Summary
The claimant sought revocation of a patent for a safety needle including an attachment for rendering the needle safe after use in order to reduce the risk of so called “needle stick injuries”. The attachment includes an arrangement whereby a deformable sleeve slides along the surface of a hub from a first position covering the needle, to a second position where the needle is exposed. Elastic deformation of the sleeve is used to store sufficient energy to return the sleeve to a position covering the needle after use, thus rendering it safe. The patent also includes details of a rotational locking mechanism for locking the sleeve in the safe position after use. The claimant argued that the patent lacked novelty, inventive step and was insufficient to enable the invention over the full breadth of the claim (so called “Biogen insufficiency)
The Hearing Officer found that the claims were in no way limited to syringes having hollow needles nor were they restricted to the conventional structure of a syringe having a hub. As a result, claim 1 was found to be invalid, as it was anticipated by a number of documents showing lancets with similar safety arrangements. However, he held that a conditional amendment offered by the defendants limiting the claims to a safety needle assembly including a hollow needle was allowable. The Hearing Officer also found the disclosure sufficient to enable the claim.