Does your existing filing have a problematic flaw? Perhaps we can help: call us. A dermatology manufacturer did, and here’s what happened:
Ferndale Laboratories Inc. was the U.S. licensee for Yamanouchi’s Locoid® topical hydrocortisone 17-butyrate. Ferndale found a new, more stable (lotion) formulation, and filed a patent application on it. That application, however, had a number of drafting errors, leading the U.S. Patent Office to reject it several times over. Complicating matters, Glenmark Generics, Inc., a large generic manufacturer, published the fact that it had developed a manufacturing process to make Locoid®.
At about this time, Ferndale Laboratories decided to divest the product.
The acquirer, Triax Pharmaceuticals LLC, asked us to assume responsibility for the IP. We reviewed the file and identified the source of the problem. We then designed a way to address it, fixing a problem with this drug formulation patent application by using a tool used for biotechnology patent prosecution.
The creative approach worked: 61 days after we became new attorneys of record, the Patent Office issued a Notice of Allowance. The patent (US7378405) was listed in the Orange Book soon thereafter, protecting the new formulation from generics.