Section 112: Recent Cases and Functional Claiming

SUE WANG, SIDLEY AUSTIN LLP

JILL J. SCHMIDT, GENENTECH

35 U.S.C. § 112:Relevant Provisions(a) In General.— The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.(b) Conclusion.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.…(f) Element in Claim for a Combination.— An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

Section 112• Recent written description (and enablement) cases

• Amgen Inc. v. Sanofi• Idenix Pharm. v. Gilead Sci.• Nalpropion Pharm. v. Actavis Labs.• Nuvo Pharm. v. Dr. Reddy’s• Centrak v. Sonitor Techs.

• Proposed changes to Section 112(f)

Amgen Inc. v. Sanofi872 F.3d 1367 (Fed. Cir. 2017)

Representative Claim:

1. An isolated monoclonal antibody, wherein,

when bound to PCSK9,

the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3,

and wherein the monoclonal antibody blocks binding of PCSK9 to LDL-[Receptor].

Amgen Inc. v. Sanofi872 F.3d 1367 (Fed. Cir. 2017)

• “[T]o satisfy the statutory requirement of a description of the invention, it is not enough for the specification to show how to make and use the invention, i.e. to enable it.”1

• Rejected “newly characterized antigen” test for written description.• Remanded for consideration under appropriate test: “representative species”

or “common structural elements.”• Post-priority-date evidence of additional species can reasonably bear on

sufficiency of disclosure.

• Amgen petitioned for certiorari review of Federal Circuit’s separate written description and enablement requirements.2

• Supreme Court denied certiorari January 2019.

1 Amgen, 872 F.3d at 1377 (citing Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345-46, 1347-48 (Fed. Cir. 2010) (en banc). 2 https://www.scotusblog.com/case-files/cases/amgen-inc-v-sanofi/

Idenix Pharm. v. Gilead Sci.941 F.3d 1149 (Fed. Cir. 2019)

Claim:

1. A method for the treatment of a hepatitis C virus infection,comprising administering an effective amount of a purine or pyrimidineβ-D-2'-methyl-ribofuranosyl nucleoside or a phosphate thereof, or apharmaceutically acceptable salt or ester thereof.

Idenix Pharm. v. Gilead Sci.941 F.3d 1149 (Fed. Cir. 2019)

• “Full scope” of the claim was not enabled or adequately described.

• “The immense breadth of screening required to determine which 2’-methyl-up nucleosides are effective against HCV can only be described as undue experimentation.”1

• The specification “fails to provide sufficient blaze marks to direct a POSA to a specific subset of 2’-methyl-up nucleosides that are effective in treating HCV.”2

• Lists and examples of effective nucleosides provide no guidance into what compounds beyond the examples and formulas would provide the same result.

1 Idenix, 941 F.3d at 1162.2 Id. at 1164.

Nalpropion Pharm. v. Actavis Labs.934 F.3d 1344 (Fed. Cir. 2019)Claim:

11. A method of treating overweight or obesity having reduced adverseeffects comprising orally administering daily about 32 mg of naltrexoneand about 360 mg of bupropion, . . .

wherein the naltrexone or pharmaceutically acceptable salt thereof isadministered as a sustained-release formulation, and

wherein said sustained-release formulation of naltrexone has an invitro naltrexone dissolution profile in a dissolution test of USPApparatus 2 Paddle Method at 100 rpm in a dissolution medium ofwater at 37° C. of:◦ a) between 39% and 70% of naltrexone released in one hour;◦ b) between 62% and 90% of naltrexone released in two hours; and◦ c) at least 99% in 8 hours;

wherein . . . .

Nalpropion Pharm. v. Actavis Labs.934 F.3d 1344 (Fed. Cir. 2019)

• Adequate description even though dissolution data in specification was derived using different testing method (USP1) than claimed testing method (USP2).

• “While as a general matter written description may not be satisfied by so-called equivalent disclosure, in this case, buttressed by the district court’s fact-finding, and where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps, we affirm the district court’s conclusion. Rigidity should yield to flexible, sensible interpretation.”1

1 Nalpropion, 934 F.3d at 1351.US 8,916,195

Nuvo Pharm. v. Dr. Reddy’s923 F.3d 1368 (Fed. Cir. 2019)Claim:1. A pharmaceutical composition in unit dose form suitable for oraladministration to a patient, comprising:(a) an acid inhibitor present in an amount effective to raise the gastric pHof said patient to at least 3.5 upon the administration of one or more ofsaid unit dosage forms;(b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effectiveto reduce or eliminate pain or inflammation in said patient uponadministration of one or more of said unit dosage forms;and wherein said unit dosage form provides for coordinated release suchthat:i) …ii) at least a portion of said acid inhibitor is not surrounded by an entericcoating and, upon ingestion of said unit dosage form by said patient, isreleased regardless of whether the pH of the surrounding medium is below3.5 or above 3.5.

