Top ten patent cases 2013 May 1

7/30/2019 Top ten patent cases 2013 May 1

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Top Ten Patent Cases*

May 1, 2013

Federal Circuit appeals are shown in black with green highlightingSupreme Court Cases prior to certiorari are without highlighting

Supreme Court Merits appeals are in blue, turquoise highlighted

Rank Case Name Issue Status

1 Myriad . 101 Patent Eligibility Argued April 15

2 Bowman v. Monsanto . Seed Patent Exhaustion Argued February 19

3 FTC v. Actavis ANDA Reverse Payments. Argument Mar. 25

4 Merck(K-Dur) ANDA Reverse Payments Awaiting Cert. decision5 Limelight v. Akamai JointInducedInfringement Awaiting Conference

6 Akamai v. Limelight JointDirectInfringement Response due May 6

7 CLS Bank . Software Patent-Eligibility . Awaiting decision .

8 Momenta . 271(e)(1) Safe Harbor .. Response due May 2

9 Allcare v. Highmark Cybordj vu Response due Apr. 24

10 Lighting Ballast . Cybor dj vu . Awaiting argument .

Nokia [InterDigital] ITCDomestic Manufacture . Petition due May 10 `

Supreme Court Decisions this Term (All decisions 2013)

Case Issue Date

Al ready v. Nike Justiciable Controversy January 9

Gunn v. M inton Federal Court Jurisdiction February 20

Byrne v. Wood, Heron Federal Court Jurisdiction February 25

Ki rtsaeng v. John Wi ley International Exhaustion March 19

*About the List,see page 2.


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Wegners Top Ten Patent Cases [May 1, 2013]

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Supreme Court October 2012 TermRemaining Court Sessions for the October 2012 Term: May 13, 20 and 28 and

June 3, 10, 17 and 24; additional days to be announced.

Remaining Conferences for CertiorariVotes: May 9, 16, 23 and 30 and June 6,

13 and 20. (Decisions are expected at 9:30 AM on the date of the next regularlyscheduled session.)

Conference dates are announced for each case on the Supreme Court website,

which can be searched athttp://www.supremecourt.gov/docket/docket.aspx. A case

not scheduled for Conference will be taken up not earlier than September 30, 2013.

Oral Arguments: The next oral arguments will take place during the October2013 Term beginning October 7, 2013, that runs through June 2014.

About the List: Harold C. Wegner is solely responsible for this list. The author is

a former Professor of Law at the George Washington University Law School and is

currently a partner in the international law firm of Foley & Lardner LLP. Any

opinions or characterizations expressed in this paper represent the personalviewpoint of the author and do not necessarily reflect the viewpoint of anycolleague, organization or client thereof. The writer acknowledges participation

for an amicusparty in Top Ten No. (1)Myriad.
http://www.supremecourt.gov/docket/docket.aspxhttp://www.supremecourt.gov/docket/docket.aspxhttp://www.supremecourt.gov/docket/docket.aspxhttp://www.supremecourt.gov/docket/docket.aspx


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(1) Myriad101 Patent-Eligibility

TheMyriadcase,Association for Molecular Pathology v. Myriad Genetics, Inc.,

Supreme Court No. 12-398, challenges the split 2-1 Federal Circuit confirmation of

patent-eligibility under 35 USC 101 of claims to isolated DNA.

Status:Awaiting decision (argument April 15, 2013).

The Petition raised three Questions Presented. Certiorari was granted only as to

the first Question Presented:Question Presented (with Cert. Granted): Many patients seek genetic testing to

see if they have mutations in their genes that are associated with a significantly

increased risk of breast or ovarian cancer. Respondent Myriad [ ] obtained patentson two human genes that correlate to this risk, known as BRCA1 and BRCA2.

These patents claim every naturally-occurring version of those genes, including

mutations, on the theory that Myriad invented something patent-eligible simply by

removing (isolating) the genes from the body. Petitioners are primarily medical

professionals who regularly use routine, conventional genetic testing methods to

examine genes, but are prohibited from examining the human genes that Myriad

claims to own. This case therefore presents the following questions:

1. Are human genes patentable? ***

(2) Bowman v. MonsantoPatent SeedExhaustion

InBowman v. Monsanto Co., Supreme Court No. 11-796,proceedings below,

Monsanto Co. v. Bowman, 657 F.3d 1341 (Fed. Cir. 2011)(Linn, J.), Petitioner

challenges the denial of patent exhaustion as to harvested seeds produced from

patented plant technology, an issue discussed in Wegner,Post-Quanta, Post-Sale

Patentee Controls, IV-B-1, Restrictions on Reproduced Bio-Products: TheQuantaLoophole, 7 J. Marshall Rev. Intell. Prop. L. 682, 695-98 (2008), available

athttp://www.jmripl.com.php5-10.dfw1-2.websitetestlink.com/issues/article/173.

