Supreme Court Declines Appeal of EDVA Patent Case

Posted on February 2, 2010 by Dabney Carr

On January 11, the Supreme Court declined certiorari in the case of Astellas Pharma, Inc. v. Lupin, et al., Case No. 09-335, upholding a June, 2007 decision by Judge Payne in the Eastern District of Virginia. Our earlier post on the Federal Circuit's Decision can be found here.

The Astellas case involves a generic version of the drug Omnicef (cefdinir), which is an antibiotic used to treat a number of common infections. The generic manufacturer, Lupin, alleged that Astellas’ patent on crystalline cefdinir only covered the Crystal A form of the drug, and Lupin alleged that its generic version of Omnicef only contained the Crystal B form.

In his claim construction opinion, Judge Payne ruled that Astellas’ patent was limited to the Crystal A form, effectively deciding the case in favor of Lupin. In short, the claims at issue were “product by process” claims, and Judge Payne ruled that each of the process steps in the claim were limitations on the invention. In an en banc decision, the Federal Circuit agreed, settling a long-standing split of authority on product by process claims.

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What's patentable?

Posted on September 1, 2009 by Bernie Pike

As you may know, the United States Supreme Court will help clarify what is patent eligible subject matter in the case Bilski v. Kappos.  The holding in Bilski will tell us how determine whether business method/software/medical process inventions are patentable and whether many issued patents with such claims are still valid.  But before the Supreme Court issues its opinion (Oral argument is not scheduled until November 9, 2009), the examiners of the United States Patent and Trademark Office (USPTO) must continue to make decisions on patentability every day.  The examiners just can't wait for the Supreme Court to ponder, mull and then opine on the issue.

So the USPTO has provided their examiners Interim Examination Instructions for Evaluating Patent Subject Matter Eligibility to help them determine which claims are directed to patent eligible subject matter under 35 U.S.C. § 101.  The examiners should follow these instructions until further notice.

These instruction are important so that we may know exactly what the examiner is looking for in your patent claims to determine patentability and to prepare arguments against the increasing number of rejections of business method/software and other method claims in patent applications.

 

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Mr. Bilski Goes to Washington

Posted on June 4, 2009 by Bernie Pike

In 2008, the Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion in In re Bilski establishing the rule for determining whether a new process or improvement to a process is eligible for patent protection. Generally, processes are patentable subject matter in the United States. U.S. Patent Law provides that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

The CAFC held Mr. Bilski’s process, a method of managing the risk for commodity seller, was ineligible for patent protection because it did not meet their “machine or transformation” test. In stating the test, the CAFC held that a “process is surely patentable subject matter if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” This test does not establish the clearly resolve the question of whether business method or software inventions are patentable subject matter. It is surely not a bright line test. The CAFC opinion leaves open that other processes or methods may be eligible for patent protection, but if meets the “machine or transformation” test is surely patentable subject matter. The CAFC also stated that the old test stating that the method must produce a “useful, concrete and tangible result” test from State Street is not to be relied upon by patent owners.

This week, the justices of the U.S. Supreme Court granted Bilski’s petition for writ of certiorari and will review the decision of the CAFC. Hopefully, the Supreme Court will be able to review the precedent and provide clarity to the issue. Many issued patents include claims directed to business methods, biotechnology, and software may not meet this “machine or transformation” test. The validity of these patents and patentability of many pending patent applications is at stake in this case. We anticipate many amicus briefs zealously arguing both sides of this contentious issue.

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