Double Patenting: Proving Distinctiveness Based on Later Developed Evidence

Takeda Pharma. v. Doll (Fed. Cir. 2009)

For several decades, Hal Wegner has been the shepherd of Takeda’s family of Cepham patents claiming priority back to 1974. The question on appeal in this case involves double patenting and whether post-filing developments in the art can be used to inform the question of whether two claims are “patentably distinct.” Takeda’s evidence that its claims were distinct was generated in this decade, but the PTO argued that double patenting must be determined based on evidence pre-dating the priority application. Takeda could file a terminal disclaimer, but that would destroy the valuable pre-GATT patent term.

Obviousness Type Double Patenting is also known as non-statutory double patenting because … the theory is not based on any statute. Rather the doctrine is a judicially created mechanism designed to prevent a patentee from unfairly extending the term of patent rights through consecutive patents. To the extent this problem existed, much of it was eliminated in the 1995 changes that linked the patent term with the filing date rather than the issue date. Under the doctrine, separate claims with different patent terms will not both be patentable unless their subject matter is “patentably distinct.” Today the double patenting issues may arise most frequently when family-member patent terms differ due to patent term adjustments based on PTO delay during prosecution.

Product and Process: Takeda’s case involves a change in claim form. The PTO argued that the company’s latter manufacturing process claims are not patentably distinct from its earlier product claims. Generally, a product and its manufacturing process are deemed patentably distinct when “the product as claimed can be made by another materially different process.” MPEP § 806.05. Here, the “materially different process” was not known until well-after the applications were filed.

Holding: In its holding, the Federal Circuit compromised: Evidence of distinctiveness can be post-filing, but must be prior to the filing of the secondary application because that filing “actually triggers the potential of an unjustified extension of patent term.”   The case is then remanded for a determination of whether Takeda can prove distinctiveness using evidence that predates the second application (which was filed in 1990).

Judge Schall concurred in the judgment of remand, but disagreed with the rule of law that post-filing information should be available to prove distinctiveness. “I believe that tying the inquiry to the invention date is most commensurate with patent law as a whole and the policy goals relating to obviousness-type double patenting.” Judge Schall noted that the double patenting doctrine is one of patentability – and thus should be judged based on the date of invention.

Comments: I do not pretend to know the correct rule. However, Judge Rader’s decision looks to be incorrect. His judgment was based on the filing date of the second application as being the triggering date for the potential of an unjustified extension of patent term. Of course, the potential having double patenting problems was at least implicitly created in the original filing. If you are looking for an explicit trigger, that might not even be found in the second application as filed since claims are usually amended during prosecution. If selecting a triggering date – I would have chosen the date that the second patent issues. Until that point, there is no double patenting.

Note:

  • Judge Moore joined Judge Rader’s majority opinion.

11 thoughts on “Double Patenting: Proving Distinctiveness Based on Later Developed Evidence

  1. 11

    Federally Circuitous,

    It is my understanding that prosecution laches is a rather “sparingly” used equitable doctrine, reserved for “egregious cases of misuse of the statutory patent system.” Symbol v. Lemelson (Fed. Cir. 2005).

    Although potentially “unfair,” as you put it, do you really think that this case falls within the Fed. Cir.’s intended category of “unreasonable and unexplained” delay in prosecuting the application? Those examples include delaying cases for decades by filing continuations….

  2. 10

    The claimed process isn’t obvious in view of the earlier CLAIMS on the product, and for OTDP the criterion is obviousness in view of the earlier claims, not the earlier disclosure. The claims on the process should have been smacked down b/c the claimed process was disclosed 15 years earlier, in the original application, and it’s not fair to get an effective extension of term (so far this sounds like OTDP, but…) -> can anyone say prosecution laches? THAT would have been a good reason. Same policy issue as OTDP, but using OTDP jurisprudence rather than prosecution laches to reject the process claims is putting a square peg in a round hole.

  3. 8

    “Generally, a product and its manufacturing process are deemed patentably distinct when “the product as claimed can be made by another materially different process.” MPEP § 806.05. Here, the “materially different process” was not known until well-after the applications were filed.”

    This admission would seem to pave the way for someone to use any process outside the US (including the claimed process) and import it without worries.

  4. 7

    I like this holding. Well said “Rader got it right,” and MM right on. 35 years is unreasonably long, compared to 17-20.

  5. 6

    Eurodisnae, if I understand the American definition of the state of the art, it includes all those unpublished US patent applications of “another”, but excludes your own earlier unpublished US filings (see above). The part of it which I find illogical is the formulation of obviousness attacks based on sensitive private confidential stuff (unpublished US pat applns) which could not possibly have informed the PHOSITA. The mystery to me is why proposals for patent reform don’t ever change the definition of the prior art into something coherent, that makes sense. Changing to FtF, without changing 102 to fit FtF, strikes me as a train wreck waiting to happen.

  6. 5

    From reading the case, including Judge Schall’s concurrence/dissent, I agree that Judge Rader’s view is more in step with the purpose behind the obviousness-type double patenting doctrine. Allowing “distinctiveness” to reflect what has happened up to the filing date of the later application is also more in line with the “filing date” language of 35 USC 103, from which obviousness-type double patenting doctrine gets at least some of its roots.

  7. 4

    “Takeda’s family of Cepham patents claiming priority back to 1974”

    That’s 35 years ago.

  8. 2

    “Product and Process: Takeda’s case involves a change in claim form. The PTO argued that the company’s latter manufacturing process claims are not patentably distinct from its earlier product claims. Generally, a product and its manufacturing process are deemed patentably distinct when “the product as claimed can be made by another materially different process.” MPEP § 806.05. Here, the “materially different process” was not known until well-after the applications were filed.”

    OK, I ain’t from around here and I don’t know the patents, but taking that at face value: if the original application claimed the product and described one process for making the product (which it would have to do for enablement, unless the process was inherently obvious) and no other process was known at the time then how could a claim to the described process justifiably be entitled to a longer term than the product claims?

  9. 1

    I think the majority’s rule meshes well with the public policy goals of the double-patenting doctrine. If there was only one possible process for making the composition, then a patent on that method would, for many purposes, be a patent on the composition (and the lifetime of the composition patent protection would be effectively extended to the expiration of the method patent). However, once other materially-different processes for creating the composition were known, a patent on the first-known process does not effectively extend the lifetime of the composition.

    In view of the above, the terminal disclaimer should cease to operate whenever the materially different process became known, regardless of the either patent’s filing date.

    I can sympathize with tying the date to the latest patent’s filing though – this encourages innovative entities to invent and disclose several materially different ways of making their compositions very quickly and makes the disclaimed term much more certain and easy to calculate.

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