Nuvo Pharm. v. Dr. Reddy’s923 F.3d 1368 (Fed. Cir. 2019)

• “In light of the fact that the specification provides nothing more thanthe mere claim that uncoated PPI might work, even though persons ofordinary skill in the art would not have thought it would work, thespecification is fatally flawed.”1

• Written description does not require:• Experimental data demonstrating effectiveness;• Theory or explanation of how or why a claimed composition is effective; or• Actual reduction to practice.

• BUT, the specification here “does not provide any data showing thatuncoated PPI is effective in raising the gastric pH of a patient to at least3.5” and “whether uncoated PPI is inherently effective in raising thegastric pH to at least 3.5 is disputed.”2

1 Nuvo, 923 F.3d at 1381.2 Id. at 1382-83.

Centrak v. Sonitor Techs.915 F.3d 1360 (Fed. Cir. 2019)

• All claims recite “ultrasonic” components, but “the vast majority of the specification focuses on infrared (IR) or [radio frequency] RFcomponents.”• Specification “contemplated that the base stations 106 may also be

configured to transmit a corresponding BS-ID by an ultrasonic signal, such that base stations 106 may represent ultrasonic base stations.”1

• District court should not have granted summary judgment on lack of written description.• Conflicting expert testimony on complexity and predictability of ultrasonic

RTL systems, and district court failed to credit testimony of patentee’s expert that “the differences between IR and ultrasound, when used to transmit small amounts of data over short distances, are incidental to carrying out the claimed invention.”2

1 Centrak, 915 F.3d at 1363.2 Id. at 1367-68.

Proportionality“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s to the field of art as described in the patent specification.’ It is part of the quid pro quo of the patent grant and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.”

Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (citations omitted).

Proposed Legislative Changes to 112(f)

Senators Tillis and Coons:

“We will also consider ideas for reinforcing Section 112 of the Patent Act, which should operate to prevent inventors from claiming all possible solutions to a problem while also serving to protect inventors against those seeking to profit on trivial modifications.”

https://www.tillis.senate.gov/2019/6/tillis-and-coons-what-we-learned-at-patent-reform-hearings

Section 112(f)CURRENT TEXT

(f) Element in Claim for a Combination.—

An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

DRAFT LEGISLATION

(f) Functional Claim Elements—

An element in a claim expressed as a specified function without the recital of structure, material, or acts in support thereof shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

Draft legislation available at: https://www.tillis.senate.gov/services/files/E8ED2188-DC15-4876-8F51-A03CF4A63E26

Section 112(f)CURRENT TEXT

(f) Element in Functional Claim Elements for a Combination.—

An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

DRAFT LEGISLATION

(f) Functional Claim Elements—

An element in a claim expressed as a specified function without the recital of structure, material, or acts in support thereof shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

Draft legislation available at: https://www.tillis.senate.gov/services/files/E8ED2188-DC15-4876-8F51-A03CF4A63E26

Reactions to Draft 112(f)“[A]ll functional terms cannot be entirely avoided, particularly in method claims and health sciences. The discussion draft’s alteration of 112(f) automatically pushes all such inventions into that provision. In my judgment, it is unnecessary and unwise.”

- Judge Paul R. Michel

“The proposed expansion of § 112(f)’s remedial effects—to apply to all claims with functionally defined elements—will assure that patent claims that might otherwise be construed broadly to cover a function the invention is to perform will be properly titrated down to only those practical applications of the function specified in the claim actually described in the patent’s specification.”

- Robert A. Armitage

“One constructive approach is further strengthening Section 112. The inclusion of tightened standards beyond 112(f) can help prevent issuance of patents having claims far broader than their disclosure supports. This while still respecting the legitimate need for flexibility for other constituents.”

- David J. Kappos

https://www.judiciary.senate.gov/meetings/the-state-of-patent-eligibility-in-america-part-i https://www.judiciary.senate.gov/meetings/the-state-of-patent-eligibility-in-america-part-iihttps://www.judiciary.senate.gov/meetings/the-state-of-patent-eligibility-in-america-part-iii