By Jason Rantanen
Boston Scientific Corp. v. Johnson & Johnson (Fed. Cir. 2011) Download 10-1230
Judges: Bryson, Gajarsa (concurring-in-part), Moore (author)
The line between written description and enablement analyses is often unclear; Boston Scientific makes it even blurrier, at least in the eyes of one Federal Circuit judge.
The patents involved in this appeal relate to drug-eluting coronary stents using a particular chemical compound. One set of patents ("the 1997 patents") claims stents using either rapamycin or a macrocyclic lactone analog of rapamycin, while the other patent-in-suit, the '662 patent, claims stents using either rapamycin or a macrocyclic triene analog of rapamycin. In both cases, the the analog limitations were added well after the patents' priority date. For purposes of the appeal, both analogs were broadly defined to be any molecule with structural similarity to rapamycin.
The district court granted summary judgment of invalidity of the 1997 patents based on a lack of enablement and lack of adequate written description, and granted summary judgment of the '662 patent based on lack of adequate written description. The patent holders appealed.
Species-Genus Analysis
On appeal, the majority applied the "species-genus" framework to hold the patents invalid for lack of adequate written description. Under that approach, "a sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Slip Op. at 17, quoting Ariad, 598 F.3d at 1350. Here, the 1997 patents contained no examples of macrocyclic lactone analogs of rapamycin and gave no essentially guidance as to how to determine whether a compound falls into that category. Similarly, the '662 patent, although disclosing the broad genus of "analogs" of rapamycin, failed to disclose the sub-genus of "macrocyclic triene analogs" of rapamycin.
Lack of Examples is Telling
In reaching its conclusion, te majority paid particular heed to the lack of any examples of the claimed genera. "Although examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described." Slip Op. at 18.
Use of POSITA Knowledge to Fill In the Blanks
Although acknowledging that in some cases it may be appropriate to look to the knowledge of one of skill in the art when performing a written description analysis, the majority imposed a substantial limit on this approach. "Because the specification is viewed from the perspective of one of skill, in some circumstances, a patentee may rely on information that is "well-known in the art" for purposes of meeting the written description requirement….However, when the four corners of the specification directly contradict information that the patentee alleges is "well-known" to a person of skill at the effective filing date, no reasonable jury could conclude that the patentee possessed the invention." Slip Op. at 22-23. In this instance, the majority concluded that "specification of the 1997 patents itself refutes any conclusion that the structural elements and its mechanism of action and biological activity was known….Thus, there is insufficient correlation between the function and structure of rapamycin and its analogs to provide adequate written description support for the entire genus of macrcyclic lactone analogs of rapamycin." Slip Op. at 23 (internal citation omitted).
Judge Gajarsa: Stop Using Written Description When Enablement Will Do
Concurring in the judgment of invalidity and with the majority's ruling on the '662 patent, Judge Gajarsa wrote separately to express the view that "[t]he enablement requirement of 35 U.S.C. § 112 ¶ 1 is the appropriate tool for invalidating claims that are broader than their disclosure." The result is a blurring of the line between enablement and written description:
The majority’s opinion further extends the written description requirement into the realm of enablement. Much of the confusion in this case is due to the difficulty of determining what constitutes a genus or a subgenus, the relationship between the structure and the function of compounds, and how the written description requirement applies to novel compounds as opposed to novel combinations of known elements. These are legal inquiries predicated on disputed issues of material fact. Applying the enablement requirement would help to clear the thicket of jurisprudence regarding § 112 ¶ 1. As discussed briefly below, in this case, the enablement analysis is simpler and more appropriate.
If you could have claimed it but didn’t, the DOE can help you.
But if what you claim to be an equivalent was unclaimable in the first place?
Well, I agree with you there, 6.
You walk, They ride,
you pay for the Tux.
And when you get there
they waddle the Ducks.
The splash of Handwriting,
it sinks in the pool.
Like all the Ducks feces,
you play by their rules.
If only you knew,
that’s what they meant.
With your’s being there,
They still went with Kent.
You had you a Letter,
go forward it claims.
But nothing ever happens,
your playing their Game.
If Kent did exist,
it wasn’t with Poly
coming down from the cold,
It’s again trying to volley.
But when you have step one,
keeping you from Tennessee.
the action in Mass.,
is a fata complete.
A link in the Chain,
that forcing a crash.
The game of intent,
is awareness to none other than Ash.
where both WD and enablement might have been an issue. I don’t agree that we should limit ourselves to enablement when it would do. Written desc should always be brought up when there is no indication that the applicant possessed the invention at time of filing. (Indeed, it should be a tool to quash DOE nonsense).
Lulz, you wish.
You’re even dummer than that examiner Alun Palmer got reversed.
Lulz, you wish.
Gajarsa is being an ass here.
Gajarsa Says: Because undue experimentation was required to practice the 1997 patents, the district court’s grant of summary judgment of invalidity should have been affirmed on enablement grounds.
IMTN Says: Fine.
Gajarsa Says: The enablement requirement of 35 U.S.C. § 112 ¶ 1 is the appropriate tool for invalidating claims that are broader than their disclosure.
IMTN Says: Wrong
You just confirmed that you have no clue.
The divided line between written description and enablement started to really blur in Enzo Biochem v. Gen-Probe. This case continues that blurring problem. In fact, this case also raises an issue under 35 USC 112, second paragraph, for “indefiniteness” as what constitutes “macrocyclic lactone analogs of rapamycin” isn’t defined by the patents in suit.
As a patent professional I can maybe appreciate the arguments being made here. But as a chemist, looking at the big honking ring structure of rapamycin, there aren’t that many logical places to put a lactone functional group in the thing. 2, maybe 3?
I just read an article in Litigation 2011 about Arnold & Porter litigator Matthew Wolf arguing for Boston Scientific in one case and for Hologic in another case on the same day at Federal Circuit.
Appears he won both. Well done.
Lulz, it provides them a windfall, that’s what.
I’m sorry you spent a great deal of time looking into it. You clearly wasted your time. You haven’t a clue as to what the DOE provides patentees.
Run along now.
Oh I’m quite aware of what the “big people tools” are here and how to use it and how the courts apply it. Indeed I spent a great deal of time looking into it. And it makes me sick. What a joke the DOE is. It practically takes every patent concept (WD etc) that is normally applicable and then says F U to them and then magically goes its own way. All in the name of providing a hand out to 100% undeserving inventors who couldn’t be bothered to draft their claims broadly enough along with their originally filed spec.
If you don’t have WD support for the proposed thing which you claim is an “equivalent” to a limitation in your claim(s) then why in the heck should we believe you possessed it? And if we don’t believe you possessed it, then why should we believe that you invented it at the time you filed? And if you didn’t invent it, why would we allow you to assert your claims that are not literally infringed to encompass that which you did not invent?
Bottom line, if you couldn’t have gotten a claim to it at the time you filed due to WD issues, DOE shouldn’t magically make up the difference. But it does, apparently, in many cases, because: magic. In fact, as I understand it, it is practically a condition that you couldn’t have foreseen the “equivalent” to x limitation in your claim in order to be able to assert the DOE because if you could have foreseen it then it was your failure not to draft properly. Arse backwards if I ever heard something arse backwards.
This is what happens when you let children play with big-people tools.
“(Indeed, it should be a tool to quash DOE nonsense).”
What?
Meh, sounds like an instance where both WD and enablement might have been an issue. I don’t agree that we should limit ourselves to enablement when it would do. Written desc should always be brought up when there is no indication that the applicant possessed the invention at time of filing. (Indeed, it should be a tool to quash DOE nonsense).
first.
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