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May 19, 2009

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Comments

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.

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.

"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.

Dear Keep:

Premarin.

Thanks for the comment.

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!


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.

What happens if one party does not perform all the process steps? Does it avoid infringement under Paymentech/Muniauction?

"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.

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.

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.

Kevin: 1
Keep it Real: 0.

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).

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.

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

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.

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