Recent Federal Circuit Nonobviousness Opinions: Alcon v. Apotex

By Jason Rantanen

I'm catching up with recent Federal Circuit opinions this week.  First up, a trio of precedential opinions involving nonobviousness, a surprisingly hot topic.

Alcon Research, Ltd. v. Apotex Inc. (Fed. Cir. 2012).  Panel: Prost, Moore (author), O'Malley Download 11-1455

Apotex submitted an Abbreviated New Drug Application to the FDA seeking approval to market a generic version of the anti-allergy eye drop PATANOL; in response, Alcon sued Apotex for patent infringement under 271(e)(2)(A).  In a bench trial, the district court held that eight of the asserted claims of the patent were nonobvious, and Apotex appealed.

The Federal Circuit reversed on six of the claims.  Focusing on the primary issue, whether there was a motivation to adapt the formulation disclosed in the prior art (which was tested in guinea pigs) for use in in treating humans, the CAFC concluded that the district court had applied an overly strict reason to modify requirement to the six claims involving a range that overlapped with the prior art.   Given the district court's factual finding that "animal tests, including guinea pig models, are predictive of a compound's antihistaminic activity and its topical ocular activity in humans," the "district court clearly erred when it concluded that a person of skill in the art would not have been motivated to use the olopatadine concentration disclosed in Kamei in human eyes."  Slip Op. at 12.  It did not help Alcon's argument that its patent was based only on in vitro tests of the compound in human cells. 

The CAFC reached a different conclusion on two claims that did not cover a range of the active compound that overlapped with the prior art, finding no clear error in the district court's conclusion that "a person of ordinary skill in the art would not have a reasonable expectation of success for increasing the highest dosage used in [the prior art] by an order of magnitude."  Slip Op. at 17. 

While the CAFC considered the objective evidence, it played a relatively secondary role.  On the six claims that the panel concluded were obvious, despite agreeing with the district court that the objective considerations fell in Alcon's favor, the CAFC nevertheless concluded that after balancing the objective evidence against the strong case of obviousness presented by Apotex the claims were obvious.  No explanation of why this was so was offered.  Similarly, on the two claims in which there was no reasonable expectation of success, the court commented that the objective evidence "further supports" the nonobvious holding, citing particularly evidence of commercial success.

Comment:  The opinion avoids labeling the first part of the analysis as a "prima facie" case of obviousness, perhaps in response to recent concerns about the confusing use of that term in infringement suits.  See In Re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063 (Fed. Cir. 2012)The court refers to it only as the "evidence of obviousness discussed above" when contrasting it with the objective indicia of nonobviousness.  But this is somewhat cumbersome, and sparks the question of how should we refer to this stage of the obviousness analysis if not as the "prima facie case of obviousness?"  Possible suggestions, all of which have their problems: the first three Graham factors; the 'paper case' of obviousness; the 'theoretical' case of obviousness. Other suggestions? 


11 thoughts on “Recent Federal Circuit Nonobviousness Opinions: Alcon v. Apotex

  1. 11

    I guess if thet got away with tearing up one check, they tore up the other and switched Inventors. I wonder if claiming a Continuance has anything to do with the loss of entiltlement also?

  2. 10

    So when the Check for 5,560,312 was torn up when paying Issue Fees Itallics was there. So if 5,832,857 also was in Itallics, was it because the Fees weren’t paid for me either. and he filed it himself as his Idea?

  3. 9

    So now I know that itallics means ” loss of entitlement!” Why would I lose my Entitlement? Who is responsible for that?

  4. 7

    Good point SA. I was thinking that an EPO “use” claim can succeed even where US-allowable claims would fail. The EPO prosecution was in August 2001. At first glance, the US court had the advantage of better art. Clearly, I need to look into these matters more deeply. Soon as I get the chance. Meanwhile, perhaps you would care to look?

  5. 6

    The tenor of your post seems to have changed upon reading of what transpired in the EP, Max. Pray for tell why…?

  6. 4

    There is a EP equivalent EP0799044. I’ll leave it to you Max to decide if it has a juicy broad use claim.

  7. 3

    “But was there any hint of this surprising result in the app as filed? I rather think not? Does this matter?”

    Iirc evidence of unexpected results can be presented after the fact. We generally allow it at the office, I presume it is so in the courts.

    Although yes, it is a case of the invention having only been possessed after the app was filed with regards to other claims. They tried significant claim drafting chicanery which Moore (iirc) caught them on. And the only reason that was engaged in is blatantly because they didn’t really possess what was therapeutically effective at time of filing. Indeed, substantial portions of the scope of the first few deps (and thus the ind) was admittedly not enabled because it did not work. Of course the patentee argues that if it doesn’t work then it isn’t covered… /facepalm.

    This case presents an intersection of people patenting before they possess, overclaiming into that which is not enabled and does not work, and use of functional/intended use language that probably ought not be allowed in the first place all rolled up into one big ol 103.

  8. 2

    Is this another case of an invention having been made only after the pat appln was filed? Look, the parties agreed at trial that a concentration of 0.1% works, but anything less doesn’t. Because this performance jump, on moving from lower concentrations up to 0.1%, was not obvious, claim 4 was found not invalid.

    But was there any hint of this surprising result in the app as filed? I rather think not? Does this matter?

    In Magsil, claiming too broadly was fatal to the patent, even though the Magsil patent disclosed a good invention. Here, the patentee gets his exclusive rights, even though the non-obvious step was entirely absent from the app as filed. Doesn’t seem right somehow.

    I wonder whether Alcon got a juicy broad “use” claim at the EPO. Anybody know?

  9. 1

    “No explanation of why this was so was offered. ”

    On the contrary: “the strong case of obviousness ”

    It was a strong case of obviousness. When weighing, you’re going to need a lot of objective evidence o secondaries to tip dem scales in the non-obviousness direction from rest if there is a strong case of obviousness on the other side.

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