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Abstract

BACKGROUND:

Patent protection of therapeutic antibodies and T cell receptors is an important tool to enable the path to the market. In view of the substantial spendings for R&D and regulatory approval, sponsors expect exclusivity for their drug for a given period of time. Different categories exist to protect therapeutic antibodies and T cell receptors. One of these categories are epitope-based patent claims, with regard to which in the different jurisdictions, different patentability standards exist, which, furthermore, are constantly changed by courts and lawmakers.

OBJECTIVE:

This article tries to explain the patentability issues related to epitope-based patent claims.

METHODS:

For this purpose, an overview is given on the respective legal provisions and court decisions.

RESULTS:

The study reveals that the respective patentability standards are constantly changed by courts and lawmakers.

CONCLUSIONS:

Companies developing therapeutic antibodies or T cell receptors need to consider these developments in their strategic planning.

Keywords

Antibodies T cell receptors patent epitope

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References

Decision Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004).

Board of Appeal decision T018/09; https://www.epo.org/lawpractice/case-law-appeals/advanced-search.html.

Köhler

and Milstein

, Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 256 (1975), 495–497.

Storz

, The nine lives of epitope-based antibody patents. Hum Antibodies 28(2) (2020), 89–110.

Stewart

Kent

Smith

and Bassinder

, The special inventive step standard for antibodies. epi Information 11(2) (2011), 72–76.

EPO Guidelines for Examination G II 5.6.1.6, accessible underhttps://www.epo.org/law-practice/legal-texts/html/guidelines/ .

Board of Appeal decision T018/09; https://www.epo.org/lawpractice/case-law-appeals/advanced-search.html.

Board of Appeal decision T1964/18; https://www.epo.org/lawpractice/case-law-appeals/advanced-search.html.

Board of Appeal decision T0435/20; https://www.epo.org/lawpractice/case-law-appeals/advanced-search.html.

10.

et al.Eli Lilly and Company, 598 F3d. 1336(Fed. Cir. 2010).

11.

35 U.S. Code §112 (a) “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such (…) exact terms as to enable any person skilled in the art to which it pertains, (…)”.

12.

Board of Appeal decision T0845/19; https://www.epo.org/lawpractice/case-law-appeals/advanced-search.html.

13.

Decision Amgen v. Sanofi, 872 F.3d 1367, 1378-79 (Fed. Cir. 2017).

14.

Storz

Cox

and Doranz

, Functional Antibody Patents Are Dead: Long Live Functional Antibody Patents, Panel at the BioConvention 2018 in Boston, Wednesday, June 6, 2018.

15.

Aquino

J.T.

, Antibody Claims Must Move Toward Structure, Panelists Say, Bloomberg BNA (2017).

16.

Amgen Inc. v Sanofi, 598 U.S. 594 (2023).

17.

Lemley

M.A.

and Sherkow

J.S.

, The Antibody Patent Paradox. Yale Law Journal 132(4) (2023), 994–1064.

18.

EPO guidelines for examination G II 5.6.1.1, accessible underhttps://www.epo.org/law-practice/legal-texts/html/guidelines/and Board of Appeal decision T0941/16; https://www.epo.org/lawpractice/case-law-appeals/advanced-search.html.

19.

Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1285 (Fed. Cir. 2007).

20.

IPR2015-01719; https://developer.uspto.gov/ptab-web/#/search/decisions.

21.

Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1336 (Fed. Cir. 2021).

22.

Uhlen

Zhang

Lee

Sjostedt

Fagerberg

Bidkhori

Benfeitas

Arif

Liu

et al., A pathology atlas of the human cancer transcriptome. Science 357 (2017), 6352.

23.

Dolgin

, First soluble TCR therapy opens ‘new universe’ of cancer targets. Nat Biotechnol 40 (2022), 441–444.

24.

Press release 21 December 2017, https://investors.immatics.com/news-releases/news-release-details/immatics-proprietary-target-selected-development-cancer/.

25.

Robinson

R.A.

McMurran

McCully

M.L.

and Cole

D.K.

, Engineering soluble T-cell receptors for therapy. FEBS J 288(21) (2021), 6159–6173.

26.

Denkberg

Lev

Eisenbach

Benhar

and Reiter

, Selective targeting of melanoma and APCs using a recombinant antibody with TCR-like specificity directed toward a melanoma differentiation antigen. J Immunol 171(5) (2003), 2197–207.

27.

Fritsch

E.F.

Rajasagi

Ott

P.A.

Brusic

Hacohen

and Wu

C.J.

