[Ip-health] Update on I-MAK’s Patent Observations Against Abbott Laboratories in Europe

Priti Radhakrishnan priti at i-mak.org
Thu Sep 6 19:49:12 PDT 2012

**Documents for this HIV drug case are available

In 2011, the European Patent Office (EPO) proceeded to grant the patent on
heat-stable lopinavir/ritonavir despite the evidence we submitted at the
pre-grant observation stage. The granted patent EP1663183 B1 (Application
No. 04816820.7) covers ritonavir and/or lopinavir, a water-soluble polymer,
and a surfactant. The polymer has a glass transition temperature of at
least 50 degrees and the surfactant can have an HLB value from 4-10.

Subsequently, five companies -- Teva, Mylan Generics UK, Roche, Hetero and
Janssen (J&J) -- have filed post-grant oppositions at the EPO against granted
patent EP1663183 B1 .  The post grant oppositions filed by these companies
raise several of the issues and evidence raised in our pre-grant
observations, but which the EPO did not require Abbott to address before
finally granting the patent. We hope the post-grant opposition process
addresses the issues that were not dealt with during examination.

The cases are pending and it will take at least another year before a final
determination is given by the EPO.

However, from the parent Application No. 04816820.7, Abbott has three
further divisional applications pending:

*EP divisional Application No. 10181250.1*: covers essentially the same
product as the granted parent patent.  I-MAK's observation against this
application was aimed at Abbott's claim that the addition of a surfactant
with a hydrophilic lipophilic balance (HLB) of 4-10 was inventive. We
argued that the inclusion of the surfactant with an HLB of 4-10 would have
been obvious to a person skilled in the art in light of Abbott's prior
patents, as well as publications in the field documenting the advantages of
using surfactants in solid dispersion formulations. We also highlighted for
the Examiner that this is a case of double patenting: the parent patent
also covers what is claimed in the divisional application.

*EP divisional application 10181268.3*: claims a method of preparing a
solid dosage form which comprises preparing a homogeneous melt of ritonavir
and/or lopinavir, at least one surfactant and at least one water-soluble
polymer having a glass transition temperature of at least 50 degrees
Celsius, and allowing the melt to solidify to obtain a solid dispersion

I-MAK's observation and evidence focused on three key issues arising from
the examination history of the application to date:

1) The fact that the divisional claims were actually product-by-process
claims and should be examined as such. Under the European Patent
Convention, product-by-process claims should be treated as product claims,
and the burden is on the applicant to demonstrate that the claimed
invention is new and inventive, and results in another product over that
already covered in the prior art.

2) If the claims were to be treated as method claims, the application
should be rejected for lack of inventive step, since the use of melt
extrusion technologies and methods as applied to poorly soluble compounds
such as ritonavir and lopinavir were well-documented in the field prior to
the application being filed and would have made their use obvious.

3) That Abbott has failed to address the technical problem it claims to
have solved, namely that the claimed invention provides for a solvent-free
method of making the solid dosage form of this product, since solvents have
a number of disadvantages. Despite the Examiner agreeing with Abbott having
solved the technical problem, our observation shows the patent
specification as filed contradicts these findings as it specifically
includes the use of a solvent process. Indeed, nowhere in the claims as
filed in the divisional application are solvents expressly excluded from
use in the claimed invention. Moreover the evidence submitted with our
observation shows that known melt extrusion technologies already solved the
problem of not needing to use solvents.

This issue was also raised in our final observation to the parent
application 04816820.7 after Abbott reformulated the problem during
examination in order to overcome objections to the patent. Unfortunately,
the EPO failed to ask Abbott to address these issues before granting the
patent. We hope the EPO takes notice of these issues this time around.
EP divisional application 10181264*: cover substantially similar claims to
the parent application. The case is still being prosecuted and the Examiner
appears unconvinced thus far about the patentability of this application.
I-MAK is monitoring the examination of the application.

It should be noted that Abbott’s strategy of filing multiple divisional
patent applications does not fall squarely within the classic defintion of
life cycle management, or “evergreening”. The divisional patents, if
granted, would expire at the same time as the parent patent. Instead,
Abbott’s strategy of using divisional applications appears to be aimed at
ensuring the broadest scope of protection given the various amendments to
the claims it had to make as a result of our observations during the
examination of the parent application.  Abbott is also likely concerned
that since the post grant oppositions having been filed against the granted
parent patent, obtaining granted patents for the divisionals may further
delay any potential generic entry in Europe as post-grant oppositions at
the EPO can take up to 2-3 years. To that end, these divisonals form part
of the patent strategies companies use to increase transaction costs for
generic entrants who might be seeking to challenge patents.

These cases at the EPO could have serious implications for low- and
middle-income countries (LMICs) since patent examiners in LMICs (e.g. Viet
Nam) often rely on EPO examinations in their own examination process.

More updates to follow.

Priti Radhakrishnan


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