ABBOTT LABORATORIES, AND FOURNIER INDUSTRIE ET SANTÉ AND LABORATOIRES FOURNIER S.A. v. NOVOPHARM LIMITED

Citation: 323 F.3d 1324Docket: 02-1387

Court: Court of Appeals for the Federal Circuit; April 30, 2003; Federal Appellate Court

SummaryOriginalCytator Case TreatmentBackward CitatorAnalysis

EnglishEspañolSimplified EnglishEspañol Fácil

Fournier Industrie et Santé and Laboratoires Fournier S.A. (Fournier), along with Abbott Laboratories (Abbott), appealed the U.S. District Court for the Northern District of Illinois' decision granting Novopharm Limited (Novopharm) summary judgment of noninfringement regarding U.S. Patent 4,895,726 ('726 patent). The Federal Circuit affirmed this decision. The '726 patent, assigned to Fournier, includes claims for a therapeutic fenofibrate composition, its manufacturing method, bioavailability improvement methods, and treatment methods for hyperlipidemia and hypercholesterolemia. Abbott, as Fournier's exclusive licensee, markets fenofibrate capsules under the name TRICOR, supported by an FDA-approved New Drug Application (NDA).

In December 1999, Novopharm filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to sell a generic micronized fenofibrate formulation before the '726 patent's expiration. Novopharm submitted a 'paragraph IV certification' stating that its proposed product would not infringe the '726 patent and notified Fournier and Abbott of this filing, including a detailed explanation of its noninfringement stance as mandated by law.

Fournier and Abbott initiated legal action against Novopharm, claiming that Novopharm's generic TRICOR® infringed the '726 patent. They argued that Novopharm's submission of an Abbreviated New Drug Application (ANDA) for fenofibrate capsules before the patent's expiration was an infringement under 35 U.S.C. § 271(e)(2), which prohibits submitting applications for patented drugs with the intent to commercialize before patent expiration. Fournier and Abbott sought a ruling affirming the validity and enforceability of the '726 patent, a stay on Novopharm's ANDA approval until January 19, 2009, and an injunction against Novopharm's commercialization of infringing products. 

Novopharm amended its ANDA twice, each time introducing a new dosage form and providing a paragraph IV certification, prompting Fournier and Abbott to file new complaints. The district court consolidated these actions. Novopharm subsequently sought summary judgment of noninfringement.

The '726 patent includes two independent claims: Claim 1 describes a gelatin capsule composition for treating hyperlipidemia and hypercholesterolemia, specifically requiring a co-micronized mixture of fenofibrate and a solid surfactant with a mean particle size of less than 15 microns. Claim 10 outlines a method to enhance the bioavailability of fenofibrate by co-micronizing it with a solid surfactant to achieve a similar particle size. 

Claim 1 was amended during prosecution to clarify that the composition contains a co-micronized mixture rather than simply stating that fenofibrate and surfactant were co-micronized. The patent specification provides data indicating that this composition offers improved properties compared to prior formulations, which either added solid surfactant without co-micronization, micronized fenofibrate alone, or separately micronized and mixed fenofibrate with surfactant. Fournier distinguished its invention from earlier formulations that granulated fenofibrate in larger particle sizes.

The district court determined that Fournier successfully differentiated the amended claimed invention from prior art by highlighting that the prior art did not disclose or suggest co-micronization of fenofibrate and a solid surfactant, which enhances bioavailability and dissolution rates. Fournier emphasized that the prior art did not teach co-micronization to produce particles under fifteen microns. The court noted the '726 patent specifies that co-micronization significantly improves fenofibrate’s bioavailability beyond methods involving separate micronization or mixing with a surfactant.

The court concluded that Fournier's claims do not include mixtures created by merely adding a surfactant to fenofibrate or by separately micronizing and then mixing them. Sodium lauryl sulfate (SLS) was identified as the sole solid surfactant example, with the '726 patent detailing co-micronization of fenofibrate and SLS before adding excipients like lactose or starch. The court clarified that 'co-micronization' in claims 1 and 10 refers strictly to the micronization of fenofibrate and a solid surfactant, excluding any other excipients. 

