By Randall Osborne
West Coast Editor
A federal judge in Boston issued no ruling on Amgen Inc.'s bid for summary judgment and took the matter under advisement, in the ongoing fight between the company and Transkaryotic Therapies Inc. (TKT) over the former's blockbuster erythropoietin (EPO) product for anemia, Epogen. More hearings are expected next month.
The dispute began in 1997, when Thousand Oaks, Calif.-based Amgen sought an injunction preventing Cambridge, Mass.-based TKT and Hoechst Marion Roussel (now Aventis Pharma AG) from making, importing, using or selling EPO in the U.S.
Amgen claimed in its lawsuit that TKT's EPO has the same structure and biological activity of EPO identified in Amgen's patents and, like Amgen's product, TKT's EPO is neither isolated from human urine nor obtained from blood or other natural sources and, thus, is non-naturally occurring. (See BioWorld Today, April 17, 1997, p. 1.)
TKT and Hoechst, of Frankfurt, Germany, developed gene-activated erythropoietin, or GA-EPO, which is in Phase III trials. TKT said it had created an approach to large-scale production of therapeutic proteins that does not require cloning genes and inserting them into non-human cell lines. Therefore, TKT said, it avoids any patented ways of making proteins, such as Amgen's, that use conventional genetic engineering - activating genes in human cells to produce the protein, instead of manufacturing them by introducing cloned human genes into bacterial, yeast or non-human mammalian cells.
A federal judge refused to throw out the lawsuit. But a district judge in Boston said the case would be stayed until TKT and Hoescht lose the protection of the clinical trial exemption, as provided by the Waxman-Hatch Act. Either party had the option to reopen the case. TKT and Hoechst did so last June. (See BioWorld Today, June 10, 1999, p. 1.)
In federal district court Monday and Tuesday, both sides put forth arguments regarding the definition of terms in Amgen's patents related to Epogen. Six Amgen patents are asserted against TKT, with 18 claims. Of those claims, two contain various terms that the parties disagree about.
Among the terms are "vertebrate cells" and "mammalian cells." Edmund Pitcher, an attorney in the Boston law firm of Testa, Hurwitz & Thibeault LLP, said the judge in the case preferred a literal interpretation. "As far as he was concerned, a vertebrate cell was any cell that came from a vertebrate," Pitcher said, adding that the judge had "a foggy understanding of [the definition of mammalian cells], but he got most of it right" when he declared that a mammalian cell is any cell from a mammal.
TKT then "spoke for approximately 45 minutes to an hour, attempting to prevail on the judge" and make him believe the words as used in Amgen's patent did not have the "ordinary meaning," when used in the patent, Pitcher said.
"The first two points went to Amgen," said Pitcher, who was hired by New York-based PaineWebber Inc. to analyze the proceedings.
S.G. Cowen Securities Corp., of Boston, said Wednesday in a bulletin that claims generally "were defined in a very literal and somewhat broad sense, in concordance with the wishes of Amgen's counsel. Whether the interpretation of these claims will have any relevance to the future direction of the Amgen/TKT dispute remains to be seen." The judge "on several occasions" during the hearing said he expects the trial to go forward "into full court proceeding, regardless of whether a summary judgment is handed down or not," Cowen said in the bulletin.
Cowen said it "continues to believe TKT will ultimately prevail," and issued a "buy" recommendation for TKT's stock (NASDAQ:TKTX), which ended the day at $53, down $8.50. Amgen's shares (NASDAQ:AMGN) closed Wednesday at $62.25, down 56.25 cents.