anticipation by inherency - intellectual property and ... anticipation by inherency... ·...

Mark S. Ellinger, Ph.D., J.D.

Senior Principal

Fish & Richardson P.C.

March 9, 2011

Anticipation by Inherency

What Are We Talking About?

“Humans lit fires for thousands of years before realizing that oxygen is

necessary to create and maintain a flame. The first person to discover

the necessity of oxygen certainly could not have obtained a valid patent

claim for „a method of making a fire by lighting a flame in the presence

of oxygen.‟ Even if prior art on lighting fires did not disclose the

importance of oxygen and one of ordinary skill in the art did not know

about the importance of oxygen, understanding this law of nature

would not give the discoverer a right to exclude others from practicing

the prior art of making fires.”

- EMI Group N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d

1342 (Fed. Cir. 2001)

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Anticipation by Inherency: The Basics

Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (Fed. Cir. 2003):

“A patent is invalid for anticipation if a single prior art reference discloses each and every limitation of the claimed invention [quoting Lewmar Marine]. Moreover, a prior art reference may anticipate without disclosing a feature of the claimed invention if that missing

characteristic is necessarily present, or inherent, in the single anticipating reference. [quoting Continental Can]”

“[T]his court rejects the contention that inherent anticipation

requires recognition in the prior art.”

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A. Accidental vs. Inherent Anticipation

1. Tilghman v. Proctor, 102 U.S. 707 (1880)

• patent claims to process for separating components of fats and

oils, including “fat acids” useful in making candles and soaps,

using high heat and pressure in the presence of water

• prior art: animal fat employed to lubricate pistons of steam

engine, possibly producing fatty acids

• Court: if acids were “accidentally” and “unwittingly” produced,

while operators were in pursuit of other and different results, and

without knowledge of claimed result, no anticipation

Case Highlights

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2. Eibel Process Co. v. Minnesota & Ontario Paper

Co., 261 U.S. 45 (1923)

• claims to improved paper-making machine, with elevated pitch

of the paper-forming wire mesh

• prior art: paper-making machines that had pitched wire meshes,

for drainage purposes

• Court found that any sufficiently “high” pitches in prior art

machines were unusual, since pitch needed for drainage was

small

• “accidental results, not intended and not appreciated, do not

constitute anticipation”

Case Highlights

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3. In re Marshall, 578 F.2d 301 (C.C.P.A. 1978)

• claims to process for achieving weight loss by periodically

administering an anesthetic (e.g., oxethazaine) prior to eating

• prior art: taught use of oxethazaine to treat colitis, ulcers and

other gastro-intestinal problems by dosing periodically prior to

eating and at bedtime

• Court: “Nothing in the [prior art reference] remotely suggests

taking oxethazaine to lose weight. If anyone ever lost weight by

following the [prior art] teachings, it was an unrecognized

accident. An accidental or unwitting duplication of an invention

cannot constitute an anticipation.”

Case Highlights

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4. Additional cases – products and processes:

• In re Seaborg, 328 F.2d 996 (C.C.P.A. 1964)

• In re Felton, 484 F.2d 495 (C.C.P.A. 1973)

• Verdegaal Bros., Inc. v. Union Oil Co. of Cal., 814 F.2d 628

(Fed. Cir. 1987)

• Continental Can Co. U.S.A. v. Monsanto Co., 948 F.2d 1264

(Fed. Cir. 1991)

• MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362 (Fed.

Cir. 1999)

• Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342 (Fed. Cir. 1999)

Case Highlights

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4. Additional cases (cont.):

• In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed. Cir.

2002).

• Elan Pharms., Inc. v. Mayo Found. for Med. Educ. &

Research, 304 F.3d 1221 (Fed. Cir. 2002), vacated and reh’g

granted, 314 F.3d 1299 (Fed. Cir. 2002) (en banc), substituted

opinion, 346 F.3d 1051 (Fed. Cir. 2003)

• Schering Corp. v. Geneva Pharms., 339 F.3d 1373 (Fed. Cir.

