IP Update - September 2009

Bilski Meets Biotechnology Claims

Are Humans Animals?

Ninth Circuit Weighs In on Compulsory Nature of

Antitrust Claims and Choice of Law Issues

Teachings Incorporated by Reference for

Anticipation Purposes Need Not Be Individually Named

Concurrences Provide Insight into Federal

Circuit's Views on Stays Pending Re-Examination

Tracking Prosecution History to a Narrow Claim

Construction

Res Judicata Applies Unless Material Differences

Exist In Contested Limitations

Follow the Bouncing Ball ... But Not Outside the

United States

Court Not Lured by Arguments for Attorneys'

Fees

Federal Circuit to Consider Enablement and Written

Description Requirements En Banc

USPTO Releases Post-Bilski Section 101 Examination

Guidelines

On Its Face, Federal Circuit's Decision on

Fraud Provides Substantial Relief to Trademark Registrants

The Third Circuit Defines "Use" in the

Context of Counterfeiting Statute

The Effect of Stipulated Dismissal

Webcasting Music Services Not

"Interactive" When Users Cannot Directly Control the

Songs They Hear

Tenth Circuit Overturns Grant of Summary Judgment

Despite Defendant's "Powerful Arguments" Regarding

Interpretation of Copyright Ownership License

Whether a Process Is a Trade Secret Requires

Consideration of the Process Elements in the Aggregate

Bilski Meets Biotechnology

Claims

By Astrid R. Spain

In a decision that undoubtedly evoked a collective sigh of

relief from the biotechnology community, the U.S. Court of Appeals

for the Federal Circuit reversed a summary judgment of invalidity

and held that methods for calibrating proper drug dosage satisfy

the transformation prong of the Bilski

machine-or-transformation test for patent-eligible subject matter

under 35 U.S.C. section 101. Prometheus Laboratories, Inc. v.

Mayo Collaborative Services, Case No. 08-1403 (Fed. Cir.,

Sept.16, 2009) (Lourie, J.).

Prometheus is the sole and exclusive licensee of two Mayo owned

patents that claim methods for calibrating the proper dosage of

thiopurine drugs, which are used for treating both gastrointestinal

and non-gastrointestinal autoimmune diseases. The drugs are

ultimately broken down by the body into various metabolites; the

patents involve measurements of two of the metabolites,

6-methyl-mercaptopurine (6-MMP) and 6-thioguanine (6-TG). The

patents claim methods that seek to optimize therapeutic efficacy

while minimizing toxic side effects and typically include two

separate steps: "administering" a drug that provides 6-TG

to a subject and "determining" the levels of the

drug's metabolites. The measured metabolite levels are then

compared to pre-determined metabolite levels, "wherein"

the measured metabolite levels "indicate a need" to

increase or decrease the level of drug to be administered so as to

minimize toxicity and maximize efficacy of treatment.

Prometheus marketed a PROMETHEUS Thiopurine Metabolites test

that used the technology covered by the patents in suit. Mayo

initially purchased and used Prometheus's test, but in 2004,

Mayo announced that it intended to begin using and selling its own

test. Prometheus sued Mayo for infringement and ultimately appealed

to the Federal Circuit the district court grant of Mayo's

motion for summary judgment of invalidity under § 101. The

district court found that the "'administering' and

'determining' steps are merely necessary data-gathering

steps for any use of the correlations" and that "as

construed, the final 'wherein' clause is only a mental

step."

On appeal, the Federal Circuit commenced its analysis by noting

that the key issue is whether the claims are drawn to a fundamental

principle (unpatentable) or an application of a fundamental

principle (patentable). The Court noted that it articulated a

"definitive test" for determining whether a process is

patent-eligible under § 101 in Bilski. The

Bilski machine-or-transformation test is a

"two-branched inquiry," under which a patentee may show

that a process claim satisfies § 101 either by showing that

his claim is tied to a particular machine, or by showing that his

claim transforms an article.

Regarding transformation, the Court concluded that the methods

of treatment claimed in the patents-in-suit squarely fall within

the realm of patentable subject matter because they "transform

an article into a different state or thing," and this

transformation is "central to the purpose of the claimed

process." The Court pointed to the transformation of the human

body following administration of a drug and the various chemical

and physical changes of the drug's metabolites that enable

their concentrations to be determined. The Court also noted that

the asserted claims are in effect claims to methods of treatment,

"which are always transformative when a defined group of drugs

is administered to the body to ameliorate the effects of an

undesired condition." The Court further opined that even for

those claims lacking an administration step, patentability is

undiminished because the determining step is also transformative

and central to the claimed methods, as levels of 6-TG or 6-MMP

cannot be determined merely by inspection and without some form of

manipulation. Having concluded that the claimed methods meet the

transformation prong under Bilski, the Court did not

consider whether they also meet the machine prong.

