Wednesday, August 19, 2009

Excerpts of the Decision -- Singular® (Montelukast) Patent Infringement Case

Here is an interesting quote, from the Singular® (montelukast) patent infringement decision handed down this morning, in the US District Courthouse in New Jersey (Full 102 page PDF file):

. . . .MSD asserts that “Mr. Lopez sometimes read less of a proposed manuscript if there were indications that suggested to him that approval of the manuscript would not be problematic.” Id. at ¶ 565. MSD further notes that Mr. Lopez testified that some of the factors that would influence the amount of time that he would devote to certain manuscripts were whether: (1) the author, especially an author that Mr. Lopez trusted, indicated that there was nothing in the manuscript that had not been approved before; (2) a patent had been issued regarding the subject matter of the manuscript; or (3) a patent application had been filed regarding the subject matter of the manuscript. Id. at ¶ 566. As to the several manuscripts which Mr. Lopez reviewed and which included the Young 89 Model as well as the manuscript of what was eventually published as Young 89, MSD asserts that Mr. Lopez testified that either: (1) he did not recall whether he specifically saw or paid attention to the depiction of the LTD4 receptor model in the figures attached to the back of the manuscript; or (2) he did not recall the line of inquiry that led him to understand that all of the material included in a certain manuscript could not have been cleared in the previous publication when he made notations to that effect. Id. at ¶¶ 568-602. MSD further argues that other manuscripts that included references to Young 89 or the Young 89 Model did so without identifying the model as the Young 89 Model and without further elaborating on its properties. Id. at ¶¶ 582-602.

In light of the foregoing, MSD asserts that: (1) Mr. Lopez did not necessarily review these publications in detail due to his heavy workload and Dr. Young’s position; (2) while he did approve for release a manuscript of what was eventually published as Young 89, this approval occurred more than two years before the filing date of ‘887 application, the earliest continuation-in-part to which the ‘473 patent claims priority; and (3) Mr. Lopez does not recall ever considering whether or not to disclose Young 89 to the PTO during the prosecution of the ‘473 patent or of making a conscious decision to do so or not to do so. Id. at ¶¶ 612, 614, 616. MSD also argues that Mr. Lopez understood that he had an obligation to disclose information to the PTO that was material to the patentability of pending claims during his work on the prosecution of the ‘473 patent. . . .

[Editor's Note: at about 40 pages later, in the findings, quoting cases:]

. . . .it is inequitable to permit a patentee who obtained his patent through deliberate misrepresentations or omissions of material information to enforce the patent against others, it is also inequitable to strike down an entire patent where the patentee [Merck] only committed minor missteps or acted with minimal culpability or in good faith. . . .

Interesting. [Thanks go to Salmon for asking, in comments, about the so-called LTD4 receptor and Young 89 analyses.]

After taking a few minutes to read all the way through this non-precedential decision, I think it fair to say that the Judge made this decision mostly on "burden of proof" issues. That is to say, the judge found that Teva had not proved -- by "clear and convincing evidence" (the required standard, here, in the face of an already-issued patent) -- Merck's "inequitable conduct" (in allegedly hiding the Young 89 prior art), nor had Teva proved that the invention (the construction of the montelukast compound) was "obvious", from that prior art -- again, by "clear and convincing" evidence.

Thus this decision does not primarily find that Merck's montelukast patent is a particularly strong one -- just that Teva didn't muster "clear and convincing" evidence (as opposed to a simple preponderance of the evidence standard) for its defenses.


Anonymous said...

Thank you.

Notice you bolded that "he did not recall". I can't tell you the number of times I've heard that when I believed someone was intentionally trying to conceal something. However as you indicated it's really about what you can prove.


Condor said...

Again -- you are dead-on -- that is exactly why I highlighted it.

Ethically "pliable" lawyers occasionally advise their clients that "I cannot recall" prevents any confirmation, or disclosure of unfavorable information, without much risk of a perjury trap -- unless documents or other evidence points to a selectively fuzzy memory.