2003)

• SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331

(Fed. Cir. 2005)

Case Highlights

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• Difficult to reconcile

• Difficult to come up with consistent criteria for distinguishing

accidental from inherent anticipation

• Criteria to consider:*

• Was the prior art product or process useful (did it benefit the public)?**

• But note: SmithKline v. Apotex (2005) calls this into question (see

next PowerPoint)

• Was the product obtained, or did the process occur, under “unusual”

conditions?

* See, Anne Brown & Mark Polyakov, The Accidental and Inherent Anticipation

Doctrines: Where Do We Stand and Where Are We Going?, 4 J. MARSHALL REV.

INTELL. PROP. L. 63 (2004).

** See, Dan Burk & Mark Lemley, Inherency, 47(2) William and Mary Law

Review 371 (2005).

Case Highlights

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• SmithKline v. Apotex

• Claims to paroxetine hydrochloride hemihydrate

• Found inherently anticipated by prior disclosure of processes for

preparing the anhydrous form that necessarily resulted in formation

of at least trace amounts of the hemihydrate

• “Trace amounts” – useful? Has the public benefited?

Case Highlights

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B. Recognition by a Person of Ordinary Skill

Two lines of cases:

1. PHOSITA recognition required: Continental Can

Co. USA v. Monsanto Co., 948 F.2d 1264 (Fed. Cir.

1991)

• Evidence “must make clear that the missing descriptive matter is

necessarily present in the thing described in the reference, and

that it would be so recognized by persons of ordinary skill.”

(emphasis added)

• Several subsequent Fed. Cir. opinions interpreted this to mean

that recognition by a PHOSITA had to have been within the prior

art time frame

Case Highlights

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2. PHOSITA recognition NOT required:

• Atlas Powder Co. v. IRECO, 190 F.3d 1342 (Fed. Cir. 1999)

• claims to composite explosives – with “sufficient aeration

entrapped”

• Prior art: same explosives; no explicit disclosure of sufficient

aeration entrapped limitation

• But, calculations showed that air was inevitably trapped; inherent

anticipation found

• “[i]nherency is not necessarily coterminous with the knowledge of

those of ordinary skill,” and insufficient understanding “does not

defeat a showing of inherency.”

Case Highlights

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2. PHOSITA recognition NOT required (cont.):

• Titanium Metals Corp. v. Banner, 788 F.2d 775 (Fed. Cir. 1985)

• Although the claimed alloy’s good corrosion resistance was

unknown in the prior art, this newly discovered property did not

“render the old composition patentably new.”

• MEHL/Biophile International Corp. v. Milgraum, 192 F.3d

1362 (Fed. Cir. 1999)

• Method claim for laser-induced hair depilitation was inherently

anticipated by a prior art publication teaching alignment of a laser

over hair follicles.

• That the authors did not appreciate the hair removal aspect was “of

no importance.”

Case Highlights

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2. PHOSITA recognition NOT required (cont.):

• In re Cruciferous Sprout Litigation, 301 F.3d 1343 (Fed. Cir.

2002)

• Claims to methods of preparing food products rich in glucosinolates, by

harvesting sprouts prior to the 2-leaf stage, to form a food product having a

plurality of sprouts.

• The prior art included the same sprouts, but did not evidence recognition of

the presence of glucosinolates with their cancer-fighting properties.

• Fed. Cir. held the claims invalid; since the inventors merely discovered

some inherent, unappreciated properties of the sprouts, the claims were

anticipated.

Case Highlights

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3. “Resolution” of the case law conflict:

• Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373 (Fed.

Cir.), review en banc denied, 348 F.3d 992 (Fed. Cir. 2003)

– Claims to a natural metabolite of loratadine (active ingredient of Claritin),

descarboethoxyloratadine (DCL)

– Prior art: Schering’s own earlier patent on loratadine, which taught

administration to humans

– Both parties agreed the claims covered DCl regardless of its method of

production, including metabolism of loratadine by the human body

– Fed. Cir. affirmed district court’s judgment of invalidity by inherent

anticipation

– Prior art taught administration of loratadine, which inevitably let to

production of DCL (according to Fed. Cir. majority)

Case Highlights

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3. “Resolution” of the case law conflict (cont.):

• Schering v. Geneva (cont.)

