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August 4, 2010

Pig Out

Merial got a line on a virus infecting swine, and patented it: 6,368,601. Intervet developed a vaccine for treating the virus. Then Intervet filed a declaratory judgment action against Merial. The district court ruled noninfringement in summary judgment based on claim construction of six disputed terms. Merial squealed and appealed. Dissent by Judge DYK raised the specter of a rehearing, as to whether an isolated DNA sequence is patentable subject matter (§101).

Intervet v. Merial (CAFC 20091568) precedential

Claim construction is a question of law that is reviewed de novo. Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc). To the extent possible, claim terms are given their ordinary and customary meaning, as they would be understood by one of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 131213 (Fed. Cir. 2005) (en banc). Idiosyncratic language, highly technical terms, or terms coined by the inventor are best understood by reference to the specification. Id. at 1315. Such understanding is informed, as needed, by the prosecution history, if it is in evidence. Id. Construing the claims in light of the specification does not, however, imply that limitations discussed in the specification may be read into the claims. It is therefore important not to confuse exemplars or preferred embodiments in the specification that serve to teach and enable the invention with limitations that define the outer boundaries of claim scope. Id. at 1323.

Merial had a genus claim, after disclosing five genetic sequences (and depositing them with the USPTO). The district court limited claim scope to those five sequences.

The district court was persuaded by Intervet's arguments that the patent specification defined the invention as being these five sequences, and contained no disclosure from which to infer that any other sequences were also part of the invention.

It is clear enough to us, however, that the patent states that the five deposited strains and listed sequences are "representative of" a "type of porcine circovirus," and thus do not constitute the entire scope of the invention. '601 patent col.1 ll.6061 (emphases added). Sequences are representative of the scope of broader genus claims if they indicate that the patentee has invented species sufficient to constitute the genera. Enzo Biochem, Inc. v. GenProbe, Inc., 323 F.3d 956, 967 (Fed. Cir. 2002); In re Smythe, 480 F.2d 1376, 1383 (C.C.P.A. 1973). Here, the deposited strains are representative species of the larger "type II" genus, where the genus is identified and claimed as the invention.

Claims properly directed to a genus may be adequately supported by the patent disclosure if a sufficient number of species is disclosed so as to properly identify the scope of the genus. Id. Here, the patentee has disclosed five species of PCV2, provided the full sequences for four, and identified the potential coding portions of the sequences. The patentee also provided a counterexample, PCV1, that by definition lies outside the scope of the claimed genus, as well as a representative species of the counterexample, its sequence, and potential coding portions for the representative.

The district court failed to get a grip on what constitutes prosecution estoppel, and the scope of its effect.

The district court found that prosecution history estoppel precluded Merial from invoking the doctrine of equivalents.

Whether prosecution history estoppel applies to a particular argument, and thus whether the doctrine of equivalents is available for a particular claim limitation, is a question of law. Bai v. L & L Wings, Inc., 160 F.3d 1350, 1354 (Fed. Cir. 1998); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1460 (Fed. Cir. 1998) (en banc). Where an amendment narrows the scope of the claims, and that amendment is adopted for a substantial reason related to patentability, the amendment gives rise to a presumption of surrender for all equivalents that reside in "the territory between the original claim and the amended claim." Festo Corp. v Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 740 (2002) (Festo VIII). This presumption can be overcome by showing that "at the time of the amendment one skilled in the art could not reasonably be expected to have drafted a claim that would have literally encompassed the alleged equivalent." Id. at 741. One way to make this showing is to demonstrate that "the rationale underlying the narrowing amendment bore no more than a tangential relation to the equivalent in question." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1368 (Fed. Cir. 2003) (en banc) (Festo IX). Although there is no hard-and-fast test for what is and what is not a tangential relation, it is clear that an amendment made to avoid prior art that contains the equivalent in question is not tangential. See Pioneer Magnetics, Inc. v. Micro Linear Corp., 330 F.3d 1352, 1357 (Fed. Cir. 2003).

The applicability of prosecution history estoppel does not completely bar the benefit of the doctrine of equivalents from all litigation related to the amended claim. See Festo VIII, 535 U.S. at 73738 ("There is no reason why a narrowing amendment should be deemed to relinquish equivalents . . . beyond a fair interpretation of what was surrendered.") The scope of the estoppel must fit the nature of the narrowing amendment. A district court must look to the specifics of the amendment and the rejection that provoked the amendment to determine whether estoppel precludes the particular doctrine of equivalents argument being made.

Merial was estopped by claim amendment, but not so broadly as the district court found.

The district court thus erred in finding that prosecution history estoppel precluded Merial from arguing that the accused product is equivalent to one of the exemplary embodiments of the asserted claim. The district court is thus instructed on remand to compare the accused product with the claims as construed herein for a determination of infringement literally or pursuant to the doctrine of equivalents, if applicable.

