The Federal Circuit Review is a monthly newsletter featuring the latest case summaries handed down from the U.S. Court of Appeals for the Federal Circuit.

1. Federal Circuit Review
VOLUME 2 | ISSUE 9 SEPTEMBER 2012
Hatch-Waxman Safe Harbor Extends to Information-Gathering
Activities
In Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Docket No. 2012-1062), the Federal Circuit vacated a
preliminary injunction for applying an “unduly narrow interpretation” of the Hatch-Waxman safe harbor, 35 U.S.C. § 271(e)(1).
Momenta, assignee of a patent relating to methods for analyzing enoxaparin, brought suit alleging that Amphastar infringed the
claimed methods during quality control batch testing of its commercial enoxaparin product. Amphastar argued that its activity fell
within the § 271(e)(1) safe harbor, as the testing was required by the FDA for continued approval and sale of its product. The district
court disagreed, and issued a preliminary injunction.
The Federal Circuit reversed, holding that the safe harbor of § 271(e)(1) is not limited to ANDA filings, but rather applies to both pre-
approval and post-approval information-gathering activities “[a]s long as the allegedly infringing use is ‘for uses reasonably related’
to the development and submission of that information . . . .” Amphastar’s post-approval quality testing was in accordance with
FDA regulations requiring the maintenance of batch records that “shall be readily available” for inspection by the FDA. The Federal
Circuit held that the possibility of FDA inspection was sufficient to constitute “submission” of the records to the FDA under § 271(e)
(1). The availability of non-infringing methods to meet the FDA’s requirements was not relevant.
Judge Rader dissented, arguing that the statute was ambiguous, and based on the legislative history and precedent such as
Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661 (1990),
and Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), Judge Rader concluded that § 271(e)(1) only applies to pre-
marketing approval activities.
Patent Invalid for Lack of Enablement in Light of “At Least 10%”
Limitation
In Magsil Corp. v. Hitachi Global Storage Technologies, Inc. (Docket No. 2011-1221), the Federal Circuit affirmed the district
court’s grant of summary judgment of invalidity for lack of enablement.
In This Issue
• Hatch-Waxman Safe Harbor Extends to • Recapture Rule Clarified
Information-Gathering Activities
• Liability for Induced Infringement Can Occur
• Patent Invalid for Lack of Enablement in Light of Even if No Single Actor Is a Direct Infringer
“At Least 10%” Limitation
• Isolated DNA Is Patent Eligible Subject Matter

2. MagSil filed suit against Hitachi alleging that Hitachi’s disk drive products infringe MagSil’s patent. After claim construction, the
district court granted summary judgment of invalidity for lack of enablement.
The Federal Circuit affirmed, concluding that Hitachi had provided clear and convincing evidence that one of skill in the art could
not have taken the disclosure in the specification and achieved the full scope of the claims. The asserted claims broadly claim a
tunnel junction that “causes a change in the resistance by at least 10% at room temperature.” The Federal Circuit determined that
the open ended claim language of “at least 10%” covered all changes from 10% to infinity and that the specification could not enable
such broad claim language. The Federal Circuit found that the specification only disclosed enough information to achieve an 11.8%
resistance change and that, during prosecution, MagSil believed the highest possible resistive change to be 100%. The Federal
Circuit concluded that the specification only enabled a person of ordinary skill in the art to achieve a small subset of the claimed
range and that the record contained no evidence that a skilled artisan could use the specification to achieve the modern values of
600% change in resistance without undue experimentation.
Isolated DNA Is Patent Eligible Subject Matter
In Association For Molecular Pathology v. U.S. Patent And Trademark Office (“MYRIAD”) (Docket No. 2010-1406), the Federal
Circuit maintained its previous holding that composition claims to isolated DNA molecules cover patent-eligible subject matter.
Plaintiffs sought declaratory judgment of invalidity of certain claims of Myriad’s patents. The district court found that composition
claims to isolated DNA molecules were patent-ineligible subject matter under 35 U.S.C. § 101. The Federal Circuit reversed this
holding in an earlier decision. The Supreme Court remanded the case to the Federal Circuit for reconsideration in light of Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).
The Federal Circuit maintained its previous decision with regard to the patent-eligibility of isolated DNA molecules. Like the prior
decision, the Federal Circuit found that “the distinctive nature of DNA molecules as isolated compositions of matter” renders them
patent eligible subject matter. Specifically, the Federal Circuit found that the chemical structure of the isolated DNA in question
renders it “markedly different” from naturally occurring DNA. The Federal Circuit rejected the argument that the physiological use
or benefit of the DNA is necessarily relevant to patent eligibility analysis. In reaching its decision, the Federal Circuit stated that,
“[w]hile Mayo . . . provide[s] valuable insights and illumate[s] broad, foundational principles, the Supreme Court’s decisions in
[Diamond v. Chakrabarty, 447 U.S. 303 (1979)] and Funk Brothers [Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)] set out the
primary framework for deciding the patent eligibility of compositions of matter, including isolated DNA molecules.”
