Month: July 2007

  •     By Donald Zuhn — Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) approved three new follow-on biologic drugs:  Binocrit (Sandoz GmbH), Epoetin alfa Hexal (Hexal Biotech Forschungs GmbH), and Abseamed (Medice Arzneimittel Pütter GMBH & Co.).  The approved biosimilars are generic versions of Johnson…

  •     By Jason Derry — Merck has announced an agreement to acquire NovaCardia for $350 million.  NovaCardia, a biotechnology company based in San Diego, has a lead drug candidate, KW-3902, in Phase III clinical trials for treating acute congestive heart failure.  Merck hopes to expand its pipeline for cardiovascular therapeutics with the purchase of…

  •     By Donald Zuhn — The U.S. Patent and Trademark Office (USPTO) announced today (July 25, 2007) that the Office of Management and Budget (OMB) completed its review of the new continuation and claims rules earlier this month.  More importantly, the Patent Office also announced that the continuation and claims rules would be published…

  •     By Donald Zuhn — Last Friday, the U.S. Patent and Trademark Office (USPTO) announced that it has sent draft obviousness examination guidelines to the Office of Management and Budget (OMB) for review.  The draft training guidelines are to be used by examiners in determining whether a claimed invention is obvious in view of…

  •     By Jason Derry — Organon and MRC Technology have announced an intent to collaborate in the development of a humanized antibody for treating various cancers.  Under the agreement, MRC will use its CDR grafting technology to generate a humanized antibody based on one of Organon’s murine antibodies as a candidate for clinical development. …

  •     By Baltazar Gomez — The biotech industry needs lots of capital for research, new product development, and lots of funds for daily operations.  The current trend of mergers and acquisitions in the biotech industry arises in order to satisfy the needs of the industry.  Many biotech firms have promising technologies and low stock…

  •     By Sherri Oslick — Ortho-McNeil, Inc. announced late last week that it has settled its lawsuit against Par Pharmaceutical Companies, Inc. and its subsidiaries, Par Pharmaceutical, Inc. and Kali Laboratories, Inc., over the patent covering Ortho’s Ultracet® (tramadol hydrochloride and acetaminophen, used to treat acute pain). As part of the settlement agreement, Par/Kali…

  •     By Donald Zuhn — Last month, the European Medicines Agency (EMEA) released a paper entitled "Questions and Answers on biosimilar medicines (similar biological medicinal products)," in which the EMEA provided answers to a number of questions concerning the authorization of biosimilars.  The European biosimilar regulatory pathway was established in 2004.  In view of…

  •     By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases, and a few interesting cases will be selected for periodic monitoring. Ortho-McNeil Pharmaceutical, Inc. v. Apotex, Inc.1:07-cv-04050; filed July 18, 2007 in the Northern District of Illinois Infringement of U.S. Patent No. RE39,221…

  • September 18-19, 2007 – Pharma/Biotech Patent Boot Camp (American Conference Institute) – San Francisco, IL*** September 26-27, 2007 – Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA*** ***Patent Docs is a media sponsor of this conference or CLE.