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« Follow-on Biologics News Briefs - No. 10 | Main | Senator Leahy: "Time Is Now" for Patent Reform »

December 01, 2009

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"Enablement, the amicus argues, "serves a different and distinct purpose" -- providing a disclosure that would permit the worker of ordinary skill to practice the invention."

Kevin,

What I find interesting, as well as puzzling, is why the parties, as well as the amici, keep saying that the requirements of 35 USC 112, first paragraph, should be judged against one of "ordinary skill in the art." By contrast, the language of 35 USC 112, first paragraph, says these requirements are to be judged against "any person skilled in the art to which it pertains." Why this disconnect?

Comment for Ariad Post

Kevin,

I’ve discovered where the “disconnect” comes from: it’s the Federal Circuit and it’s not always consistent treatment of the “level of skill” when it comes to 35 USC § 112, first paragraph. I’ve traced this at least as far back as the 1989 case of In re Gosteli ("the description must clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.") By comparison, the 1991 case of Vas-Cath, Inc. v. Mahurkar makes no mention of “ordinary skill” ("the applicant must . . . convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.") Ironically, both of these statements come side-by-side in the 1996 case of In re Alton.

Interestingly, In re Alton (opinion by Schall, with Michel and Friedman on the panel) specifically says that the “written description” requirement is ”distinct from the enablement and best mode requirements.” Also, despite 35 USC § 112, first paragraph, saying “any person skilled in the art,” the Federal Circuit has also judged “enablement” against an “ordinary skill in the art” standard. See 2007 case of Automotive Technologies v. BMW of North America (“That general description, however, fails to provide a structure or description of how a person having ordinary skill in the art would make or use an electronic side impact sensor.”).

That still leaves two unanswered questions: (1) what does “any person skilled in the art to which it pertains” really mean?; and (2) does it apply to the “written description” requirement or only the “enablement” requirement?

Dear EG:

Thanks for sleuthing this out. I think the court has read "ordinary" into the phrase, because it seems a reasonable qualifier. It is in section 103, and has "bled into" section 112. I would guess the standard should be the same for written description and enablement, but in one case it denotes the capacity to understand the technical language and in the other (combined with the artisan's skill from the prior art) the capacity to practice the invention.

Thanks for the comment.

"Put the invention in the hands of the public at the end of the patent term as part of the quid pro quo bargain for exclusive rights"

Does the publication requirement violate the quid pro quo bargain? How does the pendency time effect this bargain? In my opinion this is a clear break of the social contract and has hurt innovation in the US. See http://hallingblog.com/2009/05/18/intellectual-property-socialism-part-iii-patent-legislation-supreme-court-rulling-since-2000/

To me the distinction between the enablement requirement and the written description requirment is part of the trend of increase formalism in patents. This is not good for innovation and makes patents a byzantine system that does not serve inventors or society.

Dear Dale:

I suppose the "provisional rights" that attach after publication upon actual notice to an infringer are meant to uphold the quid pro quo (but how well, I don't know - I don't think there has been a case).

You could make the argument that publication is just a more thorough form of "Patent pending," with the advantage that the public knows exactly what is "pending."

I agree that patents, as they have become more important to more industries have also come under more scrutiny, and that the scope of claims has been narrowed. This trend may be formalistic, but it is also a product of the maturity of the two late-20th century technologies - computers and biotech - that have most inventions being less pioneering and more niche-filling. The effects on innovation, or more importantly protecting the commercial embodiments of innovation, are increasingly greater than they were 20 years ago But I think that may not be avoidable.

Thanks for the comment.

EG,

I posted the following at Gene's blog, but it may not make it past the filter, so I'll post it here as well:


"My answer to the first question is an emphatic 'yes', unless you want to overrule the 1996 case of In re Alton which clearly says that the 'written description' requirement is 'distinct from the enablement and best mode requirements.' "

Some food for thought: In re Alton should be overruled.

isn't that precisely what the Ariad brief indicates to do? Isn't the premise of the Ariad brief that the courts have grafted a "possession" requirement where the plain language of the statute does not actually have one?

If instead of an emphatic "yes", one indulges the view of the Ariad brief, then does the question posed here, being "a conundrum more perplexing than the two questions now before the en banc Federal Circuit in the Ariad case" even exist? If the now infamous comma is allowed to serve its plain language gramatical function, the imposed insufficiently self-standing clause would not need to find its own standard.

