Cozen O’Connor: When is a Disclosure Not a Disclosure? [Alert]

When is a Disclosure Not a Disclosure?

Alert

November 1, 2018

On October 24, 2018, the Federal Circuit issued a decision in FWP IP APS v. Biogen MA, Inc., an appeal from a Patent Trial and Appeal Board decision in an interference between FWP and Biogen.

Biogen owns U.S. Patent No. 8,399,514, which describes and claims a method of treating multiple sclerosis (MS) with a 480 mg daily dosage of fumaric acid esters (fumarates). Prior to Biogen’s filing of the application that issued as the ‘514 patent, FWP filed a patent application (U.S. Patent Application No. 11/576,871), titled “Controlled Release Pharmaceutical Composition Comprising a Fumaric Acid Ester” and directed to the minimization of gastrointestinal side effects through the use of controlled-release fumarates.

FWP’s ‘871 application was still pending when Biogen’s ‘514 patent issued. Shortly after Biogen’s ‘514 patent issued, FWP filed an amendment canceling the then-pending claims in its ‘871 application and adding new claims tracking Biogen’s ‘514 patent claims, provoking the PTAB to declare an interference between FWP’s ‘871 application and Biogen’s ‘514 patent.

The interference count between Biogen and FWP comprised three limitations: (1) a treatment for MS that involves administering (2) dimethyl fumarate (DMF), monomethyl fumarate (MMF) or a combination of DMF and MMF at (3) a dosage of 480 mg per day. Biogen moved the PTAB for a judgment that the ‘871 application claims1 were not supported by the ‘871 application’s specification. The PTAB determined that each of the count’s limitations was mentioned separately in FWP’s ‘871 application, however, because the application did not disclose the claimed invention in a manner that adequately described the claimed MS treatment (i.e., it did not show that the inventors of the ‘871 application had possession of the claimed invention), the ‘871 application did not meet the written description requirement of 35 U.S.C. § 112. FWP appealed. The Federal Circuit affirmed.

The Federal Circuit began by reiterating the test for whether a patent or patent application satisfies the written description requirement:

Section 112 ¶ 1 provides that “[t]he specification shall contain a written description of the invention.” 35 U.S.C. § 112. The written description requirement examines “whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad, 598 F.3d at 1351. To demonstrate possession, the inventor must provide enough description in the specification to demonstrate that he actually invented what has been claimed — a “mere wish or plan for obtaining the claimed invention” is not enough.

Turning next to the ‘871 application’s disclosure, the Federal Circuit agreed with the PTAB’s finding that while the ‘871 application teaches that the active ingredient could be any fumarate, the ‘871 application did separately identify DMF, MMF, and their combination as particularly useful treatments. In other words, the ‘871 application teaches limitation (2) of the interference count. FWP did not fare as well with respect to limitations (1) and (3) of the count.

With respect to limitation (1), i.e., a treatment for MS, the ‘871 application states that the fumarate compositions taught therein are “contemplated to be suitable to use in the treatment of one or more of the following [over 20] conditions,” one of which was MS. The Federal Circuit determined that a reasonable reading2 of that statement is that the ‘871 application inventors had yet to conclude that fumarates were effective in treating all of the more than 20 conditions identified in the ‘871 application. In addition, the only conditions discussed in detail in the ‘871 application are psoriasis and psoriasis-associated conditions — not MS.

With respect to limitation (3), i.e., a dosage of 480 mg per day, FWP argued that a table in the ‘871 application expressly discloses the 480 mg dosage during the seventh week of a contemplated nine-week scale-up period. FWP argued that one of ordinary skill in the art would have recognized that all of the dosages included in the table are therapeutically effective to treat all of the conditions listed in the ‘871 application’s specification. The Federal Circuit agreed with the PTAB’s rejection of this argument, finding that the table does not discuss therapeutically effective dosages, rather the table provides guidance on gradually increasing dosage over a nine-week period to help patients’ gastrointestinal systems acclimate to the side effects of fumarates.

Accordingly, the Federal Circuit affirmed the PTAB’s finding that the ‘871 application would not “guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day” and, therefore, the ‘871 application’s claims were not supported by the application’s specification as required by 35 U.S.C. § 112.

Conclusion

The Federal Circuit’s FWP IP APS v. Biogen MA, Inc., opinion shows that mere mention in a patent application’s specification of all limitations of a claim will not necessarily support a claim. Rather, as the Federal Circuit explained in another recent case, Nike, Inc. v. Adidas AG, the written description requirement “serves the same function as blaze marks on the trees to help find[] one’s way through the woods.” Id., 812 F.3d 1326, 1347 (Fed. Cir. 2016) (citation and internal quotations omitted). The patent application’s specification, unlike FWP’s ‘871 application, must set forth the blaze marks necessary to guide a person of ordinary skill to the claimed invention.

This case provides a noteworthy reminder of the heightened importance that the written description plays in situations where a patent applicant adds claims during prosecution to cover competitors’ activities or products in the marketplace.3 Those accused of patent infringement should be mindful that the written description requirement may be a useful arrow in a defendant’s quiver, especially when the patentee added or amended patent claims in view of the defendant’s activities.

1 Representative ‘871 application claim 69 read:

69. A method of treating a subject in need of treatment for multiple sclerosis comprising

(a) a therapeutically effective amount of dimethyl fumarate and

(b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate is about 480 mg per day.

The other ‘871 application claims covered methods of treatment using MMF or a combination of MMF and DMF.

2 Because the PTAB found below that the ‘871 patent application’s claims were not supported by the ‘871 application’s specification, the Federal Circuit needed only to determine whether that decision was supported by sufficient evidence.

3 In its October 24, 2018, opinion, the Federal Circuit explained that “[t]he written description requirement is particularly important when, as here, claims are added later during prosecution in response to development by others. Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (‘[T]he purpose of the written description requirement is to prevent an applicant from later asserting that he invented that which he did not ...’).” Slip op. at 9.

 


Authors

Martin B. Pavane

Vice Chair, Intellectual Property Department
Co-Chair, Hatch-Waxman & Biologics Litigation

mpavane@cozen.com

(212) 883-4994

Darren S. Mogil

Member

dmogil@cozen.com

(212) 883-4976

Related Practices


To discuss any questions you may have regarding the issues discussed in this Alert please contact Martin Pavane at (212) 883-4994 or mpavane@cozen.com or Darren Mogil at (212) 883-4976 or dmogil@cozen.com.