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As CAFC Reverses Construction of Claims for Pig Virus Vaccine, Judge Dyk Questions Patentability Under §101

August 4, 2010

In a case where the U.S. Court of Appeals for the Federal Circuit reversed a district court’s reading of claims covering a pig virus vaccine, Judge Timothy B. Dyk disagreed with the majority’s reading of one term and went on to raise the broader question of whether the claimed “isolated” DNA sequence is simply a naturally occurring substance unpatentable under Section 101 of the Patent Act (Intervet Inc. v. Merial Ltd., Fed. Cir., No. 2009-1658, 8/4/10).

Postweaning Multisystemic Wasting Syndrome (PMWS) is a disease affecting livestock pigs, and Merial Ltd. has a patent (6,368,601)  covering certain vectors and other DNA molecules that contain portions of the PCV-2 gene sequence. These molecules are believed to be useful in diagnosing and vaccinating against PMWS, by stimulating the production and activity of antibodies against PCV-2.
In this case, Intervet Inc. sued for a declaratory judgment that its “Porcine Circovirus Vaccine Type 2” vaccine containing a porcine circovirus nucleotide sequence in a vector for treating PMWS in pigs does not infringe the ’601 patent.

Merial appealed the district court’s summary judgment that Intervet’s PMWS vaccine does not use an infringing PCV-2 sequence.

The Federal Circuit found that the district court misconstrued certain patent claim terms and vacated the summary judgment of noninfringement.

Judge Sharon Prost, joined by Judge William C. Bryson, found that the district court erred by narrowly construing “ORFs 1-13” in Claim 9 to mean the precise limits of the representative ORFs listed in Example 13, and the exact DNA sequence of SEQ ID 4. Read properly, the majority concluded, this term means “lengths of translatable DNA between pairs of start and stop codons, corresponding to the 13 ORFs identified in the patent specification.”

Judge Timothy B. Dyk agreed with the majority’s reading of Claim 32, but disagreed with its reading of Claim 9. In his view, the district court’s limited reading of this term was proper given the intrinsic evidence.

Dyk went on to clarify that claim construction is not a decision on whether “the claims as construed are limited to patentable subject matter.” He argued that Claim 32 broadly claims DNA sequences that were not in fact isolated by the inventor and are distinct from the five isolated strains disclosed in the ’601 patent. To Dyk, “[t]he question is whether the isolated DNA molecule, separate from any applications associated with the isolated nucleotide sequence (for example, the production of a vaccine) is patentable subject matter.”

Dyk continued:

Neither the Supreme Court nor this court has directly decided the issue of the patentability of isolated DNA molecules. Although we have upheld the validity of several gene patents, … , none of our cases directly addresses the question of whether such patents encompass patentable subject matter under 35 U.S.C. § 101. Although the U.S. Patent and Trademark Office (“PTO”) believes that at least some of these patents satisfy section 101, see Utility Examination Guidelines, 66 Fed. Reg. 1092 (Jan. 5, 2001), thus far the question has evaded judicial review.

I think that such patents do in fact raise serious questions of patentable subject matter. The Supreme Court’s recent decision in Bilski v. Kappos has reaffirmed that “laws of nature, physical phenomena, and abstract ideas” are not patentable. … Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain, … , so too would allowing the patenting of naturally occurring substances preempt the use by others of substances that should be freely available to the public.

Quoting Diamond v. Chakrabarty, 447 U.S. 303 (1980), Dyk observed that “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.” These aspects are properly conceptualized as representing a public domain, “free to all men and reserved exclusively to none,” he said, further quoting that case. Although Chakrabarty involved a man-made bacteria that the Supreme Court said had “markedly different characteristics from any found in nature,” Dyk stated that it is not at all clear that the “isolated” DNA sequence here meet that test.

Intervet was represented by William G. James II of Kenyon & Kenyon, Washington, D.C. Merial was represented by J. Patrick Elsevier of Jones Day, San Diego.

Read the Intervet Inc. v. Merial Ltd. opinion.

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