– Since DCL was a “natural result” of the prior art teachings, not an

“accidental” result of “unusual circumstances” (distinguishing Tilghman

and Eibel); this was a true inherent anticipation

– Schering was a case of first impression, because the prior art had NO

express disclosure of any part of the claimed subject matter; prior cases had

dealt with prior art PARTIAL disclosure where inherency supplied the

missing aspect(s)

– Nevertheless, Fed. Cir. saw no reason to limit the doctrine to gap filling; if

the inherent disclosure places the claimed invention in the public domain,

end of story

– The prior art disclosure also was enabling, since the claims covered all

forms of DCL, including the “naturally” produced metabolite of loratadine

(a prior art species anticipates a claimed genus)

Case Highlights

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– As a result of this decision, is it impossible to claim natural metabolites of

prior art drugs?

– Anticipating this question, the Schering court took pains, in dictum, to point

out claim drafting techniques that might avoid inherent anticipation:

» Claim a metabolite in pure/isolated form

» Claim as a pharmaceutical composition

» Claim methods of using/administering the metabolites/pharmaceutical

compositions

– Note: none of these alternative claims would have covered Geneva and the

other generics, because they wanted to sell generic loratadine only

Case Highlights

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– The “resolution” of the case law conflict:

» Continental Can had been misinterpreted: “[I]n Continental Can, this

court did not require past recognition of the inherent feature, but only

allowed recourse to opinions of skilled artisans to determine the scope

of the prior art reference.” (Judge Newman likely would disagree)

» Summary judgment was vacated in Continental Can not because past

recognition was required, but because there were conflicting expert

testimonies on the presence/absence of the inherent feature (hollow

ribs in a plastic bottle)

» In contrast, undisputed evidence showed that DCL necessarily formed

when loratadine was ingested

» Dissent by Judge Newman: recognition is required; dissents by Judges

Newman and Lourie in the denial of en banc review: the prior art

reference was not enabling

Case Highlights

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– Subsequent Fed. Cir. Cases generally have followed Schering with

respect to recognition by a person of ordinary skill, e.g.:

• Toro Co. v. Deere & Co., 355 F.3d 1313 (Fed. Cir. 2004)

– “Simply put, the fact that a characteristic is a necessary feature or

result of a prior-art embodiment (that is itself sufficiently described

and enabled) is enough for inherent anticipation, even if that fact

was unknown at the time of the prior invention.”

• SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331

(Fed. Cir. 2005)

– “[I]nherent anticipation does not require a person of ordinary skill

in the art to recognize the inherent feature in the prior art…”

Case Highlights

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• Abbott Labs v. Baxter Pharm. Prods., 471 F.3d 1363 (Fed. Cir.

2006)

– “Our cases have consistently held that a reference may anticipate

even when the relevant properties of the thing disclosed were not

appreciated at the time.”

• In re Omeprazole Patent Litigation, 483 F.3d 1364 (Fed. Cir.

2007)

– “Artisans of ordinary skill may not recognize the inherent

characteristics or functioning of the prior art.” [quoting In re

Cruciferous Sprout Litig.]

• Caution: Schering remains a panel decision; en banc hearing

denied

Case Highlights

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C. What does “necessarily” present mean?

• “Inherency, however, may not be established by probabilities or

possibilities. The mere fact that a certain thing may result from

a given set of circumstances is not sufficient.” [Continental Can]

• Some commentators have argued that the Fed. Cir. has not been

completely consistent on the “necessarily” requirement.*

*See, e.g., Janice Mueller and Donald Chisum, Enabling Patent Law’s Inherent

Anticipation Doctrine, 45 Houston Law Review 1101 (2008).

Case Highlights

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Case Highlights

• Novo Nordisk Pharms, Inc. v. Bio-Tech Gen. Corp., 424 F.3d 1347 (Fed.

