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USPTO Withdraws Newly Characterized Antigen Test For Written Description Of Antibodies

The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the “newly characterized antigen test” for written description of antibodies, and advises that additional written description examination guidance is forthcoming.

The Memo On Written Description Guidance

The memorandum was issued by Deputy Commissioner for Patent Examination Policy, Robert W. Bahr, and discusses three aspects of USPTO written description guidance.

Amgen and the Newly Characterized Antigen Test

First, the memorandum addresses the recent Federal Circuit decision in Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which criticized the “newly characterized antigen test.” The test had been embodied in jury instructions stating that “the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties” may satisfy written description of a claimed antibody. The Federal Circuit found the instructions to be inconsistent with its decision in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010), and “the statutory ‘quid pro quo’ of the patent system where one describes an invention, and if the law’s other requirements are met, one obtains a patent.” The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself.

The memorandum advises that the “newly characterized antigen” test should not be used in determining whether there is adequate written description for a claim drawn to an antibody.

Outdated Written Description Guidance 

The memorandum also notes that portions of the USPTO’s 2008 Written Description Training Materials are outdated. In particular, the memorandum states that several examples require further analysis for subject matter eligibility under 35 U.S.C. 101. Thus, the USPTO will prepare new guidance “to reflect changes in the law since 2008.”

Useful Written Description Guidance 

The memorandum closes by highlighting existing guidance that remains useful:

  • MPEP 2161.01 and 2163 except for the newly characterized antigen test in MPEP 2163
  • The 2015 training module entitled “Examining Claims for Compliance with 35 USC 112(a): Overview & Part I – Written Description”
  • The 2015 Written Description Workshop materials
  • The 2015-16 training slide set entitled “Antibody Decisions and Their Compliance with the Written Description Requirement,” except for slide 17, bullet 2, which references the 2008 USPTO Written Description Training Materials

These materials are available on the Examination Guidance and Training Materials page of the USPTO website.

© 2019 Foley & Lardner LLP


About this Author

Alexander Lodge Pharma-Patent Lawyer Foley

Alexander Lodge, Ph.D., is an associate with Foley & Lardner LLP, where he is a member of the firm’s Chemical, Biotechnology & Pharmaceutical Practice.

In 2015, Dr. Lodge was a summer associate with Foley in the firm’s Madison office. He also worked as a research assistant with the University of Iowa, College of Law, where he conducted research on cases and current issues in patent law and generated a database of Federal Circuit Court of Appeals on slip opinions mapping trends in patent decisions for academic writing.

Courtenay C. Brinckerhoff, intellectual property  law attorney, Foley & Lardner  Law Firm

Courtenay Brinckerhoff is a partner and intellectual property lawyer with Foley & Lardner LLP. Ms. Brinckerhoff’s practice focuses on client counseling in all aspects of obtaining, licensing and enforcing patents and conducting freedom-to-operate and due diligence investigations. She is chair of the firm’s IP Law and Practice committee, immediate past vice chair of the firm’s Chemical, Biotechnology & Pharmaceutical Practice and a member of the firm's Patent Trials group, Appellate Practice and Life Sciences Industry Team. She also is involved with Foley’s Medical Device Initiative and Nutraceuticals Team. Ms. Brinckerhoff is the editor and primary author for Foley’s PharmaPatentsBlog.com.

Over the past 20 years, Ms. Brinckerhoff has represented clients before the U.S. Patent Office, the Patent Trial and Appeal Board, and the U.S. Court of Appeals for the Federal Circuit, and has been involved in complex patent matters, including a four-party interference, Inter Partes Reexaminations, Inter Partes Reviews, and ANDA litigation.

Ms. Brinckerhoff works with clients in diverse industries, including pharmaceuticals (chemical and biotechnological), human and animal food products, nutraceuticals, and medical devices. She has particular experience with transdermal pharmaceutical products (patches, gels, and liquids), oral dosage forms (including controlled/extended release formulations), enzyme-based technologies, diagnostic and therapeutic antibodies, active and passive immunization therapies, and personalized medicine.

She has served as vice chair of the firm’s Chemical, Biotechnology & Pharmaceutical Practice and is an active member of the firm's Appellate Practice and Life Sciences Industry Team.