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Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc., No. 2010-1419 (Fed. Cir. July 21, 2011) (Judges Lourie, Gajarsa, and Dyk)

I told you a couple of weeks ago that Judge Lourie likes to write the opinions in the biotech and pharmaceutical cases, if he is in the majority. (Read that blog post here.) He wrote this opinion, too, for the court.

If you say things during prosecution that affect the patent examiner’s understanding of the technology that your claims cover, you run the risk of being held to those positions when litigation occurs. You are held to those representations under the doctrine of prosecution history estoppel.

This theme, which we encounter regularly in patent cases, was fatal to Duramed’s infringement case at the summary judgment stage.

Duramed owns a patent on estrogen pharmaceutical compositions used for hormone replacement therapies (and has FDA approval for a replacement product called Cenestin®). These compositions are highly water-soluble; they degrade or dissolve quickly when exposed to water.  To counteract that issue, the product is coated with a moisture-barrier ingredient called ethylcellulose, which allows it to break down and dissolve slowly in the body.

Paddock requested FDA approval to market a generic version of this product that contains a polyvinyl alcohol moisture-barrier coating, inciting this ANDA litigation (brand vs. generic lawsuit) under the Hatch-Waxman Act. After this request was filed with the FDA, Duramed sued Paddock for infringement, but lost on this issue at the summary judgment stage.

The Federal Circuit agreed that Duramed’s claims could not cover Paddock’s product. It made an interesting comment on its reasoning: when the language of the claims begin with the words “a pharmaceutical composition,” that language defines the field of the invention when determining whether a particular alternative ingredient would be a “forseeable” alternative to the moisture-barrier layer that Duramed claimed. Drawing from literature that described coatings and ingredients that were known in the pharmaceutical field at the time, Paddock demonstrated that the ingredient in its product was known in this community. Since it had the chance to include that ingredient in its claims but did not do so, Duramed was blocked from covering it as an equivalent in this litigation.

Read the Duramed opinion here.

 

In re Jeff Lovin, No. 2010-1499 (Fed. Cir. July 22, 2011) (Judges Bryson, Dyk, and Mayer)

The inventors appealed from a Board of Patent Appeals and Interferences (BPAI) decision that a number of their friction-welding claims are obvious. The BPAI and Federal Circuit determined that they did not really tell the examiner or the BPAI why many of their claims are not obvious. Instead, they merely recited the language of the references and their claims when attempting to show that a patent should be granted.

The BPAI “interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.” Slip op. at 16. The court concluded that the inventors’ briefs and papers did not make specific substantive (read detailed) arguments to overcome the examiner’s rejection that satisfied the BPAI’s interpretation of its Rule 41.37.

The Federal Circuit deferred to the PTO’s interpretation of its rules, and launched into a detailed discussion of the body of law relating to court deference to an agency’s interpretations of its rules. The court also discussed the previous rule that governs the substance of arguments made to the BPAI.  Since Lovin did not provide substantive arguments in its appeal brief regarding the dependent claims, the court upheld the BPAI’s decision to not address those claims separately when determining whether the pending patent claims were obvious. They fell with the broadest independent claims.

I wrote a blog post a couple of weeks ago about another case in which the party tried to resurrect dependent claims but did not separately argue them.  (Practitioner point: don’t go the claim-consolidation route if you aren’t ready to deal with the consequences when all of the patent applications claims rise or fall together).

This opinion is essentially a treatise on Rule 41.37’s roots and the complicated law relating to court deference to agency interpretations of their rules. If you aren’t familiar with Chevron deference, or the Seminole Rock case, and you practice in this area, you should read it. It will be a bit thick for others.

Read the Lovin opinion here.

 

Furnace Brook LLC v. Aeropostale, Inc., No. 2011-1025 (Fed. Cir. July 22, 2011) (Judges Bryson, Moore, and O’Malley)

This appeal focuses on a factual determination made in a prior litigation that relates to the question of whether the defendant in this case infringes a patent. In the earlier litigation involving the same patent, the Federal Circuit held that accessing a catalog website over the Internet using a computer or cell phone does not meet the “telephone terminal” limitation of the patent claims.  Furnace Brook LLC v. Overstock.com, Inc., 230 F. App’x 984, 986 (Fed. Cir. 2007). In both litigations, Furnace Brooks accused websites accessed over the Internet (by computers or cell phones) of infringement. The district court concluded that the prior factual findings relating to infringement (in light of the Federal Circuit’s construction of “telephone terminal”) applied equally in this case, and that the defendant Aeropostale does not infringe. The Federal Circuit agreed.

The interesting opinion is the dissent, written by former district court (and recent Federal Circuit appointee) Judge O’Malley. She expresses concern that a summary judgment decision in the earlier case, which was appealed to the Federal Circuit, provided the basis for the collateral estoppel decision here. That panel, in her view, made a decision based on a narrow and incomplete record and should have returned the infringement issue to the district court after it announced its new claim construction.

Where, as here, the record was limited by the narrowness of the trial court’s claim construction, and was further narrowed by the summary procedural posture in which the issues were presented and resolved, and where the trial court did not resolve all issues presented to it, this court should remand after revising the governing claim construction. Only by doing so in such circumstances can we be sure that we have not deprived the parties of the right to fully and fairly litigate their disputes.

Slip op. at 3 (O’Malley, J. dissenting).

This is an excellent point, and Judge O’Malley makes—in my view—a compelling argument for remanding the infringement issue after laying out the background of the prior litigation. It’s not surprising to me that a former district court judge is expressing concern regarding the litigants’ ability to fully develop the factual record at the trial court. As a litigator, I share her concern. Some commentators have accused the Federal Circuit of overreaching when disposing of issues that involve factual determinations at the appellate level. For many years, members of the Federal Circuit bar have pushed to add district court judges to the court, so that the court might gain the benefit of their perspective. This case highlights the value that perspective brings to the appellate bench.

Read the Furnace Brooks opinion here.