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« Conference & CLE Calendar | Main | Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021) »

November 28, 2021


Kevin, you mention EPO opposition practice. I find it interesting to compare the US WD requirement with the EPC's "no new matter" test. You report the view of the Fed Ct that "cases vary" because they are fact-intensive. Just so. But that has not prevented the EPO from deriving what is now called its "Gold Standard" as its test for WD, namely whether the post-filing amendment is free from anything that was not already "directly and unambiguously derivable" by the PHOSITA from the originally filed disclosure. The cases, thousands of them by now, flesh out what "derivable" means. The notional addressee, being skilled in the art, is quite good at deriving technical meaning from an application as filed. Perhaps that is why the European patent family member survived all "added matter" attacks advanced in opposition proceedings at the EPO

In the interests of legal certainty, and levels of confidence in writing FTO opinions, I wonder how the Fed Ct is coming along in the development of its own WD Gold Standard? I mean, now that the USA is a First to File jurisdiction, WD is going to play an ever more crucial role in determination of the validity of patents.

Should we be puzzled that MaxDrei remans ever in the dark when it comes to the US Sovereign's no new matter rule?

I get that he takes every opportunity to shill for the EPO system, but that just does not excuse his lack of grasp (for SEVERAL YEARS now) that "no new matter" means exactly that.

As to what is "directly and unambiguously derivable," this too has been commented upon in that those drafting for the US Sovereign know well (or should know well) how the judicious use of what has been termed 'boilerplate' not only keeps the door open for claiming the full depth of the disclosure (which is still provided at the time of filing), but also inoculates against how the patent office will cobble together prior art (including secret prior art).

He mentions "in the interests of legal certainty" but then conflates that certainty with attempts to insert the EPO for the US Sovereign's choices. I get that he has much difficulty in understanding a viewpoint other than his own, and that operating so (for decades) likely means that he just won't "get it" no matter how many times he is led to the well of wisdom.

What to do with such willful and stubborn ignorance?

Well, this is where an application of John Maynard Keynes can at least provide a little enjoyment.

“I wonder how the Fed Ct is coming along in the development of its own WD Gold Standard?… [N]ow that the USA is a First to File jurisdiction, WD is going to play an ever more crucial role… .”

As if in answer to your question, Max, the CAFC handed down Biogen v. Mylan, which moves the §112(a) WD requirement a material step in the direction of the EPO’s “directly and unambiguously derivable” standard.

More on Biogen v Mylan tonight (which of course Max didn’t have when he posted).

But I think the issue in Indivior was a little different: the claim wasn’t supported by the spec so it’s (to me) more a question of possession than new matter (although they are two sides of the same coin). Judge Linn’s dissent argues that the disputed claim scope would have been understood by the skilled artisan, while the majority seem to think the skilled worker shouldn’t have to guess what the scope is. While it’s good for Europe to have come up with a formula to use in making these determinations that just shifts the question to whether the formula fits the facts of a particular case. The benefits may be more illusory than they appear - sounds like a good law review topic to try to derive a “rule” under US law. Thanks for the comment, all

Totally off-topic, Dr N, but I am very much enjoying your work on LinkedIn of late.

Kevin, thanks. You observe that new matter and WD are two sides of the same coin. I prefer to think of i) WD, ii) new matter, iii) entitlement to priority and iv) novelty destruction as four sides of the same First to File patent law cube.

I mean, the EPO's legal test "directly and unambiguously derivable" applies with equal rigor and relevance to all four faces of that cube. It is simply a test to determine what teaching the PHOSITA will derive from any given document (whether it be the application as filed, the priority document, or D1 the alleged novelty-destroyer). It is a prerequisite of each legal situation to fix what each document teaches. You can't duck out of such a determination. If you have to do it, best I would say is to do it the same way, each time you have to do it.

As you write, each case requires the court to map the peculiar facts onto the standard legal test. We can't do anything to simplify the facts, but we can do a lot to simplify the legal test. As the poster "skeptical" would remind us, given half a chance, that test should be as simple as possible but not so simple that it over-simplifies the determination.

You muse that the benefits of the EPO Gold Standard "may" be "illusory". I wonder, what is the source of your doubts about the efficacy and effectiveness and fitness for purpose of the EPO's astonishingly simple catch-all test. Is it that, under it, your clients are being deprived of justice from the EPO? If so, do tell.

Thanks also to Greg, who perhaps also might like to add a comment. For example, if we imagine the EPO test mapped on to the Indivior facts, would Judge Linn have determined that the skilled reader would have derived the teaching in question whereas the other two judges would not.

Just think: If the advocates in Indivior had instead been directing their efforts to the EPO Gold Standard test question, would then the three judges have perhaps found it easier to agree with each other on whether the test was or was not satisfied. I mean, the easier and clearer and more ubiquitous the test to be applied to any given and unique matrix of fact, the easier it becomes for the advocates to speak to it and for the judges to adjudicate it. Is that not so?

Thanks, Greg. What surprises me most about that site is that I would expect people would know that prospective employers would look at it when vetting them for a job. It isn't the sometimes bizarre ideas and beliefs they espouse that surprises me; it is the off-the-rails vitriol and plain nuttiness about what they spout. I wouldn't hire them.

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