By Kevin E. Noonan --
In an otherwise unremarkable decision affirming the district court's claim construction and summary judgment of noninfringement in Abbott Laboratories v. Sandoz, Inc., the Court of Appeals for the Federal Circuit took the opportunity to reconcile a long-standing conflict in its precedent. Deciding this portion en banc, the court expressly overruled its earlier panel decision in Scripps Clinic & Research Foundation v. Genentech, Inc. in favor or the contrary panel decision in Atlantic Thermoplastics Co. v. Faytex Corp.; the decision affirms the Atlantic Thermoplastics view that a product by process claim is infringed only if the accused infringer practices the process steps recited in the claim, not merely produces the product by any method.
In an opinion by Judge Rader, joined by Judges Michel, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore (and over a dissent by Judge Newman joined by Judges Mayer and Lourie, and a separate dissent by Judge Lourie; Judge Schall not participating in the en banc opinion), the Federal Circuit reviewed the history of the split between the separate panels in the Scripps Clinic and Atlantic Thermoplastics cases. This portion of the opinion, Section III.A.2, was taken up en banc sua sponte but was prompted by plaintiff Abbott's argument that the District Court erred in construing claims 2-5 of U.S. Patent No. 4,935,507 as product by process claims. The claims at issue recite:
3. Crystalline substance of claim 2, wherein a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) is an aqueous solution of an alkali metal salt of said compound.
4. Crystalline substance of claim 3, wherein the acidifying of the solution is carried out at the temperature from room temperature to 40°C. at the pH from 1 to 4.
5. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by dissolving 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem-4-carboxylic acid (syn isomer) in an alcohol, continuing to stir the solution slowly under warming, then cooling the solution to room temperature and allowing the solution to stand.
Abbott joined the issue directly, arguing that the District Court erred in construing the "process" claims as requiring performance of the process steps in the claims to constitute infringement according to Atlantic Thermoplastics rather than under the more inclusive Scripps Clinic test.
Judge Rader's majority opinion cites "extensive support" for its decision in prior Supreme Court precedent, including:
The Federal Circuit opined that in these cases, the Supreme Court had consistently held that process terms used to define a product in product by process claims constitute "enforceable limitations" in construing the claims; these canons of construing product-by-product claims were supported by numerous cases decided by the CCPA. The majority also turned to appellate opinions by different courts of appeal (including the 1st Circuit (Hide-Ite Leather v. Fiber Prods., 226 F. 34, 36 (1st Cir. 1915) ("It is also a well-recognized rule that, although a product has definite characteristics by which it may be identified apart from the process, still, if in a claim for the product it is not so described, but is set forth in the terms of the process, nothing can be held to infringe the claim which is not made by the process" and the 3rd Circuit (Paeco, Inc. v. Applied Moldings, Inc., 562 F.2d 870, 876 (3d Cir. 1977) ("A patent granted on a product claim describing one process grants no monopoly as to identical products manufactured by a different process.")). Some of this precedent had to do with ensuring that the accused product was actually the claimed product, so that the Supreme Court held that "unless it is shown that the process of [the patent claim] was followed to produce the defendant's article, or unless it is shown that that article could not be produced by any other process, the defendant's article cannot be identified as the product of the process of [the patent claim]." Cochrane v. Badische Anilin & Soda Fabrik, Id. at 296. The majority opinion also cited Warner-Jenkinson Co. v. Hilton Davis Chemical Co. for the proposition that "each element contained in a patent claim is deemed material in defining the scope of the patented invention." "To the extent that Scripps Clinic is inconsistent with this rule, this court hereby expressly overrules Scripps Clinic":
Judge Newman's dissent (perhaps predictably, since she wrote the Scripps Clinic decision) accuses the majority of "overturn[ing] a century of precedent and practice" in making its decision. She reviews the history of product by process practice and precedent, as well as providing her own assessment (as she did in her In re Bilski dissent) of the cases cited by the en banc majority. She dissents on both substantive and procedural grounds, noting that "[t]he court has given no notice of this impending en banc action," which she asserts is contrary to the Federal Rules of Appellate Procedure as well as the Federal Circuit's own procedural rules. Her lengthy dissent focused on the en banc Court's abrogation of the (heretofore) "inviolate rule that patent claims should be construed the same way for validity and infringement" and on how the panel decision misapplied the en banc Court's product by process claim decision.