, HLA-binding properties of tumor neoepitopes in humans. Cancer Immunol Res. 2(6) (2014), 522–529.

28.

Dao

Yan

Veomett

Pankov

Zhou

Korontsvit

Scott

Whitten

Maslak

Casey

Tan

Liu

Zakhaleva

Curcio

Doubrovina

O’Reilly

R.J.

Liu

Scheinberg

D.A.

, Targeting the intracellular WT1 oncogene product with a therapeutic human antibody. Science Translational Medicine 5(176) (2013), 176.

29.

Ataie

Xiang

Cheng

Brea

E.J.

Scheinberg

D.A.

Liu

and Ng

H.L.

, Structure of a TCR-Mimic Antibody with Target Predicts Pharmacogenetics. J Mol Biol 428(1) (2016), 194–205.

30.

Baeuerle

P.A.

Reinhardt

, Bispecific T-cell engaging antibodies for cancer therapy. Cancer Res. 69(12) (2009), 4941–4944.

31.

Bunk

Hofmann

Unverdorben

Alten

Hutt

Wagner

Schoor

Ferber

Fritsche

Weinschenk

Singh-Jasuja

Maurer

and Reinhardt

, Development of highly potent T-cell receptor bispecifics with picomolar activity against tumor-specific HLA ligands, Cancer Res 78(13) (2018), 2789.

32.

Board of Appeal decision T018/09; https://www.epo.org/lawpractice/case-law-appeals/advanced-search.html.

33.

Lemley

M.A.

and Sherkow

J.S.

, The Antibody Patent Paradox. Yale Law Journal 132(4) (2023), 994–1064.

34.

Fritsche

Rakitsch

Hoffgaard

Römer

Schuster

Kowalewski

D.J.

Priemer

Stos-Zweifel

Hörzer

Satelli

Sonntag

Goldfinger

Song

Mahr

Ott

Schoor

and Weinschenk

, Translating Immunopeptidomics to Immunotherapy-Decision-Making for Patient and Personalized Target Selection. Proteomics 18(12) (2018), 1700284.

35.

Linette

G.P.

Stadtmauer

E.A.

Maus

M.V.

Rapoport

A.P.

Levine

B.L.

Emery

Litzky

and Bagg

et al., Cardiovascular toxicity and titin cross-reactivity of affinity-enhanced T cells in myeloma and melanoma. Blood 122(6) (2013), 863–871.

36.

Chinnasamy

Wargo

J.A.

Rao

Frankel

T.L.

Riley

J.P.

Hong

J.J.

Parkhurst

M.R.

Feldman

S.A.

Schrump

D.S.

Restifo

N.P.

Robbins

P.F.

Rosenberg

S.A.

and Morgan

R.A.

, A TCR targeting the HLA-A*0201-restricted epitope of MAGE-A3 recognizes multiple epitopes of the MAGE-A antigen superfamily in several types of cancer. J Immunol. 186(2) (2011), 685–696.

37.

EPO Guidelines for Examination G VII 12, accessible underhttps://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_vii_12.htm.

38.

Section 3 in The Patents Act, 1970: “The following are not inventions within the meaning of this Act: (…) (c) the (…) discovery of any living thing or non-living substances occurring in nature”.

39.

35 U.S.C. §101 “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor (…).” US Courts have interpreted the statutory categories to exclude laws of nature, natural phenomena, and abstract ideas.

40.

Rammensee

H.G.

Bachmann

Emmerich

N.N.

Bachor

O.A.

and Stevanovic

, SYFPEITHI: database for MHC ligands and peptide motifs. Immunogenetics 50 (1999), 213–219.

41.

Z.Y.

Gao

Y.F.

Y.H.

Liu

Sun

Zhai

M.X.

Y.M.

and Ye

, Identification of a novel CD8+ T cell epitope derived from cancer-testis antigen MAGE-4 in oesophageal carcinoma. Scand J Immunol. 74(6) (2011), 561–567.

42.

Schaap-Johansen

A.L.

Vujovifi

Borch

Hadrup

S.R.

and Marcatili

, Front Immunol. 12 (2021), 712488.

43.

Fritsche

Kowalewski

D.J.

Backert

Gwinner

Dorner

Priemer

Tsou

C.C.

Hoffgaard

Römer

Schuster

Schoor

and Weinschenk

, Pitfalls in HLA Ligandomics-How to Catch a Li(e)gand. Mol Cell Proteomics 20 (2021), 1001100.

The rebirth of epitope-based patent claims

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSIONS:

Keywords

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References