In addition, in line with its prior decision, the Federal Circuit affirmed the district court’s holding that jurisdiction existed under the
Declaratory Judgment Act, reversed the district court’s holding that method claims to screening via cell growth rates is patent-ineligible
subject matter and affirmed the district court’s holding that method claims directed to comparing or analyzing gene sequences is
patent-ineligible subject matter.
Judge Bryson dissented with respect to the composition claims to isolated DNA molecules, arguing that the altered chemical
structure of the isolated DNA was a result of the isolation process, and did not render the compositions patent eligible. Rather, he
argued that, under Chakrabarty, the similarity in structure as well as in utility between the claimed isolated DNA and the naturally
occurring DNA rendered the claimed composition patent-ineligible as a naturally occurring substance.
Recapture Rule Clarified
In Greenliant Systems, Inc. v. Xicor LLC (Docket No. 2011-1514), the Federal Circuit affirmed the grant of a declaratory judgment
holding reissue claims invalid under the rule against recapture.
Greenliant filed a declaratory judgment seeking a declaration that Xicor’s reissue claims are invalid and not infringed. The district
court entered a judgment in favor of Greenliant that certain claims of the patent are invalid under the recapture rule.
The Federal Circuit affirmed. In addressing whether a patentee surrendered subject matter in the original prosecution which is
encompassed by broadened reissue claims, the focus is on arguments actually made by the patentee: “It does not matter whether
the examiner or the Board adopted a certain argument for allowance; the sole question is whether the argument was made [by
the applicant].” Thus, the Federal Circuit rejected Xicor’s argument that there was no disclaimer of the subject matter because its
arguments were not persuasive to the Examiner or the Board. Rather, the Federal Circuit found that Xicor clearly and unmistakably
represented to the Examiner and the BPAI that the relevant subject matter was a necessary component that imparted features
distinguishing the claimed subject matter over prior art during the original prosecution. Thus, the patentee was not allowed to
recapture the broader subject matter that it had given up.
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3. Liability for Induced Infringement Can Occur Even if No Single
Actor Is a Direct Infringer
In Akamai Technologies, Inc. v. Limelight Networks, Inc. (Docket No. 2009-1372), the Federal Circuit reversed two district courts’
granting of summary judgment and JMOL for defendants.
In reviewing two district court decisions, Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc.
v. Epic Systems Corp., the Federal Circuit examined whether a defendant may be held liable for induced infringement if no single
party has performed all of the steps of a patented method, but the defendant has induced others to act such that all method steps
have been performed.
In Akamai, Limelight performed all steps of Akamai’s patented method of efficient delivery of web content, except a step of modifying
a content provider’s web page to reference particular servers. Limelight provided instructions on how to perform that step to its
customers, some of which elected to perform the step. In McKesson, Epic Systems sold software to healthcare providers, which
used the software to communicate electronically with patients. Epic Systems did not perform any steps of McKesson’s patented
method, but those steps were practiced by a combination of the healthcare providers and the patients when Epic’s product was used
as intended. In both cases, the lower court found that no single entity directly infringed, and thus there could be no inducement of
infringement.
The en banc Federal Circuit expressly overruled BMC Resources, 498 F.3d 1373 (Fed. Cir. 2007), which required that, in order for
a party to be liable for induced infringement, some other single entity must be liable for direct infringement. The Federal Circuit held
that, while all the steps of a claimed method must be performed to find induced infringement, “it is not necessary to prove that all the
steps were committed by a single entity.” Thus, the requirement that inducement gives rise to liability only if the inducement leads to
actual infringement remains. However, the Federal Circuit distinguished between the concept of direct infringement, and liability for
direct infringement: “Requiring proof that there has been direct infringement as a predicate for induced infringement is not the same
as requiring proof that a single party would be liable as a direct infringer.” “If a party has knowingly induced others to commit the
acts necessary to infringe the plaintiff’s patent and those others commit those acts, there is no reason to immunize the inducer from
liability for indirect infringement” simply because no single defendant is liable for direct infringement. A party that induces several
actors to collectively practice the patented method should be treated the same as a party that induces a single actor to practice the
patented method. The impact on the patentee is the same. Thus, “infringement” in the context of 35 U.S.C. § 271(b) refers to “the
acts necessary to infringe a patent, not to whether those acts are performed by one entity or several.” The Federal Circuit found
this reasoning consistent with the legislative history of the 1952 Patent Act, and liability principles in other areas of law such as tort
and criminal law. In so holding, the Federal Circuit expressly declined to revisit any of the principles regarding the law of divided
infringement as it applies to liability for direct infringement under 35 U.S.C. § 271(a).
In remanding McKesson and Akamai, the Federal Circuit advised that Epic and Limelight may be liable for induced infringement by
showing (1) they knew of the patent; (2) they either induced the performance of all of the method steps, or performed some steps
and induced performance of the remaining steps; and (3) all the steps were performed.
Judge Newman filed a dissent, arguing that inducement under § 271(b) should require an underlying act of infringement for which a
party is liable under § 271(a), but would have overturned earlier opinions requiring a single infringer for direct infringement, instead
looking to apportionment of damages in cases of divided infringement.
Judge Linn filed a dissent joined by Judges Dyk, Prost, and O’Malley, arguing that liability under § 271(b) requires an act of
infringement under § 271(a) by a single entity or joint enterprise.
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