Cir. 2005)

• Claims to process of producing “ripe” human growth hormone (hGH) using

genetically engineered E. coli, having a 191-amino acid sequence identical to that

of pituitary-purified hGH, and having the same biological activity

• Prior art reference disclosed another hGH protein derived from genetically

engineered monkey kidney cells

• Fed. Cir. concluded that production of the prior art protein must necessarily have

resulted in the claimed invention: tests disclosed in the reference indicated the

hGH protein had the same structure and activity as pituitary-purified form.

• As such, the prior art hGH necessarily had the 191-amino acid sequence and the

relevant biological activity.

• Claims held invalid for inherent anticipation.

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Case Highlights

• Atlas Powder

• Criticized by Mueller and Chisum as NOT satisfying what they term the

“inevitability” test for inherent anticipation:

• claims to composite explosives – with “sufficient aeration entrapped”

• Prior art: same explosives; no explicit disclosure of sufficient aeration entrapped

limitation

• Fed. Cir. asserted that calculations showed air was inevitably trapped in prior art

explosives

• Mueller & Chisum point out:

• Sufficient aeration was satisfied in some, but not all, cases (only when

numerical ranges of ingredients overlapped)

• Also, the prior art doc arguably taught away from air entrapment, teaching the

desirability of filling all spaces between particles to give added density; this

could be accomplished using particular grinding techniques, presumably known

in the art

• So, how certain was it that the claimed invention was “necessarily” present?

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Case Highlights

• In arguing for a heightened enablement standard for inherently anticipating

prior art, Mueller and Chisum also criticized the reasoning in Schering:

• They noted the Fed. Cir.’s statement that “DCL necessarily and inevitably forms

from loratadine under normal conditions, suggesting (to Mueller and Chisum)

that DCL might not have formed under “nonnormal” conditions.

• They also took note of the fact that the prior art patent described administration

of loratadine only in prophetic examples.

• They agreed with Judge Lourie’s dissent from denial of rehearing en banc, that

the “minimal, boilerplate” disclosure of the prior art patent was “hardly an

enabling disclosure of how to make any metabolites, whatever they might turn

out to be, sufficient to anticipate them by inherency.”

• They emphasized parts of the expert testimony record, discounted by the Fed.

Cir., questioning whether DCL actually always forms upon ingestion of

loratadine

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Case Highlights • But in most cases, the Fed. Cir. has adhered to a strict “necessarily

present” standard; e.g.,

• Toro v. Deere:

• Claimed technology related to lifting and fracturing soil, for better turf growth, by

injecting liquid into the soil at jet pressure

• Although the prior art had some overlapping features, the court found that Deere

failed to raise a genuine issue of material fact re whether the prior art always

performed the lifting and fracturing features; inherency not found

• In re Omeprazole Patent Litigation:

• Claims to process for making Prilosec® formulations with a core, a protective layer

around the core, and a separating layer between the core and protective layer

• In upholding the district court finding of inherent anticipation, the Fed. Cir. Stated:

“The district court did not settle for proof that in situ formation [of the separating

layer] could result [from the prior art process]…; rather, the district court credited

evidence that in situ formation does result [from the prior art process].”

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Case Highlights • MEHL/Biophile:

• Claims to use of laser aligned over hairs for depilitation

• Judge Rader noted: “It is not a question of probabilities as to whether a person of

ordinary skill following the teachings of the article will align the laser light applicator

over a hair follicle. The researchers focused their study on the epilated backs of

guinea pigs. No one disputes that guinea pigs have hairy backs. Indeed, the article

itself is replete with references to the irradiation of hair follicles and resulting

follicular damage.”

• In re Crish, 393 F.3d 1253 (Fed. Cir. 2004):

• Claims to purified DNA molecules comprising a recited sequence, having promoter

activity for the human involucrin gene

• Prior art: the same promoter had been isolated and engineered into a plasmid, but not

sequenced

• Fed. Cir.: “The starting material plasmid necessarily contains the gene of interest.”

