For clinical-stage products, a carefully-managed appeal can provide an interesting venue for product life cycle management, moving years of patent term from the clinical stage of the product life cycle (where patent protection is usually not needed) to the post-approval commercial stage of the product life cycle (where patent protection may be critical). Might extended patent term be a valuable addition to your clinical-stage products? If so, Contact Us. A leading pharmacognosy research and development company did, and here is what happened:
HP Ingredients developed a pharmacognosy-derived, small-molecule new chemical entity useful to treat rheumatoid arthritis. When the Examiner rejected the claims, we filed an appeal to the Board. The Examiner’s SPE found our Appeal Brief cogent enough to require the Examiner to withdraw her rejections.
When the Examiner rejected the claims again, we filed a second appeal. This time, the Board found our appeal brief cogent enough to require the Examiner to withdraw her rejections.
These repeated appeals ultimately convinced the Examiner to allow the case (US8084495). The appeals also provided a valuable commercial benefit: by forcing the Examiner to repeatedly concede that her rejections were not sustainable, the resulting patent won a patent term extension of nearly 4 ½ years. This extension was important commercially, because it took nearly 4 ½ years of patent protection and moved it from the clinical stage (where patent protection is not needed) to the future, post-approval commercial stage (where patent protection is critical).