by Dennis Crouch
In Abbvie Inc. v. Kennedy Institute, the Federal Circuit confirmed that the judicially created doctrine of obviousness-type double patenting (OTDP) continues to be a viable defense following the Uruguay Round Agreements Act (URAA) even though the change to a priority-date-based patent term greatly reduced the potential for abuse. Looking forward, the decision begs the question as to whether the OTDB doctrine has been eliminated as to patents examined under new the America Invents Act of 2011 (AIA). For the first time the rewritten patent statute particularly defines what evidence counts as prior art — now leaving little room for the judiciary to create further categories.
Obviousness-type double patenting (OTDB) has long been an element of patent law that operates to prevent a patent applicant from chaining-together a time-series of multiple patents in order to extend the exclusive rights beyond the expected 20-year term. Historically, the potential term expansion was made possible by filing a second or subsequent patent application (often a continuation application) that issues several years after the original patent. Because the patent term was 17-years from the issue date, later-issued patents would have additional patent term beyond the expiry date of the first-issued patent. The OTDP doctrine operates to block this outcome of extended patent term whenever the invention claimed in the extended-term-patent would be obvious (not patentably distinct) in light of the invention claimed in the first-expiring patent. In that situation, the extended-term patent is held invalid or unenforceable unless the patentee had submitted a “terminal disclaimer” that disclaims the potential extra term and also links the two patents together as if they were one big patent. Writing on this topic in a 1963 CCPA decision, Judge Rich noted:
The public should also be able to act on the assumption that upon expiration of the patent [the public] will be free to use not only the invention claimed in the patent but also any modifications or variants thereof which would have been obvious to those of ordinary skill in the art at the time the invention was made, taking into account the skill of the art and prior art other than the invention claimed in the issued patent.
See MPEP 804.
Declining Policy Concerns: Much of the need for the OTDB doctrine evaporated with the 1995 patent term transformation enacted with the URAA. Under the new law, US patent term is now calculated from the application priority date rather than the issue date with the result being that the a divided application no longer necessarily extends the patent term.
Of course, there are some caveats to the notion that OTDB is now an unnecessary relic: First, the term of a patent may be adjusted or extended due to a variety of factors with the result that family member applications may have differing expiry dates. The second source of potential term-separation comes from the statutory definitions of prior art that excludes certain prior applicant disclosures from the scope of prior art. These prior-art exclusions include certain pre-filing disclosures by the applicant as well as prior applications on file with the PTO that are not yet published as of the application latter filing date. The first situation (PTA) was a focus of Gilead Sciences v. Natco Pharma (Fed. Cir. 2014) and the second situation was the focus of AbbVie.
In AbbVie, the patentee held two separate patents both covering aspects of a rheumatoid arthritis treatment. Although both patents were part of the same patent family, only one claimed priority to a certain earlier application. It turns out that the early priority date was not needed because no intervening prior art had been identified. Under the 20-year term rules, the two patents were scheduled to have two different expiry dates. In the appeal, however, the Federal Circuit affirmed that the second patent was invalid for obviousness type double patenting because it was not patentably distinct from the claims of the first patent.
An interesting aspect of the decision involves the court’s attempt to ground the doctrine in statute rather than the judicial creation heritage that Judge Rich had accepted and recognized. Judge Dyk writes:
While often described as a court-created doctrine, obviousness-type double patenting is grounded in the text of the Patent Act. . . . § 101 forbids an individual from obtaining more than one patent on the same invention, i.e., double patenting. As this court has explained, “a rejection based upon double patenting of the
obviousness type” is “grounded in public policy (a policy reflected in the patent statute).”
Although the policy notion may be grounded in Section 101, the court explains that the practical application of the doctrine “looks to the law of obviousness generally” and is “analogous to an obviousness analysis under 35 U.S.C. § 103.” (quoting Amgen).
While unimportant for the AbbVie decision, the particular grounding of the doctrine may be important going forward because the law of obviousness has been rewritten as part of the America Invents Act of 2011.
The AIA redefines prior art in a number of particular ways. Notably for this discussion, the law spells out the scope of prior art along with certain “exceptions.” These exceptions include disclosures originating from the inventors (Section 102(b)); as well as prior patent applications from the same patent-owned and that were still unpublished by the latter filing date (Section 102(b)(2)(c)). Section 102 has also been rewritten to expressly state that it is defining “prior art” — presumably the entire scope of potential prior art. When the obviousness provision in Section 103 refers to “prior art” it is now clear that we are talking about prior art as defined in Section 102 with the exceptions as noted.