Judge Lourie, on the other hand, was succinct, making essentially three arguments. First, he noted that the Supreme Court cases cited by the majority in support of its decision in some instances "applied overly broad language to fact situations involving old products or used vague language that makes it difficult to determine whether the products were old or new." Second, he cautioned that "[t]here is arguably a different situation that should apply to chemical-biological products today than to mechanical products of more than a century ago," saying that Supreme Court precedent does not foreclose treating product by process claims as product claims regardless of how the product was obtained. Finally, he raised perhaps the most important issue (in light of recent Supreme Court disapproval of the many Federal Circuit "bright line" tests), reminding the CAFC that "there may be differing results depending upon the exact wording of a claim at issue" and that "[b]right lines have their uses, but judging should take account of differing circumstances."
Panel: Circuit Judges Rader, Plager, and Bryson
Chief Judge Michel and Circuit Judges Rader, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore joined Section II.A.2 of opinion; dissenting opinion by Circuit Judge Newman, joined by Circuit Judges Mayer and Lourie; dissenting opinion by Circuit Judge Lourie
Nice post, Kevin. Your point at the end is an excellent one. I agree that this opinion seems to fly in the face of recent Supreme Court cases which have tended to go away from bright line tests. Judge Newman did a good job of showing the variety of fact situations that may exist when construing product-by-process claims, and how they should have different outcomes. A bright line test like this one doesn't seem to make sense.
Although, as Jackie Hutter points out in a comment (here: http://bit.ly/ba41z), the situation with biotech and chemical cases may have changed enough to obviate the need for product-by-process claims.
Posted by: Brian Galvin | May 19, 2009 at 12:00 PM
Brian, the text on your site is too small for these old eyes to read, and the site is constructed in a manner that my browser can't enlarge that text. Unless the desire is to be read by only those too junior to suffer presbyopia, please consider fixing this aspect of your site. Thanks.
Posted by: yahoo | May 19, 2009 at 04:27 PM
"Judge Newman did a good job of showing the variety of fact situations that may exist when construing product-by-process claims"
Please provide one example of a composition that can not be described by reference to its structure or other objective properties which would enable an infringer to determine whether its product is identical to the claimed product, but which nevertheless meets all the other requirements for patentability.
Somehow Judge Newman forgot to do this. So did you.
I think I know why.
Posted by: Keep It Real | May 19, 2009 at 05:43 PM
Dear Keep:
Premarin.
Thanks for the comment.
Posted by: Kevin E. Noonan | May 19, 2009 at 10:12 PM
And yet in spite of Premarin being incapble of description, Wyeth managed to present an argument to the FDA that a competing generic version manufactured synthetically was structurally "different" and lacked an important component present in Premarin.
Amazing!
Posted by: Keep It Real | May 19, 2009 at 11:56 PM
Dear Keep:
As the CAFC has noted, the PTO isn't the FDA - different standards, statutes, regulations and policy considerations.
You have a point - product-by-process claiming is perhaps less necessary today than it was a century ago, in view of improvements in analytical chemistry. But 35 USC 112, 2d. para. doesn't dictate how an applicant claims her invention, and the PBP format, like Jepson claims, Markush groups and other arcane patent forms, isn't per se illegitimate.
Indeed, besides reconciling the conflicting precedent the court recognized the equity in requiring a patentee who relies on the PBP form to accept the consequences of a narrow claim. Like "means plus function" claiming (expressly recited in the statute), a PBP claim is one that looks broad but turns out to be narrow, in keeping with any vagueness in claiming that might otherwise be used to the patentee's benefit and the public's detriment.
Thanks for the comment.
Posted by: Kevin E. Noonan | May 20, 2009 at 05:44 AM
What happens if one party does not perform all the process steps? Does it avoid infringement under Paymentech/Muniauction?
Posted by: SK | May 20, 2009 at 07:34 AM
"You have a point - product-by-process claiming is perhaps less necessary today than it was a century ago, in view of improvements in analytical chemistry."
That's not my point. Product-by-process claiming was *never* "necessary." There are no **patentable** compositions that are "impossible" to describe by objective properties and there never were. Statements in the case law to the contrary are simply wrong.
Posted by: Keep It Real | May 20, 2009 at 12:45 PM
Dear Keep:
Wrong. Sorry, but just wrong. There were objectively novel distillates of complex biological mixtures that were beyond the capacity of the analytical chemistry at the time to identify. It's tough to remember days without cell phones, iPods, faxes, etc. but those days existed. At in those times PBP claims were in fact necessary.
I'll do some research to support my statements but I don't have time now.
Thanks for the comment.
Posted by: Kevin E. Noonan | May 20, 2009 at 07:56 PM
Kevin: "There were objectively novel distillates of complex biological mixtures that were beyond the capacity of the analytical chemistry at the time to identify"
How can a composition be objectively novel if it can't be described?
