By Ransdell Pierson
Aug 19 Eli Lilly and Co, now facing one of the
worst patent cliffs in its history, could find $15 billion in
sorely needed relief if it beats the odds and wins a closely
watched patent battle with generic drugmaker Teva Pharmaceutical
While a Lilly victory is not widely expected, a
number of patent attorneys and industry analysts say the patent
being challenged by Teva, beginning Monday in Indianapolis
federal court, will pass legal muster.
The U.S. Court of Appeals in Washington last summer upheld
the validity of the basic patent on the chemical structure of
Alimta. That protected Lilly's $2.6 billion-a-year lung cancer
drug from generics until January 2017, including a six month
patent extension granted by U.S. regulators for testing the drug
The Indianapolis court will weigh the merits of a separate
"method-of-use" patent on the way Alimta is administered. If the
court upholds the patent, Lilly would be able to fend off
generic alternatives to Alimta until 2022.
The so-called '209 patent covers administration of two
nutrients - folic acid and vitamin B12 - to patients before they
receive Alimta, to prevent side effects of the drug. Alimta's
package insert label instructs doctors to administer the
nutrients prior to and during use of the medicine.
For a generic to win approval, it usually has to copy the
language of the branded drug's label, Ben Hsing, a partner in
the law firm of Kaye Scholer in New York, said in a recent
But generics could have a hard time doing so because of
Lilly's patented descriptions of the need to take the nutrients
and how to do so, said Hsing, who last year successfully
defended Roche Holding AG's Tarceva lung cancer drug
from patent challenges by generic drugmaker Mylan Inc.
"This is the first time I've heard of a company going down
this route to defend a patent, by adding nutrients" to a drug
regimen, said Les Funtleyder, a healthcare strategist at
investment firm Poliwogg. "So the likely outcome of this case is
not clear cut."
The majority view, however, is that Teva will prevail over
Lilly, according to Morningstar analyst Damien Conover, who said
most method of use patents do not stand up in court.
Generic drugmakers Teva and Fresenius SE & Co KGaA
have challenged the validity of the '209 patent. The
companies on Monday declined to comment on the case.
Lilly has said it expects cheaper copycats to flood the
market in 2017, after Alimta's basic patent lapses. But the
drugmaker on Monday said it plans to vigorously defend the
"We believe this patent is valid and enforceable and we are
prepared to defend our intellectual property," said company
spokesman Ed Sagabiel. "The significant scientific research that
Lilly performed in support of the vitamin dosage regimen patent
deserves intellectual property protection."
Sagabiel declined to comment further, including whether
Lilly had changed its view and now expects to prevail in the
Lilly badly needs to hold onto whatever revenue it can, and
to launch new products, to offset plunging sales of other drugs
that have been hit by generics or soon will be.
Its Zyprexa schizophrenia treatment, with one-time annual
sales of $4.5 billion, lost patent protection in late 2011, and
its current flagship product, $5 billion-a-year antidepressant
Cymbalta, goes generic in December. Adding to the pain, copycat
forms of its blockbuster Evista osteoporosis treatment are due
to arrive in early 2014.
Aside from assuring continued blockbuster sales of Alimta, a
patent victory in Indianapolis would enable Lilly to use the
drug as a calling card to introduce new cancer therapies to
doctors, Funtleyder said, including a promising lung cancer
medicine called necitumumab now in late-stage trials at Lilly.