Although a seeming small change in the statute, these alterations repeatedly make clear that certain prior disclosures by an inventor/owner simply don’t count as prior art either for novelty or obviousness purposes. At the margins there continues to be potential for applicants to “play games” with the filing system in order to extend their effective patent term. However, that potential is so reduced from ages past and the statute now defines prior art at such an explicit level of detail that we leave little room for a judicially created doctrine that further eliminates patents.
Creating versus Eliminating Prior Art: At this point, it would be rather odd for the court to create additional forms of prior art that extend beyond the statute. What is unclear is whether the courts will be willing to apply the rewritten statute in a way that eliminates old forms of prior art that are no longer part of the statute. Like OTDP ‘prior art,’ the court will be faced with a similar situation involving prior secret sales or non-public commercial uses by the patentee that previously served as prior art but that do not seem to fit within the re-written definition of Section 102.
One problem with the doctrine is that it is slowly developing. The first challenges may come from a patent applicant who refuses to file a terminal disclaimer in order to get its patent allowed.
= = = = =
I should say that Congress potentially recognizes that double patenting doctrine is potentially problematic and Rep. Goodlatte has proposed an amendment that would codify double patenting.
[…] that statutory-double patenting is said to stem from 35 U.S.C. 101 and, likewise, we learned in AbbVie v. Kennedy Institute that obviousness-type-double-patenting also finds its roots in Section 101. The problem with that […]
Dennis, you say:
“The first situation (PTA) was a focus of Gilead Sciences v. Natco Pharma (Fed. Cir. 2014)…”
PTA was not at issue in Gilead as neither patent had a PTA award. Their differences in term were the result of different earliest non-provisional filing dates.
Since I agree with several of the below comments, I would only add that as I understand AIA 102, if commonly owned or same inventive entity application B is filed before their A is published then apparently A is not prior art, and the only possible rejection of B based on A is for §101 “double patenting,” or for judicially created “obviousness-type double patenting” [which is curable by effective terminal disclaimers tied to the first to expire and retained common ownership]. [Note that double patenting rejections could be applied before either A or B are published.] Unless the PTO also adopts an anticipatory or provisional §102(a)(1) rejection in anticipation of application A being published (as occurs in the 90%+ of applications where non-publication is prohibited by foreign filing, or is not requested). Akin to the MPEP §706.02(k) “Provisional Rejection (Obviousness) Under 35 U.S.C. §102(e)/103” for copending applications having different effective filing dates wherein each application has a common assignee or a common inventor. The practice tip is to try to file “improvement” applications B within 18 months of the filing date of the earlier application A, thus before A publishes, to avoid A being prior art against B.
Re “double patenting” case law note that as illustrated recently in In re Hubbell, a patent examiner may reject an applicant’s pending patent claims based on obviousness-type double patenting even where there is no common ownership with the conflicting patent. Also, as very recently noted in In re Dinsmore, common ownership is a requirement for an effective terminal disclaimer. Note also Gilead Sciences, Inc. v. Natco Pharma Ltd. re respective issue and expiration dates. Some other Fed. Cir. decisions on double patenting in recent years are not models of clarity or consistency.
Paul, do you have any information whether the folks who lost Gilead plan to petition the Supreme Court? Such a violent refusal to follow controlling precedent to the contrary, upsetting well established law of very long vintage, by a panel nonetheless, has got to merit some attention by someone.
It is a pity that the Federal Circuit did not take the case en banc.
While I don’t understand why disclaimers of the patent term were required since 1995, I do see value in requiring agreeing to common ownership, which is a part of the terminal disclaimer. Otherwise, potential infringers are going to have to deal with two or more parties for what could be essentially the same invention.
I agree that maintaining common ownership is now the primary value of disclaimer practice in these cases.
But don’t forget patent term adjustments, which could still give different expiration dates for various members of a patent family, depending on PTO-caused delays in prosecution.
Good point as to PTA. I recall seeing a discussion between Prof. Crouch and a commenter a few months ago where the commenter thought perhaps he had gotten “The Longest PTA, Evah!”. But DC said no, someone else (IBM?) had it. But that one was, IIRC, on the order of 8 years or more.
So, anyway, a lot of words to say I agree with your comment and that PTA can be significant in some cases.
For an example of the truly lame “reasons” examiners give for OTDP rejections, see 12/287,481. The APJ who affirmed it needs some serious remedial training.
Typo in the s/n? I don’t see an ODP or Board decision in 12/287,481.
Sorry for the typo, see 12/287,471.
Awful. Truly awful.
