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Recent Chemistry Cases in the US
Speaker: Donald G. Lewis
US Patent Attorney
California Law Firm
IP Case Law Seminar
Royal Society of Chemistry, Law Group
London
28 November 2013
US Developments Don Lewis
LifeScan v. Shasta Tech (Fed. Cir. 2013)
Expansion of Exhaustion Doctrine:
Chemical method claims ruled unenforceable against seller of “test strips” following gift of apparatus by patentee to end users. US Developments Don Lewis
Exhaustion Doctrine An equitable defense, sometimes known as the First Sale Doctrine, that renders a patent unenforceable with respect to articles put into commerce with an unrestricted, authorized sale by the patentee. The patentee’s right of exclusivity is said to be “exhausted” with respect to such articles and the purchaser is free to use or resell such articles without further restraint from patent law.
US Developments Don Lewis
LifeScan’s Technology
LifeScan makes a glucometer and disposable test strips for testing blood glucose levels.
LifeScan owns U.S. Patent No. 7,250,105 (‘105), directed to a method by which the glucometer, together with the test strips, are employed for measuring blood glucose levels.
The glucometer and the disposable test strips employed by the patented method and sold by LifeScan are unpatentable. US Developments Don Lewis
Business Model
LifeScan provides physicians with bulk quantities of free glucometers, on the condition that the physicians distribute the glucometers to their patients without cost. Patients are then supposed to purchase their test strips from LifeScan in order to use their free glucometer. US Developments Don Lewis
How the invention works
Sample blood is applied to a test strip having sample electrodes 6 and 8, each coated with glucose oxidase. The glucose oxidase oxidizes blood glucose in the sample and generates a potential. The test strip is then inserted into the glucometer. Once inserted, the “working sensors” of the glucometer are contacted with sample electrodes 6 and 8; the glucometer
compares the currents generated by two sample electrodes and gives an error indication if they are too dissimilar.
US Developments Don Lewis
The “Infringement”
Shasta sells knock-off test strips specifically
designed
for
use
with
LifeScan’s
glucometers. Shasta’s test strips have no
other use.
Shasta markets its test strips to owners of
glucometers gifted from LifeScan and urges
such device owners to use LifeScan’s
patented method.
US Developments Don Lewis
Issue
Are the method claims of ‘105 enforceable against Shasta, in view of the Exhaustion Doctrine? • Does the Exhaustion Doctrine apply if there was a gift but no sale by the patentee?
• Does the Exhaustion Doctrine apply to contributory infringement? • Does the Exhaustion Doctrine apply to infringement by inducement? US Developments Don Lewis
Application of Exhaustion Doctrine to method claims: “The question is whether the strips embodied the inventive features of the claims that were actually allowed by the examiner.” (LifeScan v. Shasta Tech, Fed. Cir. 2013)
US Developments Don Lewis
There are two approaches to determining whether the test strip “embodies” the method claim:
1.Deconstruct the method claims;
2.Deconstruct the prosecution history.
US Developments Don Lewis
Claim 1: A method of measuring the concentration of a substance in a sample liquid comprising the steps of: providing a measuring device comprising: a first working sensor part . . . .; a second working sensor part . . . .; and a reference sensor part . . . .; wherein said first and second working sensor parts and said reference sensor part are provided on a disposable test strip; applying the sample liquid to said measuring device; measuring an electric current at each working sensor part proportional to the concentration of said substance in the sample liquid; comparing the electric current from each of the working sensor parts to establish a difference parameter; and giving an indication of an error if said difference parameter is greater than a predetermined threshold.
US Developments Don Lewis
“. . . . the strips do not embody the claimed invention and are themselves not patentable.”
(LifeScan v. Shasta Tech, Fed. Cir. 2013)
US Developments Don Lewis
Deconstruction of the prosecution history to determine whether the test strip “embodies” the method claim
“Having accepted the rejection of its claims drawn to the strips themselves by abandoning those claims in both its original and continuation applications, LifeScan cannot now argue that the strips themselves were the invention.” (LifeScan
v. Shasta Tech, Fed. Cir. 2013)
US Developments Don Lewis
Holding:
“. . . . the meter rather than the strips performs the inventive feature of the patent [method] claims that were actually allowed.”
(LifeScan v. Shasta Tech, Fed. Cir. 2013)
The court found that LifeScan’s method claim was unenforceable against Shasta with respect to Shasta's inducement/ contributory infringement activity because, under the doctrine of patent exhaustion, LifeScan had exhausted its patent rights when it gave away glucometers that “embodied” their method claim. US Developments Don Lewis
The mirror image situation of LifeScan
would have had the opposite result:
Using the logic of LifeScan:
if Life Scan had given away its test strips to end users and if Shasta had marketed a knock‐off of Life Scan’s glucometer to such recipients of Life Scan’s test strips, urging them to use the glucometer with the test strips according to Life Scan’s claimed method, then Shasta would have been found to infringe Life Scan’s method patent by inducement or contribution; and since the test strips do not “embody” Life Scan’s method claims (according to the LifeScan court), then
the Exhaustion Doctrine would not have been available as a defense to Shasta, i,e, Life Scan’s method patent would have been enforceable against Shasta. US Developments Don Lewis
Conclusions
As a rule of thumb, a patentee’s transfer
action exhausts a patent if that same transfer
action, when done by another, would
constitute infringement.
In view of LifeScan, that same principle
applies when the underlying claim is
inducement or contributory infringement.