In fact, the question posed here actually reinforces the view that the courts have indeed grafted a requirement not contemplated by the legislature into 112 paragraph 1.

I have mentioned on the Trainwreck blog that I recognize that there is more than one path to law, and that this appears to be a case where the paths do not align. The Judicial law making and the Legislative law making are different. My actual comment was:


The legislative Law harkens to Ariad's case. However, Lilly has made a substantial argument that judicial Law has trumped legislative Law. The intent of the separate written description is admirable, but it is an incorrect reading of the pure word of Law.

The purist in me is torn, as I recognize both that Law is made legislatively as well as made judicially, and this appears to be a battle of ascendency - which Law is more "right". At this point I lean ever so slightly to Ariad based on the ultra-thin construction of the first question to the court, and I am reminded of a wise man's view when faced with alleged ambiguity in the letter of the Law - ask yourself, what does the letter of the Law actually say.

The court is faced with the choice of acting in a deterministic fashion or an interpretive fashion. Lilly and its amici artfully conflate the two, asking the court to interpret past judicial determinism (and staying away from the source).

I do suspect that the Federal Circuit will not have the last word on this, and fear that in part, their decision will be put together like the abomination of Bilski, not in a ruling that can stand on its own; but rather, as a tee for the Supremes to take a whack.

http://www.patentlyo.com/patent/2009/11/patently-o-bits-and-bytes-2.html

Kevin and EG,

My response has been salvaged from the filter at IPWatchdog and is now posted there.

Noise above Law,

As you know, I got your response, and definitely thanks for taking the time to think through and respond. That's more than I can say for what MM and 6 usually say.

Well, EG, Malcolm and 6 are hardly the standard (I hope).

Noise, I don't think we know the legislative intent surrounding the written description requirement, since I don't think the drafters thought about that comma one little bit, and if they did I don't know how to discern whether what they thought is what Ariad thinks the comma means. The comma issue is one of inferring intent, and with all the hoopla about patent "reform" I don't remember anyone proposing a legislative "fix" to the problem. Ariad isn't the first patentee to believe that there is a decided anti-patent slant to the law with regard to technologies like biotech, and the written description requirement is one aspect of the Federal Circuit's jurisprudence that is cited in support of that proposition. And, as I recall, the academic commentators have also raised the issue.

Part of the reason that no amici have supported Ariad (even if they oppose a separate written description requirement) is the zeitgeist, that patents are bad and need to be limited. But part of the ascension of the written description requirement in biotech is the fact that enablement outstrips disclosure in some contexts (as in Lilly). Wishing (and Judge Linn) doesn't make it so - enablement is not sufficient to prevent an applicant from claiming a nucleic acid she does not possess. We could make the policy decision that this outcome is acceptable, but we haven't (and I don't think most would).

Add to this the fact that Rochester and Ariad have taken fundamental biological processes and crafted claims that have ensnared conventional drugs (developed at least in part without any cognizance of the underlying, patented process) and there is an equitable tug towards preventing what looks like overreaching.

So here we are.

Thanks for the comments

Kevin and EG,

While I appreciate the historical perspective, I have difficulty actually dismissing the letter of the law so quickly.

To me, the letter of the law is the opposite of the inferring intent that Kevin alludes to directly above. The letter of the law is the strength of the Ariad position and Lilly's position much more heavily relies on inference (and judicial determinism) than on actual legislative law (popular or not).

As I have posted at Patently-O and reiterated above, the legislative Law harkens to Ariad's case, while Lilly has made a substantial argument that judicial Law has trumped legislative Law.

IMHO, deterministic judicial law making should not override the direct letter of the law, when that letter is not clearly ambiguous (as opposed to the very strained non-plain English language renditions offered by Lilly Amici). The law WAS written as it was written. There is not a need to search for inference (unless you need to search for an inference to peg the "possession" requirement. Had Congress wanted to have such a requirement, the choice for clarity was there.

Noise, there are none more strict about the "letter of the law" than myself.

The thing requires a written description. Unquestionably. And an "enabling disclosure" standard as the courts have created for enablement is simply not the same. No amount of wishing, or even justices on the Fed circuit is ever going to make it so.