Status: Awaiting decision at some point before the end of June 2013; argued

February 19, 2013.
http://www.jmripl.com.php5-10.dfw1-2.websitetestlink.com/issues/article/173http://www.jmripl.com.php5-10.dfw1-2.websitetestlink.com/issues/article/173http://www.jmripl.com.php5-10.dfw1-2.websitetestlink.com/issues/article/173http://www.jmripl.com.php5-10.dfw1-2.websitetestlink.com/issues/article/173


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Question Presented: Patent exhaustion delimits rights of patent holders byeliminating the right to control or prohibit use of the invention after an authorized

sale. In this case, the Federal Circuit refused to find exhaustion where a farmer

used seeds purchased in an authorized sale for their natural and foreseeable

purpose - namely, for planting. The question presented is:

Whether the Federal Circuit erred by (1) refusing to find patent exhaustion inpatented seeds even after an authorized sale and by (2) creating an exception to the

doctrine of patent exhaustion for self-replicating technologies?

Discussion:Respondents counsel Seth Waxman gave one of his better

performances both in briefing and argument. Given the transcript of the argument,

it is difficult to see the exhaustion issue applied to a farmers making ofprogeny seed from purchased/patented Roundup Ready seed.

(3) FTC v. Actavis(AndroGel)ANDA Reverse Payments

InFTC v. Actavis, Inc., Supreme Court No. 12-416, opinion below, 677 F.3d 1298(11th Cir. 2012), the Court is reviewing theAndroGelANDA reverse payment

settlement case. Justice Alito is recused.

Status: Awaiting decision (argument March 25, 2013).

Question Presented: Federal competition law generally prohibits an incumbentfirm from agreeing to pay a potential competitor to stay out of the market. See

Palmer v. BRG of Ga., Inc., 498 U.S. 46, 49-50 (1990). This case concerns

agreements between (1) the manufacturer of a brand-name drug on which themanufacturer assertedly holds a patent, and (2) potential generic competitors who,

in response to patent-infringement litigation brought against them by themanufacturer, defended on the grounds that their products would not infringe the

patent and that the patent was invalid. The patent litigation culminated in a

settlement through which the seller of the brand-name drug agreed to pay its

would-be generic competitors tens of millions of dollars annually, and those

competitors agreed not to sell competing generic drugs for a number of years.Settlements containing that combination of terms are commonly known asreverse payment agreements. The question presented is as follows:


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Whether reverse-payment agreements are per se lawful unless the underlyingpatent litigation was a sham or the patent was obtained by fraud (as the court below

held), or instead are presumptively anticompetitive and unlawful (as the Third

Circuit has held).

Possibility of a 4-4 Nonprecedential Affirmance: The recusal of one of the

members of the Court (Alito, J.) leaves open the possibility of a nonprecedential tievote. If that were to occur, Top Ten No. (4)Merck, currently being held for a

certiorari vote afterActavis is decided, could well be a vehicle to break the 4-4 tie.

(4) Merck(K-Dur)-- ANDA Reverse Payments

Merck & Co., Inc. v. Louisiana Wholesale Drug Co., Inc., Supreme Court No. 12-245, and Upsher-Smith Laboratories Inc. v. Louisiana Wholesale Drug Co., Inc.,

Supreme Court No. No. 12-265, each involve ANDA reverse payment settlement

decisions in conflict with No. (3)FTC. v. Actavis, which will be argued March

25th with a merits decision by the end of June 2013.

Status: It is apparent that both Merck is being held forcertiorari review

following a merits decision inFTC v. Actavis. If there is a precedential opinion in

Actavis, the possibility for a GVR outcome forMerckremains open.

Possibi l i ty this Case could break a 4-4 Tie Vote in Actavis: If theActavis

decision is a 4-4 nonprecedential tie decision, it is conceivable that certiorari

might well be granted in theMerckcase to break the tie. Ifcertiorari is granted in

this case, briefing would take place over the summer with argument in the October

2013 Term that runs through June 2014.

Question Presented in Merck: Whether the federal antitrust laws permit a brandname manufacturer that holds the patent for a drug to enter into a settlement of

patent litigation with a prospective generic manufacturer, where the settlementincludes a payment from the brand manufacturer to the generic manufacturer but

does not exclude competition beyond the scope of the patent.