• Fed. Cir.: “[J]ust as the discovery of properties of a known material does not make it

novel, the identification and characterization [by sequencing] of a prior art material

does not make it novel.”

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Scenarios

1. Claim to compound X, wherein X dissolves amyloid

plaques upon intravenous administration to humans.

- Identical X is in the prior art, used as a treatment for RA; no

disclosure in the prior art of treating Alzheimer’s or effects on

amyloid plaques

See, e.g., Titanium Metals, Crish

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Scenarios

2. Claim to method of treating Alzheimer’s disease by

intravenous administration of X

- All Alzheimer’s patients respond to X

- Only Alzheimer’s patients with gene polymorphism Q respond to

X (about 50% of Alzheimer’s patients)

- Prior art teaches treating 1,000 RA patients by intravenous

administration of X

- None of the RA patients had Alzheimer’s

- 10% of the RA patients had Alzheimer’s

- Alzheimer’s status of RA patients is unknown (and unknowable)

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Scenarios

3. Claim to metabolite Z of drug X

- Prior art states that drug X can be given to patients to treat RA; no

patients actually treated

- Prior art discloses actual treatment of 1,000 RA patients with X

- 100% (or 20%) of humans administered drug X produce metabolite

Z (discovered before vs. after claim’s priority date)

- 100% of humans administered drug X produce metabolite Z, but

only if the subjects have fasted for at least 5 hours prior to

administration (discovered before vs. after claim’s priority date)

See, e.g., Schering; see also, Glaxo Group Ltd. v. Teva Pharms. USA,

Inc., 2004 WL 1875017 (D. Del.), appeal dismissed 143 Fed. Appx.

361 (Fed. Cir. 2005)

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Scenarios

4. Claim to biological molecule X (e.g., polypeptide, nucleic

acid) having sequence Y

- Prior art discloses a purified version of X; no sequence provided

- X was available to the public more than one year prior to claim’s

priority date (e.g., via access to deposited, unsequenced version)

- X was not available to the public prior to claim’s priority date,

although prior art document discloses how X was obtained

- Different outcomes for specific MAb’s vs. other biological

molecules such as nucleic acids?

See, e.g., In re Crish

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Claim Strategies • Product claims (e.g., metabolites):

• E.g., see Schering dictum for pharmaceuticals:

• Claim a metabolite in pure/isolated form

• Claim as a pharmaceutical composition

• Claim methods of using/administering the metabolite/pharmaceutical

composition

• Claim (even slight) modification to product, e.g., label or other tag,

novel salt form, hydration form etc.

• Or, claim combinations of products not found in prior art, e.g.,

antibody with a vaccine adjuvant

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Claim Strategies • Process claims:

• A method of treating Alzheimer’s Disease by administering X (X in prior art as treatment for rheumatoid arthritis)

• Possible fixes:

• ID an Alzheimer’s patient in need of treatment

• Test for, or monitor, Alzheimer’s biomarkers before, during or after treatment

• Particular doses, timing regimens

• Administer X in combination with another agent (e.g., second drug)

• Kit claim with instructions for treating Alzheimer’s Disease (but see, In re

Ngai (Fed. Cir. 2004), and AstraZeneca v. Apotex (Fed. Cir. 2010), effectively

foreclosing reliance on the content of written instructions as the sole point of

novelty in a kit claim)

• Watch out for multiple party infringement issues

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Additional Useful Secondary

References:

Cynthia Chen, Schering Corp. v. Geneva Pharmaceuticals, Inc.:

Clarification of the Inherent Anticipation Doctrine and Its Implications, 20

Berkeley Technology Law Journal 95 (2005)

Alfredo De La Rosa, A Hard Pill To Swallow: Does Schering v. Geneva

Endanger Innovation Within the Pharmaceutical Industry? VIII The

Columbia Science and Technology Law Review 37 (2007)

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QUESTIONS?

Mark S. Ellinger

Senior Principal

Fish & Richardson P.C.

Minneapolis, MN

612-337-2504

[email protected]

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