Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers

Obviousness-type double patenting (ODP) is, at present, nonstatutory and is intended to prevent an inventor from improperly extending a patent’s life by having two patents on the same invention. ODP may arise between pending applications, between a patent and one or more pending applications, and even between multiple patents, even if not owned by the same party.

In 2014, in Gilead Sciences Inc. v. Natco Pharma Ltd., the Federal Circuit extended the scope of ODP by holding that a later-granted but earlier expiring patent was able to render invalid an earlier-granted, commonly owned, later-expiring patent with patentably indistinct claims. And while Gilead involved two essentially independent lines of patents, the district court in Magna Electronics Inc. v. TRW Automotive Holdings Corp. (W.D. Mich. Dec. 10, 2015), relied on Gilead in holding that ODP applies to related patents having the same filing date where the first-to-issue and last-to-expire patent (because of PTA) was found not patentably distinct from a different second-to-issue and first-to-expire patent which virtually wiped out the PTA of the patent that issued first but expired later due to PTA.

According to the district court in Janssen Biotech Inc v. Celltrion Healthcare Co. Inc. (D. Mass. Aug. 19, 2016), the reasoning of Gilead even applies when “the later-issued patent expires earlier because of the change to patent terms resulting from the [URAA].” The Federal Circuit affirmed this decision on Jan. 23, 2018, particularly holding that a patent owner cannot retroactively bring its challenged patent within the scope of the safe harbor provision by amendment in a reexamination proceeding. And in Novartis Pharms. Corp. v. Breckenridge Pharm. Inc., 248 F. Supp. 3d 578 (D. Del. Apr. 3, 2017), appeal filed June 16, 2017, involving a pre-URAA and a post-URAA patent, the district court applied Gilead: “The only relevant issue is the earlier expiration date of the ‘990 patent, as it is the extension of the period of exclusivity by virtue of the ‘772 patent’s later expiration date that violates the principles underlying the double patenting prohibition.”

A terminal disclaimer can cure ODP, as long as ownership of the two patent instruments is identical. The disclaimer is not an admission of invalidity, but the patent will not be enforceable beyond the term of the other patent. A company may prefer to avoid a terminal disclaimer if the latter days of the patent term are valuable. Once the patent upon which ODP is based expires, a terminal disclaimer is of no use. Counsel must carefully weigh considerations, such as necessity, feasibility and costs, in deciding to file a terminal disclaimer.

Instead of a terminal disclaimer, arguments of separate patentability are an option. Separate patentability is free of ODP doctrinal impediments, particularly as long as the patent with the “ODP” problem is separately patentable over the ODP reference patent. Arguments for separate patentability may be supported by carefully presented real-world objective evidence of patentability, such as commercial success, long-felt need and failure of others.

Listen as our authoritative panel of patent attorneys examines ODP, including the impact of recent decisions. The panel will offer best practices to defeat ODP rejections and avoid terminal disclaimers.

1. Understanding ODP
   1. ODP rejections
      1. Anticipation type
      2. Obviousness type
   2. Provisional vs. actual rejections
   3. Terminal disclaimers
   4. Safe harbor to defeat ODP
2. Common ownership, JRAs and the potential impact of ODP
3. Recent court treatment
4. Best practices
   1. Defeating ODP rejections
   2. Avoiding terminal disclaimers

The panel will review these and other key issues:

• What is the scope of double patenting?
• What is the examiner’s duty for presenting double patenting rejections?
• What steps can be taken to defeat double patenting rejections?
• What best practices can be employed to avoid terminal disclaimers?
• How can practitioners craft terminal disclaimers with an eye towards patent litigation?