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Genentech Arzerra Article


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  • 1. January 31, 2011<br />Genentech seen as likely to prove inducement of infringement by GSK/Genmab's Arzerra, faces validity challenge from GSK <br />Roche/Genentech (PINK:RHHBY) and Biogen Idec (NASDAQ:BIIB) are likely to be able to prove inducement of infringement by GlaxoSmithKline (NYSE:GSK) and Genmab’s (FRA:GE9) through marketing of Arzerra (ofatumumab) in view of the patents for Rituxan (rituximab), patent attorneys said. However, Genentech will need to defend its patent against strong invalidity and unenforceability arguments, they added.<br />Last year, Genentech and Biogen sued GSK in federal district court for the Southern District of California alleging inducement of infringement by Arzerra of US Patent No. 7,682,612. The patent clams methods of treating chronic lymphocytic leukemia, using an anti-CD20 antibody.<br />Infringement by inducement is described as a type of "secondary liability for patent infringement," where someone who does not infringe directly, but "asks or induces another to do so, or sells a product with advertising or instructions about an infringing use may be held liable for inducing infringement." Genentech is seeking both injunctive relief and monetary damages in the ongoing litigation.<br />Inducement requires proving third party direct infringement, such as doctors and nurses using the product in an infringing way, said Brian O’Shaughnessy, a partner at Buchanan Ingersoll. The plaintiff must prove that the drug is not a “staple article of commerce capable of substantial non-infringing uses,” and have to prove knowledge of the patent, as well as intent to induce infringement by the manufacturer. Although the patent statute does not specifically mention intent in defining inducement, case law precedent establishes proof of intent as a necessary element for a claim of inducement.<br />Genentech should be able to prove intent to induce infringement based on the prescribing information for Arzerra, said David Robinson, an associate at Harness, Dickey & Pierce. This will depend on a future Markman, or claim construction, hearing with respect to how the court defines the claim term “anti-CD20 antibody,” he added.<br />Madeline Baer, of counsel at Vinson & Elkins in the intellectual property department, agreed that because the labeling and prescribing information specifies treatment of CLL, there would seem to be a good case for Genentech to prove GSk's intent to infringe.<br />Noting that Genentech is asserting only inducement of infringement, and not direct infringement, Kirby Drake, a senior associate at Klemchuk Kubasta, explained that the claims seem to be fairly broad so this could be difficult for GSK and Genmab to prove that there is no induction of infringement.<br />However, while it is possible to infer that GSK had knowledge of the patents, it will be challenging for Genentech to prove intent to infringe through documents and deposition testimony, O’Shaughnessy noted. GSK could argue that doctors and nurses are using Arzerra in a non-infringing manner known prior to the filing date of Genentech’s patent, he added. This may be a plausible non-infringement defense, he said.<br />O’Shaughnessy added that the Supreme Court recently agreed to hear a case dealing with the legal standard for inducement of infringement, Global Tech. v. SEB. This Supreme Court decision will have significant implications on this case, and could potentially make Genentech’s case of proving inducement harder, he added.<br />Genentech and GSK did not respond to request for comment.<br />In its defense, GSK is arguing that Genentech’s patent, which covers the method for the drug Rituxan, is invalid for inequitable conduct, or fraud on the patent office during patent prosecution, as well as invalidity due to obviousness-type double patenting, as well as an error in inventorship according to the pleadings, Robinson noted. He added that invalidity and non-enforceability may be the bigger issues in the case, and could impact Genentech’s Rituxan.<br />Proving unenforceability due to inequitable conduct requires intent, which is hard to prove, Robinson explained, so Genentech may have an advantage in defending its patent. A finding of inequitable conduct renders a patent unenforceable, and requires a showing of both materiality and deceptive intent. Robinson noted that the legal inquiry into inequitable conduct is very fact specific, as additional facts will likely come to light with fact discovery and depositions. With respect to obviousness-type double patenting, Genentech may have an advantage because the prosecution history of the patent is extensive and contains a significant amount of prior art that the Patent & Trademark Office (PTO) reviewed in its examination during prosecution.<br />GSK is arguing that statements made by Genentech’s head of oncology during prosecution of its patent found in declarations filed with the PTO during patent prosecution, as well as changes in inventorship status of the patent makes a case for inequitable conduct, explained O’Shaughnessy. Two additional inventors were added at MD Anderson and Johns Hopkins, he noted. If the discovery process shows that material prior art was withheld from these two inventors during patent prosecution, this could be a “real problem” for Genentech with respect to the validity of its patent. GSK may have a strong inequitable conduct case based on the facts in the record, he added, but noted that inequitable conduct is very fact-specific and proof will rely on document discovery and upcoming deposition testimony.<br />This may be a difficult argument for GSK to prevail on in finding the Rituxan patent unenforceable, Drake noted. She added that inequitable conduct is a very challenging defense to improve, due to the requirement of finding deceptive intent on the part of the patentee.<br />Robinson noted that the inventorship on the patent may be incorrect, which could subject the patent to invalidity. However, it is more likely that Genetech will be able to correct the inventorship error during the course of the litigation.<br />by Sasha B. Coffiner<br />