Archive for June, 2009

ABBOTT LABS. v. SANDOZ, INC. – ONE RULE FITS ALL?

Friday, June 5th, 2009

Or “what’s sauce for the goose is sauce for the gander”?

Posts and pens have been busy reporting that the Federal Circuit, en banc, overruled Scripps v. Genentech, and ended the debate over whether a product-by-process claims should be construed to be limited by its process steps for the purposes of determining infringement. Judge Newman weighed in with an eloquent 39 page dissent, defending the need for a “rule of necessity” for difficult-to-define inventions and pointedly pointing out that there now are difference legal standards for validity and infringement:

“According to the majority, a patentee can continue to obtain product claims using process descriptors, but such product claims are treated as process claims for infringement. The applicant would still have to demonstrate patentability of the new product as a product (independent of the process), while enforcement of the patent against an identical product would be limited to the infringer’s use of the process steps used as a descriptor. For the first time, claims are construed differently for validity and for infringement.”

But, what does Judge Newman mean by “For the first time”? Isn’t “patentability before, validity after”? While Judge Newman spends a page citing authority for the “inviolate rule” that patent claims are to be construed the same way for validity as for infringement, neither the majority nor the dissent seemed bothered by the fact that the PTO determines patentability of product-by-process claims without giving any weight to the process steps in the claims. As stated by the majority: [T]his court itself had articulated that rule; ‘For this reason, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.’ In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985)(emphasis added by the Abbott court). Later, the majority explained its position on claims for “products … difficult or impossible to describe”:

“[T]his court clarifies that the inventor is absolutely free to use process steps to define this product. The patent will issue subject to the ordinary requirements of patentability. The inventor will not be denied protection.” (Slip op. at 20)

Not so fast! For years, we practitioners have had to struggle with the fact that the Patent Office does not apply the “ordinary requirements of patentability” to product-by-process claims, if “ordinary requirements” includes giving weight to all claim elements or “limitations.” MPEP 2113 (8th ed. Rev.7) “Product-by-Process Claims” begins by stating that “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” In re Thorpe is the first authority cited. Here is some further language from the MPEP, without the citations:

“’The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in conventional fashion…. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art process.”

While the burden on applicants is clear, the burden on the examiners is couched in so many “qualifiers” that it is as light as a feather in comparison. The only rationale for this shift in the burden of persuasion is simply that, “[a]s a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.”

While no one would expect the overloaded Patent Office to run a testing laboratory, we can expect them to search the prior art for claim elements. My modest proposal is that product-by-process claims be examined in the same manner for patentability as they will later be evaluated when determining infringement. The Federal Circuit has now made it crystal clear that product-by-process claims are always a sub-genus of “pure” product claims; they are simply narrower in scope. It some ways they resemble “inventions of selection” or potentially patentable sub-genuses or species of generic Markush claims. They cover less than the scope of the original claim, but still cover compounds within the scope of the original claim.

I would revise MPEP 2113 to direct Examiners to search the art for the process steps in question and to state that a product-by-process claim on an old product is patentable if the process it is made by, as recited in the claims, is novel and unobvious in view of the prior art.

In her dissent, Judge Newman explains the need for a “rule of necessity” that would permit product-by-process claims of a scope equal to “pure” product claims in certain circumstances, and she mourns the demise of this rule. A future post will consider what, if anything, has been lost to inventors in the “complex sciences”.

Abbott Labs v. Sandoz, Inc.

Congratulations

Friday, June 5th, 2009

MERCEDES K. MYER, J.D., Ph.D., a partner at Drinker Biddle in DC was recently nominated (read “appointed”) to the Board of Directors of AIPLA. She was a the PTO Relations Subcommittee Chair when I was chair of the Biotechnology Committee and is currently vice-chair of the Biotechnology Committee. She will bring always-needed biotech patent law expertise to the Board. I congratulate Mercedes on this well-deserved recognition.