[Ip-health] Generic companies sue Wyeth for antibiotic Zosyn patent evergreening

[Judit Rius Sanjuan]

http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biote=
ch/3_cos_sue_Wyeth_over_Zosyn_patent/articleshow/1556744.cms

3 cos sue Wyeth over Zosyn patent
NOEMIE BISSERBE

TIMES NEWS NETWORK
SATURDAY, FEBRUARY 03, 2007 02:57:28 AM]

Three generic pharmaceutical companies, including one from India, have
taken legal action against US pharma major Wyeth. Their grouse is that
Wyeth is unfairly delaying the entry of generic versions of a
blockbuster drug.

Chennai-based Orchid Chemicals, Sandoz (Novartis=92 generic arm) and
Abraxis Pharmaceutical Products (APP) have filed citizen petitions with
the USFDA against Wyeth, after the pharma major filed a new patent on
its blockbuster drug Zosyn, extending its patent life to 2023. The
patent was set to expire this month.

Wyeth discontinued its original formulation for antibiotic drug Zosyn in
November 2005 and subsequently launched a new version with a fresh
patent, delaying for years the entry of generic players in the US market.

According to USFDA rules, a company is allowed to withdraw a product
from the market only for reasons related to safety and efficacy. In case
the product is withdrawn from the market, it is subsequently removed
from the approved drugs=92 reference list, and therefore no pharmaceutical
company can market a generic version of this same drug.

"Zosyn is a safe and efficient drug. This is just a move to extend the
patent life of the drug and prevent the entry of generic players in the
market," K Raghavendra Rao, managing director, Orchid Chemicals &
Pharmaceuticals, told ET.

"While Wyeth has added an excipient to its drug, other players should be
allowed to market generic versions of the original formulation for
Zosyn," he added. Sandoz India=92s management declined to comment on the
issue.

=91Evergreening=92 is the term used to describe the process by which the
innovator patents trivial modifications of already-existing drugs which,
in turn, extends their monopolies beyond the 20-year period granted for
the original patent. It is a common practice in the pharmaceutical industry=
.

Wyeth has been selling its injectible antibiotic, Zosyn, for the past 13
years in the market. In May 2005, the company added a purifying agent to
its molecule and filed a fresh patent for Zosyn, before withdrawing its
original product from the market in November 2005.

"Wyeth has withdrawn its original version of the drug to comply with
USFDA regulations. The new version of Zosyn can now be mixed with other
substances such as amikacin and ringer lactic in a wire tubing for
hospitalised patients," said Dr Shilpa Patel, medical director, Wyeth India=
.

With annual sales of $892 million, Zosyn represents a significant
opportunity for generic players. Orchid Chemicals, Sandoz and Abraxis
pharma have already filed Abbreviated New Drugs Applications (ANDAs) in
order to market a generic version of Zosyn's original formulation in the US=
.

Injectible antibiotic is an attractive market to generic players since
few companies make these drugs. And as a result, price erosion is
significantly lower compared to other generic products.

A generic version of an injectible antibiotic would typically be sold at
25-30% of the innovator=92s price, as against to 2-10% for the rest of the
generic market, according to Rao. The US FDA is expected to rule on this
case within the next few months

--
Judit Rius Sanjuan
Attorney
judit.rius@cptech.org
www.cptech.org

Consumer Project on Technology,
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