Third-Party Generic Strip Litigation

The third-party strip fight with the fullest public court record we could find is LifeScan's case against GenStrip, a lower-cost strip made for OneTouch Ultra meters. LifeScan won an order blocking GenStrip in March 2013. The Federal Circuit reversed it that November, ruling that once LifeScan sold or gave away a meter, its patent couldn't dictate which strips went into it [1]. Here is what the court and patent records show about that case and a second one brought by UniStrip.

The patent at the center

U.S. Patent 7,250,105, "Measurement of substances in liquids," was filed in May 2003 and issued July 31, 2007, with LifeScan Scotland Limited named as assignee [2]. Its one independent claim is a method. The strip has two working electrodes, and the meter compares the current from each and shows an error if they differ too much, which catches problems like too little blood [1]. According to LifeScan, its OneTouch Ultra system uses that technology [1].

Here's the detail that ended up deciding the case. LifeScan also tried to patent the strip itself, but the examiner rejected those claims as anticipated by earlier patents, and LifeScan abandoned them [1]. Only the method claims issued.

GenStrip and the 2011 lawsuit

LifeScan sued on September 9, 2011, in the U.S. District Court for the Northern District of California [1]. The defendants were Shasta Technologies, Conductive Technologies, Instacare Corp. and PharmaTech Solutions. LifeScan's theory was indirect infringement: each person testing with a GenStrip would perform the patented method, making the strip sellers liable for helping [1]. The FDA cleared Shasta's GenStrip through its 510(k) premarket process on November 30, 2012 [3].

The complaint also asserted two strip patents [4]: 6,241,862, "Disposable test strips with integrated reagent/blood separation layer," and 5,708,247, "Disposable glucose test strips, and methods and compositions for making same" [5][6]. On March 19, 2013, Judge Edward J. Davila granted a preliminary injunction, an order issued before any trial, finding that GenStrip sales likely infringed the '105 patent indirectly [4][1]. The FDA clearance didn't protect GenStrip in court. The injunction came less than four months after it [3][4].

The defendants answered with Sherman Act antitrust counterclaims in March and April 2013, alleging that LifeScan used its market power to shut their strip out [7].

Why the Federal Circuit reversed

The Federal Circuit put the injunction on hold on April 29, 2013, and reversed it on November 4, 2013, by a 2-1 vote [1]. The ruling turns on patent exhaustion: once a patent owner authorizes the transfer of a product that substantially embodies its patent, it can't use the patent to control how the new owner uses that product [1].

The majority found that the meter, not the strip, performs the measuring, comparing and error steps that made the method claims patentable [1]. So handing a patient the meter used up LifeScan's rights. The opinion records that LifeScan sold about 40% of its meters below cost and gave the other 60% away through health care providers. Deciding the question for the first time, the court held that a free, unconditional transfer exhausts a patent just as a sale does [1].

The majority compared LifeScan's position to a tying arrangement, where buying one product obliges you to buy another from the same company [1]. That's the razor-and-blade business model in legal terms. A notice on the meter packaging about using LifeScan strips didn't change the result, because LifeScan conceded it wasn't a binding contract [1]. Judge Reyna dissented. In his view the three-electrode strip, used up in every test, carried the method's essential features [1].

The patent office's role

The U.S. Patent and Trademark Office (USPTO) granted the defendants' request to reexamine the '247 and '862 patents in November 2012 [7]. That route didn't help them. In October 2013 the office confirmed all claims of the '862 patent and claims 1-16, 24-32 and 34 of the '247 patent, with none of the asserted claims amended [8].

The '105 patent faced inter partes review, a trial-like challenge before the Patent Trial and Appeal Board. PharmaTech petitioned in April 2013, the board began the review that August, and the defendants reported its final decision to the court in August 2014 [8][7][9]. LifeScan appealed (IPR2013-00247). On January 20, 2016, the Federal Circuit affirmed the board in a one-line judgment [10]. We couldn't open the board's decision itself, so the record we read doesn't say which claims it ruled on.

How the GenStrip cases ended

LifeScan and Johnson & Johnson had also sued Decision Diagnostics Corp. and PharmaTech under the Lanham Act, the federal false-advertising and trademark law [11]. In June 2015 LifeScan dropped its '247 claim and its demands for money damages on the '862 patent and the Lanham Act claims [11]. On April 29, 2016, after the parties reported a settlement, Judge William H. Orrick dismissed both cases with prejudice, so they can't be refiled [12]. The order doesn't disclose the terms.

UniStrip's antitrust case

UniStrip Technologies went to court as the plaintiff, on antitrust grounds rather than patents. The FDA cleared its UniStrip 1 strip on November 6, 2013 [13]. On July 29, 2014, UniStrip sued LifeScan in the Eastern District of Pennsylvania under the Sherman and Clayton Acts, the main federal antitrust laws. It alleged that LifeScan made resellers' rebates and discounts conditional on not buying rival strips for OneTouch Ultra meters [14].

On December 28, 2015, Judge Joel H. Slomsky let five of UniStrip's six claims proceed [14]. That ruling found only that the allegations were plausible, not that they were true. As of October 2026 we found no later ruling in the federal court opinions we could search.

When the generic side held the patents

Later the roles reversed. PharmaTech sued LifeScan in Nevada, claiming the OneTouch Ultra infringed its patents 6,153,069 and 6,413,411, and lost on summary judgment [15]. On November 22, 2019, the Federal Circuit affirmed. What the inventors had argued to the patent office to win their claims barred PharmaTech from stretching those claims to cover LifeScan's meter, a rule called prosecution history estoppel [15].

What the record settles, and what it doesn't

The 2013 exhaustion opinion is the part with reach beyond these parties; unlike the 2016 judgment, it isn't marked nonprecedential [1][10]. Its scope is narrow, though. It reviewed a preliminary injunction on one method patent, and LifeScan's '862 strip patent stayed in the case until the 2016 settlement [1][11][12].

The court records also don't tell you which meters a third-party strip fits. The FDA decision summaries do: GenStrip was cleared for OneTouch Ultra-family meters bought before July 2010, and UniStrip 1 for Ultra-family meters bought before October 2012 [3][13]. Our article on white-label and generic test strips covers those clearances. Which strips suit your care is a decision for you and your care team or pharmacist.