Are Humans Animals?

By Robert H. Underwood

Addressing an interesting issue of patent claim construction,

the U.S. Court of Appeals for the Federal Circuit, sitting as an

expanded five-member panel, held that a human is an animal.

Martek Biosciences Corporation v. Nutrinova, Inc, Case

Nos. 08-1459, -1476 (Fed. Cir., Sept. 3, 2003) (Gajarsa,

J.)(Lourie, J. dissenting-in-part).

Martek owns several patents that cover various aspects of making

and using omega-3 highly unsaturated fatty acids. Nutrinova sells

allegedly infringing products for human consumption. One of the

patents claims a method for increasing the concentration of the

omega-3 acids in an "animal." The district court

concluded that the claim term "animal" does not include

humans. Based on this claim construction, Martek stipulated in the

district court that the claims were not infringed.

The Court, in a three-person majority opinion, concluded that a

human is an animal. The Court reached this conclusion by following

the well-established rule that when a claim term is explicitly

defined in the specification, that definition controls. The patent

specification states that "animal" means any organism

belonging to the kingdom Animalia. According to the Court, the

definition in the specification controls and, because it is

undisputed that humans are members of the kingdom Animalia, the

district court erred in limiting the term "animal" to

exclude humans.

The majority was not persuaded by Nutrinova's assertions

that the disclosure in the specification of a preferred use of the

omega-3 acids to produce food products from economic food animals

and the enumeration of preferred food animals, constitutes a clear

intention to limit the term "animal" to exclude humans.

Again relying on well-established precedent, the Court concluded

that the scope the claimed invention is not so limited, because the

specification does not clearly disclaim coverage of humans. In the

majority's view, this was particularly true because Martek

expressly defined "animal" broadly enough to encompass

humans and also disclosed uses of the claimed invention that are

applicable to humans.

In dissent, Judge Lourie while agreeing with the precedent

relied on by the majority, concluded that this case presents an

"unusual situation" in which the purported definition of

the term "animal" does not comport with the full

description of the invention. In the view of the dissent, based on

the use of the term "animal" in the claims and

specification, one of ordinary skill in the art would conclude that

the term "animal" does not include humans.

Practice Note: While patentees can be their own

lexicographers—and express definitions of claim terms in

the specification are controlling—patent drafters should

take steps to ensure that the broader written description of the

invention and its embodiments comports with any express

definitions. This case was heard by an expanded (five judge) panel

of the Federal Circuit; a rather unusual circumstance. Judges

Newman dna Moore joined in the panel decision and Judge Rader

joined in the dissent.

Ninth Circuit Weighs In on Compulsory

Nature of Antitrust Claims and Choice of Law Issues

By Rachael Lewis and William Diaz

The U.S. Court of Appeals for the Ninth Circuit affirmed the

lower court's dismissal of antitrust claims; finding that in

the claims in issue were compulsory counterclaims that the

defendant had failed to plead in response to a prior patent

infringement lawsuit. The Court held that Destiny Tool failed to

satisfy the pleading requirements for malicious prosecution and

abuse of process under Ohio law. Destiny Tool v. SGS Tools

Company, Case No. 07-17109, 2009 WL 2700319 (9th Cir., Aug.

27, 2009) (per curiam)(non-precedential)

SGS, Dauphin and Destiny manufacture and sell precision-cutting

drill heads. In 2004, SGS and Dauphin filed a patent infringement

suit against Destiny with respect to its "Improved Cutting

Tool." After district court in Cleveland, Ohio, granted

Destiny's motion to dismiss the case with prejudice, Destiny

countered with claims against SGS and Dauphin in the Northern

District of California for malicious prosecution, abuse of process,

monopolization and attempted monopolization. Destiny claimed $2

million in damages in addition to attorneys' fees because of

the initial patent infringement claim. The U.S. District Court for

the Northern District of California dismissed Destiny's suit;

Destiny appealed.

The parties disputed whether Ohio or California law governed the

malicious prosecution and abuse of process claims. While

acknowledging the state of California's interest in protecting

its citizens from unwarranted and...