Damage to Our Patent System by Failure to Honor the U.S. Legal Framework: Double Patenting

By Sherry Knowles
August 27, 2019

“The doctrine of judicially-created non-statutory obviousness-type double patenting is the flip side of the coin of the patent eligibility issues… The term ‘non-statutory’ double patenting is an unqualified admission that this doctrine is not authorized by a congressional statute. Congress is the only branch of the government authorized to create substantive patent law.””

 Failure to Honor the U.S. Legal Framework: Double Patenting - https://depositphotos.com/13456269/stock-photo-we-the.htmlAs the summer winds down, it is time again to focus on how to fix the U.S. patent system. In June, the Senate Judiciary’s IP Subcommittee held unprecedented hearings on patent eligibility. They are now back in closed door sessions with selected stakeholders to further consider language to amend Section 101, having received extensive feedback. My testimony in part addressed the unconstitutionality of the U.S. Supreme Court’s cases on patent eligibility, which have created judicial exceptions that arrogantly ignore the plain wording of Congress’ statute (“invention or discovery” in the disjunctive in Sections 100(a), (f) and (g) and Section 101) and its legislative history, and despite the fact that the U.S. Constitution gives Congress the sole power to create patent law (Knowles & Prosser, Unconstitutional Application of 35 U.S.C. §101 by the U.S. Supreme Court, 18 J. Marshall Rev. Intell. Prop. L. 144 (2018)).

Courage Amidst the Chaos

I also co-authored, with Meredith Addy, one of the only three amicus briefs submitted requesting rehearing in the Athena Diagnostics case. On July 3, the Federal Circuit denied rehearing in a fractured and lengthy decision, confirming the utter chaos at the appellate court level on patent eligibility, the cornerstone of our innovation system. None of the judges waxed poetic about the shiny colors and hues of the Emperor’s new clothes, but also, none of the judges in the majority were willing to risk a Supreme Court slap down, regardless of how honorable it would have been (and consistent with the Judge’s Oath which embeds its primary obligation to uphold the Constitution). I would like to thank the judges who had the courage to agree to take on a discussion (Moore, Newman, O’Malley, Stoll and Wallach). Judge O’Malley stated that “the Supreme Court has ignored Congress’ direction to the courts to apply 35 U.S.C. sections 101, et seq. as written—the Supreme Court has instructed federal courts to read into Section 101 an inventive concept requirement—a baffling standard that Congress removed when it amended the Patent Act in 1952.” Judge Moore ended with the following statement: “And, oh yes, that the statute clearly permits the eligibility of such inventions and that no judicially-created exception should have such a vast embrace.” Judges Newman and Wallach commented that “the public interest is poorly served by adding disincentive to the development of new diagnostic methods. This is a severe criticism; and when presented by the entire industry, and stressed by thoughtful scholars, it warrants attention.” Let’s hope Athena Diagnostics files a Petition for Cert to the Supreme Court.

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The Double Patenting Example

The doctrine of judicially-created non-statutory obviousness-type double patenting is the flip side of the coin of the patent eligibility issues.  A rejection for “non-statutory obviousness-type” double patenting is based on a “judicially-created doctrine” grounded in public policy and which is primarily intended to prevent prolongation of the patent term by prohibiting claims in a second patent not patentably distinct from claims in a first patent. This is problematic for at least these reasons:

  • The term “non-statutory ” double patenting is an unqualified admission that this rejection is not authorized by a congressional statute. Congress is the only branch of the government authorized to create substantive patent law.
  • The “judicially-created doctrine” of obviousness-type double patenting is ultra vires because the U.S. Constitution does not grant power to the courts to create patent law, regardless of the underlying public policy. Any assertion of statutory stare decisis cannot be used to bootstrap the unauthorized judicial creation of substantive patent law to judicial self-authorization.
  • The terms “patentably distinct” and “patentably indistinct” do not exist in Chapter 35 of the United States Code.
  • There has been no clear delegation of authority under Chevron U.S.A., Inc. v. Natural Resource Defense Council, 467 U.S. 837 (1984) to the U.S. Patent and Trademark Office (USPTO) to generate an entire body of regulatory law on obviousness-type double patenting and associated terminal disclaimers.

A patent policy preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming assertedly patentably indistinct variations of the same invention must be based on Congressional statutory authority, as the judicial branch of the government is not authorized to create patent law based on its own thoughts about effects on infringers, and which affects the ownership of patents.

