Friday, April 06, 2007

Getting drugs out as economically as possible?

The article by Lash entitled "Government Nixes Stem Cell Patents," included text:

If [WARF doesn't drop all its claims], however, the case could eventually reach the U.S. Supreme Court, which under Chief Justice John Roberts has shown growing interest in patent cases.

"It seems they're becoming more restrictive in interpreting the rights of the patentee," said Wetherell. "There's a lot of pressure to get drugs out there as economically as possible, and [this court] seems more proactive to create that environment."

IPBiz notes that John Wetherill may have been talking about the MedImmune case (he certainly wasn't talking about Festo]. Of "as economically as possible," IPBiz thinks back to the costs involved in the Medicare Prescription Drug Bill:

On April 1, 2007, "60 Minutes" had a discussion of the Medicare Prescription Drug Bill that one probably won't find in C&E News. There were interviews with Dan Burton, Walter Jones, and Billy Touzain (with Touzain a beneficiary of the drug Avastin). There were allegations that a revised projection of cost (from 395 billion to 534 billion) was withheld prior to the (220-215) vote. Reminds one of the discussion of patent royalties PRIOR to the vote on Proposition 71.[The spelling Touzain is incorrect; it should be Tauzin]

[as noted on IPBiz.]

Of the "get the drugs out there" part, one notes the current legal debate over reverse payments in the Schering-Plough case and in the Joblove case.

One has text in an article by Legal Times about Joblove v. Barr Labs (No. 06-830)[Tamoxifen] :

The Eastern District of New York granted the defendants' motion to dismiss, reasoning that because the monopoly extension came within the patent context, it did not amount to an unreasonable restraint on trade. On appeal, the 2nd Circuit affirmed. In conflict with decisions by the 6th and 11th circuits in similar Hatch-Waxman cases, it declined to hold that reverse settlements are per se Sherman Act violations and it agreed that nothing about the particular settlement constituted an illegal restraint on trade.

The petitioners, represented by Patrick Cafferty of Miller, Faucher & Cafferty, argue in their cert petition that reverse settlements violate the Sherman Act and fly in the face of Congress' intent for the Hatch-Waxman Act. Further, they urge, the Supreme Court needs to reconcile inconsistent standards being applied by various circuits on the issue.

The respondents, represented by Arthur Golden of Davis Polk, & Wardwell, counter that there is no problem with the settlement because it was a resolution of a legitimate patent dispute that did not exceed the bounds of a monopoly granted by patent.

Weighing in on the side of the petitioners as amici, a group of 41 professors, led by Mark Lemley of Stanford Law School, argue that what they term "exclusion payments" should be prohibited because they preserve monopoly profits in a manner that harms consumers, competition and public health.

Notably, just last term the Federal Trade Commission unsuccessfully asked the Court to consider the same issue in FTC v. Schering Plough. In that case, the solicitor general -- in a brief filed at the Court's invitation -- recommended that certiorari be denied, explaining that the case was a poor vehicle for review of the antitrust issues involved. Here, by contrast, neither the FTC nor the Justice Department has weighed in on the issue before the Supreme Court.

Aspects of the article by Alex Lash had earlier been criticized on IPBiz.


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