Patent Baristas

Hal Wegner, former Director of the Intellectual Property Law Program and Professor of Law, George Washington University Law School and now Partner at Foley & Lardner, updated his list of the Top 10 Patent Cases.

We’ll be keeping an eye on these and more in 2009:

(1)  Lucent v. Gateway:   Where indirect infringement is found, can damages be based on the entire market value of the accused products where the allegedly infringing features are neither necessary for use of the products nor the basis for consumer demand and where there is no evidence of any instance of direct infringement?  Patent damages are a key sticking point in the patent reform debates.

(2)  Prometheus  v. Mayo:  What Hal calls “Metabolite déjà vu II,” concerns a patent for a means to measure the level of 6-thioguinine (6-TG) and 6-methylmercaptopurine (6-MMP), which indicates that an adjustment in drug dosage may be required at certain metabolite levels.  The patent includes only two active steps, “administering” the drug and then “determining” metabolite levels.  The claim really just explains the correlation between metabolite levels and therapeutic efficacy and “what the inventors claim to have discovered is that particular concentrations of 6-TG and 6-MMP correlate with therapeutic efficacy and toxicity in patients taking AZA drugs.”

(3)  Cardiac Pacemakers v. St. Jude:   A panel decision found that the export of subject matter to be used offshore in a patented process could constitute a “component” within the meaning of 35 USC § 271(f), is in conflict with Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007).

(4)  Bilski v. Doll:  A decision that revisits earlier decisions on patent standards in which the Federal Circuit limited patentability to inventions (1) tied to a particular machine or (2) that transform an “article” into a different state or thing. The court also confirmed previous cases holding that fundamental principles of mathematics or science are not patentable.  But, since the claims in Bilski were not tied to particular hardware, the court did not consider the viability of patenting specific functions carried out by a computer. Now, how the phrase “tied to a particular machine” will be applied to software patents.

(5)  Lupin Ltd. v. Abbott Labs: – Deemed Quanta déjà vu, it concerns whether product-by-process claims are infringed by sale of a claimed product produced by a different method.  The Scripps Clinic & Research Foundation v. Genentech case (opinion by Judge Newman) held that it would, while Atlantic Thermoplastics Co., Inc. v. Faytex Corp. (opinion by Judge Rader) held that it did not.

(6)  In re Kubin: – This is significant in two critical areas of biotechnology patent law in (a) it repudiates Deuel, keyed to language taken from the Supreme Court KSR decision as well as the Federal Circuit Kahn opinion that preceded KSR; and (b) it adopts the controversial Enzo line of “written description” biotechnology case law as the position of the PTO Board.  The Board upheld an examiner’s rejection that claims for a polynucleotide coding for a polypeptide 80% identical to a disclosed polypeptide were unpatentable under 35 U.S.C. § 103 for being obvious and under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.  The Board based its obviousness determination on its interpretation of the KSR Int’l Co. v. Teleflex decision that it would have been “obvious to try” to isolate the claimed gene using well-established molecular biological techniques.

(7)  Biomedical Patent Management v. State Of California: – The case looks at (a) whether a state’s waiver of Eleventh Amendment immunity in one action extends to a subsequent action involving the same parties and the same underlying transaction or occurrence and (b) whether a state waives its Eleventh Amendment immunity in patent actions by regularly and voluntarily invoking federal jurisdiction to enforce its own patent rights.  At the district court, Judge Marilyn Hall Patel dismissed the lawsuit but expressed concern over the fact that California could sue for patent infringement on one hand while using sovereign immunity to keep from being sued for patent infringement itself:  “The court is indeed troubled by the University of California’s ability to reap the benefits of a patent system without being exposed to liability for infringement,” she wrote. “Similarly situated private universities enjoy no such advantage.”

(8)  United States v. Eurodif: – Looks at whether the Federal Circuit should have accorded Chevron deference to the Commerce Department’s construction of 19 U.S.C. § 1673. That statute allows the Commerce Department to impose duties on imports of foreign merchandise when that merchandise is “being, or is likely to be, sold in the United States at less than its fair value” – a practice known in the international trade world as dumping – and where the dumping causes or threatens to cause material injury to a U.S. industry.

(9)  Tafas v. Dudas: – concerns the appeal of the claims and continuations rules promulgated by the USPTO which were preliminarily enjoined and ultimately permanently enjoined by the District Court.  One critical piece here is whether Congress provided the USPTO the rule making authority explicitly for the purpose of expediting patent applications.  Judge Rader asked whether the real issue in this case is whether the PTO is entitled to Chevron deference and whether the rules were procedural or substantive.  That is, the rules of statutory construction dictate that “the agency’s interpretation as long as it is based on a permissible construction of the statute’” would control the case.

(10)  Ariad v. Eli Lilly: – This addresses patent validity and enforceability issues where Lilly contends that the asserted claims of US 6,410,516 are invalid for including non-statutory subject matter, for being obtained through inequitable conduct, and are unenforceable due to prosecution laches.  Lilly argues, and of course Ariad disputes, that the claims cover unpatentable naturally-occurring phenomena, that Ariad withheld critical documents from the patent examiner not only to get the patent issued, but to avoid the risk of losing 13 years of patent term.