Britain's SmithKline Beecham PLC, the maker
of the popular anti-depressant Paxil, is facing a federal
investigation into whether it violated antitrust laws by preventing
or impeding the marketing of generic equivalents.
The investigation was revealed this week in court documents
filed in federal court in Chicago by Apotex Corp., which is trying
to market a generic version of Paxil.
SmithKline officials said they are cooperating with the probe.
The company ``has been requested to supply documents voluntarily in
connection with our listing of patents for Paxil,'' said Brian
Jones, a company spokesman.
``We believe we are acting lawfully to legitimately protect our
products on which we hold valid patents,'' he said Thursday.
The Federal Trade Commission confirmed it is investigating
SmithKline but declined to provide details.
SmithKline, which has its U.S. headquarters in Philadelphia,
sold $2.11 billion worth of Paxil last year and has registered
sharp increases this year. It is the company's No. 1 drug and has
been approved by the Food and Drug Administration to treat
depression, panic attacks and social anxiety.
In 1998, SmithKline filed a lawsuit against Apotex accusing it
of infringing on its patent for Paxil. Apotex denies that and said
SmithKline is using the lawsuit as a delaying tactic to prevent
sales of a Paxil generic.
In the court documents filed Tuesday, Apotex requested the
public disclosure of documents that ``disclose and document a
conscious and considered plan by SmithKline to erect barriers to
the entry of generic competition for Paxil.''
Under the federal Food, Drug and Cosmetic Act, the filing of the
lawsuit automatically delayed FDA approval of Apotex's generic drug
for 30 months, said Tim Gilbert, a lawyer for Apotex.
A resolution of the 1998 case is expected shortly, but
SmithKline has obtained eight additional patents since then and has
filed more lawsuits, producing additional 30-month delays in the
FDA's approval of Apotex's generic drug, Apotex spokeswoman
Michelle T. Slattery said.
``It is a serial abuse of the FDA regulations,'' Gilbert said.