Let's be honest, you'd have to get around smart people to make it so, and the 9 will never be swayed to your side. Chief Justice Roberts (pictured below) will see to it.

http://en.wikipedia.org/wiki/File:Darktower.jpg

sorry

http://en.wikipedia.org/wiki/John_G._Roberts

EG and Kevin,

As I respect your viewpoints and believe that you are interested in an earnest exchange of ideas, I would like your opinions on another areas of fallout from the non-straight-letter-of-the-law reading of 112 paragraph 1 that Ned Heller and I were discussing at http://www.patentlyo.com/patent/2009/11/patently-o-bits-and-bytes-2.html#comments


First, my invitation:

Ned,
I would like your impression on two related items.

The first is the right of an applicant to request a Reissue within two years of a patent grant in order to capture material that the applicant had a right to claim but had not (broadening re-issue). Do you have any problems with this perfectly legal mechanism in light of the written description discussion?

Second, you seem to point out an issue that the amici have with continuations that capture late claims to subject matter disclosed and enabled. Interestingly, the office often allows such continuations under the legal test in such cases (and remember that such continuations must be initiated while the parent is still active in order to obtain the critical date) that there must not be new matter introduced. Such continuations are routinely deemed NOT to have new matter introduced, yet introduce new claims (new descriptions), and are routinely allowed by the Office (all other requirements being met), under the presumption of Law.

It appears that these are two instances of current routine legal operations where the Lily amici arguments seem to utterly fail.

Posted by: Noise above Law | Nov 25, 2009 at 09:41 AM


And after a view tradeoffs, Ned’s answer:

Noise, upon further consideration, I will concede the point about continuations and reissues to this degree: the RULES do provide that one can claim previously disclosed and unclaimed subject matter provided one files a oath as provided by 1.67(b).
"A supplemental oath or declaration meeting the requirements of § 1.63 must be filed when a claim is presented for matter originally shown or described but not substantially embraced in the statement of invention or claims originally presented."
I will further grant that Section 111(a)(4) can be construed to permit the filing of a continuation before the abandonment of the parent and obtain the benefit of the filing date of the parent in a case where no oath whatsoever has ever been filed.

Ergo, the Rules seem to provide for the filing of an oath in a continuation for previously disclosed and unclaimed subject matter in a parent.

Therefore, you seem to be right that if this is permitted, there should be no objection to late claiming subject matter disclosed, unclaimed and not fairly embraced in the statement of the invention in the specification as filed.
But you should be aware that Section 112, p.1 long predated 111(a)(4), so if there is a separate written description requirement in Section 112, p.1, the Fed. Cir. should harmonize its holding with what appears to be a conflict in the statutory scheme created by Section 111(a)(3) and (4).

Good discussion.

Posted by: Ned Heller | Nov 25, 2009 at 06:14 PM

"Noise, there are none more strict about the "letter of the law" than myself."

LOLOLOLOLOL.

no, wait...

LOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOLOL.

ah, 6. You are without a doubt the WORST offender of the letter of the Law that posts on the various legal blogs and is not a blatent anti-patent freak. You are famoose that way (and that's not a good thing).

Now run along and let the grown-ups have their discussion.

...else 6 we may have to move the discussion over to Gene's IPWatchdog, where you are the only person EVER to be banned for patent stupidity.

Dear Noise:

I have often felt that the anguish voiced by the IT community and the academics they support (like Professor Lemley) about the problem of patentees "late claiming" to encompass inventions they didn't invent runs afoul of just the points you make (see our post on the Google amicus brief). However, I don't think there is a disconnect between Lilly's position and either broadening reissues or continuations. They are both predicated on there being a written description in the specification as filed.

Interestingly, both are instances where Sec. 132 requires a written description (as opposed to new matter) and I don't think anyone argues about the requirement in the context of Sec. 132. Nor is there controversy about examining amended claims for new matter, as in species claiming after generic disclosure and claims to specific subsets of broadly-disclosed ranges. In all these cases, requiring express disclosure is accepted as a way to prevent just the kind of "late claiming" problems the IT community believes are plaguing them.

