Issue 234 | August 4, 2004
Knoll v. Teva
Nystrom v. Trex

Knoll v. Teva

In Knoll Pharmaceutical Co., Inc. et al. v. Teva Pharmaceuticals USA, Inc., No. 03-1300 (Fed. Cir. May 19, 2004), the federal circuit reversed the grant of summary judgment of invalidity of Knoll抯 �2 patent, based on obviousness under �3.

The �2 patent is directed to methods and compositions for treating pain by administering a combination of hydrocodone and ibuprofen in amounts sufficient to provide an analgesic effect. The ratio of hydrocodone to ibuprofen is such that administration of the composition provides a greater analgesic effect than that obtainable by use of either one of them.

The district court held that the prior art expressly taught the combination of an opioid with an NSAID, and thus, one of skill in the art would have had a reasonable expectation of success in combining hydrocodone, a narcotic analgesic, with ibuprofen, an NSAID.

The federal circuit disagreed, stating there was no prior art teaching or suggestion to combine hydrocodone with ibuprofen, or that the combination would demonstrate an enhanced biomedical effect. In contrast, the court pointed to the �2 patent specification, which expressly acknowledged the surprising efficacy of the combination. The federal circuit also held it was error for the district court not to have considered evidence of unexpected results developed after issuance of the patent:

Evidence developed after the patent grant is not excluded from consideration, for understanding of the full range of an invention is not always achieved at the time of filing the patent application. It is not improper to obtain additional support consistent with the patented invention, to respond to litigation attacks on validity.

Finally, Knoll抯 evidence of the failure of two other pharmaceutical companies to develop an opioid-NSAID combination, including abandonment of certain FDA registration applications, should have been considered in a light most favorable to Knoll.

To view the full decision visit http://www.aplf.org/mailer/Issue234Knoll.doc

Nystrom v. Trex

In Nystrom v. Trex, et al., No. 03-1092 (Fed. Cir. June 28, 2004), the federal circuit reversed grants of summary judgment of non-infringement and invalidity of Nystrom抯 �1 patent and affirmed the denial of sanctions under 28 U.S.C. �27.

Nystrom抯 �1 patent is directed to boards for use in constructing an exterior floor, such as a deck. The boards are shaped to shed water and provide a surface on which it is comfortable to walk and stand. Nystrom sued Trex for patent infringement. Trex counterclaimed, seeking a declaratory judgment of non-infringement, invalidity, and unenforceability, and alleging antitrust violations. Eventually, Trex withdrew the antitrust counterclaims, and Nystrom sought sanctions for bringing baseless and vexatious claims. After a Markman hearing, the district court issued its construction of three claim terms, under which Nystrom conceded there would be no infringement.

On appeal Nystrom challenged as too restrictive the district court抯 construction of 揵oard,� as meaning made 揻rom wood cut from a log.� (The accused Trex product is made from composites of wood fibers and recycled plastic.). Using dictionary definitions, the federal circuit first found the plain and ordinary meaning of 揵oard� included wood and 揳 similarly rigid material adapted for a special use.� Next, the court looked to the intrinsic record and determined there was no clear disavowal of this broader definition: neither the statement in the specification that the decking board of the invention 搚ields a superior product when cut from a log,� nor a statement in a response to a rejection that a prior art reference was "not concerned with materials made from wood" amounted to a clear disavowal of the broader definition of 揵oard.�/p>

In light of its construction of 揵oard� (encompassing materials made not only from wood but from other rigid materials as well), the court disagreed with the district court抯 construction of 搈anufactured to have� in claim 1 as being limited to woodworking techniques.

Finally, the federal circuit held that it was error for the district court to have applied arguments made in the prosecution history about the term 揷onvex top surface� to all other claims in the issued patent: 揫t]here is no indication that Nystrom intended the term 揷onvex top surface� in all of the pending patent claims to be limited to a specific radius of curvature ratio.�/p>

The federal circuit reversed the district court determination of invalidity based on evidence improperly derived from a patent drawing, and affirmed the denial of sanctions against Trex for its withdrawn antitrust counterclaims.

To view the full decision visit http://www.aplf.org/mailer/Issue234Nystrom.doc

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.

The information contained in this email is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.

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