Monday, March 26, 2007

Pfizer loses Novasc case at CAFC

Pfizer had beaten Mylan over Norvasc and Pfizer had beaten Apotex over Norvasc, BUT the CAFC has determined claims covering Norvasc are obvious in the case Pfizer v. Apotex. The patent in question was US 4,879,303.

The active ingredient in Norvasc is amlodipine besylate. Amlodipine is a dihydropyridine, a heterocylic molecule with a ring of 5 carbons and one nitrogen. The besylate compound is formed by reaction of the basic amlodipine with benzene sulfonic acid. [Besylate is a synonym for benzene sulfonate. An insult to chemistry occurs in footnote 3 of the opinion, wherein hydrochloride is referred to as an "anion." The CAFC blames Pfizer.]

The CAFC details the prosecution history. Of relevance to patent reform, the patent in question arose as a continuation filed to dispute a final rejection.

At district court, an obviousness rejection had been made over the '909 patent and an article by Berge (which showed besylate anions were used at a frequency of 1 in 400 drugs). The district court found there was no predictable way to determine how an anion would influence drug properties AND that the besylate compound was UNEXPECTEDLY superior. [Footnote 4 of the opinion, dealing with how the district court dealt with Berge, cautions against oral bench rulings in a trial such as this.]

The CAFC criticized a number of aspects of the district court ruling. The district court had ruled there was a prima facie case of obviousness (which favored Apotex) because the examiner had found one DURING prosecution. The self-evident problem with that thinking is that the patent ISSUED. Thus, there is a presumption of validity. The CAFC cited Faulding, 230 F.3d 1320, although they could have cited a textbook.

The patent challenger must present a prima facie case of obviousness, and then the patentee must rebut.

The CAFC made an interesting point which produced Pfizer's demise. The CAFC admitted neither the claims nor the specification of the prior art '909 disclosed the besylate anion, but they didn't exclude it either. Thus, the broad genus claimed in the '909 encompassed the later species claimed in the '303.

Of interest to the coming decision in KSR v. Teleflex, the CAFC noted the district court failed to find "motivation to combine" but deemed this harmless error. Later, in the case, the CAFC cites DyStar, 464 F.3d at 1361. The CAFC got into the matter than Berge disclosed 53 pharmaceutically-acceptable anions. The CAFC emphasized that the anion used (the besylate part of the drug) had no therapeutic effect. The CAFC found there was clear motivation to combine.

The CAFC next moved to "reasonable expectation of success." Yes, the CAFC did cite In re O'Farrell, 853 F.2d 894. Curiously, statements made by Pfizer in the Dr. Reddy's case came back to haunt Pfizer in this case. (359 F.3d at 1366)

The CAFC had a separate section on "obvious to try." The CAFC included text from DyStar, 464 F.3d at 1367. The CAFC likened this case to an "optimization of range" case and cited In re Peterson, 315 F.3d 1325. Finding the besylate anion was deemed nothing more than routine experimentation strategy. The CAFC cited Merck, 874 F2d at 809.

The CAFC held there was a prima facie case of obviousness and moved on to secondary considerations.

2 Comments:

Blogger Moss said...

IMHO, this is a lousy decision. The CAFC lost sight of what "motivation" really is (or should be). It basically treats that which COULD be done (based on the teachings of prior art) as obvious. That is not the proper standard (unless the S/Ct tells us it is). There was no motivation in the art to tell Pfizer that it SHOULD be done the way that it ultimately was done.

Implicitly, the court calls two D/Ct judges "unreasonable factfinders" because at least two districts held that the patent is not obvious. (The CAFC uses the language "no reasonable factfinder...") It almost seems that the CAFC is punishing Pfizer because the CAFC felt that the D/Ct judge in this case didn't do a particularly thorough or tidy job.

I might also point out that there was nothing stopping Apotex from doing an NDA on the maleate version, for which they could already be on the market. So the commercial success argument, and a copying argument, should both be strong arguments of nonobvious. But the CAFC didn't even consider that.

Finally, it is ironic that Apotex gains either nothing or next-to-nothing from this decision (unless they are in bed with Mylan somehow). Mylan was the first-filer and should get the exclusivity period (if anyone does). And since this decision was released on March 22, the 180-day period moves up the free-for-all date only by a few days. Then Apotex gets to compete with any players who get approval.

9:20 AM  
Blogger Lawrence B. Ebert said...

Wegner in IPFrontline mentions the case:

Where a final decision is delayed in reexamination by a year, this may result in a patent tax to consumers of a billion dollars or more. Thus, the value of a patent in some areas can be measured in terms of billions of dollars per year. For example, in the suggestion for rehearing en banc in Pfizer Inc. v. Apotex, Inc., 480 F.3d 1348(Fed. Cir. 2007)(a case not involving reexamination), the patentee asked the Court not to forget about its expired patent: “[T]he issue of the patent's validity is not moot. It remains critical to Pfizer's right to six months of … exclusivity[ ] having a value of over one billion dollars."

Wegner further notes:

The rate of two billion dollars a year in the Pfizer case exceeds the budget of the PTO.

If the PTO with its $ 1.6 billion budget is unable to move the handful of commercially very important reexaminations to conclusion by allocating its resources, the patent community can hardly have confidence in a post-grant review system under the control of the PTO...

8:28 PM  

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