Exceeding Authority and Ignoring the APA

As an administrative agency, the USPTO is limited to making rules pursuant to a constitutionally valid delegation of power from Congress. While Congress has delegated authority to the USPTO to make certain rules (for example the PTAB regulations, see Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016)), no statute exists that delegates the authority to make or implement a rule on non-statutory obviousness-type double patenting. The Federal Circuit (CAFC) has confirmed on several occasions that Congress did not vest the USPTO with any general substantive rulemaking power. The USPTO is instead vested with the power to make procedural rules and to apply statutes passed by Congress. Thus, promulgation of rules related to obviousness-type double patenting and insistence on the submission of a terminal disclaimer that can affect patent term and ownership runs contrary to prior court holdings that have found agency action outside the scope of a clear delegation of authority provided by Congress to be unconstitutional.

Even if Congress had delegated authority to the USPTO to promulgate a rule on non-statutory obviousness-type double patenting, which it has not, and could not, because there is no such statute, the current Manual of Patent Examining Procedure (MPEP) guidance and rules are procedurally defective under the Administrative Procedure Act (APA; 5 U.S.C. 500-596). The APA has strict procedural requirements that agencies must follow to make new rules. The requirements of APA Sections 553, 556, or 557 apply to all substantive rulemaking by the USPTO. At a minimum, these rules require that a notice of proposed rulemaking is provided for substantive rules, and a comment period allowed and then the final rule must be published in the Federal Register. The USPTO has not published proposed or final rules on the metes and bounds of non-statutory obviousness-type double patenting in the Federal Register. And it is well established that the MPEP does not have the force of law and is internal guidance only. It is not a substitute for the notice and comment provisions of the APA for substantive rules.

Tracing obviousness-type double patenting to the first MPEP (§ 9-4-1 MPEP 1948), the rule still fails to meet the procedural requirements of the original APA, which even in 1946 required publication in the Federal Register (60 Stat. 237, 238, 1946). In fact, to the best of my knowledge, there has never been a rule implementing the law on non-statutory obviousness-type double patenting in the Federal Register that complies with the APA. And, notwithstanding, the USPTO cannot do so because by definition there is no clear delegation from Congress on this matter because there is no statute.

Harm to Inventors, Damage to the System

Where the U.S. Constitution grants sole authority to Congress to create law in an area, the U.S. Supreme Court is limited to statutory construction. “Judicially-created” obviousness-type double patenting by definition cannot be a reasonable interpretation of a statute because there is no statute on which it is based—hence the name “non-statutory”.

The application of the “judicially created doctrine” on “non-statutory” obviousness-type double patenting harms innovators because to overcome the rejection, innovators must submit a Terminal Disclaimer that substantively affects patent ownership and any agreement to the Terminal Disclaimer runs with the patent and is binding on the grantee, its successors and assigns.

This post does not take any position on what the correct law of double patenting should be. This post is meant to highlight the damage caused to the system itself when the strict rules for the responsibility to create and enforce our laws as set out in the Constitution are not honored.

One of the biggest problems caused by the failure to honor the basic structure of our government is that we can’t put the toothpaste back in the tube. It has historically been the case that when courts change the law, it applies retroactively (often because the courts use the ruse that they are interpreting what the law always was, even when we know that isn’t the case and the new law causes a draconian change in how business is carried out). On the contrary, Congress cannot pass a statute (for example, a double-patenting statute) that retroactively enacts or ratifies a law or retroactively delegates past authority to the USPTO that didn’t previously exist. So, how can the lack of Constitutional and Congressional authority to create the double-patenting laws be fixed if the fix cannot apply retroactively to ratify years of application of unauthorized law? What a mess.

The failure to honor the basic structure of our government in the area of patent law results in doctrine creep. In the 101 area, innovators are victims of doctrine creep whereby the Supreme Court has instructed federal courts to read into Section 101 judicially created exceptions and an inventive concept requirement, which, as Judge O’Malley points out, is a baffling standard that Congress removed when it amended the Patent Act in 1952. In the double patenting area, we find doctrine creep as the requirement slides from application only to directly overlapping claims, to application to claims that are held obvious over those in related patents, to claims rejected over claims in a related patent in combination with a third-party reference, and on it goes.