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(5) L imelight v. AkamaiJoint Indirect Infringement

The Federal Circuit split 6-5: Or was it 7-4? .see A 6-5 (or 7-4) Fractured Federal Circuit, pp. 10-11 .

In Limelight Networks, Inc. v. Akamai Techs., Inc., Supreme Court No. 12-786,

opinion below, Akamai Techs., Inc. v. Limelight Networks, Inc., 692 F.3d 1301

(Fed. Cir. 2012)(en banc)(per curiam), active inducement infringement of a

combination claim was found under 35 USC 271(b) despite the fact that no

single party performed each and every element of the combination so that there

was no direct infringer under 35 USC 271(a). The six vote per curiam majority

was offset by five dissents that challenged a ruling of induced infringement in the

absence of an act of direct infringement. (One critic recasts a dissenting opinion as

a concurrence that creates a fractured vote of 7-4 instead of 6-5, as discussed in the

box, infra, A 6-5 (or 7-4) Fractured Federal Circuit.

Status:A vote whether to grant certiorari is expected before the end of June 2013.

(Respondents petition stage filing took place April 3, 2013.)

CertiorariToday or Downstream: It is clear that at some point the Supreme

Court will grant certiorari to review the manifest judicial legislation exhibited by

the majority inAkamai. Whether that occurs in this case is unclear, given that the

Court accepts only about one (1) percent of all cases where a petition for review is

filed.

Question Presented in L imelight:[The patent claims] a method involving

redirecting requests for Internet content and selecting optimal servers. The FederalCircuit acknowledged that neither [the accused infringer] nor customers using [the

accused infringer's service directly infringe [the] patent under 35 U.S.C. 271(a)

because no one performs all the steps of the patented method. The Federal Circuit

nevertheless held that [the accused infringer] could be liable, under 35 U.S.C.

271(b), for inducing infringement if (1) it knew of [the] patent; (2) it performed


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all but one of the steps of the method; (3) it induced its customers to perform the

final step of the claimed method; and (4) the customers performed that step. The

question presented is:

Whether the Federal Circuit erred in holding that a defendant may be held liable

for inducing patent infringement under 35 U.S.C. 271(b) even though no one has

committed direct infringement under 271(a).

Question Presented in L imelight (per Akamai): The question on which

Limelight seeks certiorari mischaracterizes the Federal Circuit's holding below

inAkamai by asserting that the Federal Circuit held that a party can be liable for

induced infringement under 35 U.S.C. 271(b) where no one directly infringes

the claim. This assertion is not correct. InAkamai, the en banc Federal Circuitexplicitly held that a determination of induced infringement requires a showing of

direct infringement. Contrary to Limelight's assertion, the en banc court merely

overruled a portion of a recent 2007 decision, which incorrectly held that, for a

party to be liable for induced infringement, somesingle entity must be liable for

direct infringement under 35 U.S.C. 271(a). Properly read,Akamai merely

corrected the bizarre result created by this recent precedent, which allowed a

party that induced infringement of a method claim to escape all liability for

infringement so long as it itself performed one step of the method. Accordingly, a

more accurate representation of the question presented is:

Whether the Federal Circuit correctly held that a determination of induced

infringement under 271(b) does not require a predicate finding that a single entity

was liable for infringement under 271(a), under circumstances where all of the

steps of a method claim are performed, but the inducer performs some steps itself

and induces another to perform the remaining steps?

The Wisdom of the late Giles Suther land Rich: Upon enactment of the 1952

Patent Act, the principal architect of 35 USC 271 in his seminal analysis of that

section of the patent law made it clear that there mustbe an act of direct

infringement by a third party for liability to attach to an active inducer:


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Active inducement implies that there is not a directinfringement by the one doing

the inducing and that the direct infringement was by another. Giles S. Rich,

Infringement Under Section 271 of the Patent Act of 1952, 21 Geo. Wash. L. Rev.

521, 541 (1953)(emphasis added).

