[Ip-health] Pre-grant patent opposition against palbociclib dosage forms

Luis Gil Abinader luisgilabinader at gmail.com
Wed Mar 14 20:31:08 PDT 2018


Today I filed a pre-grant opposition against Dominican patent application
P2017-000280, which claims “solid dosage forms” of well-known breast cancer
drug palbociclib. The pre-grant opposition document is available here:

English: http://examendefondo.org/wp-content/uploads/Palbo-pre-

Spanish: http://examendefondo.org/wp-content/uploads/Palbo-pre-grant-ES.pdf

Palbociclib (brand name Ibrance) is indicated as first and second line
treatment for several types of breast cancer. Approved in 2015, Pfizer has
already reported north of 5 billion U.S. dollars in revenue for Ibrance
sales – in part because the company has set excessive prices for this drug.

In the U.S. and several other countries, including the Dominican Republic,
palbociclib compound patents are set to expire in 2023. Nevertheless, as
CEO Ian Read acknowledged during an earnings call in January 2017, Pfizer
has “a very robust life-cycle program for Ibrance.” In the pharmaceutical
industry “life-cycle program” or “life-cycle management” generally refers
to the practice of filing secondary patent applications, most of which are
unmerited, to try to keep competitors with cheaper generic versions out of
the market. A common manifestation of evergreening strategies in the
Dominican Republic is filing new dosage forms claims.

Adjusting the dosage of a known compound has been previously considered a
method of treatment by Dominican patent examiners, as several non-final
office actions cited in my pre-grant opposition explain. Pursuant to
article 2 of Law 20-00, methods of treatment are not eligible for patent
protection in the Dominican Republic. This is the main argument I submitted.

The EPO worldwide legal status database (INPADOC) shows that Pfizer has
filed the same dosage forms patent application in several other countries,
including Argentina, Australia, Canada, China, Japan and Taiwan. The legal
arguments I submitted in my pre-grant opposition may apply, mutatis
mutandis, at least in some of these countries.

Luis Gil Abinader

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