From 35,000 feet, a series of Federal Circuit and PTAB decisions written about in this blog may show favorable times of which patent owners should take note and try to leverage as much as possible.

Ex parte Gleave, Appeal 2012-004973 (P.T.A.B. Jan. 22, 2014), provided an issued life science means-plus function claim, giving an example of obtaining broader scope using the means-plus-function format. Taking care to carefully link the “means for” in the claim to the specification can help avoid prior art and avoid written description and enablement issues. This may mean added difficulty for third parties challenging patentability at the PTAB or validity in district court. The potential uncertainty of the scope of literal statutory equivalents under §112(f) for a life science patent also creates obstacles to third-party design-arounds.

In Sanofi v. Watson, 875 F.3d 636 (Fed. Cir. 2017), Sanofi’s label cross-referenced the clinical trial data in the label’s Indications and Usage section and recited the clinical trial results in the Clinical Studies portion of the label. Sanofi obtained a patent claiming the clinical study results and matching the label. Sanofi. In later litigation, used this ingenious label/patent claim strategy to corner the generic manufacturers into having to propose the same labeling, ultimately sealing their fate for inducement to infringe. According to the Federal Circuit: “The content of the label in this case permits the inference of specific intent to encourage the infringing use.” Id. at 646. Sanofi thus achieved the valuable result of 10 more years of patent exclusivity. To the extent, as in Sanofi v. Watson, that the generic/biosimilar manufacturer has to copy the label to obtain FDA approval, method-of-treatment claims that appear to be very narrow can defeat the generic/biosimilar manufacturers. Of course, the innovator needs to obtain claim limitations based on a U.S. patent specification that closely corresponds with the label language and the clinical trial results. And, of course, for this strategy to work in the U.S. the initial patent application loaded with all that clinical trial information must be filed BEFORE the clinical trial results become disabling prior art under 35 U.S.C. § 102(a) in the absence of any 102(b) exception(s). Early and frequent coordination between the patent, research, and the regulatory arms of the NDA holder/reference product sponsor can facilitate this strategy.

The Federal Circuit rejected the USPTO’s calculation of patent term adjustment in Supernus v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019), leading to Supernus’ victory and receiving the disputed 546 days as additional patent term. The USPTO refused to subtract from the calculated applicant delay any time based on the submission of an IDS after a RCE. Supernus argued that it should not have been penalized the 546 days between its filing of a RCE (Feb. 22, 2011) and the EPO notification of the Sandoz Opposition (Aug. 21, 2012). Supernus pointed out that there were no efforts it could have undertaken during this time to further prosecution; there was no way for it to know about any filings in the EPO earlier than Aug. 21, 2012. The district court granted judgment in favor of the USPTO and held that the decision in Gilead v. Lee “foreclosed, as a matter of law, Supernus’s statutory interpretation arguments that 37 C.F.R. §1.704(c)(8) and § 1.704(d)(1) are arbitrary, capricious, and otherwise contrary to the PTA statute.” The Federal Circuit reversed. “Gilead does not foreclose Supernus’s statutory interpretation argument” because Gilead didn’t address whether there was a failure to engage in reasonable efforts. “Gilead ruled only that the regulation reasonably drew no line between actual and potential delay[.]” Supernus could not have engaged in reasonable efforts to concluded prosecution for the 546 days between filing the RCE and the EPO’s notification of the Sandoz opposition. Therefore, the days counted by the USPTO against Supernus improperly exceeded the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.” A take home is to check PTAs awarded in recently issued cases to determine whether your facts match those of Supernus and whether days that were docked do not in fact stem from a “failure to engage in reasonable efforts.” Another is don’t wait for the PTO to issue a final rule on Supernus. Proactively, apply that decision to your PTA calculus.

In both Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018) and Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical, 909 F.3d 1355 (Fed. Cir. 2018), the Federal Circuit decided in favor of the patent owner, Novartis. The decisions clarified that Gilead’s and AbbVie’s focus on expiration dates in the ODP analysis are restricted to situations involving patents filed post-GATT. In Novartis v. Ezra, the Federal Circuit held that a second-filed, second-issued patent cannot be asserted as an obviousness-type double patenting (ODP) reference against a first-filed, first-issued patent where the statutorily defined patent terms are different due to pre-URAA and post-URAA status and a patent term extension. Novartis’ pre-GATT ‘229 patent claimed compounds, including fingolimod, and expired Feb. 18, 2014, with a patent term extension under 35 U.S.C. §156 to Feb. 18, 2019. Novartis’ GATT ’565 patent claimed a method of administering fingolimod and expired on Sept. 23, 2017. The Federal Circuit held in favor of Novartis, upholding a patent owner’s choice of which patent term to extend. Any “effective” extension of the ’565 GATT patent by virtue of the ‘229 patent is a “permissible consequence of the legal status conferred upon the ’229 pre-GATT patent by § 156.” Id. “[A]greeing with Ezra would mean that a judge-made doctrine [ODP] would cut off a statutorily-authorized time extension.” Id. at *6. It “decline[d] to do so.” Id.

In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical, the Federal Circuit reversed a district court decision holding that a later-filed, earlier-expiring, GATT patent could serve as an ODP reference to invalidate a first-filed, later-expiring pre-GATT patent and thus deny that pre-GATT patent from enjoying a full seventeen-year term from issuance. Novartis’ pre-GATT ’772 patent expired on September 9, 2014, with a patent term extension under 35 U.S.C. §156 to September 9, 2019. The asserted invalidating reference, Novartis’s GATT ’990 patent was filed after, and issued after the ‘772 pre-GATT patent, but expired before the ‘772 pre-GATT patent. Both patents claimed the same priority date. The lifespan of the ‘772 pre-GATT patent encompasses and extends beyond that of the ’990 GATT patent, even without considering the PTE. According to the Federal Circuit, its Gilead reasoning was limited to URAA patents. In this [Breckenridge] case, the order of expiration of the patents is by operation of statute; there was no “patent prosecution gamesmanship.”

Barry v. Medtronic, 914 F.3d 1310 (Fed. Cir. 2019), was another positive decision for patent owners. In Barry, the Federal Circuit found that Dr. Barry’s invention was not barred by public use or sale before the critical date because (1) the invention was not ready for patenting prior to the critical date, and (2) that up to the critical date, there was only experimental use, which negates both public use and sale. “[E]xperimental use negates invalidity under the public use bar.” The majority, concluding that “the timing of knowledge that the invention will ‘work for its intended purpose’ is important to both experimental use and readiness for patenting,” emphasized that the “’intended purpose’ need not be stated in claim limitations that define the claim scope.” Showing experimental use to negate public use or on sale argument is a very fact-intensive inquiry. The more inventors can do to record the development path of their invention as it is happening and articulate the “intended purpose” of the invention with specificity in the claims and/or specification, the stronger a theory of experimental use may be, as well as the stronger a theory of not ready for patenting may be. The decision in Barry pushes out the time an invention is “ready for patenting” until the applicant knows the invention will work for its “intended purpose.” In Barry, “ready for patenting” was at the conclusion of a third surgery and evaluation of its results. Two previous surgeries and evaluation of the results thereof were not considered to establish “ready for patenting.”

The pendulum of patent-friendliness of court decisions constantly swings. Patent owners should take note of these current patent-friendly decisions and try to leverage them as much as possible, particularly in the areas of means-plus-function in the life sciences, induced infringement, patent term adjustment, obviousness type double patenting, and public use bearing in mind the factual backdrop of each of these recent decisions