Clearly, the inducer cannot be a direct infringer: Reliance on [35 USC 271(b)]

as a basis for liability is in itself a clear indication that the party held liable is not a

directinfringer and if he is to be called any kind of an infringer there is no

applicable recognized term except contributory infringer. Id. (original

emphasis)

Limelights Argument: The Federal Circuit's holding that [the accused infringer]may be liable, under 35 U.S.C. 271(b), for inducing infringement of [the] patent

even though no party directly infringed the patent under 271(a) conflicts with this

Court's holding, repeatedly reaffirmed, that ifthere is no directinfringement of a

patent there can be no [indirect] infringement.Aro Mfg. Co. v. Convertible Top

Replacement Co.,365 U.S. 336, 341 (1961) (Aro I) (referring to principle as a

fundamental precept ofpatent law);see Global-Tech Appliances, Inc. v. SEB

S.A., 131 S. Ct. 2060, 2065 (2011);Deepsouth Packing Co. v. Laitram Corp., 406

U.S. 518, 526 (1972);Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U.S.476, 483 (1964);see also Dawson Chem. Co. v. Rohm & Haas Co., 448 U.S. 176

(1980);Mercoid Corp. v. Mid-Continent Inv. Co., 320 U.S. 661, 677 (1944)

(Frankfurter, J., dissenting).

Akamais Argument Presented in the Conditional Appeal: Akamai boldly

argues that the all elements rule does not apply in the case where a partyperforms fewer than all the elements of a combination claim. The earliest Supreme

Court case cited isWarner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co.,

520 U.S. 17 (1997). The green paper attached as an appendix (Akamai: Origins ofthe All Elements Rule) focuses upon the origins of the all elements rule in

Barrett v. Hall, 2 F.Cas. 914 (No. 1047)(D. Mass. 1818)(Story, J.), 180 years

before Warner-Jenkinson.


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A Deeply Fractured Federal Cir cuit: The senior member of the Court explains:

This en banc court has split into two factions, neither of which resolves the issues

of divided infringement. A scant majority of the court adopts a new theory of

patent infringement, based on criminal law, whereby any entity that advises,encourages, or otherwise induces, or causes, urges, encourages, or aids the

infringing conduct, is liable for the infringing conduct. The majority further holds

that only the inducer is liable for divided infringement, and that the direct

infringers are not liable although the patent rights are plainly being violated by the

actors' joint conduct. These are dramatic changes in the law of infringement.

On this new inducement-only rule, the inducing entity is liable on greatly

enlarged grounds, such as merely advising or encouraging acts that may constitute

direct infringement. This new rule is not in accordance with statute, precedent, andsound policy. It raises new issues unrecognized by the majority, and contains vast

potential for abuse. Akamai, 692 F.3d at 1319 (Newman, J., dissenting).

The second senior-most member of the four dissenting judges (who has himselfnow taken senior status) explains the former majority viewpoint:

[T]his court assumes the mantle of policy maker. It has decided that the plain text

of 271(a) and (b) fails to accord patentees certain extended rights that a majorityof this court's judges would prefer that the statute covered. To correct this situation,

the majority effectively rewrites these sections, telling us that the terminfringement was not, as was previously thought, defined by Congress in

271(a), but instead can mean different things in different contexts.

The majority's approach is contrary to both the Patent Act and to the SupremeCourt's longstanding precedent that if there is no direct infringement of a patent

there can be no contributory infringement.Aro Mfg. Co. v. Convertible TopReplacement Co., 365 U.S. 336, 341 (1961);Deepsouth Packing Co. v. Laitram

Corp., 406 U.S. 518, 526 (1972) (quotingMercoid Corp. v. MidContinent Co. (

Mercoid I), 320 U.S. 661, 677 (1944) (Frankfurter, J., dissenting on othergrounds));see also Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 774 (Fed.Cir.1993)(Liability for either active inducement of infringement or for contributory

infringement is dependent upon the existence of direct infringement.); C.R. Bardv. Advanced Cardiovascular Sys., Inc.,911 F.2d 670, 673 (Fed.Cir.1990) (same).

Akamai, 692 F.3d at 1337 (Linn, J., joined by Dyk, Prost, OMalley, JJ.).


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Two Cr itical Votes by the Two Newest Members of the Federal Ci rcui t: The

Federal Circuit is a court in transition. What was once was an apparent solid

majority for the viewpoint of what became the dissent in the opinion below was

swung to a 6-5 per curiam majority thanks to the votes of the two newest membersof the Court, Wallach, Reyna, JJ. With the possible exception of the senior

member of the Court, the penultimate member of the Court has the highest ratio of

separate opinionsconcurring, dissenting (or concurring dubitante)versus

majority opinions of any member of the Court. Both have taken a positive attitude

to become deeply involved with the most important matters of the Court, a sharp

departure from a generation ago when newer members of the Court were reluctant

to vote foren banc consideration of cases; it was then very difficult to obtain

review of clear conflicts within the Circuit. This was perhaps best manifested by

the conflict between Scripps Clinic & Research Found. v. Genentech, Inc., 927

F.2d 1565 (Fed.Cir.1991), and Atlantic Thermoplastics Co. v. Faytex Corp.,

970 F.2d 834 (Fed.Cir.1992).

The Court repeatedly refused to resolve this conflict through an en banc

proceeding, e.g., SmithKline Beecham Corp. v. Apotex Corp., 453 F.3d 1346 (Fed.

