Congressman Goodlatte Proposes to Codify Obviousness-Type Double Patenting

06 June 2013 PharmaPatents Blog

As I wrote previously, Congressman Goodlatte (R-Va.) released “a discussion draft” of patent reform legislation on May 23, 2013. Although the stated purpose of the draft legislation is to “address the ever increasing problem of abusive patent litigation,” it also includes other significant proposed changes, including provisions that would eliminate Section 145 actions and eliminate Exelixis I-type Patent Term Adjustment (PTA), as I summarized in this article. Here, I look at the provisions that would codify the doctrine of obviousness-type double patenting (OTDP).

The Judicially-Created Doctrine of Obviousness-Type Double Patenting

In a recent case addressing OTDP in the pharmaceutical patent context, Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit explained that the doctrine of obviousness-type double patenting (also referred to as “non-statutory double patenting”) is “grounded in public policy that prevents the extension of the term of a patent . . . by prohibiting the issuance of the claims in a second patent not patentably distinct from the claims of the first patent.” In accordance with the USPTO’s Manual of Patent Examination and Procedure (MPEP), the language you might see in an Office Action explains it this way:

A rejection based on nonstatutory double patenting is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent.

Section 804 of the MPEP includes a complex flow chart illustrating when an OTDP rejection should be raised, but there are three basic requirements:

  1. There must be a common inventor or owner or a joint research agreement linking the cited patent/application and the patent application at issue. (In In re Hubbell, the Federal Circuit upheld the USPTO’s practice of imposing OTDP rejections when the patents/applications have overlapping inventorship but are not owned by the same entity.)
  2. The subject matter claimed in the application at issue must be obvious in view of the subject matter claimed in the cited patent/application, or vice versa.
  3. There must not have been a Restriction Requirement that resulted in the subject matter at issue being pursued in separate patent applications.

As the Federal Circuit explained in Otsuka, an OTDP situation “is analogous to [a failure to meet] the non-obviousness requirement of 35 U.S.C. § 103 . . . . [but] [i]mportant differences remain.”

  • First, “the patent principally underlying the double patenting rejection need not be prior art.” This means that the asserted patent/application may have been filed earlier, simultaneously with, or after the application at issue.
  • Second, the claims at issue are not evaluated in view of the specification of the cited patent/application, although the specification may be consulted to determine the meaning of the cited claims, and “may be considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent.” See MPEP § 804.

The Goodlatte Proposal

Currently, there is no statutory basis for OTDP. The Goodlatte draft legislation would change this by codifying OTDP in new 35 USC § 106:

(1) AMENDMENT.—Chapter 10 of title 35, United States Code, is amended by adding at the end the following new section:
§ 106. Prior art in cases of double patenting.
A claimed invention of a patent issued under section 151 (referred to as the ‘first patent’) that is not prior art to a claimed invention of another patent (referred to as the ‘second patent’) shall be considered prior art to the claimed invention of the second patent for the purpose of determining the non-obviousness of the claimed invention of the second patent under section 103 if—
(1) the effective filing date of the claimed invention of the first patent is on or before the effective filing date of the claimed invention of the second patent;
(2) the—
(A) first and second patents name the same inventor; or
(B) claimed invention of the first patent would constitute prior art to the claimed invention of the second patent under section 102(a)(2) if an exception under section 102(b)(2) did not apply and, if applicable, if both claimed inventions did not have the same effective filing date; and
(3) the patentee of the second patent has not disclaimed the rights to enforce the second patent independently from, and beyond the statutory term of, the first patent.

What Does This Mean?

It is not clear whether this proposed statute is meant to expand or contract the scope of OTDP, or whether it is meant to replace the current, judicially created doctrine or fill a gap that the current doctrine might not reach.

Parsing through the proposed language, it appears that focus on the “claimed invention” of the “first patent” would continue to focus the OTDP analysis on the claims of the cited patent, and not its disclosure. Thus, in this respect, the proposed statute appears to be consistent with current OTDP doctrine. Likewise, 35 USC § 106(3) appears to be consistent with current practice, in that it provides that OTDP can be overcome with a terminal disclaimer. However, other statutory language appears to depart from current OTDP jurisprudence.

