[Pharm-policy] Gardiner Harris in WSJ on Evergreening of US (Pri)locec

[love@cptech.org]

Thanks to MG for this pointer to a Gardiner Harris story about something
that looks a lot like what happened in the BMS case with Taxol.  Patents
by third parties appear at the last minute to trigger 30 month
Hatch/Waxman delays, in this case for the largest grossing drug the
world.   Jamie


http://interactive.wsj.com/fr/emailthis/retrieve.cgi?id=SB995580784482710590.djm

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July 20, 2001    

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Health
Research Company Receives 2 Patents,
Could Delay Generic Forms of Prilosec
By GARDINER HARRIS 
Staff Reporter of THE WALL STREET JOURNAL


In another sign of the legal hurdles facing generic-drug companies, a
North Carolina research company received two patents Tuesday that may
delay the launch of cheap generic versions of the huge-selling ulcer
drug Prilosec.

Aai Pharma Inc. of Wilmington, N.C., said its patents describe the ratio
of two crystalline structures within Prilosec, and that generic
companies are unlikely to be able to make Prilosec properly without
using -- and therefore paying for -- Aai's discoveries. Prilosec is made
by AstraZeneca PLC, which has a nonexclusive licensing agreement to the
patents, said Fred Sancilio, Aai's chairman and chief executive.

Mr. Sancilio said he would offer to license the patents to generics
makers but not necessarily on the same terms offered AstraZeneca. If
generic companies refuse to pay his company, "I think there is a threat
of a lawsuit" filed by Aai against the generic companies, he said.

Aai's patents could prove beneficial to AstraZeneca, which has been
fighting for years to extend its exclusive hold on Prilosec, the world's
biggest-selling brand drug with $6 billion in annual sales.
AstraZeneca's exclusive rights to Prilosec expire in October.

Chris Spooner, an analyst for Bank of America, said Aai's patents aren't
likely to hold up to a court challenge but could delay generics' launch
by "at least four months and that alone would provide around $350
million free cash flow" for AstraZeneca.

Mr. Sancilio said his company finally figured out the true chemical
structure of Prilosec, something he contends AstraZeneca has never known
and originally described incorrectly when the drug was patented and
approved for sale.

If AstraZeneca chooses to list Aai's patents in a federal registry
called the orange book, the patents could delay generic competitors to
Prilosec by as much as 30 months -- which would be a multibillion dollar
boon to AstraZeneca but harm consumers, the generic makers say.

"Consumers have the right to expect that AstraZeneca ... will now do the
right thing and not abuse the system," said Elliot F. Hahn, president of
Andrx Group, Fort Lauderdale, the lead generic company.

Rachel Bloom Baglin, a spokeswoman for AstraZeneca, said the company is
evaluating the patents and that "no decision has been made whether the
patent qualifies for listing in the orange book."

Write to Gardiner Harris at gardiner.harris@wsj.com