But application of the same requirement to originally-filed claims raises the 112 issue, as in Ariad. I think some of this is historical, because when you are claiming a plow merely reciting the original claims may be enough to convince the skilled worker that the applicant is in possession of the claimed invention. Not so much with DNA, for example, and not so much for the inventions claimed in the Rochester and Ariad cases. Patent law is replete with instances where the law is applied to prevent an early filing date and later identification of the "true nature" of the invention - a problem more problematical formerly when the patentee could enjoy 17 years of exclusivity from the date the patent was granted. Today, the 20-year term provides a natural brake on the tendency to file before the invention is truly appreciated.

In addition, the provisional rights provisions for published applications can be viewed as a way to reward the applicant who has at least one published claim that recites an invention that a copier will exploit. But since I know of no case involving damages for such rights, their importance is undetermined.

Thanks for the comment, and the invitation.

Noise I think I'll just keep laughing while Kev tells you the same thing I told you.

"You are without a doubt the WORST offender of the letter of the Law"

Hahahahaahhahaha, wait wait, you mean except for the LEGIONS of lawyers that insisted for years that TSM was to be applied rigidly when the statute couldn't be more clear that nothing was further from the truth? Or perhaps the "paradigm" claiming lawyer? Or maybe the lawyers that can't read the words "written description of the invention"?

Or maybe you mean except for the attorney that thinks that some evidence (read reference) must already be on the record to reopen prosecution after an appeal?

HAHAHAHAHAHAHAHHAHAHAHAHAHH

Or wait wait wait, maybe you mean that lawyer that doesn't really believe 151 when it says "appears"?

Surely, you must have meant to include some of those people as exceptions in your insane maligning of me. Or perhaps you give them a free pass on account of them being disqualified since they blatantly don't know how to read.

6,

You love bringing your own rope.

Requirements of all business transactions in the Office to be in writing and the reopening issue - by the way, my friend won his case, so you and the examiner in question were DEAD WRONG.

151 - reading the entire sentence (don't forget "under the law") - how many times do you want me to put you in your place?

How about them claim continuation rules...?

Let's not forget Alappat - what was that that your Lord Kappos said about that?

Even the 112 paragraph one homework you never finished and my trouncing you with the very tools you brought to the table - forgot that haven't you?


6, do you have ANY examples of your reading the letter of the law correctly?

ANY?

"by the way, my friend won his case, so you and the examiner in question were DEAD WRONG."

You know the deal, serial or it didn't happen. Screenshot in a pinch.

"How about them claim continuation rules...?"

You mean the ones that were not affected by the statutes in dispute because the panel read the laws EXACTLY HOW I INTERPRETED THEM? Oh you mean those? Oh THOSE! I remember those!

"Let's not forget Alappat - what was that that your Lord Kappos said about that?"

Just another misguided lawyer that apparently hasn't troubled himself to read the case. And probably doesn't understand the beatdown that the Supremes would give to any sort of nonsensical holding. In fact, I'd wager that had the argument been correctly made in Alappat then the Fed Circ would not have spoken in such confusing terms for you people who have trouble reading.

"6, do you have ANY examples of your reading the letter of the law correctly?"

Currently on deck we have me "correctly" reading 112 and you (and many others) "incorrectly" reading it. Of course, you're too much of a pansy to put your money were your mouth is, even though you make a sht ton and probably don't have any kids or major expenses. I asked for odds on this case, go ahead, give me some, and give me a max amount you'll bet against.

Actually, if just money doesn't spark your interest, I'll go one better. I'd put 100$ against you making me a sandwich and hand delivering it, with a big-double sided board proclaiming that you were wrong about 112. What do you say? We can make the double-sided board optional, but it seems to me like it would be entertaining.

See you at the Fed Circ monday if you come. I'll keep an eye out for you.

6,

It looks like my response has been caught in the filter, so I'll try again to address your inadequacies (like you haven't heard that before).

WHen one falls back to the Malcolm-like - "I need numbered proof or it never happened" you know the argument well has run dry. As noted in that thread, it's not my case and I am not at liberty to share the identifying details.

Regarding Continuation rules, you are relying on a vacated panel decision which was about to be overturned en banc while I am relying on the Actual Law (and this is about the Law, remember? Or does the Cacharis ruling escape you?) If you want to bet, let's bet on this one m'K?

