[Ip-health] Gilead Sciences Gets Ambushed By The Patent Troll, AbbVie

Jamie Love james.love at keionline.org
Thu Nov 20 18:43:02 PST 2014

This a pretty bad precedent, as regards patenting combinations of drugs.


Seeking Alpha

Gilead Sciences Gets Ambushed By The Patent Troll, AbbVie
Nov. 12, 2014


AbbVie has been granted five US patents that specifically claim use of
sofosbuvir and ledipasvir, the drug combination that Gilead sells under the
trade name Harvoni.

Gilead has been granted no patents for the Harvoni combination, although an
application was filed in Sep2011, a month prior to ABBV’s earliest

AbbVie cannot market Harvoni since it does not own patents on either
individual drug in the combination, but can potentially compel royalty
payments and damages from Gilead.

Each side has filed lawsuits – resolution could take years.

Gilead (NASDAQ:GILD) is angry - real angry. AbbVie (NYSE:ABBV) has ambushed
them, obtaining five "method of use" and "utility" patents for the drug
combination marketed as Harvoni. Gilead has zero such patents. By marketing
Harvoni, Gilead is currently infringing the ABBV patents.

The first question that comes to mind is: how could it happen that the
company that is now selling Harvoni has no granted "method of use" patent
on the combination therapy while the company that cannot sell this drug
combination has five? The answer: ABBV concocted a clever (or devious,
depending on your point of view) strategy for convincing the patent office
that they have invented a novel computer model to predict effective
combination therapies.

The difficulty in obtaining patents on most combination therapies is
overcoming obviousness. It makes sense that combining two drugs, especially
those that work by different mechanisms, to treat a disease might be better
than using only one. In addition, combination therapy is standard for
treating viral diseases such as HIV, so it is a no-brainer to anticipate
combination therapy would be effective for HCV as well. Because of these
constraints, the inventor who applies for a patent on a drug combination
for HCV needs to demonstrate a novel or unexpected outcome would result.
AbbVie overcame the obviousness hazard by crafting an argument that a
sophisticated computer model they developed allowed them to conduct virtual
clinical trials to test combinations of drugs for treating HCV. The outcome
of these virtual clinical trials was the identification of a few drug
combinations that would be most effective, in the shortest amount of time,
while not requiring interferon or ribavirin - all without the need to
subject patients to many ineffective combinations by trial and error
through actual clinical trials. While this all may be a fairy tale, ABBV
created a compelling story in their patent applications and convinced the
patent office they had a novel, unexpected, and useful invention.


James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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