Eh. There are much better cases to get outraged about. I think I agree with the board – the examiner’s assertion that “all limitations of the present invention are met by the conflicting claimed invention” seems like a pretty straightforward (albeit very brief) explanation of anticipation. I don’t know what additional information a claim chart would have provided. Note that the applicant didn’t challenge this at all, which suggests that maybe the examiner was right?
Huh? If your claims are strictly broader (and therefore anticipated by) the claims in your other patent, then your claims are obvious in view of the claims of your other patent. All the appellant had to do was point out a single limitation in their claims on appeal that wasn’t recited by the claims in the conflicting patent, but instead, they made a lame argument about the sufficiency of the rejection and didn’t address the merits. No wonder they lost.
Even if they won, they would still be left with claims that they know are anticipated by their earlier patent’s claims. So what was the point of not filing a terminal disclaimer, anyway?
I didn’t see your comment before I posted mine, plurality. I think you’re right.
“…they made a lame argument about the sufficiency of the rejection and didn’t address the merits.”
The rejection had no merits. There was nothing to respond to. The examiner did not point out a single difference between the pending claims and the applied claims, or provide any explanation at all as to how the pending claims were “merely broader” than the applied claims.
“All the appellant had to do was point out a single limitation in their claims on appeal that wasn’t recited by the claims in the conflicting patent…”
You have the burden backwards. Explaining the difference between the pending claims and the applied claims, and providing a reason why the differences would have been obvious, is the examiner’s burden, not the applicant’s.
Explaining the difference between the pending claims and the applied claims, and providing a reason why the differences would have been obvious, is the examiner’s burden, not the applicant’s.
That would be true if the examiner were asserting that the conflicting claim rendered the pending claim obvious. But he wasn’t. He said that the conflicting claim anticipated the pending claim, because the pending claim was “merely broader.” That’s a succinct way of explaining both the difference between the claims and why the pending claim is anticipated.
plurality is correct – if the examiner’s assertion was wrong, it would have been really easy to traverse. But that didn’t happen. The OTDP argument in the appeal brief was a throwaway argument and the APJ recognized it as such.
Not gonna dispute that the appellant’s argument was a throwaway. But in my experience the use of “anticipated” and “merely broader” in the OTDP rejections is almost always an indication of examiner laziness. In those instances I will always point out one difference that is not a “merely broader” distinction and instruct the examiner to point out all the differences and explain why they would have been obvious, or withdraw the rejection. And I don’t wait until the appeal brief to do that.
There is absolutely no requirement for the reference used in an OTDP rejection to be prior art. This post confuses obviousness with OTDP. MPEP 804 is pretty clear.
Strictly a personal opinion does not reflect the views of my employer:
You will note the CAFC’s legislative basis for Obviousness Type Double patenting:
Page 9 AbbVie, Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust,
“While often described as a court-created doctrine, obviousness-type double patenting is grounded in the text of the Patent Act.
Section 101 reads: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, . . . may obtain a patent therefor.”
35 U.S.C. § 101 (emphasis added). Thus, § 101 forbids an individual from obtaining more than one patent on the same invention, …..”
Actually a more texturally correct interpretation of section 101 is that each “composition of matter” etc is entitled to a single patent rather than each “invention” encompassed within it.
This is extremely radical but the language of section 101 certainly equally supports this interpretation.
Forgive me if I’m being dense, but what do you see as the practical distinction among a prohibition of multiple patents on an “invention” and a prohibition on multiple patents on a “process, machine, manufacture, or composition…”?
OTDP is one solution I suppose, but there are others, to the ubiquitous problem of how to manage a stream of patents coming off of a research project, a stream in which each successive application is directed to subject matter that is new relative to the earlier filings but might not be inventive over them.
Ned, are you familiar with the concept of the “Patent of Addition” an artefact of First to File patent Systems, notably that of the former British Empire. It is an elegantly simple concept: designating your patent application as one for a “Patent of Addition” renders it invulnerable to Prior art attacks which invoke Applicant’s earlier filings, the catch being that the Patent of Addition expires with the end of the term of the patent to which it is designated a patent “of Addition”.
But all that nonsense was swept away by the EPC, in which the statutory Art 54 definition of what is prior art simply eliminates any “double patenting” issues before they ever arise.
The EPC was a step too far for the USA I guess, when moving to a First to File framework. So be it. No shortage of work for patent lawyers, eh?
Long-winded comment coming.
