.
According to our Act, the patent is revoked if the invention is
obvious. So the secondary considerations cannot change that. It is
true that the applicant has not filed any evidence by way of affidavit, but the
prior arts have been filed and on the facts of this case this material is
sufficient.
S.8 disclosure and
non-compliance:- This particular section destroys a patent which is
otherwise patentable on grounds which have nothing to do with the invention,
but only with the Inventor’s failure to comply with foreign filing particulars during
the grant proceedings.
IPAB explains the
intent of the law makers. Further
regarding this section, it has been stated 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. We earnestly hope that this practice has
died a natural death. It is important that the Patentee furnishes details of
those search reports where there are objections like obviousness objections and
shall not suppress them. If one of the major Patent offices alone has raised an
obviousness objection, it is ‘the duty of the Patentee to disclose it,
considering the Object of the Act”.
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. The facts have to be pleaded and the applicant must state how the
particular undisclosed application was for the same or substantially the same
invention. In any event, in the absence
of pleading and proof of violation, we reject this ground of attack.
Final Judgement: the invention is obvious and is hit by S.3(d) and Patent No 221171 is
revoked. The Petition is allowed with costs of Rs.50,000/-.
This judgment
provides the generic companies an opportunity
to manufacture/Launch lapatinib ditosylate after the expiry of substance patent
of Lapatinib in India (2019). This provides two years earlier market entry for
the generic companies as patent revoked has normal expiry of 2021, which is now
not a concern. But still the GSK has a chance to file Appeal against this decision.
Now we can wait for the further step of GSK.
Whole judgment can be read here
