Posted below is article on today's testimony in the Amgen suit that prompted my question and comments.
Also, here are some off the cuff thoughts of mine posted on the Amgen thread (it's not real active and I don't know offhand that any patent lawyers post on it.)
Message 14340232
Message 14340304
========================
Amgen Lawyer Testifies Drug Patent Claims `Not False'
Boston, Sept. 6 (Bloomberg) -- Transkaryotic Therapies Inc. shares rose 12 percent, after a lawyer for rival Amgen Inc. faced tough questioning in federal court over allegations that his client withheld material information about disputed patents from government examiners.
Shares of Transkaryotic, which is being sued by Amgen for infringing patents on the top-selling anemia drug Epogen, rose 5.13 to 47 on the Nasdaq Stock Market. Amgen shares fell 4.44, or more than 6 percent, to 68.06.
Transkaryotic contends the Epogen patents shouldn't be enforced because Amgen withheld material information during the patent review process.
Michael Borun, a lawyer who helped prepare Amgen's Epogen patent applications, denied misleading government examiners. He testified he wasn't obliged to disclose that Amgen had already sued Transkaryotic over three Epogen patents while awaiting approval for two others, despite requirements that patent applicants reveal anything that could affect their claims.
``What I heard today, even if it can't prove intentional deception, raises questions about whether the patents are valid,'' said Robert LeBoyer, an analyst with Leerink Swann & Co. ``I think that's one of the important reasons the (Transkaryotic) stock is up.''
Anemia Treatment
Amgen, the world's largest biotechnology company, is suing to block Transkaryotic from selling its own version of Epogen, a drug used to stimulate red-blood cell production in kidney dialysis patients who become anemic. The drug is a form of the human protein erythropoietin.
Borun, an outside patent lawyer for Amgen, testified via closed-circuit television before U.S. District Judge William Young in Boston, who will decide the case.
Borun lives in the Chicago area and was unavailable to fly to Boston to testify in person. Cambridge, Massachusetts-based Transkaryotic is expected to present its final defense witness tomorrow, with closing arguments to follow.
Under patent law, applicants have a duty to tell examiners about anything that could affect their claims.
In about three hours of testimony, Schwartz pressed Borun on whether he failed to reveal material information that could have affected Amgen's Epogen claims. Borun testified that the ``information was considered correct'' at the time.
Schwartz asked Borun whether he told examiners while awaiting approval for two pending patents that Amgen had already sued Transkaryotic over the three other Epogen patents.
`No Obligation'
Schwartz asked if there was ``No obligation to tell the Patent Office about the existence of this lawsuit?''
``That's right,'' Borun replied.
``So you made a conscious decision not to tell the Patent Office about this lawsuit?'' Schwartz followed up.
``I don't recall that,'' Borun answered.
Jonathan Hangartner, a patent litigator in San Diego, said inequitable conduct -- or intentionally withholding material information -- is a ``great defense, but often difficult to prove.''
``If the judge thinks the information was not disclosed and should have been, he is likely to find the patents are unenforceable,'' Hangartner said. ``If a witness is hedgy, like saying he can't remember or is unwilling to commit to a firm answer, a judge will often discount the testimony.''
Drugmakers, investors and patent attorneys have been monitoring the trial closely since it began in May -- and not just because it involves a drug with estimated U.S. sales in 2000 of $4 billion.
Young's ruling, and any later appeals court decisions, could shape the biotechnology industry for years to come, experts say. Should Young decide for Transkaryotic, it would clear the way for up-and-coming gene therapy companies to challenge the established pharmaceutical companies' dominance, patent experts say.
Broad Implications
The case has broad implications because it could help determine how far drug companies can go in using patents to control competition, experts say.
Thousand Oaks, California-based Amgen claims Transkaryotic and Aventis SA predecessor Hoechst Marion Roussel Inc. infringed five of its patents by developing their own version of erythropoietin.
Transkaryotic contends it didn't infringe Amgen's patents because it used an entirely different method to develop erythropoietin.
While Amgen inserts a cloned gene into an animal cell to make its product, Transkaryotic has developed a method of inserting a DNA sequence into a human cell. The DNA sequence functions as a ``switch'' that causes the cell to produce erythropoietin.
If Transkaryotic wins, analysts say, other companies might try to make competing versions of other Amgen products, including Neupogen, which is used to prevent infections in chemotherapy patients.
Besides marketing Epogen itself, Amgen licenses the drug to Johnson & Johnson, which sells it in the U.S. as Procrit and in Europe as Eprex, a treatment for anemia caused by other than kidney damage.
Transkaryotic has yet to put a product on the market. The company was sued in July by Genzyme Corp. for allegedly infringing a patent for a drug that treats Fabry disease, a rare metabolic disorder.
Sep/06/2000 17:22 ET |