Dennis, as someone whose practice includes representation before the Israel PTO, I’ve paid a lot of attention to the OTDP doctrine over the years, because the ILPTO hasn’t yet figured out the distinction between real, 101-type same-invention double-patenting and OTDP, and the results have been unpleasant (and illogical). On my own blog I have argued for some time for the ILPTO to adopt a terminal disclaimer policy akin to that in the US, something I think is within the scope of the ILPTO’s powers.
It’s not clear to me if you’re asserting that under the AIA, rejections that previously would have been raised as OTDP rejections should now be made as 101 same-invention double-patenting rejections, or if you’re saying there’s no basis for OTDP rejections, and only 101 DP rejections are left. Even if the latter, I would be concerned that the USPTO would start to fold both types of rejections together, as the ILPTO now does. Either way, based on the Israeli experience, I think it would be prudent to retain the OTDP doctrine.
Turning to your analysis, I don’t think the AIA did away with OTDP, as I think you’ve confused prior art with OTDP, which has nothing to do with prior art. Perhaps calling it “non-statutory double patenting” instead of OTDP would remove the basis for the confusion. Prior art comes into play when I compare the claims of my application to the entire disclosure of a prior art document, to determine if my claims are obvious in view of the prior art and therefore not allowable.
In contrast, for OTDP, as you point out, the concern is different: OTDP aims to prevent a temporal extension of my term of protection, and to prevent the possibility that the two patents with claims on obvious variations wind up two different hands, thus raising transactions costs for potential infringers. In my mind, the question in OTDP analysis is really, “Could the applicant in principle have obtained these claims in the earlier application, i.e. is he now claiming an obvious variation of what’s claimed in his earlier application?” Hence, ,unlike 101 DP analysis, for OTDP I compare the claims of my application to the *claims* of my earlier-filed application/patent, and the question is whether the later pending claims are obvious in view of the earlier *claims*. Even if my earlier application doesn’t count as prior art for 103 obviousness purposes – say, for example, that it hadn’t yet published at the time I filed the follow-on application – the question of whether or not I am effectively multiplying the number of patents I have that claim obvious variations of one another remains.
I think the invention of the terminal disclaimer, which as you note effectively makes the later and earlier filings into a single patent, is a great solution to this policy problem. It effectively allows the patentee to take a mulligan, adding claims to its portofolio that it theoretically could have had granted in the first application but didn’t, but without extending patent term, and while ensuring that potential licensees or infringers will need to negotiate with a single party. And the patentee pays a fine in the form of twice as many renewal fees to pay (with a nice windfall for the PTO as a result).
Dan, all this talk about “earlier/later” shows that you have not figured out the consequences of Gilead.
The new rule is that order of issuance is irrelevant.
All patents claiming obvious variations must expire on the same date.
This can create chaos because patent terms do not reliably expire 20-yrs. from filing due to extensions.
It’s a combination of extensions and the language in the terminal disclaimers that is causing the problem.
As noted by Dan, the underlying policy concern is over-extension of a patent’s term. One straightforward way to avoid the creation of a rat’s nest is a rule that says that the term of co-owned patents whose claims are obvious in view of each other is the term of the first patent in the “family” (related by the obviousness of the claims in view of each other) to grant.
There are other similar straightforward rules that might work and maybe other “tweeks” that could address perceived unfairness to the patentee (e.g., if the first patent granted has no extensions and also has narrower claims that fall within the scope of a broader patent, granted later and with an extended term). But the weirdest scenario — the one that I think needs to be avoided — is to extend the term of a first patent (or revive it?) based on extensions given to a later granted co-owned patent with claims that are obvious in view of the first patent.
TD fees are a huge (and easy) money maker for the PTO. Expect this enormous lobby to vociferously oppose any curtailment of OTDP rejections.
$160.00 per
up from $40 a few years ago
I’ll look forward to hearing what this “enormous lobby” has to say.
Law firms make a bit of change off filing TDs. It takes about twenty seconds for the attorney to push the button after his/her secretary prepares the TD. But nobody does timekeeping in increments that small.
Dennis,
Aren’t you forgetting about the other public policy reasons for OTDP? That is the policy with respect to the “common ownership” requirement to prevent multiple infringement suits by different assignees asserting essentially the same patented invention.
For some case law, see the following:
In re Hubbell, 709 F.3d at 1145 (“The second rationale is to prevent multiple infringement suits by different assignees asserting essentially the same patented invention.”); see also In re Van Ornum, 686 F.2d 937, 944–48 (C.C.P.A. 1982).
Annie Mouse, but the patents are not invalid if held by different parties. They are just unenforceable for that period. When and if ownership is again restored, the patents become enforceable once more.
