Tag Archives: Singulair Teva Merck Insurers Wholesalers Antitrust Patent Invalidity Obviousness August 17 2009

Singular® (montelukast) Patent Victory For Merck — Generic Due In 2012. . . .

UPDATED — 08.19.09 @ 1:15 PM EDT: It seems the judge ruled in favor of Merck, in part, on the basis that Merck’s patent lawyer did not read some of the prior art — that is, he felt mere lack of diligence (in not reading, and thus not pointing out to the USPTO, the specific portions of the so-called Young 89 prior art — art that turned out to be highly-relevant to making the specific montelukast compound now known as Singulair®) should not be considered “inequitable conduct“. [Full 102 page decision, as a PDF file, available shortly.]


Teva loses Singular® (montelukast) patent spat; may appeal — but generic Singular is now a 2012 certainty.

Per AP wire-stories:

. . . .In his decision, Judge Garrett E. Brown upheld Merck’s patent on SINGULAIR and ruled that Teva committed infringement. Judge Brown also issued an injunction blocking the approval of Teva’s generic versions until the August 2012 expiration of the patent.

“The court appropriately ruled that the patent for SINGULAIR in the U.S. is valid,” said Bruce Kuhlik, executive vice president and general counsel of Merck. “We invest heavily in the R&D that is needed to discover innovative medicines like SINGULAIR, and we will vigorously defend our intellectual property rights.”

Merck filed the patent infringement lawsuit against Teva in February 2007. The trial was heard before Judge Brown in February 2009. . . .

Indeed. This likely spells the end of the insurers’ and wholesalers’ antitrust claims — as well.

I’ll keep you informed — on that — though.

Merck And Teva: Both Awaiting A Decision, on 2007 Singulair® Patent Suit — Any Day Now. . . .

In addition to the suits just filed this past Wednesday, a more straight-forward Singular® (montelukast) patent infringement bench trial concluded on February 26, 2009, in the New Jersey federal courthouse — and both parties expect a decision any day now — perhaps before this coming Friday, August 22, 2009. That case is Merck Sharp Dohme Pharmaceuticals, SRL v. Teva Pharmaceuticials USA, Inc., et al. (Case no. 07-1596, US Dist. Ct. NJ).

Thus, given the box-car numbers potentially involved, here, it might be useful to take a look at Teva’s claim, in seeking to avoid Merck’s patent, that Merck effectively affirmatively deceived the US Patent and Trademark staffers, when it filed for the ‘473 patent — a patent that teaches the chemical construction of the montelukast molecule, in a solid (powedered) form, suitable and stable enough to be the active ingredient in the branded Singulair pill.

If that Teva “deception” defense prevails, over Merck’s assertion of Teva’s infringement, in this straight-ahead patent infringement suit, it will be a truly-ominous sign for New Merck’s future. Why? Well, first of all because it is Merck’s single largest selling franchise. Next, because the crux of the wholesalers’ and insurers’ claims — of unlawful restraint of trade, and related unlawful monopolist practices — likewise would turn on just such a finding. As I just mentioned, the damages in such a setting could equal or exceed $8.4 billion (and that is before interest is assessed!), for the past seven years. So let’s examine the “obviousness” defensive positions staked out by Teva (and allegedly hidden by Merck, from the PTO), as set forth in Teva’s pre-trial briefs, back in February 2009, here:

. . . .[Merck’s] Young teaches that the Q2 position of the compounds claimed in the ’473 patent (which binds to the area of the receptor that receives the C-1 carboxyl group of LTD4) should be occupied by a functional group that is polar, not ionized, and capable of hydrogen bonding. MSD did not tell the PTO about these three criteria for the Q2 position, nor did it otherwise disclose the Young LTD4 receptor model. This allowed MSD [Merck] to mislead the PTO [Patent and Trademark Office] into believing that the use of a tertiary alcohol at the Q2 position was not suggested by the prior art, even though a tertiary alcohol was indeed suggested. The tertiary alcohol met each of the three criteria taught by the Young LTD4 receptor model for the Q2 position. (See Ex. K, Leger Dep. 89:4-6 (tertiary alcohol is polar); Ex. L, Xiang Dep. 68:2-4 (tertiary alcohol has capability to form hydrogen bonds); Ex. M, Zamboni Dep. 42:14-19 (“Tertiary alcohol will not ionize.”).). . . .

[Merck] Inventor Labelle certainly understood the materiality of the information conveyed by the undisclosed Young LTD4 receptor model. Labelle acknowledged that the tertiary alcohol at the Q2 position was a “likely modification” given the information conveyed by the model:

Q. So from your perspective, the tertiary alcohol was a likely modification?

A. Yeah.

Q. And why did you think that was a likely modification?

A. Because it fitted with what we know — what we thought we needed at that stage in the project.

Q. What do you mean by that?

A. At that stage, my understanding of what we needed was a lipophilic part on the left, specifically a quinoline, an acidic chain on the top, a so-called q1 chain, and a q2 chain that included some form of a polar group. [Note: The LTD4 receptor model described in the Young publications conveyed this information, and then some.]

Q. And a tertiary alcohol is a polar group?

A. That was the thinking at the time, yes.

Q. And that’s why you thought the tertiary alcohol would be a likely modification?

A. Yes.

(Ex. N, Labelle Dep. 87:8-88:4). . . .

Indeed, the undisclosed Young LTD4 receptor model was actually used by lead inventor Belley as the road map to the allegedly non-obvious tertiary alcohol. In early 1989, when MSD was looking to replace the prior art amide group at the Q2 position, Dr. Young showed inventor Belley the Young LTD4 receptor model. Promptly upon being shown the model, Belly determined that “it would be a good idea to try” a tertiary alcohol in place of the amide at the Q2 position. . . .

Nobody involved in the prosecution of the ’473 patent made sure that this highly material prior art was disclosed to the PTO during the prosecution of the ’473 patent. Nor has anyone involved in the prosecution provided an explanation for the non-disclosure. The named inventors did not explain their failure to disclose the Young LTD4 receptor model to the PTO during the prosecution of the ’473 patent. (See, e.g., Ex. K, Leger Dep. 166:22-168:1; Ex. N, Labelle Dep. 152:10-21; Ex. O, Belley Dep. 137:4-139:12.) Patent attorneys Lopez and Yang likewise did not explain their failure to disclose this prior art, nor did MSD’s patent liaison, Dr. Atkinson, offer one. (See Ex. P, Lopez Dep. 106:22-107:22; Ex. Q, Yang Dep. 107:6-24; Ex. R, Atkinson Dep. 65:2-8). . . .

Stay tuned. Both here, and there.