Copaxone Trial Day 10: Final Day of Testimony
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The final day of testimony in the Copaxone trial featured the final
expert witnesses for the defense. The central topic of the day was
enablement, whether there was an established way to measure the relevant
molecular weights in Copaxone at the time the patents were filed, or if Teva
should have explained the process behind their measurements more fully.
The parties will now turn to the task of summarizing the trial and the
legal issues at hand in their various rounds of briefs to be filed from
October 10th – 31st.
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The issue of molecular weight revisited: The defense called Dr. Thomas
Wall, a UCLA medical school professor, who was adamant about the idea
that there was no readily known technique for measuring molecular weight at
the time the patents at issue were filed. He admitted that there while there
were ways to measure molecular weight at the time, none of the available
techniques would have worked. Additionally, he argued that each of the
available measurement techniques available would have yielded wildly
different results. He was resistant to say that Teva “struggled” with their
determination of molecular weight, but he does believe that Teva was
uncomfortable with the data gathered from their measurements. Teva’s
lawyers countered with 2 points: 1) an emphasis on the fact that Teva itself
employed a technique that accomplished the relevant measurements at the
time in question, and 2) they asserted that the technique used by Teva
would have been known to someone skilled in the art at the time, and it was
not a technique that Teva invented.
A second expert witness focused more squarely on enablement: Dr. Stephen Kent
was called by the defendants to argue the issue of enablement from a different angle.
His main message was that Teva did know a lot about the Copaxone molecule
(copolymer-1) and the production process at the time of patenting, but that Teva failed
to disclose the necessary information in their patents; information that would enable
someone skilled in the art to produce the same molecule. Dr. Kent’s testimony will
likely be used to support several of the defense’s theories, each of which in one way or
another accuses Teva of hiding information. Our legal expert, however does not
believe this testimony was enough to champion those issues, and reminded us that the
legal standard here heavily favors Teva. Teva has also put forth reasonable
arguments that the disclosures made in their patents were sufficient from the
perspective of someone skilled in the art.
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The day 10 proceedings were punctuated by conflicts between the lawyers: At
one point the lawyers argued over whether certain evidence should be admitted at this
late date in the trail. The evidence would have supported Dr. Wall’s point that different
measurement techniques available at the time the patents were issued would actually
yield entirely different estimates for molecular weight. The judge refused to allow Dr.
Wall’s testimony regarding this evidence to be admitted, but the point was clear even
without the formal admission of the evidence. In another instance the judge shut down
a line of questioning that revolved around an unrelated patent and what it might teach
about prior art knowledge, refocusing the lawyers on the core issues in the case.
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Filing of briefs is scheduled from Oct. 10th to 31st, to be followed by an eventual
ruling: With the trial now over, each side will file their briefs per the judge’s proposed
schedule: the first briefs would be due October 10 with responses due October 24, and
then further responses due October 31. It unlikely that the court would rule before the
briefs are filed. Our legal expert believes it would take the court at least 6 weeks to
analyze the briefs once the final submissions are made, and that a decision could
come in the December timeframe, but noted that there are no real deadlines for a
judge to rule in a case like this. MNTA has publicly commented that this judge typically
takes 6-12 months to make a ruling once the trial has ended, although the briefing
schedule in this case could imply a potentially speedier decision. |
