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.
Copies of the post grant oppositions are available here. 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.
A copy of our observation and supporting evidence is available here.
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 product.
I-MAK's observation and evidence, a copy of which is available here, 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 have 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.