patent - finals reviewer

7/26/2019 Patent - Finals Reviewer

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5. DISCLOSURE AND ENABLEMENT

TRIPS Agreement - Article 29

Conditions on Patent Applicants

1. Members shall require that an applicant for a patent

shall disclose the invention in a manner sufficiently clear

and complete for the invention to be carried out by a person skilled in the art and may require the applicant to

indicate the best mode for carrying out the inventionknown to the inventor at the filing date or, where priority

is claimed, at the priority date of the application.

2. Members may require an applicant for a patent to

provide information concerning the applicant'scorresponding foreign applications and grants.

IP Code - Section 35. Disclosure and Description of the

Invention. - !.1. "isclosure. - #he application shall

disclose the invention in a manner sufficiently clear and

complete for it to be carried out by a person skilled in the

art. $here the application concerns a microbiological process or the product thereof and involves the use of a

micro-organism which cannot be sufficiently disclosed in

the application in such a way as to enable the invention to

be carried out by a person skilled in the art, and such

material is not available to the public, the application shall

be supplemented by a deposit of such material with an

international depository institution.

!.2. "escription. - #he %egulations shall prescribe the

contents of the description and the order of presentation.

&ec. 1(, %.). *o. 1+!a

5.1 Undue Experimentation

ncandescent amp /atent &10!

- awyer and Man made a broad claim for every

fibrous or tetile material, when in fact an

eamination of over +333 vegetable growths

showed that none of them possessed the peculiar

qualities that fitted them for that purpose.

- f the description be so vg!e nd !ncertin that

no one can tell, ecept by independent

eperiments, how to construct the patent device,

the patent is void.- 4ow would it be possible for a person to know

what fibrous or tetile material was adapted to the

purpose of an incandescent conduct ecept by themost careful and painstaking eperimentation5

n re $ands &10

- "6/7# necessary for enablement where the

starting materials &i.e., living cells used to practice

the invention, or cells from which the required

cells can be produced are &1 not readily available

to the public8 7% &2 readily available but it woul

require undue eperimentation to make the cells o

the invention from the starting materials.

- #he keyword is 9undue,: not 9eperimentation.:

- "ctor# to be considered in determining whether

disclosure would require undue eperimentation;

1. <uantity of the eperimentation necessary8

2. )mount of the direction and guidanc

presented8

. /resence or absence of working eamples8(. *ature of the invention8!. tate of the prior art8

+. %elative skill in the art

=. /redictability or unpredictability of the ar

and

. >readth of the claims

- *ot undue eperimentation ? methods needed t

practice the invention were well known

5.2 Speculation and Prophesy

@anssen /harmaceutica v. #eva /harms. &2330

- /atent granted without the result of the anima

testing eperiments

- 6nablement is determined as of the effective filin

date of the patentAs application.

- f the patent claim fails to meet the utilit

requirement because it is not useful or operative

then it also fails to meet the how-to-use aspect o

the enablement requirement.

- 7nly an 9unproved hypothesis: - the specification

even read in light of the knowledge of thos

skilled in the art, does no more than state

$%&ot$e#i# and propose testing to determine th

accuracy of that hypothesis

5.3 Doctrine of Sound Prediction

)pote v. $ellcome Boundation &2332

- #he doctrine balances &1 the public interest i

early disclosure of new and useful inventioneven before their utility has been fully verified b

tests8 and &2 public interest in avoiding th

cluttering of the public domain with useles

patents and granting monopoly rights in echangfor speculation or misinformation.

- #hree components;

1. Bactual basis for the prediction8

2. nventor must have at the date of the paten

application an articulable and 9sound: line o

reasoning from which the desired result can b

inferred from the factual basis8 and

. /roper disclosure

- /resupposes that further work remains to be done

5. Uses of examples in the specification



n re trahilevitC &102

- $e recogniCe that working eamples are desirable

in comple technologies and that detailedeamples can satisfy the statutory enablement

requirement.

- *evertheless, eamples are not required to satisfy

enablement.

5.5 !ritten Description "e#uirement

Dsell v. Eap-@ue &1030

- "octrine of mechanical equivalents ? )n alteration

in a patented combination which merely

substitutes another old ingredient in the patented

combination, is an infringement of the patent, if

the substitute performs the same function and was

well known at the date of the patent as a proper

substitute for the omitted ingredient.