We Must Get Back to the Blueprint

When building a house, the construction team constantly refers to the blueprints. When deciding how to spend money at a company, the Board repeatedly refers back to the approved business plan to see if the spend is consistent. When manufacturing products, companies repeatedly check the specifications and design. So why is it verboten to strictly refer to the nation’s blueprint, the U.S. Constitution, to check to make sure the government is conducting itself according to the established balance of powers between the branches of government when carrying out the country’s business? And why, for example, are the courts so comfortable applying tax code as written by Congress but not the patent code?

There are a range of views on the Constitution, from “originalist” to “living”. However, these range of views pertain to subtleties such as interpretation of wording when ratified versus today. Regardless of your proclivities on how to interpret words of the Constitution, these differences cannot rise to the very structure of government itself, or else we would have no framework. If the Constitutional structure of the government unambiguously grants power to only one branch of government to create law, that is neither subtle nor interpretable in different ways.

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The Author

Sherry Knowles

Sherry Knowles is Founder of Knowles Intellectual Property Strategies and an intellectual property attorney with 30 years of experience in global corporate and private practice. From 2006-2010, Ms. Knowles was the Senior Vice President and Chief Patent Counsel at GlaxoSmithKline, where she served as the worldwide head of patents for all litigation and transactional matters, and managed a global department of over 200 people in 12 offices. At GSK, Ms. Knowles was a member of the Scientific Advisory Board, the Technology Investment Board, the Product Management Board, the Legal Management Team and she led the Global Patents Executive Team.

For more information or to contact Sherry, please visit her Firm Profile Page.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 10 Comments comments. Join the discussion.

  1. Pro Say August 27, 2019 6:32 pm

    Thanks Sherry — yet another excellent treatise among many.

    “And why, for example, are the courts so comfortable applying tax code as written by Congress but not the patent code?”

    Why? Simply this:

    Because when it comes to the patent code (unlike with the tax code), the courts believe that they know better than Congress does.

    Congress; what say you?

  2. Concerned August 27, 2019 6:34 pm

    Bravo. How can anyone argue against your premise: Follow the Rule of Law?

    Yet, there will be those who say I know, but….

  3. Mark Summerfield August 28, 2019 3:26 am

    This might be a case of being careful what you wish for, Sherry. I understand that you are not taking a position on what the correct law of double patenting should be, but your article strongly implies that you believe the current law disadvantages patent-owners by truncating the term of their ‘follow-on’ patents.

    In contrast, I have always thought that obviousness-type double patenting, and terminal disclaimer practice, in fact works to the benefit of patent-owners, by correcting what appears to be an unintentional oversight in the US patent law. Because, as far as I can see, the alternative would be that any ‘patentably indistinct’ claims in a later patent application would be invalid, on grounds of obviousness, over the applicant’s disclosure in their own earlier application. The judge-made law, and terminal disclaimer practice, thus saves the later claims, despite truncating their maximum term.

    All of this stems from the unique feature of the US system that a prior application, as yet unpublished at the priority date of the later claims, is effective as prior art for purposes of both novelty and obviousness. Everywhere else (at least to the extent of my experience) such applications are prior art only for novelty purposes (and, in some jurisdictions, only to the extent that the later application actually seeks to claim an invention already claimed in an earlier patent). We simply accept that, absent a prior public disclosure, it is quite possible for patents to issue, whether to common or different applicants, with claims that are patentably indistinct.

    There is, it seems, an ambiguity or omission in the US statute, which addresses double patenting in relation to the effect of a prior application with respect to anticipation, but is silent as to the corresponding effect with respect to obviousness. It is hard to see how the courts, or the USPTO, should have dealt with this other than by making their best guess at what the legislature might have ‘intended’.

    I agree that this is a policy issue, and that it should be up to the US Congress to clarify its intentions. You might be right that this is constitutionally necessary – I do not presume to know anything about US constitutional law. However, Congress has had ample opportunity to overrule the courts by legislating, and has not sought to do so. That seems to say something about where it stands.

  4. Anon August 28, 2019 7:53 am

    As to:

    regardless of how honorable it would have been (and consistent with the Judge’s Oath which embeds its primary obligation to uphold the Constitution).

    It is gratifying to see (yet another) point of mine being adopted and brought to the table for discussion.

    While my point has been to the ethical considerations that most all attorneys have sworn to operate under, the same “must not elevate the judicial branch (for example, the Supreme Court) above the Constitution” is clearly in mind here from Miss Knowles.

