Paxil Patent Case: New Mandate

SmithKline Beecham v. Apotex (Fed. Cir. 2006, 04–1522o).

In February 2006, the CAFC affirmed a lower court’s invalidation of Apotex’s Paxil patent — finding that its product-by-process claims were invalid because they attempted to recapture the end-product from the public domain. According to that decision, “once a product is fully disclosed in the art, future claims to that same product are precluded, even if that product is claimed as made by a new process.”

On petition, the CAFC has now refused to rehear the case.  However, the court indicated that a new “mandate of the court will issue on June 29, 2006.”

Judge Newman dissented from the rehearing decision.  She argued that this case should be used to clarify the difference between products that could only be described by the way they are made (Scripps) and products whose production require use of a certain process (Atlantic Thermoplatics). 

This decision holds that a product-by-process claim that, for instance, claims “product X made by performing steps A, B, and C,” will be invalid if product X is known in the art — regardless of whether the known X was made through those steps.  This makes the claimed steps (A, B, and C) meaningless or, in Judge Newman’s words, “expands on the existing confusion by suggesting that the specific language of the claims is not relevant to anticipation.”

Paxil Cases: There are at least two Paxil patent cases that are ongoing. In 2005, the CAFC ruled that the patent covering the drug compound was inherently anticipated. The Supreme Court recently declined to hear that case on appeal.

Comments

[Blaise Mouttet]

The difficulty some Examiners have with obviousness is nothing compared to the difficulty in examining product-by-process claims. It is almost impossible to reject such claims without weak inherency arguments (or access to a laboratory which is infeasible for examination purposes). It is also common practice for many attorneys to stick product-by-process claims in dependent claims where they are ignored or given little serious examination by the Examiner. I really never understood why such claims were ever permitted by the patent laws and rules. If an inventor (or the inventor's attorney) can't figure out a way to claim a product in terms of structure of functionality than the inventor probably didn't invent a new product and doesn't deserve patent rights to a product.

An example of how product-by-process claims will lead to serious legal problems down the line can be found by looking at an emerging art area called reconfigurable electronics. Basically these devices are offshoots of field programmable gate arrays among other electronic architectures that can change their structure to perform different functions under different conditions (for example a signal filter could change to a pulse generator or a multiplexer circuit could change to an adder circuit). Theoretically one could draft an independent claim for the process of reconfiguring such an electronic device and a dependent claim for an electronic circuit generated by such reconfiguration. Potentially the dependent claim could represent numerous different possible circuits of the prior art and possibly even useful circuits that have not even been contemplated yet by the inventors. I can't see how a Patent Examiner (or anyone else) could possibly determine the scope of such dependent claims.

[Rick Barnes]

product by process claims can be extremely useful, in that they broaden patent protection in a way that can be more clearly defined by the specification as a whole, without a multiplicity of apparatus claims or words in a single apparatus claim.

basically, the claim reads only on products that are "physically" distinguishable from prior art products because of the process by which they are formed. famously, if a sheet of glass formed by a patentable process is distinguishable from other sheets of glass formed by other processes, then the product is patentable.

the nice thing about product by process claim is that you don't need to state in the claim the exact physical aspects of the product that make it discernable from the prior art products. this provides wide latitude later on to identify the aspects of the product that make it discernable from the prior art product.

[David J. French]

David French writes:

In 1919 the UK Patent Act was amended to stipulate that chemically produced products and food and pharmaceutical compositions could only be claimed in a process-dependant form:

38A—(1) In the case of inventions relating to substances prepared or produced by chemical processes or intended for food or medicine, the specification shall not include claims for the substance itself, except when prepared or produced by special methods or processes of manufacture described and claimed or by their obvious chemical equivalents.

This was done to weaken chemical and pharmaceutical patents which German inventors had been very successful in obtaining in the period leading up through the First World War. Canada adopted similar provisions over the period 1936 - 1989.

Accordingly, it cannot be intrinsically impractical to define patent claims for compositions in terms of the process by which such compositions are made.

[Malcom Mooney]

Blaise wrote

"I really never understood why such claims were ever permitted by the patent laws and rules. If an inventor (or the inventor's attorney) can't figure out a way to claim a product in terms of structure of functionality than the inventor probably didn't invent a new product and doesn't deserve patent rights to a product."

I strongly agree that product-by-process claims are the devil. You want a method claim? Write a method claim. You want a composition claim? Write a composition claim.

The idea that a composition could be distinguished and rendered non-obvious in view of a prior art composition simply by reciting a PAST EVENT is absurd.

The devious lawyers who foisted this mess on us should be congratulated, then ...

[Malcom Mooney]

Rick writes

"the nice thing about product by process claim is that you don't need to state in the claim the exact physical aspects of the product that make it discernable from the prior art products."

Why is that a "nice thing"? What happened to the quid pro quo?

"this provides wide latitude later on to identify the aspects of the product that make it discernable from the prior art product."

When is "later on"? During litigation?

What happened to the quid pro quo?

[Dennis Crouch]

Malcom -- I don't know about being "the devil," but 35 USC 271(g) already provides for implicit product-by-process protection:

"Whoever without authority imports . . . or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer."

[Eric Ede]

This decision appears to shift US practice into line with European Patent Office practice c.f. T219/83, and particularly T 664/90, where the board stated that "once the product itself is part of the state of the art and is thus not novel according to the criterion of novelty as set out in Art. 54(1) EPC, the fact of defining this product by reference to a new process is irrelevant to the question of novelty." Also UK practice is now aligned with EPO practice c.f. Kirin-Amgen Inc. and others v Hoechst Marion Roussel Ltd and others [2004] UKHL 46 (House of Lords)

[Dr.Deepthi]

Dear Dennis

I have been following up the case on paxil. I don't remember having read an article in the blog about supreme court's denial in inherent anticipation case of Paxil, however the denial by the solicitor general was published. I would like to know if the denial by supreme court is confirmed? and the issue of inherent anticipation is further confirmed?

Thanks in advance

Regards
Deepthi