Dodines v. Fourt of )ppeals &100

- #ests to determine infringement;

1. iteral infringement ? Gutapose the claims of the patent and the accused product within the

overall contet of the claims and

specifications, to determine whether there is

e'ct identit% o( )) mteri) e)ement#

2. "octrine of equivalent ? when a device

appropriates a prior invention by incorporating

its innovative concept and, albeit with some

modification and change, performs

#!*#tnti))% t$e #me (!nction in

#!*#tnti))% t$e #me +% to c$ieve#!*#tnti))% t$e #me re#!)t.

Brank v. Hosuyama &10

- t is obvious that the 9spindle: is not an integral

part of the machine patented by the plaintiffs on

the ground that it was eliminated in their

application.

- *o infringement ? no essential part of the machine

manufactured and sold by him, which was

unknown to the public

Ias-Fath ncorporated v. Mahurkar &1001

- "rawings alone may be sufficient to provide the

9written description of the invention.:

5.$ %imitations on Amendments

Section ,. Amendment of Application. - )n applicant may

amend the patent application during eamination;

/rovided, #hat such amendment shall not include new

matter outside the scope of the disclosure contained in the

application as filed. &n

#he Dentry Dallery v. >erkline Forporation &100

- "etermination of infringement requires; &1 claim

must be properly construed to determine its scopand meaning8 and &2 claims as properly construe

must be compared to the accused devise o

process.

5.& Definite 'laims

7rthokinetics v. afety #ravel &10+

- 9wherein said front leg portion is so dimensioned:

- ) decision on whether a claim is invalid unde

enablement requires a determination of whethe

those skilled in the art would understand what i

claimed when the claim is read in light of th

specification.

- #he phrase 9so dimensioned: is as accurate as th

subGect matter permits, automobile being o

various siCes

- )s long as those of ordinary skill in the a

realiCed that the dimensions could be easil

obtained, ection 112 required nothing more.

. O/NERS0IP O" PATENT AND TRANS"ER O" R I10TS

)lbana v. "irector of /atents &10!

- )ssignments of patents and inventions covere

thereby may be recorded in books and records kep

for the purposes in the /atent 7ffice if presentein due form8 but the appellant does not ask for th

registration of the alleged agreement, because as

is not in due form it cannot be recorded, but praythat the "irector compel the applicant-inventor t

acknowledge it

(.1 Priority Date

>oothe v. "irector of /atents &103

- t is imperative that the application be complete i

order that it may be accepted. t is essential to th

validity of etters /atent that the specifications b

full, definite, and specific.

- /etition only complete when they submitted th

additional pages on the pecifications and Flaims

2. PATENT DRA"TIN1 AND CLAIMS ANAL4SIS

Merrill v. Eeomans, 0( J.. !+ &1==

- 9new manufacture of the deodoriCed heav

hydrocarbon oils:

- /rior to Merill ? claims played a primary role

- Fourt looked into the #&eci(iction# i

determining the meaning of the claims



/hilips v. )wh Forporation &233!

- 6pert background;

1. >ackground

2. 4ow invention works

. Fonsistent with /7)(. /articular meaning in the pertinent field

- 4ierarchy of evidentiary sources

- Intrin#ic evidence

1. $ords of the claims

2. pecifications

. /rosecution history and other documents in

the file wrapper

- E'trin#ic evidence

1. *ot part of the patent8 does not have the

specificationAs virtue of being created at

the time of patent prosecution for the

purpose of eplaining the patentAs scope

and meaning

2. 6trinsic publications may not be written by a skilled artisan hence will not reflect

the understanding of a skilled artisan in

the field8

. 6pert reports and testimony ? not

obGective since generated at the time of

and for the purpose of litigation8

(. Jniverse of potential etrinsic evidence of

some marginal relevance that could be

brought to bear on any claim construction

question

!. May be used to change the meaning of

claims in derogation of the intrinsic

evidence, thereby undermining the public

notice functions of patent

Markman v. $estview nstruments, nc. &100+

- /rior to Markman ? patent construction done by

Guries

- )ccording to Markman, must be done by the Gudge

? patent claims are )eg) in#tr!ment#

- "istrict courts now use specific hearings known as

Mr6mn $ering#

- 2-step process

1. Fourt must construe or interpret the patent

claims - 7!dge

. Fonstrued claims must be evaluated against

the alleged infringing device or process ? 7!r%

#eva /harmaceuticals J), nc v. andoC, nc. &231!