First, by expressly invoking § 103, the proposed law may eviscerate the subtle differences that exist between obviousness and OTDP. For example, Federal Circuit precedent indicates that OTDP can be overcome by showing that the claims at issue are “patentably distinct,” even if the standards for establishing non-obviousness under § 103 are not satisfied. For example, as set forth in MPEP § 806.05, OTDP may not be proper if the first invention would not infringe the  second invention, and vice versa. Also unique to OTDP situations is the treatment of product claims and method of manufacture claims, where one relevant inquiry under OTDP is whether the product can be made by another materially different process. The invocation of § 103 also raises a question as to the time frame from which OTDP would be assessed.

Another point is that, by its discussion of first and second patents, the proposed statute appears to apply only to OTDP arising between two granted patents. Since a literal construction of this language might prevent the USPTO from citing § 106 in a rejection against a pending patent application, this choice of words may be a drafting oversight, although it could reflect a deliberate intention to craft the statute narrowly to apply only to post-grant proceedings and court challenges.

Interestingly, it appears that paragraph (1) of proposed new § 106 means that the new statute would not apply if the “first patent” has an effective filing date after that of the claims at issue. Does this mean that later-filed, earlier-granted patents no longer could give rise to OTDP issues? While the emphasis on effective filing date fits with other first-inventor-to-file statutes, OTDP never has been about “prior art.” Does the title of the proposed statute reflect a paradigm change in the role of OTDP?

I also note that the proposed statute does not have any exception for patents stemming from a common application in which a Restriction Requirement was issued. The first patent issued from such an application would have an effective filing date “on” the effective filing date of the divisional application and often would name the same inventor, and so would satisfy paragraphs (1) and (2)(A) of the proposed statute. Hopefully this is an oversight that would be rectified if this proposal gains traction.

To understand paragraph (2)(B), it helps to recall the language of the cited paragraphs of the first-inventor-to-file version of 35 USC § 102:

(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—
(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

(2) DISCLOSURES APPEARING IN APPLICATIONS AND PATENTS.—A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if—
(A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor;
(B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or
(C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.

Sections 102(c) also may be relevant:

(c) COMMON OWNERSHIP UNDER JOINT RESEARCH AGREEMENTS.—Subject matter disclosed and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person in applying the provisions of subsection (b)(2)(C) if—
(1) the subject matter disclosed was developed and the claimed invention was made by, or on behalf of, 1 or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention;
(2) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and
(3) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.

Reading proposed § 106(2)(B) together with § 102(B)(2)(C) in effect provides that if the first and second patents do not name the same inventor (in which case § 106(2)(A) would apply), OTDP nonetheless can arise if there is common ownership, an obligation to assign to the same owner, or a joint research agreement. This is consistent with current OTDP doctrine.

Reading proposed § 106(2)(B) with reference to § 102(B)(2)(A) and (B), seems to provide that OTDP can arise if the subject matter claimed in the first patent was derived from the inventor of the second patent, even without common inventorship or ownership. However, the end result of such a provision would be to grant a patent to the first-to-file party who derived the claimed subject matter from the first inventor, while refusing or invalidating the patent of the first inventor. Perhaps § 106(2)(B) is meant to refer only to § 102(B)(2)(C). That would be consistent with current OTDP doctrine, where OTDP issues can arise only if the patents/applications at issue have common inventorship or common ownership. Otherwise, proposed § 106 appears to mandate an OTDP situation where the America Invents Act amendments to 35 USC § 135 would provide for a derivation proceeding.

Effective Date of Proposed § 106

According to the draft legislation, proposed § 106 only would apply to OTDP arising between two patents that are both subject to the first-inventor-file provisions of the America Invents Act:

(4) EFFECTIVE DATE.—The amendments made by this subsection shall take effect on the date of the enactment of this Act and shall apply only if both the first and second patents described in section 106 of title 35, United States Code, as added by paragraph (1), are patents that are described in section 3(n)(1) of the Leahy-Smith America Invents Act .

By operation of this effective date, this statute could have retroactive effect to cases already filed when it is enacted.

What Is Driving This Change?

This proposal to codify OTDP in new § 106 would be easier to understand if I knew what was driving this particular legislative initiative. Without knowing the problem that it is designed to solve, the gap(s) that it is intended to fill, or the judicial construction that it is meant to rectify, it is hard to evaluate whether it will improve or confuse the current state of the doctrine of OTDP.

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