Patent Baristas

What: American Conference Institute’s FDA Boot Camp.  Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts. The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports… patent concerns… exclusivity. — all are critical aspects in the commercialization process for drugs, biologics, and devices which are governed by FDA law and regulation. […]

What: American Conference Institute’s FDA Boot Camp.  Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. — all are critical aspects in the commercialization process for drugs, biologics, and devices which are governed by FDA law and regulation. Recent court […]

“There are 10,000 baby boomers entering Medicare every day… If you could delay the onset of Alzheimer’s by five years, you’d save Medicare $50 billion a year. That’s what biotechnology companies do.”  ~Jim Greenwood James Greenwood, President & CEO of the Biotechnology Industry Organization (BIO) gave the keynote speech at the BioOhio conference yesterday outlining […]

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 […]

Despite the urgent need for scientific breakthroughs in biotechnology, current government policies are holding back the potential and promise of the scientific potential that resides in the thousands of biotech companies. The Biotechnology Industry Organization had looked at the changes to our policy environment that would incentivizes companies to develop the breakthrough cures, treatments, enhanced […]

Caraco Pharmaceutical Labs and Sun Pharmaceutical Ind. tried to get a rehearing en banc regarding the counterclaim provision of the Hatch-Waxman Act (HWA).  Novo Nordisk A/S v. Caraco Pharmaceutical Labs and Sun Pharmaceutical Ind., US Court of Appeals for the Federal Circuit (2010-1001). The petition for panel rehearing and for rehearing en banc was denied. […]

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 […]