28Mar 2018

Silvia Salvadori - Patent Law - Claims Drawn to Antibodies: Written Description Guidance by the USPTORecently, the United States Patent and Trademark Office (USPTO) issued a memorandum over the written description for claims drawn to antibodies. The first part of the memorandum is based on the Federal Circuit case Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). In Amgen, the Federal Circuit explained that when an antibody is claimed, 35 U.S.C. § 112(a) it requires adequate written description of the antibody itself. (Amgen, 872 F.3d at 1378-79.)

Memorandum (Part 1)

The Amgen Court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the Court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. (Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 [Fed. Cir. 2010]).

In view of the Amgen decision, adequate written description of a “newly characterized antigen” test alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen test, even when preparation of such an antibody is routine and conventional. I.e.,  the Amgen decision will be added to the MPEP in due course.

Memorandum (Part 2)

The second part of the memorandum related to the examples is described in the written description training materials issued in 2008, which are now outdated. On March 25, 2008, the USPTO issued revision 1 of the written description training materials. As indicated on the USPTO website, these training materials have been archived. Written description training materials containing examples that reflect developments in the law regarding 35 U.S.C. §§ 101 and 112 are being prepared. The archived training materials are outdated and should not be relied upon as reflecting the current state of the law regarding 35 U.S.C. § 101 and 112.

Memorandum (Part 3)

Finally, the third part of the memorandum relates to available current guidance on written description. According to the memorandum, USPTO personnel should continue to follow the guidance in the Manual of Patent Examining Procedure (MPEP) regarding written description (e.g. MPEP 2161.01 and 2163), except insofar as MPEP 2163 indicates that disclosure of a fully characterized antigen may provide written descriptive support of an antibody to that antigen. The MPEP will be updated in due course to reflect these changes.

Other guidance and training materials that remain applicable and should be followed by USPTO personnel are online here and included below:

  • 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 titled “Antibody Decisions and Their Compliance with the Written Description Requirement,” which discusses the Centocor v. Abbott, 636 F.Jd 1341 (Fed. Cir. 2011) and Abb Vie v. Janssen, 759 F.3d 1285 (Fed. Cir. 2014) decisions, with the exception of bullet 2 on slide 17 which references the dicta in Centocor that cites to the 2008 USPTO Written Description Training Materials.

Accordingly, patent examiners who handle applications containing claims drawn to antibodies should continue to follow the “Antibody Decisions” training slide set, as well as the MPEP, except as noted previously.

Contact me with questions or comments at silvia@salvadorilaw.com.

Silvia Salvadori, PhD

Silvia Salvadori, PhD

www.salvadorilaw.com

silvia@salvadorilaw.com

(212) 897-1938