[Ip-health] Question of HCV patent infringement, and declaratory judgement on damages and injunctions

Jamie Love james.love at keionline.org
Tue Aug 12 10:08:05 PDT 2014

This is a question we are researching, and we will be grateful for any
thoughtful commentary.


A non-profit organization (not KEI) seeks to make or import generic
versions of a drug under patent protection in the United States for
distribution to and use by American patients.

Making, importing and distributing the drugs in any significant scale will
be considered an act of patent infringement.

The non-profit organization is wary of the liability they might face for
infringing the patent, particularly since for a two drug combination, the
suggested price from the patent owners could be north of $1500 per day for
a two pill combination, and a full course of treatment will likely involve
84 to 168 days.

Can the non-profit organization obtain a declaratory judgment from a
federal court of what the potential damages for infringement will be,
before they incur significant liability for infringement, and what
steps/requirements must be met in order for them to do so?

To motivate this question a bit more, I will elaborate on the non-profit's
situation. They believe it is possible, but uncertain, that a federal judge
will use the four factor test for an injunction set out in the eBay v
MercExchange case, and permit infringement, subject to a running royalty to
be paid the patent holders.   However, (a) they do not know if this will be
the outcome, and (b) even if a court permits the forward looking
infringement, they don't know how much the royalty would be.  They are
willing and able to pay a royalty, particularly if it is lower than the
price of the drug from the patent holders.  However, given the cost of the
drugs -- well more than $100k for a three month combination treatment for
one patient, they cannot afford to infringe now, and find out the
consequences later. They are looking to know what the consequences will be,
before they undertake certain activities.


James Love.  Knowledge Ecology International
http://www.keionline.org, 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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