In Apotex, Inc. et al. v. Novartis AG (IPR 2017-00854, paper 47 dated Feb. 5, 2018), petitioner Apotex sought, and was granted, discovery of a Phase III clinical trial protocol from patent owner Novartis.
The patent at issue in the IPR, U.S. 9,187,405, claims a method for treating relapses in relapsing-remitting multiple sclerosis by orally administering fingolimod “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” In its petition for IPR, Apotex alleged that the prior art taught that 0.5 mg of fingolimod was known to be an effective maintenance dose for treating multiple sclerosis. Novartis responded that to the extent that the prior art taught the use of 0.5 mg of fingolimod, it was only in the context of a treatment wherein the maintenance dose is preceded by a loading dose, something that is explicitly absent from the claimed methods. See paper 8 at 25.
After the Patent Trial and Appeal Board (PTAB) instituted the IPR, Novartis elaborated on its position in its response (paper 27), stating that the effectiveness of 0.5 mg as a maintenance dose in the absence of a loading dose, as required by the claims, was a surprising discovery. Although its briefing is heavily redacted, it appears that Novartis asserted that its Phase III clinical trial was aimed at showing the effectiveness of a 1.25 mg per-day dose, and that the study included a 0.5 mg dosing only at the suggestion of the U.S. Food and Drug Administration (FDA). Novartis supported this assertion with an expert declaration authored by a member of the advisory board that helped Novartis design the Phase III clinical trial. After deposing Novartis’s expert, Apotex moved for additional discovery, seeking several documents, including Novartis’s Phase III clinical trial protocol.
January was an exciting month for patent professionals still attempting to make sense of the fallout from the Supreme Court’s 2014 Alice Corp. v. CLS Bank International decision. Hot on the heels of its Jan. 10 decision in Finjan, Inc. v. Blue Coat Systems, Inc., the Court of Appeals for the Federal Circuit decided Core Wireless Licensing v. LG Elecs., Inc. on Jan. 25, affirming denial of LG’s summary judgment motion seeking to invalidate Core Wireless’ display interface patent claims for being directed to an exception to statutory subject matter under 35 U.S.C. § 101. In combination with Finjan and earlier decisions, this potentially establishes a trend that courts are increasingly comfortable differentiating between patent claims done on a computer and the maligned “do it on a computer” claims that are the target of much eligibility exception concern.
Core Wireless sued LG, alleging infringement of claims in U.S. Patent nos. 8,713,476 and 8,434,020, both titled “Computing device with improved user interface for applications.” The patents specifically seek to allow users to quickly access data and functionality from un-launched applications using a menu listing, particularly in devices with small form factors. Claim 1 of U.S. Patent No. 8,713,476 was analyzed as representative.
- A computing device comprising a display screen, the computing device being configured to display on the screen a menu listing one or more applications, and additionally being configured to display on the screen an application summary that can be reached directly from the menu, wherein the application summary displays a limited list of data offered within the one or more applications, each of the data in the list being selectable to launch the respective application and enable the selected data to be seen within the respective application, and wherein the application summary is displayed while the one or more applications are in an un-launched state.
Claim 1 of U.S. Patent No. 8,434,020 was also analyzed, and it follows a similar structure and includes many of the same terms identified as significant by the court (including “reached directly” and “un-launched state”).
Evaluating these claims, the court turned to its earlier decisions in Visual Memory,  Thales,  Enfish  and Finjan, all of which make clear the importance of analyzing the claims with specificity and searching for technological improvements or unconventional solutions that indicate eligibility. The court rejected LG’s overbroad characterization that the claims are merely an application of the abstract idea of an index. Rather, “these claims are directed to a particular manner of summarizing and presenting information in electronic devices” that require specific manners of use with specific limitations on available data in specific device states. As with earlier decisions, the opinion looked to the specification to discern a problem and claimed unconventional solution. Because of the particularity of the solution, the court found the asserted claims were not directed to an abstract idea in Step 2A of the eligibility framework and did not proceed to Step 2B.
The synopsis of the lower court’s reasoning provides further pointers as to the difference between a “do it on a computer” abstract claim and eligible innovation realized using computers.
It held that the claims are not directed to an abstract idea because, even crediting LG’s characterization of the claims as directed to “displaying an application summary window while the application is in an unlaunched state,” the concepts of “application,” “summary window,” and “unlaunched state” are specific to devices like computers and cell phones. J.A. 9561. The court explained “LG identifie[d] no analog to these concepts outside the context of such devices.” Id. It further noted even “if claim 1 were directed to an abstract idea, it would still be patent eligible at least because it passes the machine-or-transformation test.” J.A. 9562.
This language is useful for disentangling subject matter eligibility from patentability in view of prior art. The search for an “inventive concept” and discussion of “well-understood, routine, and conventional” uses of computers inheres confusing parallels with obviousness under 35 U.S.C. § 103. Even the helpful guidance of Finjan that eligibility exists where a computer file enables a computer “to do things it could not do before” blurs the lines between eligibility and novelty. The district court’s discussion makes clear that, where the claims are directed to specific technology with no context outside devices, they should not be found abstract.
While Core Wireless is hardly the first matter involving software or computer functionality where eligibility is shown, many earlier decisions seemed to decide by exception rather than rule. DDR admonished its own application by speaking against a broad rule and was lost in a red tide of decisions finding ineligibility. Bascom was similarly decided under Step 2B and injects substantial room for argument as to what constitutes an “ordered combination.” Enfish and Visual Memory are regularly distinguished from software cases by limiting their applicability to claims improving the computer system itself as opposed to claims that add to user-controlled functionality. McRO concerned detailed claims receiving substantial attention as lacking preemption risk. If the rapid-fire decisions finding eligibility of “pure” software in Finjan and Core Wireless suggest a trend, it is that the Court of Appeals for the Federal Circuit is developing a comfort level that no longer requires finding eligible software claims to be the exception to the exception to eligibility.