Obviousness-Type Double Patenting and Splitting Ownership (CAFC Says Don't Do It)

In re Fallaux (Fed. Cir. 2009) 08-1545.pdf

The Fallaux family of patents began with a PCT filing in June 1995. The first US patent issued in November 1999. Three more patents issued from continuation applications in 2001, 2003, and and 2006. The application at issue here was filed in 2003.

The PTO's appellate board - the BPAI - rejected the most recent application under the judge-made doctrine of obviousness-type double patenting. Obviousness-type double patenting is equitable in nature and operates as a mechanism to prevent "unjust extension of patent exclusivity beyond the term of a patent." Thus, an obviousness-type double patenting rejection requires a link between the two applications - either in terms of inventorship or ownership. The doctrine is only relevant when a prior patent cannot be considered prior art as defined by Sections 102 and 103(a) of the Patent Act. (If it is prior art, then the reference is applied under those statutory provisions.)

The change in the patent term and publication of pending applications eliminated most of the need for this judge-made regime. Because patent term is calculated from the filing date, it is now difficult to extend the term while claiming priority. Likewise, published applications ordinarily create a statutory bar that operates to prevent an applicant from extending the term by not claiming priority to an earlier filing. Here, the Federal Circuit recognized the significance of the change in the law, but was not prepared at this juncture to eliminate the doctrine.

It is true that the unjustified patent term extension justification for obviousness-type double patenting has limited force in this case. Indeed, this is surely true of many double patenting rejections today, in no small part because of the change in the Patent Act from a patent term of seventeen years from issuance to a term of twenty years from filing. ... Nonetheless, we do not think that we may disregard all of our cases relying on this justification for obviousness-type double patenting. In some cases there may still be the possibility of an unjust time-wise extension of a patent arising from patent term adjustment under § 154 or patent term extension under § 156.   

Furthermore, there is a second justification for obviousness-type double patenting—harassment by multiple assignees. ... The harassment justification for obviousness-type double patenting is particularly pertinent here because the Fallaux application and the Vogels patents are not commonly owned.

Of course, careful Patently-O readers will realize that the Court's use of mismatched patent term extensions as a justification for a double patenting rejection does not sit well with the law. In 2007, the Federal Circuit in Merck v. HI-TECH held that the patent term extension should apply to further extend the patent term despite a terminal disclaimer. Id. (Holding that a patent term extension under the Hatch-Waxman Act, 35 U.S.C. § 156, may be applied to a patent subject to a terminal disclaimer under 35 U.S.C. § 253, filed to overcome an obviousness-type double-patenting rejection.) The dicta of this Fallaux decision will tend to confuse the issue.

Common Inventorship: As the court notes, in this case, the double patenting rejection is based on second patent family. Both families list multiple inventors, and the link between the families is a single common inventor. Originally, the families were commonly owned by IntroGene, but some of the patents were assigned to Crucell and others to Galapagos Genomics.

No Common Ownership: The division of ownership rights here puts the applicant in a bind. Notably, it could not file a terminal disclaimer because the prior patent and the pending application were not commonly owned.

One Way versus Two Way Test: In most obviousness determinations, the examiner applies a "one way test" - asking "whether the application claims are obvious" over the prior art. This same approach is used in obviousness-type double patenting except that the prior patent is generally not considered "prior art." More particularly, because the focus is on extending patent term, the question is whether the pending claims are only obvious variations of the already patented claims. Occasionally, courts have required a more stringent two-way test where the examiner additionally considers "whether the patent claims are obvious over the application claims.”

The two way test can be required if the PTO "is at fault" for a delay that causes an improvement patent to issue prior to the basic patent. Here, the court agreed with the PTO that

Dr. Fallaux was entirely responsible for the delay that caused the Vogels patents to issue prior to the filing of the Fallaux application. . . . there [is no] evidence to suggest—that the PTO shared any responsibility for the delay. . . . Dr. Fallaux elected to prosecute other applications and delay filing the Fallaux application [for] six years after the [original US] application was filed. During this six year period, the Vogels patents were filed for and issued. In view of the Board’s fact findings, we hold that the PTO was not responsible for the delay.

Because the PTO had not caused the delay in prosecution, it could apply the less stringent one-way test of obviousness. And, as a consequence, the Federal Circuit affirmed the rejection.

Notes:

• The Fallaux panel of Judges Schall, Archer, and Moore* have no overlapping authors with the Merck v. HI-TECH panel of Judges Linn*, Friedman, and Plager. The direct contradiction of this case and the dramatic shift in the statutory law opens it to en banc rehearing.
• Patent term adjustments (due to PTO delay) are definitely limited by terminal disclaimers. Meck ("Section 154(b)(2)(B) expressly excludes patents in which a terminal disclaimer was filed from the benefit of a term adjustment for PTO delays.").

Comments

[Just Visiting]

I think whatever conflict there is between the cases is very minute given the second justification. There are plenty of court cases establishing that the multiple-assignee harassment is important even when patents have the same termination date.

