[Ip-health] Lopinavir Crystalline - EP1268442 (WO 00174787)- Rejected by EPO

[Judit Rius Sanjuan]

 From Tahir Amin/ I-Mak:

Dear all,

We wanted to inform you that the European Patent Office (EPO)  rejected
Abbott's European Application No. 1268442 (also WO 00174787) for its
Lopinavir Crystalline form on 28 December 2006 (see attached). The EPO
found that the claimed invention lacks inventive step despite Abbott's
claims that crystal forms are not predictable and have not been
disclosed for Lopinavir per se in prior literature. Abbott has the right
to appeal this decision.

The USPTO also found that  some of the claims of Abbott's corresponding
application as filed under US2005/0124810 (a divisional of US Pat
No.6608198) amounted to double patenting. As a result these have been
abandoned by Abbott. However, US 6608198 does cover non-solvated
crystalline forms of Lopinavir which formed part of the EP application
(and the Indian application discussed below), but were refused.

How does this impact India?

Abbott's International (or PCT) Application WO 00174787 designates
India. The Indian designation was published as IN/PCT/2002/1243/ MUM,
which was opposed. As part of the opposition put together on the part of
INP+DNP+ , we cited the EPO's ongoing examination of Abbott's
application and its objections. This has now resulted in an official
refusal and has been confirmed by the EPO. As we have put the Indian
patent office on notice of the EPO proceedings (under Indian law  Abbott
must keep the Indian patent office informed of its corresponding
applications). It is hoped that they will draw the same conclusion,
particularly as polymorphs are per se not patentable unless they pass
the efficacy test.

Although the facts and claims of this case are different to the Novartis
case, it does concern the issue of polymorphs (crystalline forms) and
whether they are actually the same substance as known forms - something
which s3d strives to eradicate as a practice, unless there they meet an
efficacy requirement.

Lopinavir is an important part of the 2nd line regimen and the heat
stable Kaletra formulation, but it is not clear if Abbott has been using
the crystalline form for production. It is also not clear to date
whether there are other blocking patents in India for Lopinavir, but we
will keep you informed.

Best

--
Judit Rius Sanjuan
Attorney
judit.rius@keionline.org

Knowledge Ecology International (KEI)
www.cptech.org
1621 Connecticut Ave, NW, Suite 500 Washington, DC 20009 USA
Tel.: +1.202.332.2670, Ext 18  Fax: +1.202.332.2673