Patent Prosecution Tool Kit: Obviousness-Type Double Patenting

35 U.S.C. § 101 precludes a patentee from obtaining more than one patent on the same invention. Courts have extended this prohibition “to preclude a second patent on an invention which ‘would have been obvious from the subject matter of the claims in the first patent, in light of the prior art.’” In re Longi, 759 F.2d 887, 893 (Fed. Cir. 1985). Thus, obviousness-type double patenting (ODP) (also known as “nonstatutory double patenting”) is a judicially created doctrine intended to prevent an improper time-wise extension of a patent right by prohibiting the issuance to a single inventor of claims in a second patent which are not “patentably distinct” from the claims of a first patent. In re Lonardo, 119 F.3d 960, 965 (Fed. Cir. 1997).

1. Why should you worry about ODP?

• Filing a terminal disclaimer (TD) to obviate an ODP rejection can reduce the patent term by limiting Patent Term Adjustment (PTA) (the term cannot extend beyond that of the earlier patent). 35 U.S.C. §§ 154(b)(2) and 253. Patents having the same earliest effective filing date may have different patent terms due to different PTA. In some instances, PTA can be more beneficial than Patent Term Extension (PTE), as it extends the term of all the claims in the patent.
• If the first (earlier) patent has expired, a TD cannot be filed and the second (later) patent will be invalid for ODP.
• Note: Filing a TD does not affect PTE obtained under 35 U.S.C. § 156. Merck & Co. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317 (Fed. Cir. 2007); see also Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367, 1373 (Fed. Cir. 2018). However, any PTA time awarded to a patent subject to a terminal disclaimer will be limited by the expiration date of the reference patent, and patent term that is extended by PTA may affect the double patenting analysis under Gilead, infra. 35 U.S.C. § 154(b)(2)(B); see also Magna Electronics, Inc. v. TRW Automotive Holdings Corp., 2015 WL 11430786 (W.D. Mich. 2015).

2. When may ODP issues arise?

• During prosecution – The claims of an application can be rejected for ODP in view of claims of patents or applications that have at least one common inventor, that are commonly assigned/owned or non-commonly assigned/owned but subject to a joint research agreement as set forth in 35 U.S.C. § 103(c)(2)(3). See MPEP § 804 and In re Hubbell, 709 F.3d 1140 (Fed Cir. 2013).
• In litigation – ODP is an affirmative defense as it is a ground for invalidating one or more claims of a patent. See e.g., Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1580 (Fed. Cir. 1991); Geneva Pharms. Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1377-78 (Fed. Cir. 2003).

3. Standard for ODP

• The claims of the second patent or application are not distinct (anticipated or obvious) in view of the claims of the first patent or application.
• The “one way” and “two way” tests
  • The one way test (default):
    • Whether the claim at issue is patentably distinct over the earlier reference claim.
  • The two way test (rare):
    • Applies only in cases where the applicant could not have filed the claims in a single application and there is administrative (U.S. Patent and Trademark Office) delay.
    • Compares the patentable distinctness of both the later claim over the earlier claim and the earlier claim over the later claim.
• Obviousness analysis under ODP is analogous to an obviousness analysis under 35 U.S.C. § 103 except that
  • The first patent or application is not considered prior art. But reference to the specification of the first patent or application may be appropriate, e.g., for claim construction. In re Vogel, 442 F.2d 438, 441-442 (C.C.P.A. 1970).
  • Lead compound analysis is not required in cases involving claimed chemical compounds. Otsuka Pharmaceuticals Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1298 (Fed. Cir. 2012).
• A later claim in a patent to a method of treatment using a compound is not patentably distinct from a claim to the identical compound in a first patent disclosing the identical use. See Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003); Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008); Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010).
• A patent that issues after but expires before another patent may qualify as a double patenting reference for that other, later expiring patent. See Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014)
  • The two patents can be from the same family and have a different expiration date due to PTA. Magna Elecs., Inc. v. TRW Automotive Holdings Corp. (W.D. Mich. December 10, 2015).
  • However, an earlier expiring post-GATT patent cannot be used as a reference against a later expiring pre-GATT patent. Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical, Inc., 909 F.3d 1355 (Fed. Cir. 2018) (applying “pre-URAA obviousness-type double patenting practice” and holding that “to require patent holders to truncate any portion of the statutorily-assigned term of a pre-URAA patent that...