DOJ Changes Policy On Pharma Settlements That Delay Generics
07 July 2009 - 8:09AM
Dow Jones News
The U.S. Department of Justice on Monday took a skeptical view
on the legality of pharmaceutical patent settlements that delay the
introduction of generic drugs, the latest change in antitrust
policy under the Obama administration.
The department's antitrust division said in a court filing that
drug patent settlements should be presumed unlawful when branded
drug makers pay their generic counterparts to abandon patent
challenges that could lead to early market entry of competing
generic medicines.
For a settlement to survive legal scrutiny, a drug maker needs
to have good explanations for why the settlement doesn't impose an
unreasonable restraint on competition, the Justice Department
said.
The department expressed its views in a case in which drug
purchasers, including CVS Caremark Corp. (CVS) and Rite Aid Corp.
(RAD), challenged an agreement in which Bayer AG (BAYRY) paid Barr
Pharmaceuticals Inc. (BRL) to delay producing a generic version of
Cipro, an antibiotic drug.
A New York federal appeals court is considering the case and
invited the Justice Department to express its views on whether
so-called "pay for delay" settlements violate the antitrust
laws.
The U.S. Federal Trade Commission, which shares antitrust
authority with the Justice Department, has been an adamant opponent
of the settlements, saying that brand companies have paid potential
generic competitors handsomely to sit on the sidelines.
In a public split between the agencies, the Justice Department
under the Bush administration did not embrace the FTC's viewpoint
that the deals violated antitrust laws. The department's change in
position under the Obama administration goes a long way toward
resolving that split.
Christine Varney, who heads the department's Antitrust Division,
said during her confirmation hearings in March that she supported
the FTC's opposition to the drug settlements.
Defenders of the settlements say the deals are pro-competitive
because they often allow generic drugs on the market before a
branded drug maker's patent ends, while also removing the
uncertainty of litigation.
It's not clear what effect the government's position will have
in the Cipro case. The Justice Department, while expressing its
legal views, declined to take a position the drug purchasers'
challenge to the Cipro settlement.
The New York-based 2nd U.S. Circuit Court of Appeals, which is
considering the dispute, had previously adopted a permissive
approach to allowing the drug settlements.
The court's request for the Justice Department's viewpoint
suggests that at least some judges on the court are rethinking that
position.
The Justice Department said Monday that the 2nd Circuit's
approach was incorrect.
Lawmakers in the House and Senate have proposed legislation to
bar patent settlements that delay generic drugs. A House
subcommittee approved the legislation last month, while a Senate
committee is expected to take up the bill soon.
FTC Chairman Jon Leibowitz said in a speech last month that
banning the settlements could save consumers $3.5 billion annually
in health-care costs, an estimate disputed by drug makers.
The FTC has challenged some drug agreements in court but has had
limited success.
Most recently, the agency sued a group of drug makers in
February, alleging that Brussels-based Solvay Pharmaceuticals Inc.
(SVYSY), the maker of the testosterone drug AndroGel, entered into
an illegal agreement with generic drug companies Watson
Pharmaceuticals Inc. (WPI) and Par Pharmaceutical Cos. (PRX) to
delay the introduction of a generic competitor.
-By Brent Kendall, Dow Jones Newswires; 202-862-9222;
brent.kendall@dowjones.com