"It's tough to remember days without cell phones, iPods, faxes, etc. but those days existed"
Methods for analyzing and describing compositions predate our patent laws by many years.
I respectfully submit to you that the frequent assertion that product-by-process claims were ever *necessary* is simply false. Convenient for applicants? Yes. Necessary? No. Completely at odds with all other requirements in the patent code until very recently? Undeniably, as the majority makes quite clear in this welcome, long overdue decision.
Posted by: Keep It Real | May 20, 2009 at 11:03 PM
Kevin: 1
Keep it Real: 0.
Posted by: Pacific Reporter | May 21, 2009 at 10:48 AM
So the way to get points here is to say "I don't have time to respond"? That's interesting.
I refer again to my May 19 5:43 post.
Perhaps "Pacific Reporter" would like to present an example of a composition that was legally invented (meeting all the statutory requirements for patentability) ahd yet "cannot be described."
And then, just like the Federal Circuit, I'd like to know how the patentee determines that my composition (which also can't be described) is the composition that was allegedly invented. Assume for the sake of discussion that I practice the process in the pbp claim plus ten additional steps that aren't recited (note: the process would still fall within the scope of the claim if it were claimed as a method). Also assume that nobody except me knows how I make my product.
On what factual grounds could you possibly accuse me of selling the same product that you claimed?
Don't feel bad. Judge Newman couldn't figure it out either. Either could the majority. But of the two, only the latter knew how to fix the problem (and there's more work to be done).
Posted by: Keep It Real | May 21, 2009 at 11:48 AM
Dear Keep:
I promised you that I'll look into it, and I will.
And if I'm wrong, or can't find a good example, I'll say so.
Thanks for the comment.
Posted by: Kevin E. Noonan | May 21, 2009 at 12:32 PM
Kevin: "There were objectively novel distillates of complex biological mixtures that were beyond the capacity of the analytical chemistry at the time to identify"
Keep: How can a composition be objectively novel if it can't be described?
Keep - you seem to be shifting the goal posts somewhat. Let me first note that the words "identify" and "describe" generally have different meanings, and this is particularly true in chemistry.
One can describe a complex mixture in many ways, and yet not "identify" it (as a chemist understands the word). One can for instance note that the mixture, unlike all prior art mixtures, displays certain properties, making it objectively novel in the patent sense, without ever identifying any of its constituent components.
This is of course entirely routine for chemical compositions. Go into any lab with organic chemistry doctoral students working in it, and look at a mixture one of them is loading onto a chromatography column. There'll be all sorts of species in the mixture. If they are working on mixed reactants that polymerize they mixture will be impossible to "identify" other than as a "mixture of X, Y, Z, and a bunch of other stuff", the other stuff essentially being uncharacterizable and forgotten about, left sitting there at the top of the column after X, Y and Z have come out the other end.
Now I'm aware you also said "'impossible' to describe by objective properties" further above, and this is somewhat different from just structure. But in such cases, the objective description you are referring to may take pages and pages (one reason why theses can balloon so much). Patent offices are loath to entertain such descriptions. Why should they, when much shorter ones describing the production process instead can be used?
When I think of some of the things I produced in my PhD days any description of them in terms of physical properties would be horrific (and of course, there were never "identifiable" in any way, structurally). Which is of course why they were never "described" anywhere.
But you see, the real problem with describing such mixtures by their "properties" is that the properties themselves are *products-by-process*. If I want to describe a polymeric mixture in terms of its average molecular weight, as one almost always would want to, the result depends on whether I am talking about its vicosity-average molecular weight for instance, or one of a host of other molecular-weight estimating numbers/techniques.
The value you get from measuring a "property" depends on how you measure it - a process. Thus any non-identity (structural) property would be suspect.
Cheers, Luke
Posted by: Luke Ueda-Sarson | May 22, 2009 at 03:03 AM
Luke: "Patent offices are loath to entertain such descriptions. Why should they, when much shorter ones describing the production process instead can be used?"
This may be least compelling argument for prodcut-by-process claims I've ever seen. Why should they? Because product-by-process claims don't describe "a composition". They describe a process.
"But you see, the real problem with describing such mixtures by their "properties" is that the properties themselves are *products-by-process*."
Now you're not even trying. This is an issue of fairness in patent law and maintaining the quid pro quo. You are presenting a bogus metaphysical argument.
"The value you get from measuring a "property" depends on how you measure it - a process. Thus any non-identity (structural) property would be suspect."
Not if it is made clear to one skilled in the art how the property is measured. That is what is meant by objective criteria.
Posted by: Keep It Real | May 25, 2009 at 12:52 PM