- Flaim construction is a question of law

- ower court decision may be reviewed by

appellate court but if it involves subsidiary factual

facts, then if appealed, the standards applied shall

be for the question of fact

Intrin#ic evidence

1. C)im# ? given their ordinary and customar

meaning for the person ordinarily skilled in the ar

what was actually invented and what the invento

intended them to cover8 preserve the claim

validity &ecept where the invalidating claim

construction is consistent with the claim languag

and specification

. S&eci(iction# ? dispositive when the propose

construction most naturally aligns with the claim8! describe the manner and process of making anusing the patented invention

a. "escribed the inventionAs preferred or sol

embodiment or specifically ecludes a

embodiments from the

b. "istinguish prior art or cites particula

advantages over

c. "efines certain terms

". Pro#ec!tion $i#tor% ? written record of th

correspondence between the eaminer and th

applicantKagent during the eaminatio

&amendments8- )nalogous to the Gournals of the Fongress

- ess helpful compared to the two other

because represents the on-going th

negotiation

- may aid in claim construction in these cases;

a. disclaimed broad definition to overcom

prior art8

b. patentee may have dropped certain claim

c. amended claims either to broaden or lim

the scope

E'trin#ic Evidence ? not obligatory to be used8 only whehelpful

1. %elevant scientific principles

. Meaning of technical terms

". tate of the prior art

#. "ictionaries

$. #reaties

%. 6pert testimony

2. COMPULSOR4 LICENSIN1

/rice v. Jnited aboratories &10- #he terms and conditions of the compulsor

license were fied by the "irector after a hearin

and careful consideration of the evidence of th

parties and in default of an agreement betwee

them as to the terms of the license.

- "irectorAs findings that J*)> has th

capability to use the patented compound i

manufacture is a factual finding supported by

#!*#tnti) evidence



- #he important thing is that such capability was

proven to eist during the hearing of the petition.

mith Hline v. Fourt of )ppeals &233

- #he doctrine of equivalents requires satisfaction of

the (!nction-men#-re#!)t te#t, the patentee

having the burden to show that all three

components of such equivalency test are met.

III. PATENTS AND PUBLIC 0EALT0

%oma "rug v. %egional #rial Fourt &2330

- #he unqualified right of private third parties to

import or possess unregistered imported drugs in

the /hilippines confirmed by the %% of the %)

0!32.

- 9#he drugs and medicines are deemed introduced

when they have been sold and offered for sale

anywhere else in the world.:

- 7therwise, it discriminates, at the epense of

health, against poor Bilipinos without means to

travel abroad to purchase less epensive medicines

in favor of their wealthier brethren able to do so.

ess urgently perhaps, but still within the range of

constitutionally protected behavior, it deprivesBilipinos to choose a less epensive regime for

their health case by denying them a plausible and

safe means of purchasing medicines at a cheaper

cost.

Merck HDa) v. negra ifesciences &233!

- 6emption from infringement etends to all uses

of patented inventions that are reasonable related

to the development and submission of anyinformation under the B"F).

- *ecessarily includes preclinical studies of

patented compounds that are appropriate

submission to the B") in the regulatory process.

#here is simply no room in the state in ecluding

certain information from the eemption on the

basis of the phase of research in which it is

developed or the particular submission in which itcould be included.

8. PATENT AND UN"AIR COMPETITION

llinois #ool $orks v. ndependent nk &233+

- /atent does not necessarily confer mark

power

- $ithout proof that the patentee had mr6e

&o+er in the relevant market, its conduct a

issue in this case was neither 9misuse: nor a

9illegal etension of the patent right.:- $hile price discrimination may provid

evidence of market power, particularly

buttressed by evidence that the patentee ha

charged an above-market price for the tie

package, it is generally recogniCed that it als

occurs in fully competitive markets.

- n all cases involving a tying arrangement, th

plaintiff must prove that the defendant ha

market power in the tying product.

Bederal #rade Fommission v. )ctavis &231

-9reverse payment: settlement agreement

- Bive set of considerations lead us to conclud

that the B#F should have been given th

opportunity to prove its anti-trust claim;

1. pecific restraint at issue has th

9potential for genuine adverse effects o

competition.:

2. #hese anticompetitive consequences wi

at least sometimes prove unGustified

. $here a reverse payment threatens t

work unGustified anticompetitive harm, th patentee likely possesses the power t

bring that harm about in practice ? stron

indication of market power

(. )ntitrust action is likely prove mor

feasible administratively

5. $hat are the reasons for the settlement5

the basic reason is a desire to maintain an

to share patent-generated monopol

profits, then, in the absence of some othe

Gustification, the antitrust laws are likely t

forbid the arrangement.

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