The court adopted Novopharm's interpretation that the phrase 'fenofibrate/solid surfactant mixture' in claim 10 excludes any additional ingredients, a construction not contested by Fournier or Abbott. Similarly, it interpreted 'mixture of particles of fenofibrate and a solid surfactant' in claim 1 to mean a mixture solely of fenofibrate and solid surfactant.

Upon evaluating Novopharm's proposed fenofibrate formulations, the court found that Novopharm’s process involved pre-micronizing fenofibrate alone, then dry mixing it with other excipients. A granulating solution of povidone and SLS was prepared and added to this dry mixture, followed by a wet granulation process. The resulting product was dried and blended to create granules suitable for encapsulation in gelatin capsules.

Novopharm's motion for summary judgment argued that its method does not involve co-micronization of fenofibrate with a solid surfactant, thus asserting it does not infringe the '726 patent. In response, Fournier and Abbott contended that Novopharm's wet granulation and drying steps effectively constitute co-micronization, as they reduce the size of fenofibrate particles. However, the court found no dispute that Novopharm’s process does not involve co-micronization of fenofibrate and a solid surfactant without other excipients. Given this understanding and the court's previous claim construction, it ruled that Novopharm’s formulations could not literally infringe the patent's independent claims.

The court also dismissed the possibility of infringement under the doctrine of equivalents due to prosecution history estoppel. It reasoned that Fournier’s arguments during prosecution, which distinguished the claimed invention from prior art by emphasizing the necessity of co-micronization for improved bioavailability, indicated that they had relinquished claims that would cover Novopharm’s process. Consequently, the district court granted Novopharm’s motion for summary judgment of noninfringement.

Fournier and Abbott are appealing this decision, with jurisdiction established under 28 U.S.C. 1295(a)(1). The appellate review of the summary judgment is de novo, requiring a two-step analysis: first, the interpretation of the patent claims, and second, a comparison of those claims to the accused product. The court emphasized that each claim limitation or its equivalent must be found in the accused product for infringement to be established. Summary judgment is appropriate when no reasonable fact finder could determine equivalence, obligating district courts to grant it when the evidence does not support a finding of equivalence.

Fournier and Abbott contend that the district court incorrectly interpreted the claim term 'co-micronization' to necessitate micronization of fenofibrate and solid surfactant without other excipients, as well as misinterpreting 'mixture of' to mean 'mixture wholly of,' which excludes all other ingredients. They assert that these errors stem from the court improperly importing limitations from non-limiting examples in the patent. The court, however, upheld its interpretation of 'co-micronization,' explaining that the term had a clear definition provided in the '726 patent, indicating it refers to the micronization of an 'intimate mixture' of fenofibrate and a solid surfactant. This explicit definition signifies that the claims require a mixture consisting essentially of fenofibrate and solid surfactant. Consequently, since Novopharm's process incorporates other significant ingredients, there is no genuine issue of material fact regarding literal infringement. Additionally, Fournier and Abbott argue that the court erred in its doctrine of equivalents analysis by stating that Fournier had relinquished coverage of all pre-micronization methods during prosecution.

Fournier and Abbott argue that the court incorrectly determined there was no genuine issue of material fact regarding the infringement by equivalents, claiming the summary judgment of noninfringement was therefore improper. They challenge the district court's claim construction and assert that Novopharm's fenofibrate product experiences a decrease in particle size below fifteen microns during its wet granulation and drying processes, with fenofibrate and SLS present concurrently. They contend this reduction represents 'co-micronization.' The court acknowledged that it erred in its doctrine of equivalents analysis by suggesting Fournier had relinquished coverage of all formulations produced with pre-micronized fenofibrate. However, it clarified that while Fournier is estopped from claiming coverage over specific formulations combined without subsequent co-micronization, the patent records do not indicate a relinquishment of coverage for those subjected to further micronization in the presence of a solid surfactant. Despite this error, it was deemed harmless since Novopharm's ANDA process does not include steps mixing fenofibrate with a solid surfactant absent other excipients. Notably, the SLS used is dissolved in solution and does not count as a 'solid surfactant,' meaning that any reduction in particle size in Novopharm's process does not legally qualify as co-micronization. The court found the other arguments from Abbott and Fournier unpersuasive and ultimately upheld the summary judgment of noninfringement in favor of Novopharm, affirming the decision. Additionally, Teva Pharmaceutical, while involved in the district court actions, is not named in this appeal due to ongoing negotiations for its release from the case.