Cir. 2006)(Order den. rehg en banc). The conflict was only finally resolved

seventeen (17) years afterAtlantic Thermoplastics inAbbott Laboratories v.

Sandoz, Inc.,566 F.3d 1282 (Fed. Cir. 2009)(en banc)(Rader, J.).

A 6-5 (or 7-4) Fractured Federal Circuit: Five of the eleven judges dissented.

An esteemed colleague has suggested that there were actually seven members in

the majority, which would count one of the votes in the dissenting column as part

of the majority. Cf.Akamai Technologies, Inc. v. Limelight Networks, Inc., 692

F.3d 1301, 1310 (Fed.Cir.2012)(en banc)(Newman, J., dissenting)(I respectfully

dissent.).


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The cited jurists dissent focused upon the majoritys judicial legislation, in

common with the other dissent in the case: Issues of induced infringement are not

new, but this aspect is ill served by the majority's distortion of the inducement

statute, 35 U.S.C. 271(b), and has no support in theory or practice. This new rule

simply imposes disruption, uncertainty, and disincentive upon the innovation

communities. Id.(emphasis added). To be sure, the dissent could have elected to

style the opinion as a concurrence in the result insofar as the resultsought by the

dissent was achieved by the majority.

(6) Akamai v. L imelightJoint Direct Infringement

InAkamai Techs., Inc. v. Limelight Networks, Inc., Supreme Court No. 12-960,

opinion below, Akamai Techs., Inc. v. Limelight Networks, Inc., 692 F.3d 1301

(Fed. Cir. 2012)(en banc)(per curiam), the winning party in theAkamai case below

has filed a conditionalpetition forcertiorari to hedge its bets in case the Supreme

Court agrees with Petitioner inLimelight Networks, Inc. v. Akamai Techs., Inc.,

Supreme Court No. 12-786,supra.

Question Presented in Akamai :Whether a party may be liable for infringement

under either 35 U.S.C. 271(a) or 271(b) where two or more entities jointogether to perform all of the steps of a process claim?

Status:The Respondents brief is due May 6, 2013.

(7) CLS Bank:Software Patent-Eligibility

CLS Bank Intern. v. Alice Corp. Pty. Ltd., 484 Fed.Appx. 559 (Fed. Cir. 2012)(enbanc)(Order), vacated panel opinion, 685 F.3d 1341 (Fed. Cir. 2011)(Linn, J.)

Status:Awaiting decision following en banc argument.

The Order identifies two issues for briefing and presumably for a decision by the

en banc Court:


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The parties are requested to file new briefs addressing the following questions:

a. What test should the court adopt to determine whether a computer-implemented

invention is a patent ineligible abstract idea; and when, if ever, does thepresence

of a computer in a claim lend patent eligibility to an otherwise patent-ineligible

idea?

b. In assessing patent eligibility under 35 U.S.C. 101 of a computer-

implementedinvention, should it matter whether the invention is claimed as a

method, system, or storage medium; and should such claims at times be considered

equivalent for 101 purposes?

CLS Bank, 484 Fed.Appx. at 559-560.

Based upon recent precedent from the Federal Circuit one may expect a fractured

court where it is difficult to determine prospectively who will be in the majority.

The division within the Court is signaled by the opinion of the third member of the

CLSpanel:

The majority resists the Supreme Court's unanimous directive to apply the

patentable subject matter test with more vigor. Worse yet, it creates an entirely new

framework that in effect allows courts to avoid evaluating patent eligibility under

101 whenever they so desire. I too find it difficult to answer the questionspresented here with absolute certainty. Nonetheless, I believe that precedent and

common sense counsel that the asserted patent claims are abstract ideas repackaged

as methods and systems.

CLS Bank, 685 F.3d at 1356 (Prost, J., dissenting). The dissenting member of the

panel notes that:

When it comes to subject matter patentability, we do not write on a blank slate.

