This case concerned the condition of non-obviousness as a prerequisite for patentability. The Supreme Court of the United States (hereinafter: the Court) reinforced the objective analysis approach for applying 35 U.S.C. §103 (i.e. the domestic provision on non-obviousness) as it was established with the three determining factors in Graham v. John Deere.

The Court of Appeal confirmed the invalidity of a patent on a pharmaceutical dosing regimen based on obviousness.

In this case, the U.S. Supreme Court established that the element of non-obviousness must be assessed with the help of the following factors: (1) the scope and content of prior art, (2) the differences between the prior art and the claims at issue and (3) the level of ordinary skill in the concerned art.  Furthermore, secondary considerations may be commercial success, long felt but unresolved needs or the failure of others to find a solution.

This case concerned three main issues in the context of patent infringement litigation: (1) who bears the burden of proving validity or invalidity of the patent; (2) what is required for an invention to be “useful” or “capable of industrial application”; and (3) what degree of similarity is needed for an accused product to infringe a patent. The Circuit Court of Massachusetts/United States decided that the plaintiff in a patent infringement suit bears the burden of proving the validity of its patent by establishing novelty and industrial application.

The Federal Circuit remanded for trial (further clarification of facts) to the district court a number of motions for summary judgment regarding the validity and the infringement of certain product claims and product-by-process claims. The Federal Circuit inter alia decided that in litigation (concerning patent infringement and validity), patent claims must be construed in a similar manner as under patent prosecution (concerning the grant of a patent).

The United States Court of Customs and Patent Appeals (CCPA), which was the predecessor of the United States Court of Appeals for the Federal Circuit reversed a decision by the United States Patent Office (USPTO) to reject a patent application on the basis of alleged improper use of the “Markush claims” format. The CCPA confirmed unity of the claimed invention at issue and therefore considered the Markush claims format as being properly used.

The Federal Circuit affirmed the rejection by the US Patent and Trademark Office (USPTO) of a number of product-by-process claims based on the lack of novelty of the claimed product. Patentability of product-by-process claims is determined on the basis of the product, not the process.

The United States Supreme Court ruled that amending (i.e. narrowing) a patent claim during prosecution does not necessarily result in a complete bar to the doctrine of equivalents. It rejected the Federal Circuit’s decision that a complete bar to equivalents always results when a claim is narrowed during prosecution and thereby confirmed its own case law.

The Federal Circuit deviates from earlier precedent (Scripps Clinic, see case summary) in applying different treatment to patent claims in the context of patent prosecution on the one hand and in the context of patent litigation on the other hand. This case concerns in particular the scope of product-by-process claims. It also provides a useful illustration of how to examine infringement of a process claim in terms of literal infringement and the doctrine of equivalents.

In this decision, the United States Court of Appeal for the Federal Circuit confirmed earlier case law by stating that direct infringement of a process patent requires all of the steps of the claim to be performed by a single entity or to be at least attributable to a single entity.