With no doubt, our federal appeals courts are populated with legal thinkers and writers of the highest caliber. As such, it is a treat to see their skills applied to an area of law that some of us grapple with daily.
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For patent litigation aficionados of a certain bent, it can be thrilling when it turns out that a case you are handling, or are interested in, gets assigned to a circuit court judge sitting by designation. I won’t venture a guess as to how many others share that feeling, but I can testify that the presence of an appellate jurist in a patent case is something that gathers my interest, at least. Due to its deluge of cases and relatively small bench, Delaware is perhaps the district where you can find the longest list of visiting judges with appellate experience. Even a quick perusal of the current roster shows that judges from both the federal circuit and Third Circuit are pitching in to help with Delaware’s overflowing workload.
With respect to the former, it is easy to see the benefits when you have appellate judges getting a first-hand look at how patent cases are litigated at the district court level. It is the welcome reverse of trial court judges sitting by designation on federal circuit panels, so that they can get the benefit of seeing firsthand how cases that will be appealed from their courts in the future will be handled. Federal circuit judges themselves sitting by designation in trial courts are not the only beneficiaries of these practices. When adding in the fact that federal circuit judges really know their patent law, it can also be very instructive for practitioners to see how these judges approach issues that arise in the course of a case making its way through trial.
But as much as I enjoy the participation of federal circuit judges sitting by designation, I like it visitors from other circuit courts even more, for at least two reasons. First, we all know that patent law is complicated and can present many issues for jurists to deal with. It is interesting, therefore, to see how non-patent focused appeals court judges address patent issues that arise at the trial court level. Sometimes, they analogize those issues in interesting ways to the types of IP issues that they do encounter, such as trademark or copyright issues. More often — and of more interest — is when appellate judges really dive into an issue and try to apply federal circuit precedent to the case before them. Their fresh eyes can provide new ways of looking at even tried-and-true issues. Second, with no doubt, our federal appeals courts are populated with legal thinkers and writers of the highest caliber. As such, it is a treat to see their skills applied to an area of law that some of us grapple with daily.
One appellate jurist who has received much praise for his writing in particular is the Third Circuit’s Hon. Stephanos Bibas, who has seen former law clerks of his serve no less than six of the nine sitting Supreme Court justices. It was a treat, therefore, to see Bibas issue an opinion in a District of Delaware pharmaceutical patent case, Galderma v. Lupin (D. Del. 21-cv-1710,) involving the use of a potent antibiotic, doxycycline, in a branded pharmaceutical product called Oracea. Oracea’s formulation depends on a dual-release mechanism for its active ingredient, so that the patient can “maintain steady-state blood levels of doxycycline between 0.1 and 1.0 µg/ml.” At this lower concentration, the doxycycline’s antibiotic effects are muted so that Oracea’s “smaller dose serves as an anti-inflammatory, reducing redness in the cheeks and providing relief from rosacea.” With Oracea, the patient gets an immediate dose of 30 mg of the doxycycline, followed by a second, delayed-release dose of 10 mg once the capsule hits a higher-PH environment in the patient’s duodenum and small intestine as it makes its way through the patient’s digestive system. As we see in some Delaware pharma patent cases, there was a generic company (seeking to market a generic copy of Oracea) that had attempted to design around the patent holder’s claims. The key change that the defendant’s product incorporated was a capsule that released “22 mg of doxycycline immediately and 18 mg after a delay,” as opposed to the 30 mg/10 mg release profile found in Oracea and the asserted patent claims.
Despite the design around, the patent owner still tried to argue that the generic would infringe. But Bibas was not on board with that effort, especially because it was grounded less in evidence than in “appeals to authority” from an expert that was adjudged by the court as “unauthoritative.” According to the court, the patent owner’s expert was highly credentialed but “presented wild guesses as scientific fact, failed to back up those guesses with hard evidence, and was remarkably combative when pressed on the lack of support for his claims.” Pretty straightforward credibility determination from an appellate jurist, who also did not hesitate to attack the patent owner’s infringement claims on the merits as well. Buttressed by real-world testing that showed that the proposed generic “had a 22 mg immediate-release portion plus an 18 mg delayed-release portion,” the court rejected all of the patent owner’s arguments raised at trial, finding no evidence that the generic had “about a 30 mg immediate-release portion and about a 10 mg delayed-release portion.” Accordingly, Bibas found no direct infringement, as well as no infringement under the doctrine of equivalents due to the change in release schedule of the doxycycline adopted in the generic capsules.
Ultimately, Bibas’ opinion highlights the importance of expert credibility at trial, while putting the lie to any idea that an appellate jurist can’t make credibility determinations with the best of their trial court colleagues. It was also a pleasure to see questions of infringement handled with such clarity. Does it mean that the federal circuit will rubber stamp Bibas when this decision gets appealed? Maybe not. But they will know where he stands, as well as which side’s experts earned his designation of credibility.
Please feel free to send comments or questions to me at gkroub@kskiplaw.com or via Twitter: @gkroub. Any topic suggestions or thoughts are most welcome.
Gaston Kroub lives in Brooklyn and is a founding partner of Kroub, Silbersher & Kolmykov PLLC, an intellectual property litigation boutique, and Markman Advisors LLC, a leading consultancy on patent issues for the investment community. Gaston’s practice focuses on intellectual property litigation and related counseling, with a strong focus on patent matters. You can reach him at gkroub@kskiplaw.com or follow him on Twitter: @gkroub.