Just a few months ago, the Supreme Court reversed us in a 101 case for a secondtime in its last three terms, hinting (not so tacitly) that our subject matter

patentability test is not sufficiently exacting.Mayo Collaborative Servs. v.

Prometheus Labs., Inc., 132 S.Ct. 1289 (2012); Bilski v. Kappos, 130 S.Ct. 3218

(2010);see also WildTangent, Inc. v. Ultramercial, LLC, 132 S.Ct. 2431 (2012),

granting cert., vacating, and remanding Ultramercial, LLC v. Hulu, LLC, 657 F.3d


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1323 (Fed.Cir.2011). The Court once again iterated that the prohibition against

patenting abstract ideas cannot be circumvented by attempting to limit the use of

the formula to a particular technological environment.Prometheus, 132 S.Ct. at

1294 (quotingBilski, 130 S.Ct. at 3230). But this time the Court also made clearwhat had been written between the lines before: It is not sufficient to put an

abstract idea into use with [p]urely conventional or obvious' pre-solution

activity. Prometheus, 132 S.Ct. at 1298; cf. Bilski, 130 S.Ct. at 3231 (noting that

the claimed invention was directed at a fundamental economic practice long

prevalent in our system of commerce);Parker v. Flook, 437 U.S. 584, 594 (1978)

(Respondent's process is unpatentable under 101, not because it contains a

mathematical algorithm as one component, but because once that algorithm is

assumed to be within the prior art, the application, considered as a whole, contains

no patentable invention.). The Court accordingly declined the Solicitor General's

invitation to leave the screening of low quality patents to 102 and 103, even

though the government promised that the claims are likely invalid under those

provisions. Brief for the United States as Amicus Curiae in Support of Neither

Party at 9, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289

(2012). Now there is no doubt that to be patent eligible under 101, the claims

must include an inventive concept.Prometheus, 132 S.Ct. at 1294.

CLS Bank, 685 F.3d at 1356-57 (Prost, J., dissenting)

(8) MomentaANDA Safe Harbor

Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., Supreme

Court No. No. 12-1033, opinion below, 686 F.3d 1348 (Fed. Cir. 2012)(Moore, J.),questions the scope of the ANDA safe harbor under 35 USC 271(e)(1).

Question Presented: The Drug Price Competition and Patent Term Restoration

Act, also known as the Hatch-Waxman Act, created a safe harbor from liability forpatent infringement. The statutory safe harbor provides that it shall not be an act ofpatent infringement to make or use a patented invention solely for uses reasonably

related to the development and submission of information under a Federal lawwhich regulates the manufacture, use, or sale of drugs. 35 U.S.C. 271(e)(1). Thesafe harbor allows competitors, prior to the expiration of apatent, to engage in

otherwise infringing activities necessary to obtain regulatory approval from the


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Food and Drug Administration (FDA).Eli Lilly & Co. v. Medtronic, Inc., 496U.S. 661, 671 (1990). In this case, the Federal Circuit held that the safe harbor

immunizes respondents' use of petitioners' patented method in the course of post-

approval manufacturing of respondents' drug for commercial sale, in direct

competition with petitioners, during and throughout the life of petitioners' patent.

The question presented is:Whether the use of a patented invention in the course of post-approval

manufacture of a drug for commercial sale, where the FDA requires that a record

of that manufacturing activity be maintained, is exempted from liability for patent

infringement under Section 271(e)(1) as solely for uses reasonably related to thedevelopment and submission of information under a Federal law which regulates

the manufacture, use, or sale of drugs.

Status: Response to the petition is due May 2, 2013. A certiorari vote isexpected during the current Term. If granted, the case would be entertained in theOctober 2013 Term that runs through June 2014.

A Fractured Federal Cir cuit Panel Below: Adding fuel to the fire for grant of

certiorari is the blistering, nearly 8000 word dissent. Momenta, 686 F.3d at 1361-75 (Rader, C.J., dissenting).

The tenor of the dissent is seen from the statement that [accused infringer]

Amphastar *** delights in trespassing [on the patent right] and refuses to pay areasonable royalty to make the trespass lawful. This court would allow this

arrogance to continue by expanding the limited reach of35 U.S.C. 271(e)(1).686 F.3d at 1362.

The author is the one person on the Court with intimate, contemporary knowledge

of the legislative enactment of the statutory safe harbor under review, 35 USC 271(e)(1). He parenthetically adds that I hesitate to add that I was present through

this legislative process[.] 686 F.3d at 1366.

