Ortho-McNeil Pharm. v. Caraco Pharm. (Fed. Cir. 2006).
Ortho’s patent covers a pain-relief combo of tramadol and acetaminophen with a ratio of “about 1:5.” Caraco’s drug has a ratio of 1:8.67. The lower court construed the claims and found no infringement.
Claim Construction: On appeal, the Federal Circuit construed the term “about 1:5” by first looking at the intrinsic evidence. In the patent and claims, Ortho had used the term “about” repeatedly: disclosed ratios included about 1:1, about 1:5, about 1:19 to about 1:5, and about 1:1600.
The court reasoned that the term must have a narrow meaning in this patent because a broad meaning would leave other claimed ratios meaningless. The court also noted that the literal meaning of the term should be narrowly construed because Ortho “could have easily claimed a [broader] range of ratios”
An expert testified that the statistical range should be 1:3.6 to 1:7.1 based on a confidence interval constructed from the data in the patent, and the Federal Circuit agreed. (The patent discussed the importance of 95% CI).
Literal Infringement: The Federal Circuit found that there could be no literal infringement because the upper claimed bound for the ratio was 1:7.1 while Caraco’s ratio was 1:8.67.
Doctrine of Equivalents: No DOE because Ortho cancelled claims with broader range during reissue. Interestingly, the Court made this ruling based on vitiation rather than prosecution history estoppel:
[I]t cancelled the broader “comprising” claims, except for claim 6. In sum, having so distinctly claimed the “about 1:5” ratio, Ortho cannot now argue that the parameter is broad enough to encompass, through the doctrine of equivalents, ratios outside of the confidence intervals expressly identified in the patent. We agree with the district court that to do so would eviscerate the limitation.
Summary judgment of noninfringement affirmed
Congratulations on your page, it is really interesting
Whatever happened to Honeywell v. Hamilton Sundstrand, 370 F.3d 1131, 71 USPQ2d 1065 (Fed. Cir. 2004) (en banc)? Ortho’s reissue claim 6 has been “amended,” within the meaning of the Honeywell opinion. It has been placed in independent form and the (broader) claims on which it formerly depended have been cancelled. That leads (according to the Honeywell court) to a Festo-type presumption of surrender of all equivalents between the broader, cancelled claim and the new independent claim. Thus it would seem (at least to me) that the reissued claim has no equivalents of any consequence. When Honeywell came out I thought it was the coup-de-grace for DOE claims. But no court ever seems to cite it.
‘Having lived with both sides of the “about” problem (writing both many applications and infringement opinions), I would hate to see “about” go.’
So use of “about” results in Mr. A writing infringement opinions on patents drafted by Mr. B, and Mr. B writing infringement opinions on patents drafted by Mr. A.
Seems like win-win for lawyers and lose-lose for patent holders, prudent designers, and the general public.
Am I missing something here?
Ditto on every one of Luke’s points. In fact, I might copy the comment and save it for reposting when those same complaints of unfairness are inevitably floated again in a thread on this blog later in the week.
Bob wrote:
“The most logical and fairest definition I can recall seeing for “about” leads to a finding of infringement (subject to limits imposed by the prior art, patent disclosure and prosecution history) for those values differing from the claim’s numerical value or range that give the same function and mode of operation as values corresponding to the numerical value or range. Sounds a little like DOE without the foreseeability issue, doesn’t it?”
More than a little, which is why “about” is simply not needed. “About something” is either equivalent to it, or not. No need to enquire further, really.
And later…
“We could do away with “about” in the U.S., but each time we knock out a degree of freedom in claiming, we make it harder for the “little guy” with a great idea but not much research money and for the “big guy” who must file quickly for some reason. “First-to-file” makes the situation even more difficult”.
If a “little guy”, or indeed a “big guy” hasn’t got the time or money to do the experiments to properly define their invention, then you should be asking yourself if in fact they have an “invention”, as the word is understood in the patent world. Quite likely not – they’ve got a research plan, which is not the same thig at all. Further, I fail to see why a “little guy” is disdavantaged in this case – corporate rearchers have to work to deadlines and budgetary constraints too, as you yourself note.|Quite the contrary in fact, small-timers usually have more freedom in setting theiur research priorities. I can’t count the number of replies to office actions I’ve seen that would have been water-tight, if only the company had the time/money/inclination to allow their researcher to spend another 8 hours doing some further experiments to get those few missing date points.
And while this is more of a “the patent system is broken” point, if time is truly tight, and you are racing another research effort, knowingly or not, that is a a good indication that the “invention” is not inventive, so I am not overly impressed with time-based arguments.
Regarding first-to-file, all patent systems encourage a race to the office whether first-to-file or not, but at least first-to-file is honest about it, and doesn’t allow people to send in their research plans first and do their experiments later, or at least, not to such a large degree anyway.
Regards, Luke
It might be instructive to see how Germany has managed its transition from “central” claiming to present day peripheral claiming. It’s bad luck for those who drafted their claims 18 years ago, in the days of central claiming (The claim as a “Keep Off the Grass” sign in the middle of the protected area) but now find themselves in litigation, after the rules of the game have changed, to one in which the claim is a boundary fence. Far as I know, the courts in Germany have adjusted pretty well, without anybody (even a little guy or a poor guy) needing any obfuscation from “abouts”. The challenge, of course, is to combine “fairness” with “legal certainty” exactly what Article 69 of the European Patent Convention imposes on judges as the over-riding objective of claim construction.
