Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers

Recording of a 90-minute CLE webinar with Q&A


Conducted on Thursday, May 25, 2017
Recorded event now available


This CLE webinar will provide guidance to IP counsel for understanding Patent Term Adjustment (PTA) B-delay possibilities and double patenting, particularly in view of a desire not to lose PTA in an earlier issued patent. The panel will analyze recent court treatment and offer best practices to defeat double patenting rejections and avoid terminal disclaimers, and if a terminal disclaimer must be filed, some specific language to consider.

Description

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.

In 2014, in Gilead Sciences Inc. v. Natco Pharma Ltd., the Federal Circuit extended the scope of ODP by holding that a later-granted patent was able to render invalid an earlier-granted, commonly owned (but unrelated) patent with patentably indistinct claims. Former Chief Judge Rader dissented, finding such an expansion of the doctrine unnecessary. This decision could have far-reaching implications for patent protection. Although this decision might end up being limited to its specific facts of two essentially independent lines of patents, it could also be extended to patents in the same family (and entitled to the same priority date), subject to things such as terminal disclaimers, PTAs, and Patent Term Extensions (PTEs). We saw an example of this in Magna Electronics, Inc. v. TRW Automotive Holdings Corp., No. 1:12-cv-654; 1:13-cv-324 (W.D. Mich. Dec. 10, 2015), where the district court relied on Gilead in holding that ODP applies 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, essentially wiped out the PTA of the patent that issued first but expired later due to PTA.

Later in 2014, in AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, the Federal Circuit made “explicit what was implicit in Gilead: the doctrine of obviousness-type double patenting continues to apply where two patents that claim the same invention have different expiration dates.” The Court noted the doctrine also prevents an inventor from securing a second, later expiring patent for the same invention.

According to the district court in Janssen Biotech, Inc v. Celltrion Healthcare Co. Inc., 1:15-cv-10698 (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].”

A terminal disclaimer can generally cure ODP. 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 feasibility and costs, in making the decision to file a terminal disclaimer.

In lieu of a terminal disclaimer, arguments of separate patentability are an option. Separate patentability is generally free of ODP doctrine impediments. 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.

What if you are the alleged infringer in infringement litigation and you lose your ODP argument on summary judgment. Taking into account that the PTO and courts do not have to come to the same conclusion on patentability/validity, we will discuss the pros and cons of filing a petition for ex parte reexamination in the PTO where there is no presumption of validity, a lower standard of proof, and broadest reasonable claim construction.

And for now, the present high success rate of inter partes review challenges against patent owners will not extend to ODP, as ODP is not a statutory basis for unpatentability.

Listen as our authoritative panel of patent attorneys also provides background as to B-delay possibilities and examines ODP, including the impact of recent decisions in “safe harbor” caselaw. The panel will offer best practices to defeat ODP rejections and avoid terminal disclaimers.

Outline

  1. Understanding ODP
    1. ODP rejections
      1. Anticipation type
      2. Obviousness type
    2. Provisional vs. actual rejections
    3. Terminal disclaimers
  2. Common ownership and the potential impact of ODP
  3. B delay possibilities
  4. Recent court treatment, including analysis of Gilead and AbbVie Inc.
  5. “Safe harbor” case law, including G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015)
  6. Best practices
    1. Defeating ODP rejections
    2. Avoiding terminal disclaimers

Benefits

The panel will review these and other key questions:

  • 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?

Faculty

Thomas L. Irving, Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.

Leslie A. McDonell, Partner
Finnegan Henderson Farabow Garrett & Dunner, Boston

Ms. McDonell provides strategic counseling on the procurement and protection of IP in the pharmaceutical, biotechnology, and medical device industries. She coordinates worldwide patent portfolio strategies, evaluates and analyzes competitors' patent positions around the world, and advises and renders opinions on issues of patentability, inventorship, validity, claim scope, infringement, and freedom to operate.

Margaret J. Sampson, Partner
Baker Botts, Austin, Tex.

Ms. Sampson has a global, strategic intellectual property transaction and patent counseling practice focused in the areas of life sciences, pharmaceuticals, research tools, and medical devices. She advises clients in evaluating patent portfolio positions; analyzes freedom-to-operate issues; identifies and evaluates targets for potential investment, mergers, or acquisitions; and assists with joint development and licensing agreements. Her experience also includes Hatch-Waxman patent litigation, patent term extensions and adjustments, clinical and manufacturing agreements and royalty acquisitions.


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