Does Legislative H istory Tr ump Statutory Wording?Whether the legislativehistory as explained by the Chief Judge is correct is not the primary issue. Thefirst question is whether the statutory language compels resort to the legislative

history. See Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), asanalyzed by this writer. Wegner,Post-MerckExperimental Use and the

SafeHarbor, 15 Fed. Cir. B.J. 1 (2005).
http://web2.westlaw.com/find/default.wl?mt=208&db=1000546&docname=35USCAS271&rp=%2ffind%2fdefault.wl&findtype=L&ordoc=2028340011&tc=-1&vr=2.0&fn=_top&sv=Split&tf=-1&referencepositiontype=T&pbc=55E60148&referenceposition=SP%3b06a60000dfdc6&rs=WLW13.01http://web2.westlaw.com/find/default.wl?mt=208&db=1000546&docname=35USCAS271&rp=%2ffind%2fdefault.wl&findtype=L&ordoc=2028340011&tc=-1&vr=2.0&fn=_top&sv=Split&tf=-1&referencepositiontype=T&pbc=55E60148&referenceposition=SP%3b06a60000dfdc6&rs=WLW13.01http://web2.westlaw.com/find/default.wl?mt=208&db=1000546&docname=35USCAS271&rp=%2ffind%2fdefault.wl&findtype=L&ordoc=2028340011&tc=-1&vr=2.0&fn=_top&sv=Split&tf=-1&referencepositiontype=T&pbc=55E60148&referenceposition=SP%3b06a60000dfdc6&rs=WLW13.01


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(9) Al lcare v. H ighmark: CyborDj vu

InAllcare Health Mgmt. Sys., Inc. v. Highmark Inc., Supreme Court 12-1163,

proceedings below, Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., 701 F.3d

1351 (Fed. Cir. 2012)(Order den. pet. for rehg en banc),panel opinion, 687 F.3d

1300 (Fed. Cir. 2012), the en bancpetitioner unsuccessfully sought review of the

de novo standard of review for a fact-based determination, here, an exceptional

case determination under 35 USC 285.

Status:Response was due April 24, 2013. A Conference to vote whether to grantcertiorari is expected in either May or June.

A Deeply Fractured En Banc Panel:Plural dissenting opinions were issued

dissenting from denial of rehearing en banc, including a principal opinion byMoore, J., joined by Rader, C.J., OMalley, Reyna, Wallach, JJ., dissenting from

the denial of the petition for rehearing en banc. This is only the latest episode in athirty year struggle by the Court to deal with FRCP 52(a) deferential standard of

review of trial court fact findings.

Rule 52(a) has troubled the Federal Circuit since its inception. The issue wassquarely raised by the Supreme Court in its intervention inDennison Mfg. Co. v.

Panduit Corp., 475 U.S. 809 (1986). Here, the controversy first bubbled up intowidespread public attention in the context of the factual underpinnings for an

obviousness determination under 35 USC 103.

The current dispute is capsulized by the main dissent inHighmarkby JudgeMoore:

Our court system has well-defined roles: the trial court makes factual findings

and the appellate court reviews those findings with deference to the expertise of thetrial court. An exceptional case determination under 35 U.S.C. 285 has

traditionally been one of the questions of fact determined by the trial court that isreviewable only for clear error. Contrary to our precedent, the dividedHighmark

panel decided that a district courts exceptional case findingbased on its

determination that the infringement claims asserted at trial were objectively

baselessis entitled to no deference and should be reviewed de novo.Highmark,[687 F.3d at 1309-10].


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BecauseHighmark* * * invades the province of the fact finder, and establishes a

review standard for exceptional case findings in patent cases that is squarely at

odds with the highly deferential review adopted by every regional circuit and the

Supreme Court in other areas of law, I dissent from the denial of rehearing enbanc.

* * *

We need to avoid the temptation to label everything legal and usurp the province

of the fact finder with our manufactured de novo review. We have done it with

claim construction,see Cybor[Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454-55(Fed. Cir. 1998) (en banc)], with willfulness,see Bard[Peripheral Vascular, Inc.

v. W.L. Gore & Assocs., 682 F.3d 1003 (Fed. Cir.2012)], and now with the

exceptional case,see Highmark. When we convert factual issues, or mixedquestions of law and fact, into legal ones for ourde novo review, we undermine theuniformity and predictability goals this court was designed to advance.

CCPA Genesis of the Rule 52(a) Contr oversy: Throughout its thirty year history

the Federal Circuit has had great difficulty coming to grips with FRCP 52(a)deferential review of factual determinations in patent matters.