Claim construction reversed, noninfringement vacated, remanded for another round of infringement analysis.

Judge DYK dissented in part, most interestingly on whether claim 32 wandered outside the realm of patentable subject matter.

I write separately primarily to make clear that in construing the claims, we are not deciding that the claims as construed are limited to patentable subject matter. As we noted in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), we do not take validity into account in construing claims, unless "the court concludes, after applying all the available tools of claim construction, that the claim is still ambiguous." Id. at 1327 (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004) (quotation marks omitted)). That is not the case here.

At least claim 32 of the '601 patent raises substantial issues of patentable subject matter under 35 U.S.C. § 101. That claim is not limited to the use of a particular isolated DNA molecule in a vaccine or other application. Rather, it broadly encompasses "[a]n isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1." '601 patent col.28 ll.40-42 (emphasis added). Neither the district court nor the parties provided a precise definition of "isolated" DNA. In order to analyze the DNA or use it for applications (for example, the production of vaccines), DNA must be extracted from the cell of the living organism and separated from other cell components, such as RNA, protein, lipids, or in the case of plasmid DNA isolation, from chromosomal DNA. See generally, Peter B. Kaufman et al., Handbook of Molecular and Cellular Methods in Biology and Medicine 1-26 (1995). DNA "isolation" applies generally to the process of extracting DNA from a cell for purposes of genetic analysis. See James D. Watson et al., Molecular Biology of the Gene 740 (6th ed. 2008); see also Kaufman et al., supra, at 1-2. Isolation also encompasses techniques for selective ampli-fication or cloning of such fragments, which allows for a large number of fragments to be available for analysis and sequencing. See Watson et al., supra, at 746. The '601 patent indicates that the isolation of the genomic DNA of the viral strains was performed by a method well known in the art. See '601 patent col.10 l.5-col.11 l.43.

Patent claim 32 reads on an isolated DNA molecule that comprises a nucleotide sequence that encodes an epitope unique to PCV-2, which is defined with respect to its homology with the known PCV-1 virus. Thus, under the majority's claim construction, claim 32 covers DNA sequences that were not in fact isolated by the inventor and are distinct from the five isolated strains disclosed in the '601 patent.

The question is whether the isolated DNA molecule, separate from any applications associated with the iso-lated nucleotide sequence (for example, the production of a vaccine) is patentable subject matter. 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, see, e.g., In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995); In re Bell, 991 F.2d 781 (Fed. Cir. 1993); Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.3d 1200 (Fed. Cir. 1991), 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),2 thus far the question has evaded judicial review.

2 In response to comments urging the PTO not to issue patents for genes on the ground that genes are products of nature, the PTO remarked:

An isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because (1) an excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, or (2) synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.

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. No. 08-964, slip op. at 5 (U.S. June 28, 2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain, see Bilski, slip op. at 13, 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. Thus, "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." Chakrabarty, 447 U.S. at 309. These aspects are properly conceptualized as representing a public domain, "free to all men and reserved exclusively to none." Id. (quoting Funk Bros., 333 U.S. at 130) (quotation mark omitted).

Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with "markedly different characteristics from any found in nature." It is far from clear that an "isolated" DNA sequence is qualitatively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.

Posted by Patent Hawk at August 4, 2010 10:03 PM | Claim Construction

Comments

PH,

Judge Dyk "jumped the shark" on raising the 35 USC 101. As noted by the majority, that issue was never addressed by the district court or even raised on appeal. Leave that issue to AMP v. USPTO please.

Posted by: EG at August 5, 2010 9:10 AM

Somebody in this thread doesn't know what "jumped the shark" means.

Posted by: 6000 at August 5, 2010 3:58 PM

6000, Were you even around when the phrase "jump the shark" was born?

What do you think it means?

Posted by: Anon at August 5, 2010 6:25 PM

anon,

Thanks for the comment. I was around when that episode on Happy Days came out, but I doubt 6000 was.

Posted by: EG at August 6, 2010 4:15 AM

"Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with "markedly different characteristics from any found in nature.It is far from clear that an "isolated" DNA sequence is qualitatively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question."


This is not only wrong, but dangerously so. This is judging the patent eligible status by what an item does, and not by what it is. In the mechanical arts, it is well established that a new configuration that performs an old method with a reduction in internal components is not only patent eligible, it is precisely the type of thing that the patent system was meant to advance.

I am glad that the judicial opinion was a dissent, but it is scary that this view is held at all.

Posted by: Anon at August 8, 2010 4:20 AM

Look for the issue raised by Judge Dyk to start working its way up to the SCOTUS (maybe in Myriad?). Though it's hard to imagine the Justices completely invalidating gene patents, considering how much patent litigation and the biotech industry have relied on them in recent years. I'd like to see what kind of test they'll devise to determine the validity of gene patents. This could get interesting.

Posted by: patent litigation at August 11, 2010 12:27 PM