Linking Pigs and Humans through the Enablement Doctrine

By Dennis Crouch

Edwards Lifesciences AG v. CoreValve, Inc. (Fed. Cir 2012)

In an opinion by Judge Newman, the Federal Circuit has sided with the patentee – rejecting the challenger’s argument that the patent lacked an enabling disclosure under 35 U.S.C. § 112(1). The claims (and accused infringer activity) are all seemingly focused on using the claimed cardiac valve prosthesis in a human. However, at the time of the patent application, the invention had only been tested in a pig and the human link in the specification was only the statement that “the cardiac valve prosthesis for use in human beings has a corresponding form.” (In its brief, CoreValue also notes that none of the pigs survived more than five hours.). See U.S. Patent No. 5,411,552. The real question was whether the conversion to a human prosthesis would require undue experimentation. If not, then the specification is sufficient.

The court writes:

CoreValve [the accused infringer] argues that in no event does testing in pigs enable use in humans. However, it has long been recognized that when experimentation on human subjects is inappropriate, as in the testing and development of drugs and medical devices, the enablement requirement may be met by animal tests or in vitro data. See MPEP §2164.02 (“An in vitro or in vivo animal model example in the specification, in effect, constitutes a ‘working example’ if that example ‘correlates’ with a disclosed or claimed method invention.”). This general rule has been elaborated in various situations, e.g., In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) (“one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans”); Scott v. Finney, 34 F.3d 1058, 1063 (Fed. Cir. 1994) (“Testing for the full safety and effectiveness of a prosthetic device is more properly left to the Food and Drug Administration. Title 35 does not demand that such human testing occur within the confines of Patent and Trademark Office proceedings.”).

Rather than following any bright-line rule requiring human testing, the court refocused attention on the so-called “Wands factors” of undue experimentation summarized by the court in the case of In re Wands, 858 F.2d 731 (Fed. Cir. 1988). These factors include:

  1. the quantity of experimentation necessary,
  2. the amount of direction or guidance presented,
  3. the presence or absence of working examples,
  4. the nature of the invention,
  5. the state of the prior art,
  6. the relative skill of those in the art,
  7. the predictability or unpredictability of the art, and
  8. the breadth of the claims.

In this vein, so to speak, the patentee had provided expert trial testimony as to how someone skilled in the art would be able to take the pig results and use them for a human version without undue experimentation. Based upon that testimony, the court was able to confirm that the jury conclusion was based on substantial evidence.

Validity judgment confirmed.

Construing Claims for Enablement: From a doctrinal standpoint, the question of whether a claim is sufficiently enabled should not depend upon the accused infringing activity. In practice that link is regularly found in the caselaw where courts focus the enablement question on activities related to the accused infringement. This case is no different. It turns out that the asserted claims are not expressly limited to a product for use with humans. Rather, the claims are directed toward “a valve prosthesis for implantation in a body channel.” Now, the specification does suggest that the problem being addressed deals with people and that suggestion cold potentially limit the claim scope. However, the court does not deal with the real reality that the claims are drafted in a way that would encompass use of the device in a variety of animals – many of them vastly different from a pig. In mind, this comes together to mean that we have a de facto special claim construction for enablement purposes that is used to understand the “full scope” of the claims.

Note:

  • The case has an important remedies discussion that will be included in a future post.
  • The parallel patent has been already litigated in both Germany and the UK with both cases resulting in non-infringement determinations. The key difference here is that the US courts have more broadly interpreted the claim term “cylindrical” to include shapes that are not really cylindrical. (The relevant portion of the accused device does not have a uniform diameter along its axis). That construction was confirmed on appeal since the specification does not explicitly require constant diameter.
  • In regards to the image accompanying this post, do you read from left-to-right or right-to-left?

17 thoughts on “Linking Pigs and Humans through the Enablement Doctrine

  1. MM I agree with your post. Based on this evidence, the specification did not disclose a useful apparatus. The issue of pig vs. man seems entirely a red herring.

    The longest any pig lived was five hours. The evidence showed that substantial invention still had to be made to actually produce a useful product, even for pigs.

