Blood, Sweat, and Patent Law

Blood Sweat and Patent Law

Inventing something new requires a lot of blood, sweat, and tears, particularly when you’re developing a new control for blood cells. Research & Diagnostic Systems (R&D) tried to sweat out this infringement action at the Federal Circuit, hoping to invalidate Streck’s patents. Ultimately, R&D left in tears.

Streck, Inc. v. Research & Diagnostic Systems, Inc., No. 2011-1044 (Fed. Cir. Jan. 10, 2012) (Judges Newman, O’Malley, and Reyna)

The patents here cover a way to test the accuracy of hematology machines. These machines measure all of the components that make up blood: red blood cells, white blood cells, platelets, and reticulocytes (immature red blood cells). This invention is a control that integrates white blood cells and reticulocytes, so that the machine can simultaneously measure counts of both types of cells.

Back in October, we covered another appeal between these two parties. That case involved the same patents, but it dealt with a related interference that made its way to the Federal Circuit. The main issue in the earlier case was who invented the technology first. (The Federal Circuit said Streck was first.)

But even after the Federal Circuit decided that issue, there was still bad blood between the parties. This case addresses several issues left over from the original patent infringement action.

After the interference was over, Streck sued R&D for infringement of particular claims of its 3 patents. R&D responded that all claims of Streck’s patents are invalid because: (1) the patent specifications don’t clearly describe the invention (in patent speak, they fail the written description requirement, and (2) someone who understands this technology wouldn’t understand how to make and use the invention without undergoing a lot of testing (in patent speak, they fail the “enablement” requirement). The district court rejected all of R&D’s arguments, and R&D appealed to the Federal Circuit.

Stick to the Subject

The first argument was about how many claims R&D could ask the court to analyze for invalidity. When a patent owner sues someone for infringement, the patent owner has to list which claims of the patent the party allegedly infringes—these are the claims the patent owner “asserts.” The accused party can then ask the court to rule that some or all of the patent claims are invalid or not infringed. Most of the time, the accused party only asks the court to look at the claims the patent owner asserts. But sometimes, the accused party wants the court to look at other claims in the patent as well.

That’s what happened here: Streck initially accused R&D of infringing 12 patent claims in its 3 patents. By the time the case went to trial, Streck had narrowed that number to 9 claims. But R&D wanted the district court to decide that all 83 of the claims are invalid. The court said that it didn’t have jurisdiction over the 74 claims Streck didn’t assert against R&D.

For a court to have jurisdiction to decide whether those other patent claims are valid, there has to be a “case or controversy” between the parties with respect to those claims—in other words, there has to be some argument between the two parties about the unasserted claims. To decide whether it had jurisdiction over the unasserted claims, the court used the “reasonable apprehension of suit” test. Under this test, R&D had to show that Streck’s actions made R&D reasonably concerned that it would get sued in the future for infringing those claims.. The district court concluded that Streck didn’t show any intent to sue R&D on the other claims, so R&D couldn’t reasonably expect to get sued for infringing the unasserted claims.

The problem is, the “reasonable apprehension of suit” test is no longer the correct test. In the 2007 MedImmune v. Genentech decision, the Supreme Court said that courts should look at all of the circumstances to decide whether there’s a case or controversy, not just the “future lawsuit” question.

R&D argued that the MedImmune decision means it doesn’t have to show that it’s afraid of a future lawsuit on the unasserted claims. The Federal Circuit noted, in response, that MedImmune simply clarified that the “reasonable apprehension of suit” test shouldn’t be the only consideration, but it’s still relevant; it’s just one of several ways a court can decide if there’s an argument between the parties, which is the ultimate question. (In some other cases the Federal Circuit has taken a stronger stance on the test: “[t]he Supreme Court’s opinion in MedImmune represents a rejection of [the Federal Circuit’s] reasonable apprehension of suit test.”)

R&D still had to show that the invalidity arguments were on topic. The Federal Circuit concluded that, while the district court shouldn’t have relied exclusively on the old test, its conclusion was right: R&D didn’t show that there was actually an infringement controversy between the parties over the 74 claims Streck didn’t assert.

True and False

The other 2 invalidity questions the court considered have to do with the type of reticulocytes that Streck uses in its invention. There are 2 types of reticulocytes: true reticulocytes and reticulocyte analogs. True reticulocytes are those found in humans; reticulocyte analogs are reticulocytes from other animals. R&D argued that Streck’s patents focused on reticulocyte analogs, and the patents didn’t clearly explain how to make or use the invention with true reticulocytes, so the patents are invalid.

R&D claimed that one of the inventors, Dr. Ryan, testified that true reticulocytes weren’t part of his invention. But the court interpreted his statements as just saying he preferred to use analogs, not that he didn’t or couldn’t use true reticulocytes. Also, the patents’ specifications referred to several types of true reticulocytes. Overall, R&D’s written description argument was anemic.

R&D also argued that Streck hadn’t proved that the patents clearly teach scientists or researchers familiar with the technology how to make and use the invention using true reticulocytes, not just analogs. But, the court said that it was actually R&D’s job to prove that Streck’s patents didn’t explain the how to use true reticulocytes in the invention. The court pointed out that true reticulocytes and reticulocyte analogs work exactly the same way and are “virtually indistinguishable” to people working in that field. The amount of work required to make or use the invention is pretty much the same, whether the cells came from humans or other animals. R&D didn’t prove otherwise, so the court said the patents met the enablement requirement.

Should R&D’s blood be boiling? You can judge for yourself if you would like to read the opinion.

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