On July 28th of 2010, in Sun Pharmaceuticals v. Eli Lilly, the Federal Circuit Court of Appeal affirmed a district court's decision that the claims of US Patent 5,464,826, because of Lilly's earlier in time U.S. Patent No. 4,808,614, were invalid under the judicially crafted doctrine commonly referred to as Obvious-Type Double Patenting (or also called Non-Statutory-Type Double Patenting). Since the Federal Circuit Court panel decision that the Eli Lilly '826 patent is invalid, there have been many vocal advocates urging the Court to rehear the matter en banc and to overrule the panel decision. The panel in its reasoning for the decision in this case relied on authority from Geneva Pharm., Inc. v. GlaxoSmithKline PLC and Pfizer, Inc. v. Teva Pharm. USA, Inc. that divisional applications are the only type of application that is protected from Obvious-Type Double Patenting claims because of the provisions in 35 U.S.C. Â§ 121 which create a safe harbor.

This blog discusses the judicially created Obvious-Type Double patenting, but there exists another type of double patenting rejection called the Same Invention Type Double Patenting which is grounded in 35 U.S.C. 171 and will be discussed in a future blog. Same Invention Type Double Patenting prohibits second patents from being issued for an identical design that has already been patented.The Sun Pharmaceuticals case discussed in this blog has to do with Obvious-Type Double Patenting which occurs when claims differ in appearances or in scope but are directed to the same inventive concept and are patentably indistinct from each other. This doctrine is based on the public policy objective of preventing patent holders from extending their right to exclude others from the market through unjustified or improper means. Not surprisingly, this suit originated when Sun Pharmaceuticals filed an Abbreviated New Drug Application (ANDA) for generic gemictabine. The company then proceeded to file a declaratory judgment action that the 614' and '826 patents were invalid. The actions of Sun Pharmaceuticals were done to remove the barriers, created by the patents, to the generic product entering the market.

The main policy criticism leveled at the Doctrine of Nonstatutory-Type Double Patenting is that it negatively impacts the patentability of important uses discovered later in time and consequently lowers the incentive to innovate. For example, in Sun Pharmaceuticals, the '826 patent found to be invalid claimed ways of using gemcitabine for treating cancer. However, '826 was found to be invalid because, the earlier in time, '614 patent disclosed the use in the specification but did not claim the use. In my opinion, at a minimum, the Doctrine should not encompass disclosures made in specifications of patents where the use is not claimed. As pointed out by the Biotechnology Industry Organization (BIO) in a Brief of Amicus Curiae in support of the defendant-appellant Eli Lilly, when evaluating whether a later set of claims is patentably indistinguishable from claims made earlier under the Obvious-Type Patenting analysis, the court should not use disclosures in patent specifications to support findings of double-patenting. Otherwise, patentees will be placed between a rock and a hard place. The disclosures made by patentees that are necessary to support earlier patent claims can be used subsequently to make claims for separate subject matter 'obvious'. Such a result is unfair because it would make the specifications of patentees akin to prior art that operates only against the patentees when their patents are found to be invalid due to obviousness.