  5. TFCFM August 28, 2019 10:01 am

    Where the U.S. Constitution grants sole authority to Congress to create law in an area…

    Newsflash: The U.S. Constitution did not abolish common law, either in patent law specifically or in U.S. law generally.

    Few are the patent statutes that can be applied without the gloss that common law brings. Non-statutory obviousness-type double patenting is merely such gloss, applied to an area where Congress has failed to anticipate all possible circumstances.

    If Congress should be unhappy with the gloss the courts put onto a patent statute, Congress is free to legislate-away that gloss, codify it in its present form, or codify it in an alternate form. So too with obviousness-type double-patenting. Congress is free to alter the doctrine. However, continued existence of the doctrine through many consecutive Congresses suggests that the legislative branch is not entirely unhappy with the doctrine in its current form.

    In this and all other common-law countries, the mere fact that a legislatively-implemented statute does not spell out how the statute will apply in every imaginable (or even unimaginable) situation does not prevent our courts from applying the best interpretation they see fit when such situations are presented to them — taking into account existing statutes, the court’s best understanding of legislative intent, precedent, and (where necessary) public policy.

    Were our constitutional system otherwise, our laws would be continually deficient (constantly trying to “catch up” with the odd circumstances that find their way before the courts), and our Congress constantly overwhelmed, as statutory law was constantly re-written to address every conceivable circumstance and nuance.

  6. Steve August 28, 2019 10:43 am

    #3, you misunderstand: obviousness-type double parenting is applied to pairs of applications that have the same effective filing date–neither is prior art to the other.

  7. TFCFM August 28, 2019 11:11 am

    Query, too, whether the author intends to rid our patent system of ALL non-statutorily-specified judicial doctrines (including, for example, the non-statutory, judicially-made “doctrine of equivalents” for non-literal patent infringement), or just one or two doctrines that she dislikes?

  8. N. August 28, 2019 1:23 pm

    As a preliminary matter, obviousness-type double patenting (OTDP) can be based on a common inventor or common ownership, and without a common priority date. That was the case in In re Hubbel, 709 F.3d 1140 (2013), where judicial notice was taken of the MPEP 804 (I)(A). The “common inventor” precondition appears to be a holdover from inventorship issues addressed in the 1984 patent act, and it was around this time the Patent Office first announce this language, in “guidelines.”

    Also, the statutory basis for the judicial doctrine of OTDP appears to be section 101, which states that “a patent” may be obtained. The language of 101 has close approximation to the earliest patent statutes in this country, and the doctrine appears to go back almost as far. Justice Story, for example, stated in Odiorne v. Amesbury Nail Factory, 18 F.Cas. 578 (1819), in a case of “substantial novelty,” the precursor to modern obviousness, that “the inventor can have but a single patent for his invention; and that the first he obtains, while it remains un-repealed, is an estoppel to any future patent for the same invention founded upon the general patent act.”

    I do agree, however, that statutory changes should be made to amend judicial OTDP. One was proposed in the Innovation Act of 2015, as section 106, but never went anywhere.

  9. Anon August 28, 2019 2:15 pm

    To TFCFM’s broad declaration of “Newsflash: The U.S. Constitution did not abolish common law, either in patent law specifically or in U.S. law generally.

    It must be pointed out that Common Law law writing is NOT a “single shot” type of item, and spans actual interpretative common law as well as NON-interpretative law WRITING.

    The second type IS the type that is expressly forbidden by the Separation of Powers.

    If you have a problem accepting this from me, perhaps you would want to watch the John Houseman version of the movie The Paper Chase, noting the statement at the one hour and six minute mark.

  10. Mark Summerfield August 29, 2019 12:49 am

    Steve @6, I accept that obviousness-type double patenting based on a common priority date rather than common inventor/owner (which is the form in which I have most commonly encountered it) raises slightly different issues. But, again, the alternative to creating this doctrine might be to follow the lead of the statute on ‘strict’ double patenting, and disallow additional applications claiming patentably indistinct inventions.

    And, once again, the need for terminal disclaimer practice in this case is a result of a unique feature of the US patent system, namely that patent term is not fixed at the date of filing. This is less significant now, when only the potential benefit of term adjustment is at stake, than it was when term was 17 years from issue. In the rest of the world, granting multiple patents with different, but perhaps ‘mutually obvious’ scope, that are all going to expire, by definition, simultaneously, has simply never been regarded as a problem.

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