Partner Aydin Harston was quoted in a Law360 article titled "Fed. Circ. Gene Therapy Ruling Gives Rare Eligibility Clarity," analyzing a recent Federal Circuit decision that revived the University of Pennsylvania’s gene therapy patent and provided rare clarity on patent eligibility under Section 101.
The Federal Circuit reversed a Delaware district court’s summary judgment ruling that had invalidated the patent, which claims a human-made host cell containing a recombinant nucleic acid molecule. The district court had concluded that combining natural products in a host cell did not render them patentable because they were directed to natural phenomena. The Federal Circuit disagreed, holding that the recombinant nucleic acid molecule cannot exist in nature and therefore qualifies as patent-eligible subject matter.
“On all points of analysis, the Federal Circuit disagreed with the district court. And I think that’s going to be the test in every case,” Aydin told Law360. “You have to look at what you’re really doing.”
Aydin explained that once the recombinant molecule is created, "you're going to get certain effects that are markedly different from if you had those sequences just floating around separately somewhere. Not together, obviously, because they don't occur together. You're never going to get the same effect."
"It's a good data point to see this case and how it was explained and analyzed," Aydin noted. "There is a dividing line between the eligible versus noneligible cases. Oftentimes, if you have, for example, a composition, a solution that just mixes together two natural products and that's essentially it, that could be more leaning toward the patent-ineligible side. So you have to be more careful with those."
The article, “Fed. Circ. Gene Therapy Ruling Gives Rare Eligibility Clarity,” is authored by Dani Kass for Law360.