Ned, can you cite a case for the proposition that if common ownership is restored “the patents become enforceable once more.” There are cases that hold that the conflicting patents must be commonly owned at the time the TD is filed, so that would run counter to your proposition.
IN RE DINSMORE, No. 2013-1637 (Fed. Cir. June 10, 2014).
Thanks, Ned. Dinsmore held that a TD was proper to remove an ODP rejection when the TD recited the language specified by Rule 321 and that common ownership at the time of the TD’s filing is not a requirement for the TD to be proper and therefore there was no defective TD that could provide the basis for a reissuable error. Dinsmore did not speak to re-establishing common ownership to render patents “enforceable once more” – nor could it, because any such commentary would have been dicta in an ex parte proceeding. I want a case that supports your proposition, and Dinsmore certainly does not conflict, but I don’t think it goes far enough.
Double patenting is a 101 problem as noted by the courts. Prior art is a separate and distinct issue, and has, since 1790, been exclusively related public knowledge and use of the invention.
Whether one can obtaining two patents on the same invention does not involve issues of prior art because one’s own knowledge of the invention is not public knowledge. Pennock v. Dialogue. 27 U.S. 1, 7 L. Ed. 327 (1829).
It would be better Dennis not to confuse the issues.
Thanks Ned. I appreciate your comment and suggestion to consider Pennock v. Dialogue. (link to scholar.google.com)
I would actually use Pennock to support my view. That case serves as an ancestral origin of the statutory bar rules that patent applicants have lived with for so many years. Perhaps not properly identified as “prior art,” but in recent years many of us have identified them colloquially as such. However, the AIA eliminates the statutory bars in favor of a detailed system only looking to prior art (created by anyone) with exceptions for certain actions taken by the inventors or owners.
The obviousness type double patenting doctrine has been used as a backstop for a time when there was a strong policy argument in favor and a patent statute that was not fully fleshed-out. That scenario has largely changed now. In my mind, this is much akin to the Laches issue that I raised earlier this week.
Dennis, did you know that in England, prior to 1792, that one grounds for invalidating a patent (scire facias) was that an earlier patent had issued on the same invention, albeit, to another? Mowry v. Whitney, 81 U.S. 620, 20 L. Ed. 860, 8 S. Ct. 273 (1872).
link to scholar.google.com
It seems that the courts only extended the very well known principle to two patents on the same invention regardless of who invented.
(On a slightly different point, also note the caveat about the necessity of government involvement in writs to invalidate a patent because unless the government were involved, the patentee would be subject to numerous vexatious suit to cancel his patent for invalidity.)
Thanks Ned. Yes, and I agree with you that the scire facias doctrine should (as a policy matter) certainly be in force today. And, most of the 19th century US cases on “double patenting” were actually focused on this type of issue — i.e., earlier patenting by someone else.
A good description of the entire procedure for scire facias is set for in Chapter XXI, pages 194-211 of John Paxton Norman, Treatise on the Law & Practice relating to Letters Patent for Invention, (London, Butterworths, 1853). link to archive.org
Note the patent owner had a right to a trial by jury in the common law courts on disputed facts. The petitioner had to post a bond of 1000 pounds.
The Federal Circuit has the procedure for the writ all screwed up, thinking that because the writ was filed in Chancery, that the was no right to a trial by jury. There was. As usual, the Supreme Court has it right. Ex parte Wood & Brundage, 22 U.S. 603, 6 L. Ed. 171, 32 S. Ct. 589 (1824). link to scholar.google.com
Interesting. I had not researchd this issue.
If congress meant to eliminate ODP when passing the AIA why did it leave the ODP escape hatch for Divisionals in 35 USC 121?
Wouldn’t eliminating the doctrine of ODP make part of 121 redundant.
q, Dennis confuses prior art and 101. I do not know why.
Its a good question. Although it doesn’t mention double patenting by name, Section 121 is certainly directed, in part, to preventing OTDP from applying in the divisional situation. The question would be whether there is some other non-OTDP purpose for the following sentence:
That’s interesting. I had been thinking about cons & divs as basically interchangeable, not appreciating the differences wrt patent term.
Here’s a strategy I could see being employed: for a very valuable invention (the kind where you’d probably ultimately file 4 or 5 serial cons, and where cost isn’t really an issue), file the original app with a multitude of claims — when you get restricted, you have a bunch of divs, which will inevitably be delayed different amounts at the PTO and therefore have different expiration dates. You’d potentially get more term that way, compared to filing serial cons that all have TDs, where you’d be tied back to the shortest term in the family.
Comments are closed.