    If one cannot build a useful device using the specification….

  2. The current view of “it depends on what panel you get” reinforces what you say to an almost unbelievable level (and on more than a few topics).

  3. A point in contrast with recent threads: is the Wands factor 8 applied to the application as a whole or is it applied individually per claim?

    Last time I checked, the question of enablement is addressed individually, per claim. This is why a broad claim can be found non-enabled but a narrower-dependent claim can be found enabled.

    In the US, one can certainly look at the teaching of the “application as a whole” when addressing a specific claim construction issues, e.g., whether the term “cylindrical” includes an object with a different radius at different points along its axis. But when used properly it’s just a fudge term for weighing various sections of a specification that arguably contradict each other.

  4. Sorry Leopold – I took the third paragraph of your post as your view, rather than the concurring opinion’s view.

    Mea culpa.

  5. I do not read the statement as the presumption that you do (and thus, the decision is in accord with the law).

    Huh? How do you know how I read “the statement”?

    Mind you, I have not yet read the decision, and my comments should only be taken at the general level of how your view fits into the law as I understand it.

    Huh? I didn’t say anything about “my view,” did I?

  6. I do not read the statement as the presumption that you do (and thus, the decision is in accord with the law). The other equitable considerations must be reviewed (how else does the court know that they are absent?)

    Mind you, I have not yet read the decision, and my comments should only be taken at the general level of how your view fits into the law as I understand it.

  7. A point in contrast with recent threads: is the Wands factor 8 applied to the application as a whole or is it applied individually per claim?

    The first sounds in the Canadian case. The second sounds in my understanding of US law and claims standing (or falling) on their own and not in relation to other claims or “the application as a whole.” Further, I do not see this as a Markush claim issue (so I leave that out of the discussion intentionally).

  8. Hey anon, you might be interested in the concurring opinion. In its entirety:

    I join this opinion in all respects except one—the majority’s discussion of the permanent injunction standard.
    The majority opines that “[a]bsent adverse equitable considerations, the winner of a judgment of validity and infringement may normally expect to regain the exclusivity that was lost with the infringement.” Majority Op. 16.
    To the extent that one reads this statement as creating the presumption of an injunction once the plaintiff prevails, which must be rebutted by the defendant, that is not the law.

  9. Dennis: In its brief, CoreValue also notes that none of the pigs survived more than five hours.

    Let’s see if I got this right. Edwards has claims directed to a valve prosthesis for use in “a body”, where the body is not limited to any type of animal. The valve was tested in pigs and the pigs with the valves lived for a whole 5 hours. Not 5 days. Five HOURS. The valve has no other known use.

    Judge Newman finds the claim “enabled” because … why? Because, in her view (apparently), without undue experimentation one skilled in the art could (1) make the valve that falls within the scope of the claims (2) including critical modifications that are not taught in the application and (3) use it to keep a non-pig alive for … how long again? And the evidence for this:

    Co-inventor Knudsen wrote, in a contemporaneous report, that “questions such as size reduction, material and design optimization, and stent valve sterilization, remain unsolved,” and that “much more work had to be done before anybody ever even contemplated using this for a human.” Edwards’ expert witness Dr. Buller testified that at the time the patent application was filed, it was “a device to perform testing on” and “not a device to move in and treat patients.”

    Somehow this gets waved off by reciting the magical CAFC case of In re Brana:

    In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995) (“one who has taught the public that a compound exhibits some desirable pharmaceutical property in a standard experimental animal has made a significant and useful contribution to the art, even though it may eventually appear that the compound is without value in the treatment in humans”)

    Was any “significant and useful” utility for the broadly claimed valve demonstrated at the time of filing? I suppose the extra five hours might give the pig farmer time to say goodbye to the pig in the event of some trauma.

    The patent is a classic example of a complete USPTO failure. With the help of some not-very-thoughtful attorneys, Judge Newman tried to make a silk purse out of a pig valve but instead she birthed another turkey. Happy Thanksgiving.

  10. I read it right-to-left too, but I assumed it showed the evolution of certain USPTO examiners…or most congressmen…

Comments are closed.