The dean of the Federal Circuit early on explained that the predecessor CCPA hada laxstandard of review of Patent Office decisions: One of the things that

changed in the transition from CCPA to CAFC is much greater emphasis in thenew court on standard of review. Giles S. Rich, Thirty Years of this Judging

Business, Giles S. Rich 139, 148 (1986).

The Supreme Court Speaks in Dennison: The first open confrontation with theSupreme Court occurred four years after creation of the Federal Circuit in

Dennison:

The Federal Circuit [in its obviousness ruling] did not mention Rule 52(a), didnot explicitly apply the clearly-erroneous standard to any of the District Court's

findings on obviousness, and did not explain why, if it was of that view, Rule 52(a)had no applicability to this issue. We therefore lack an adequate explanation of the

basis for the Court of Appeals' judgment: most importantly, we lack the benefit of

the Federal Circuit's informed opinion on the complex issue of the degree to which

the obviousness determination is one of fact.In the absence of an opinion clearly setting forth the views of the Court of Appeals

on these matters, we are not prepared to give plenary consideration to petitioner's


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claim that the decision below cannot be squared with Rule 52(a). Instead, we grantthe petition for certiorari, vacate the judgment, and remand the case to the Court of

Appeals for further consideration in light of Rule 52(a). Dennison Mfg. Co. v.

Panduit Corp., 475 U.S. 809, 811 (1986).

Judge Rich took to the pages of theAIPLA Quarterly Law Journalto respond to

the Supreme Court:

[The CCPA] did not act like the Circuit Courts of Appeal. We have been breaking

that habit. Meanwhile, the criticism I hear of the [Federal Circuit] most often is

that we have been doing de novo fact finding and delving into the record on ourown when we should not. I am probably one of the offenders. But I have to say that

I do not know how one can decide whether a finding of fact is clearly erroneous

without delving into the record, and surely we have the right to make such adecision. I also must say that I have great difficulty in determining the distinctionbetween an alleged fact being wrong and being clearly erroneous, and I seem to

remember a learned colleague saying It doesn't matter; if you want to upset thefact finding, you just have to use the magic words. Rich, 14 AIPLA Q. J. at 149.

(10) L ighting BallastCybor de novoAppellate Claim Construction

The Federal Circuit has granted en banc review to consider the Cyborissue in

Lighting Ballast Control LLC v. Philips Electronics North America Corp.,__ Fed.Appx __, 2013 WL 1035092 (Fed. Cir. 2013)(en banc)(Order).

Status: Awaiting scheduling of oral argument.

Issues: The parties and amici are requested to brief the following three issues:

a. Should this court overrule Cybor Corp. v. FAS Technologies, Inc., 138 F.3d

1448 (Fed.Cir.1998)?

b. Should this court afford deference to any aspect of a district court's claimconstruction?

c. If so, which aspects should be afforded deference?

This case is being covered by litigation expert Justin Gray on GrayOnClaims.com


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NokiaITC Domestic Manufacture

Nokia v. v. International Trade Com'n, Supreme Court No. 12A933, opinion below,

InterDigital Communications, LLC v. International Trade Com'n, __ F.3d __ (Fed.

Cir. 2013)(on panel rehg), vacated panel opinion, 690 F.3d 1318 (2012),is the

expected certioraripetition will challenge ITC jurisdiction to consider patent

infringement withoutdomestic manufacture.

Status: The Petition forcertiorari is due May 10, 2013.

From the Majori ty Opinion below: [S]ection 337 makes relief available to a

party that has a substantial investment in exploitation of a patent through either

engineering, research and development, or licensing. It is not necessary that the

party manufacture the product that is protected by the patent, and it is not

necessary that any other domestic party manufacture the protected article.

As long as the patent covers the article that is the subject of the exclusion

proceeding, and as long as the party seeking relief can show that it has a

sufficiently substantial investment in the exploitation of the intellectual property to

satisfy the domestic industry requirement of the statute, that party is entitled to

seek relief under section 337. InterDigital,__ F.3d at __.

From the Dissenting Opinion: My colleagues depart from the statutory text and

purpose, in holding that the statutory requirement of domestic industry does not

require domestic manufacture. The statute says, twice, that there must be articles

protected by the patent, 1337(a)(2), (a)(3), whether produced by the patentee, or

under license from the patentee. The domestic industry requirement is not met byforeign manufactures. InterDigital,__ F.3d at __(Newman, J., dissenting).

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