“We could do away with “about” in the U.S., but each time we knock out a degree of freedom in claiming, we make it harder for the “little guy” with a great idea but not much research money and for the “big guy” who must file quickly for some reason. “First-to-file” makes the situation even more difficult.”
Finish your thought. Harder to do what exactly?
Individual and small company inventors, and sometimes large company inventors, don’t always have time or budget to explore the absolute numerical boundaries for a given claim feature/constituent, and these boundaries can even change for a given constituent (especially in a chemical case) when the amounts of other constituents vary within their disclosed ranges and in their ratios relative to one another.
“About”, properly construed, provides some relief for this problem. Admittedly it also creates work and some uncertainty for others.
The most logical and fairest definition I can recall seeing for “about” leads to a finding of infringement (subject to limits imposed by the prior art, patent disclosure and prosecution history) for those values differing from the claim’s numerical value or range that give the same function and mode of operation as values corresponding to the numerical value or range. Sounds a little like DOE without the foreseeability issue, doesn’t it?
We could do away with “about” in the U.S., but each time we knock out a degree of freedom in claiming, we make it harder for the “little guy” with a great idea but not much research money and for the “big guy” who must file quickly for some reason. “First-to-file” makes the situation even more difficult.
Having lived with both sides of the “about” problem (writing both many applications and infringement opinions), I would hate to see “about” go.
I thought the Court’s observation that Ortho could have easily claimed a broader range, if this correctly indicates that the basis for doing so was present in the description, was a persuasive argument for non-infringement.
We see from the Alun Palmer contribution why USPTO Examiners suffer so much aggression from prosecuting attorneys: if you can get “about” past the USPTO, you get a win from it, post-issue. So, get on and bully those there Examiners.
In Europe, it’s different. Forcing something past the EPO Examiner avails you nothing, because the landscape into which your darling claims hatch out, at issue, is more hostile to validity than in ex Parte pre-issue examination. Think of those new-born turtles scurrying down the beach towards the ocean, and the skuas circling overhead, and then of the 9 month post-issue EPO opposition period. Best listen to the EPO Examining Division, and take to heart all they have to say. It just might get you to a claim that withstands validity attacks after issue.
Could we have here something yet deeper: the difference between the adversarial common law environment and the more inquisitorial civil law system of Europe and Asia?
“It could be argued that by including “about” in your claim, you are trying to claim your equivalents”
No doubt. To the extent such terms are permitted in the first place (and they shouldn’t be allowed as they are per se indefinite), the use of such equivocal terms should preclude use of the doctrine to capture even more scope.
Another blown chance for the CAFC to create certainty. Will the small inventor lobby protest the decision?
I am suprised that no one referenced the submission that was given to the FDA. This is an agency that hates the word “about” and always asks for specific criteria when submitting a drug for approval.
There’s a major difference between the USPTO and a court. The PTO may reject a vague claim as indefinite, but once the patent issues the courts will construe it as best as they can. It is nor their role to control claim language, but to interpret it. A court should only find a claim indefinite if they are unable to do that, and that is generally the course that they follow.
It could be argued that by including “about” in your claim, you are trying to claim your equivalents.
Anyone who drafts an application with just “about” a value, and no range of values, is asking for trouble and will likely end up with nothing at all in most countries, including the EPO. In desperation you could try “substantially equal to”, but that will be pretty narrow.
I don’t think the lack of direct court oversight of the EPO is of any relevance – the JPO has such oversight and is just as resolute in culling “about” from claims. It is a mystery to me why the USPTO allows the word in any claim: can anybody come up with a situation in which it is actually necessary?
Regards, Luke
What’s stopping the USPTO rejecting as unclear or indefinite claims that recite “about”? I thought that claims are there to define a clear boundary to the protected area, and that “about” is there precisely to frustrate that objective. The EPO throws out “about” claims, steadfastly, and attorneys have no means to resist. Maybe the EPO has an advantage over the USPTO, because no Court can tell it what to do.
Notably, this is the first precedential patent opinion by a district judge in the CAFC’s recent experiment with judges sitting by designation.
The problem of determining the literal scope of a composition claim where one of the terms is “about X” “approximately X” or another fuzzy expression of degree is a vexing one. It’s even worse when one must consider DOE. What’s an equivalent of “about 10”? Is it “about about 10”? It’s really anybody’s guess. The Supreme Court required this sort of element-by-element approach to DOE analysis in Warner-Jenkinson.
C.J. McKinney and the panel did a good job under the circumstances — for literal infringement, look at all of the evidence bearing on what “about” meant. For DOE, just say that extending “about” too broadly would vitiate the number entirely.
“Interestingly, the Court made this ruling based on vitiation rather than prosecution history estoppel”
Actually, that’s not clear from the passage you cited. What the court said was
“[I]t cancelled the broader “comprising” claims, except for claim 6. In sum, having so distinctly claimed the “about 1:5″ ratio, Ortho cannot now argue that the parameter is broad enough to encompass, through the doctrine of equivalents…”
It seems to me that the court might be bringing up the point about vitiation for no reason except to throw another log on the blazing fire.
I wish they wouldn’t do that.
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