The only thing surprising here is the suggestion that double patenting might require identity of inventorship where there was no common ownership. I would not have expected that.

[Paul F. Morgan]

This is not the only danger or problem in differently assigning or licensing closely-related or overlapping-claims applications or patents to different entities, and that can happen inadvertently when they are assigned or licensed by subject-matter definitions rather than individually.

[John Roethel]

The law of obviousness-type double patenting is nicely explained in In re Vogel, an old CCPA case from the 70's (cite not available because I am too lazy to look it up -- have your summer associate find it for you). Newer examiners reject claims under this doctrine on the ground that "the applicant could have submitted these claims in the earlier application" based on some mumbo-jumbo in the MPEP. That is not the law and they back off that rejection if you push them.

Only the claims (not the disclosure) of the patent can be used to reject the new claims. If you argue that the new claims would not have been obvious in view of the patented claims, you stand a good chance of defeating the obviousness-type rejection and avoiding the problem of the common ownership.

Note the disclaimer language that states the second patent "shall be enforceable only for and during such period that it and the prior patent are commonly owned" PTO/SB/26. And life became much easier a few years ago when the PTO let the attorney sign the TD.

[learn something everyday]

("Section 154(b)(2)(B) expressly excludes patents in which a terminal disclaimer was filed from the benefit of a term adjustment for PTO delays.").

--And now I understand why Pharma doesn't like to file terminal disclaimers.

[question]

why isn't the patent expiration date printed on the cover sheet of the patent?

[Dan Feigelson]

DC, I see the discrepancy between this case and the Merck case, but why do you think it will necessarily lead to en banc review? In Merck, the question was whether filing a TD to avoid an OTDP rejection over an earlier application/patent precluded the granting (or the validity of) a patent term extension under 156 for the later patent. The CAFC panel said it did not: the rationale behind the OTDP doctrine did not apply in the case of an extension under 156 (which can only be obtained for one patent, and is there to compensate applicants for FDA delay in approving a new drug, therefore denying the patentee the ability to commercialize its invention and benefit from its patent). In contrast, as you note, 154 itself says that patent term adjustment to which an applicant would be entitled under 154 is waived by the filing of a TD.

There's no contradiction between the two cases with regard to 154 adjustments. Insofar as the panel in the present case asserts possible extension under 156 as a policy reason for maintaining the OTDP doctrine per se, the present panel maintains a position that is contrary to the earlier panel, and that's a no-no -- under Federal Circuit rules, the ruling of the first panel to deal with the question controls.

But the question here wasn't whether or not an extension under 156 was obviated by a TD. The question was whether non-common ownership alone remains enough of a justification for maintaining the OTDP doctrine. So to the extent that the present panel opines on 156 extensions (and in so doing contradicts the Merck panel), the present panel's statements merely constitute dicta. You yourself seem to acknowledge this conclusion in your post. Is a later panel's dictum that goes against an earlier panel's holding sufficient to warrant en banc review? Or is there some other reason you think that this decision may be the harbinger of en banc review of this question? (I realize that practically, if enough CAFC judges want en banc review, they'll find a reason that they say warrants en banc review...)

[Hm]

Is this a hint?
Neither party raised or argued the question of whether a patent may be used as a reference for an obviousness-type double patenting rejection where the patent shares only a common inventor with the application, rather than an identical inventive entity or a common assignee. The Manual of Patent Examination Procedure (MPEP) allows such a rejection. See § 804 ¶ I.A (8th ed., rev. 7, 2008) (“Double patenting may exist between an issued patent and an application filed by the same inventive entity, or by a different inventive entity having a common inventor, and/or by a common assignee/owner.”). This opinion should not be read to decide or endorse the PTO’s view on this issue.

[pat man]

I do not think that the Merck case is inconsistent at all. Merck dealt with 35 USC 156 and TD's. Here we are dealing with 154 and TD's that have statutory exclusion.

I would expect following scenarios with TD :

A) Parent filed on 1/1/07 and issued on 1/1/08 earned PTA of 50 days.
B) Child claiming benefit file on 12/31/07 earned PTA of 100 days and filed TD over A.

Both patents get 50 extra days.

Suppose A earned 100 days and B got 50

A gets all 100 and B gets 50.

Suppose A earned 0 and B earns 50

Neither patent gets PTA.

[BioPatAtty]

Wow. So it's harassment when a patent holder goes after an infringer. Next time I get pulled over by the cops, I'll make sure to file a harassment suit because I had been pulled over by different cops on earlier occasions.

And by all means let's all make sure that we continue to uphold this outdated and irrelevant doctrine because it might make an infringer's life difficult.

"A person shall be entitled to a patent unless..."
it makes some would be thief's life inconvenient.

Now I understand.

[sdfa]

Hmmn. I have a case where we filed both a utility application and later filed a design application. The design issued first, and now the examiner is requiring a terminal disclaimer in the utility application. We'd rather not file because then the utility patent has only a 14 year term. What are the odds I can call this situation delay on the USPTO's part in examining the utility application?