Conference on the Life Cycle of Orphan Drug Development & Commercialization Conducting Effective Orphan Drug Research and Clinical Trials to Expedite Orphan Drug Approval When:    January 16-18, 2013 Where:   Boston, MA Key Topics Improve current rare disease research methods used in early stages of orphan drug development with Genzyme Evaluate where the rare […]

Oh Lord, won’t you buy me a Mercedes Benz? My friends all drive Porsches, I must make amends. Worked hard all my lifetime, no help from my friends, So Lord, won’t you buy me a Mercedes Benz? ~ Janis Joplin Under Section 84 of the Indian Patents Act, 1970, any person can make an application […]

The Biotechnology Industry Organization believes that fully realizing the promise of biotechnology requires a comprehensive national strategy that fine-tunes some policies and overhauls others. BIO’s set of policy proposals address two vital needs: 1) the need to re-engineer the biotech economic model, and 2) the need to re-invent the idea-to-market pathway for biotech cures and […]

Teva Pharmaceuticals has launched a new online game promotion generic substitution among consumers. The link is below – as you can see, it allows players to replace popular brand-name drugs with their generic equivalents, and it shows how much one would save if they made the switch. According to Teva PR, they’ve had 17,000 views […]

  Lilly sued Novopharm for infringement under Canadian Patent No. 2,041,113, a selection patent for the compound olanzapine (sold under the brand name Zyprexa), owned by Lilly. Olanzapine is used to treat schizophrenia. Novopharm argued that the ‘113 Patent is invalid.  A Federal Court judge (the trial judge) agreed with Novopharm and dismissed Lilly’s action.  […]

After the US Patent and Trademark Office denied a patent term extension under 35 U.S.C. §156, to Metvixia® — with an active ingredient methyl aminolevulinate hydrochloride — Photocure ASA sought a do-over in district court under the Administrative Procedure Act, 5 U.S.C. §702. The district court held that the PTO’s ruling was “not in accordance […]

Recently, the courts looked at the question of whether separate enantiomers can have “first commercial marketing or use” status for purposes of patent term extension under 35 U.S.C. § 156. The U.S. Patent and Trademark Office, after consulting with the FDA, had granted an extension for US Pat. No. 5,053,407, which is exclusively licensed to […]

Pfizer is continuing its fight with generic drug manufacturer United Laboratories, Inc. (Unilab)in the Philippines over the issue of the validity of the patent on Lipitor (atorvastatin) as Unilab tries to have the patent canceled. Unilab filed its petition for the cancellation of Philippine Patent No. 29149 for Atorvastatin, marketed under the brand name Lipitor, […]