On June 14, 2016, the Court of Appeals for the Federal Circuit issued its opinion in the patent case Genzyme Therapeutic Products v. Biomarin Pharmaceutical, docket number 15-1720. Judge Bryson wrote for the three-judge panel.
The case was appealed from an inter partes review proceeding before the United States Patent Trial and Appeals Board (PTAB). The patents at issue were US patents 7351410 and 7655226, both of which are directed to a method of treating Pompe disease.
Like many Federal Circuit opinions, this one dealt in part with the infinitely fascinating topic of patent claim construction: how the language of patent claims should be interpreted. In claim construction, the PTAB applies a “broadest reasonable interpretation” standard (a standard that was upheld by the Supreme Court in a different case, just today).
At issue, in this aspect of the Federal Circuit’s opinion, was how to interpret the “whereby” clause in the first claim of both patents:
A method of treating a human patient with Pompe’s disease, comprising intravenously administering biweekly to the patient a therapeutically effective amount of human acid alpha glucosidase, whereby the concentration of accumulated glycogen in the patient is reduced and/or further accumulation of glycogen is arrested.
The PTAB, in accordance with its broadest-reasonable-interpretation standard, construed this “whereby” clause as non-limiting, merely describing the results of the patented method. As the PTAB put it, “[s]uch results are not generally considered a patentable feature separate from the expressly recited steps of the claimed method.”
On appeal, patent holder Genzyme argued, as paraphrased by Judge Bryson, that the whereby clause “should be construed to require that the reduction of glycogen occur in the patient’s skeletal muscles, rather than occurring anywhere in the patient’s body, including the heart, skeletal muscles, or liver.”
But the court agreed with the PTAB’s rule regarding whereby clauses, so this argument was unsuccessful — as, indeed, were the rest of Genzyme’s arguments.
Pharmaceutical patents make up a comparatively small slice of overall patent practice, but a typical pharmaceutical patent is filed (and often litigated) in far more countries than a typical electronics or software patent.
It turns out that the patent family at issue in this case is no exception. And although patent claims are much more a matter of localization and adaptation than pure translation, it’s somewhat interesting that none of the versions of these patents filed elsewhere have a results-oriented limitation corresponding to the whereby clause in the US patents.
For example, the first claim of the corresponding Korean patent application reads:
인간 산 알파 글루코시다아제를 치료에 효과적인 양을 환자에게 투여하는 것을 포함하는 폼페병 환자 치료 방법.
(Method of treating a patient with Pompe’s disease, comprising administering a therapeutically effective quantity of human acid alpha-glucosidase to the patient.)
Likewise, the first claim of the Danish version of the corresponding European patent reads:
Anvendelse af human sur alfa-glucosidase till fremstilling af et medikament till behandling af infantil Pompes sygdom, hvor den humane sure alfa-glucosidase er i 100 till 110 kD-formen, hvor medikamenet er til intravenøs indgivelse, og hvor behandlingen skal forsættes i mindst 4 uger.
(Use of human acid alpha-glucosidase for producing a medication for treating infantile Pompe’s disease, wherein the human acid alpha-glucosidase is in 100 to 110 kD form, wherein the medication is for intravenous use, and wherein the treatment is continued for at least 4 weeks.)
And while both of those (like the many others filed around the world) contain numerous additional claims, none of those claims seems to have a results-based limitation.
Although this is just one data point, it feeds into a theory I’ve been working on, that the interpretive judgment calls made by those tasked with interpreting a patent in one language and legal system, and by those tasked with adapting that patent into different languages and legal systems, will tend to converge.