Copaxone Trial Day 9: Conclusion of Teva's
Rebuttal Case
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Day 9 of the Copaxone Trial featured two of Teva’s expert witnesses
and the conclusion of Teva’s rebuttal case. Drs. Goekel and Sampson
testified on a range of infringement and validity issues. The questioning,
at times, was disjointed as lawyers from both sides often chose to focus on
small details rather than the key legal issues in play, details that will likely be
used to “connect the dots” when the lawyers compose their briefs. The
defendants are set to respond to Teva’s rebuttal today (Wednesday) in
what could be the final day of testimony, unless the defense presents
something new to which Teva would like to respond.
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Teva’s expert testimony was puzzling at times: Teva began the day by
having one of its experts, Dr. Goekel, affirm in detail that Teva itself, in the
manufacturing of Copaxone, practices the patents at issue in the case.
When asked if Copaxone and Teva’s manufacturing process meet at least
one of the asserted claims in each patent in dispute, Dr. Goekel answered in
the affirmative. This focus on Teva’s adherence to the patents, however,
seems strange as the case is about whether the defendants’ generic
versions of Copaxone infringe upon the patents. Moreover, the expert never
opined on an important argument by the defense – that they have changed
the production process in order to avoid the patented claims. Most
surprisingly, the expert did not address the one process change that the
defense emphasized earlier in the trial – the abandonment of the “time and
temperature” test reaction. Teva’s lawyers presumably have reasons for
framing their questions in the manner they did, which will likely come out
when their brief is written, but are not yet clear.
Teva’s expert revisits the amino acid ratio, emphasizing “impurities”: Dr. Goekel
went on to discuss how someone skilled in the art would measure the amino acids in
both Copaxone and the accused generics. His new emphasis was to highlight several
amino acids present in Copaxone (and the generics) aside from the 4 included in the
6:2:5:1 ratio; byproducts considered to be “impurities”. He went on to say that these
impurities should not be included in the in the molecular weights used to calculate the
amino acid ratio. This testimony was presumably entered to respond to the
defendants’ argument that their amino acid ratio differs from the patented ratio. If
some amino acids do not count, the difference between their amino acid ratio and the
patented ratio is likely muted.
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Teva’s second expert witness, Dr. Sampson, revisited the obviousness argument,
arguing that the patents in dispute include important distinguishing features relative to
the prior art. Most of his points have been argued previously during the trial. Also, we
note that the legal standard regarding obviousness heavily favors Teva, as the Patent
Office issued the Copaxone patents while taking into account the very prior art
referenced by the defense.
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Questioning from the defense did not seem to add much either: On crossexamination
of Dr. Goekel the defendants focused, primarily, on the idea that even
Teva’s manufacturing process of Copaxone uses additional steps beyond those
disclosed in the patent. Although true, this logic seems irrelevant. Per our legal expert,
a patent is infringed so long as all the patented steps are included in that process, even
if the patented steps are supplemented by others. The additional step(s) would only
matter if the process led to a product other than Copaxone, e.g. by causing the amino
acid ratio to deviate from the patented ratio. The defendants have already argued that
their amino acid ratio is different; highlighting the extra steps involved in getting there
did not seem to add much ammunition to their defense.
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Barring any surprises, testimony could conclude today: With Teva’s rebuttal case
now finished, Wednesday is open for the defendants’ response. There is a possibility
that new information will come out in the response that will prompt to Teva to present
further rebuttal. At the conclusion of testimony each side will submit briefs in October
summarizing the trial from their own perspectives and arguing the key legal issues.
The first briefs would be due October 10 with responses due October 24, and then
further responses due October 31.
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