Issue 05/39 | August 23, 2005
Intrinsic Record
 Intrinsic Record Continues to Dominate Claim Interpretation; No Inequitable Conduct for Post-Allowance Submission of a Cumulative Reference

The intrinsic record is the primary source for claim interpretation in a post-Phillips era. The contextual understanding of a claim term抯 meaning may come from the intrinsic evidence or from expert testimony that is not at odds with the intrinsic evidence. Inequitable conduct was not established where applicants submitted a cumulative reference after allowance.

In Tap Pharmaceutical Prods. v. Owl Pharm., Nos. 03-1634, -1635 (Fed. Cir. Aug. 18, 2005), the federal circuit affirmed summary judgment grants of infringement and no inequitable conduct with respect to Tap抯 �1 and �8 patents, and of noninfringement with regard to Tap抯� �3, �0 and �1 patents.

Owl sought to market a generic version of leuprolide, patented and marketed by Tap under the name Lupron Depot�. On motion for summary judgment, the district court held that Owl did not infringe Tap抯 �3 �0 and �1 patents. At trial, a jury found that the �1 and �8 patents were not invalid and that Owl抯 infringement was not willful. Following trial, the district court rejected Owl抯 claim that the �1 and �8 patents were unenforceable due to inequitable conduct based on the failure to cite two prior art references to the PTO during the prosecution of the patents.

On appeal, Owl argued that the claim language 揷omprising a copolymer . .. of lactic acid and . . . of glycolic acid� required that the copolymers be made directly from lactic acid and glycolic acid as starting materials, rather than copolymers composed of lactic acid and glycolic acid mers produced by any other method (including the use of lactide and glycolide). The federal circuit observed that neither the language of the claims nor the specification of either patent explicitly set forth the starting materials for making the copolymers, nor did the claims or the specification require that the copolymers be produced by direct polymerization. To the contrary, the specification explicitly provided that the biodegradable high molecular weight polymer that serves as the starting material for performing the method of the invention 搈ay be produced by any method.� Even treatises relied upon by the district court confirmed that copolymers of lactic acid and glycolic acid could be made either by direct polymerization or by ring opening. Because the intrinsic evidence supported this interpretation, the judgment of infringement was affirmed.

Upholding the finding of no inequitable conduct, the federal circuit was not persuaded that Tap (1) intended to deceive the PTO by submitting a European Search Report after the Notice of Allowance issued; and (2) misrepresented the materiality of the Kent application cited in the European Search Report. The European Search Report was submitted to the PTO within a month of Tap抯 attorney having received it, the EPO Report characterized the Kent application as 搈erely technological background� and thus 搉ot material to patentability,� and the evidence showed the Kent application to be cumulative of references already before the PTO examiner.

To view a copy of the case visit http://media.aplf.org/rm/20050823-public/Tap.pdf

To discuss these topics further, please feel free to contact the author Michael R. Dzwonczyk, (mdzwonczyk@sughrue.com), at Sughrue Mion, PLLC in Washington DC, USA.

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