112 being on deck doesn't count 6 - besides, I have shown that you were wrong in YOUR interpretation, as well as my being correct in the English language structural argument (you know, the Letter of the Law). You only reach the Lilly version through a tortured rendition.

I also expounded - several times now - that the "proper way" of dealing with this, or at least the way for Lilly to win was to distinguish between Legislative Law and Judicial Law. You never recognized this and chimed in only AFTER I pointed this out. You clung to your partially (and incorrectly) completed homework, wherein you were schooled with your own tools not once but twice (Sentence diagramming AND wikipedia). So if Lily does win - it will not be that I am wrong in the pure reading of 112 paragraph 1, it will be that the Law, as augmented by Judicial review, is more than the letter as written.

I have not given odds in numbers, but read again my postings - it's nearly a dead heat in my mind right now with Ariad taking the direct legislative reading (as I have pointed out) and Lilly taking the Judicial Law side.

Regarding Alappat - that's your defense? When the world all steps in one direction, but 6 steps in another, the world must be wrong? C'mon 6, you gotta do better than that.

So once again (and this time please answer with a legitmate point that you have already demonstrated - or just admit that you don't have one):

6, do you have ANY examples of your reading the letter of the law correctly?

ANY?

"As noted in that thread, it's not my case and I am not at liberty to share the identifying details."

Uh huh, riiiight. I can accept perhaps that you might need to delay when you can make the disclosure, but I assume that at some point you should be able to cite to what I presume is a public document. Well, whenever the case issues (or whatever must happen), which I presume that it must soon since supposedly the office was preempt from reopening prosecution to reject, then you go ahead and drop me some random numbers in my email.

Or perhaps the office was preempt from reopening prosecution at all and the case will subsequently never be allowed to issue?

Hahahaha.

If it isn't a public document that you will at some point be able to disclose, you'll have to forgive my disbelief. I simply find it too coincidental that the case that supposedly shows your position being validated is a secret.

"you are relying on a vacated panel decision"

I'm not relying on anything for anything. I'm telling you something that you would do well to not ignore.

"112 being on deck doesn't count 6"

Oh, right, I know, I know, all the examples that blatantly show you to be wrong "don't count". Riiiiight. Of course. Why didn't I know that from the beginning?

"I have shown that you were wrong in YOUR interpretation,"

In your own mind.

We'll see about whether or not MY interpretation was "wrong" according to the Fed Circ here in a little while.

So, about the bet.

100$ v your making me a sandwich and hand delivering said sandwhich.

I'm ignoring the rest of your nonsense, I'm bored of the same ol' same ol'. What I'm interested in is the proposed bet. Put up or shut up.

"I have not given odds in numbers, but read again my postings - it's nearly a dead heat in my mind right now with Ariad taking the direct legislative reading (as I have pointed out) and Lilly taking the Judicial Law side."

K, so 50/50 = 5$ vs your making a sandwich?

"So if Lily does win - it will not be that I am wrong in the pure reading of 112 paragraph 1, it will be that the Law, as augmented by Judicial review, is more than the letter as written. "

I'll ignore your statements where you state that your position is that if the statute is construed as you believe it should be then the court's hands will be bound to hold for you. But I can cite you for you if it'll make you happy and more inclined to agree to the above wager.

"you are relying on a vacated panel decision"

I'm not relying on anything for anything. I'm telling you something that you would do well to not ignore.

And which part of the law that is the Cacharis ruling are you refering to 6?

I'll answer your "I'm ignoring the rest of your nonsense" with your own quote: "Oh, right, I know, I know, all the examples that blatantly show you to be wrong "don't count". Riiiiight. Of course. Why didn't I know that from the beginning?"

Excpet that you misuse the quote in that I did go on and explain that you were wrong inthe part that you proferred, and only took my direction at why Lilly might win the ruling. Gosh, ya kinda overlooked that, dintcha? (to the tune of "so tell me, what DO you Do here?)

I am still waiting for you to give ANY examples of your reading the letter of the law correctly.

ANY.

"I am still waiting for you to give ANY examples of your reading the letter of the law correctly.

ANY."

If I give you one then is the wager on? What specifically shall be our terms?

If...

No. This is almost like your previous wager offer wherein I provided you with something that it was your job to know already.

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