Rapid Litigation Management v. Cellzdirect Presented by Katherine Kim © 2016 Workman Nydegger

Invention- US 7,604,929 Patent (‘929 Patent) Rapid Litigation Management v. CellzDirect Invention- US 7,604,929 Patent (‘929 Patent) An improved method of preserving hepatocytes (liver cells) using multiple freeze-thaw technique The invention in the patent at issue was an imp[roved method of preserving hepatocytes, which are liver cells, using multiple freeze-thaw technique. I will be referring to this patent as the ‘929 patent The reason why patenting this method is relevant is because Hepatocytes are extremely useful cells in biomedical reserach because they can be used for testing, diagnostic, and treatment purposes. For example how drugs are metabolized by the liver or measure a drug’s toxicity. So finding a new method of preserving the hapatocytes is quite a big deal.

Federal Circuit Court Decision Rapid Litigation Management v. CellzDirect Federal Circuit Court Decision Holding: Method of preparing hepatocytes is patent eligible This was the federal circuit court decision in this case. The method of preparing hepatocyctes is patent eligible. And the reason why this holding is so interesting and why I chose to discuss this case is because at the first-look of the method claim, you may think that this is an unexpected decision by the federal circuit. So hopefully it will be interesting to you as well. But before we really dive into this case, let’s look at the history behind preparing hepatocytes and how the current invention is different and new.

History- Cryopreservation Rapid Litigation Management v. CellzDirect History- Cryopreservation Prior Invention “cryopreservation” technique to preserve hepatocytes for later use. Method freeze hepatocytes then thaw them when needed and recover the viable cells. Problem damages cells leading to poor recovery numbers of viable cells. This is a prior invention of how labs have preserved hepatocytes. They used a technique called cryopreservation to preserve hepatocytes for later use. And the method in this patent was to freeze hepatocytes then thaw them when needed and recover the viable cells. But the problem with this technique were that there were a lot of damaged cells leading to poor recovery numbers of cells you could actually use. And this is when the current invention came to light!

New Invention! Method Claim of US ‘929 Patent Rapid Litigation Management v. CellzDirect New Invention! Method Claim of US ‘929 Patent Directed to a method of preparing frozen hepatocytes that can be thawed and re-frozen (at least twice) while remaining viable The claimed method is an artificial-selection approach of freezing then thawing a group of hepatocytes and then selecting the cells still viable. - The method claim in this new invention involved…. (READ BULLET POINTS) -The method did involve a few intermediary steps involving additional details such as using density gradient fractionation (centrifuge) to separate the viable form non viable  Also plating the cells between the first and second freeze  Using pooled preparation of hepatocytes from multiple sources - What really differentiates this from the previous method is that the inventors of the ‘929 patent discovered that some fraction of hepatocytes are capable of surviving MULTIPLE FREEZE-THAW CYCLES. And that these twice frozen cells functioned the same way when thawed as once frozen cells. - Basically the inventors found an improved process of preserving these cells

Method Claim of US 7,604,929 Patent Rapid Litigation Management v. CellzDirect Method Claim of US 7,604,929 Patent Freeze Thaw So here is just a simplified diagram of the method claim. We freeze the hepatocytes, then thaw them, then look for the cells that survived this cycle. Then we take just those viable cells to plate them again, let them grow, freeze and thaw them again then at the end of this second cycle, you take only the cells that survived this second cycle. Thaw

Rapid Litigation Management v. CellzDirect Claiming “natural law” that some hepatocytes can survive these freeze-thaw cycles? But doesn’t this seem like the inventors are simply claiming the natural law that some cells can survive these freeze-thaw cycles?

District Court for Northern District of Illinois Rapid Litigation Management v. CellzDirect District Court for Northern District of Illinois “natural law” “Lacks requisite inventive concept” Simply “reapplied a well-understood process” And this is exactly what the district court for northern district of Illinois thought! That this is natural law and Inventors simply applied a law of nature- the natural ability of some cells to survive multiple freezing and thawing cycle. The patent process Lacks requisite inventive concept Observing that upon discovering the cell’s capability of surviving multiple freeze-thaw cycles, the inventors simply ‘reapplied a well-understood freezing process’ So the inventors appealed and the federal circuit had something different to say about this invention. Holding: Patent method invalid!

Federal Circuit Holding Rapid Litigation Management v. CellzDirect Federal Circuit Holding Disagree with district court New and useful laboratory technique Not claiming “natural law” Patentable Concept Disagree with District Court’s characterization and instead found that the claims directed to a new and useful laboratory technique for preserving hepatocytes. They disagreed with the district court categorizing this method as “natural law” and held that the inventors’ method is a patentable concept.

Federal Circuit Holding Rapid Litigation Management v. CellzDirect Federal Circuit Holding “The inventors certainly discovered the cells’ ability to survive multiple freeze-thaw cycles, but that is not where they stopped, nor is it what they patented. Rather, as the first party with knowledge of the cells’ ability, they were in an excellent position to claim applications of that knowledge. That is precisely what they did. They employed their natural discovery to create a new and improved way of preserving hepatocyte cells for later use.” The court also added that just because you’re applying the natural ability of a subject matter to do something into your method claim – which in this case is the cell to be able to survive multiple freeze-thaw cycles- does not necessarily make the claim directed to that natural ability. The court gave example of treating cancer with chemotherapy where we use cancer’s inability to survive chemotherapy or treating headaches with aspirin as directed to the human body’s natural response to aspirin.

Rapid Litigation Management v. CellzDirect Ex- Treating cancer with chemotherapy where we use cancer’s inability to survive chemotherapy or Ex- Treating headaches with aspirin as directed to the human body’s natural response to aspirin. Just because you’re applying the natural ability of a subject matter to do something into your method claim does not necessarily make the claim directed to that natural ability. The court also added that a true application of the Mayo/alice system would decimate the patent system by saying this Just because you’re applying the natural ability of a subject matter to do something into your method claim – which in this case is the cell to be able to survive multiple freeze-thaw cycles- does not necessarily make the claim directed to that natural ability. The court gave example of treating cancer with chemotherapy where we use cancer’s inability to survive chemotherapy or treating headaches with aspirin as directed to the human body’s natural response to aspirin.