*1 fact, noted, employment. This to the extent that there is incident In true whether works at fixed location agency from he any guidance either informal 553.221(e) sites.”); § job or at id. different dispute, resolution proper (“Normal travel is not home to work com- in the discussion the OPM it is found pensable, employee even where the is ex- website, approach fol- which endorses report away at a location pected work in lowed court Bobo. by this employer’s premis- from location of (commut- (d) es.”); 551.422(b), § 5 C.F.R. C duty location” is ing “temporary duty compensable temporary if the station brief, appellants state In their employee’s within “the limits of the offi- this case from passing differs station,” i.e., duty prescribed cial within claim that they Adams in that “the were mileage up to 50 miles from the radius of compensable Employer re engaged station). duty light of the official ab- from home to their work quired driving any persuasive argument justify- sence of last work site to their sites and from their by alluded to the appel- distinction ” litigated at all in Adams homes was not lants, we decline to a decision base “it was not claimed that because Adams appellants’ allegations. favor on those plaintiffs’ compensable driving stop,’ and a ‘last from to a ‘first from home AFFIRMED.
stop’ suggested The distinction home.” apparently based on the passage appellants’ in the declarations
statements commuting that their they
in which assert
activity driving between often involves where
home and a location are direct occasions,
ed on other than particular regular
fixed or worksite. office BAYER PHARMA AG and SCHERING adequately ex- appellants do Pharmaceuticals, Healthcare plain why the difference between their sit- Inc., Plaintiffs-Appellants, appellants uation and that of in the requires Bobo cases a different and Adams outcome; is, why it is unclear INC., LABORATORIES, BARR employee’s travel between home and Defendant-Appellee. workplace uncompensated, fixed should be employee’s travel while the same between No. 2008-1282. varying home work locations within should be commuting compensat- area Appeals, United States Court Indeed, Depart- ed. both OPM and Federal Circuit. make regulations ment of Labor clear Aug.
if otherwise commuting does not constitute work, employee may the fact that Rehearing En Banc Rehearing sites, job commuting to different rather 26, 2009. Denied Oct. location, than a work does not make fixed § 29 C.F.R. 785.35 difference. See to work ... is a (“[Ojrdinary home travel *2 Jr., Bensinger,
Peter B. Bartlit Beck LLP, Herman Palenchar & Scott of Chica- none active IL, plaintiffs-appellants. ingredient. Drospire- as the for argued go, art at Lawrence D. none was known all times the brief was him on With Washington, contraceptive qualities relevant. Its are Day, Rosenberg, Jones well particularly producing suited *3 DC. because, in contraceptive addition to Lombardi, & Strawn George Winston C. ovulation, inhibiting it is a diuretic which IL, LLP, for defen- Chicago, argued will diminish excess water retention aris- him on the brief were dant-appellee. With estrogen component the of oral from Nutter, Graveline, K. Bradley Michael C. anti-acne contraceptives, qualities has P. Fer- Eric L. Broxterman and William promote clear skin. These desirable ranti. success; led qualities have to Yasmin’s. Drospirenone is also acid-sensitive. Nancy Tompkins, L. Townsend and acidic) (highly low-pH When LLP, of San Francis- Townsend and Crew environments such the human CA, co, amicus curiae. her on With stomach, drospirenone “isomerizes”—that Mark T. Of counsel the brief was Jansen. is, catalyzes the acid a reaction that rear- Tan and Cedric C.Y. on brief were ranges drospirenone’s molecular structure Cooklin, Washington, Kristin M. DC. composition
while its molecular remains resulting constant. The isomer non- is FRIEDMAN, NEWMAN, Before antimineralocorticoidal, meaning it' will MAYER, Judges. Circuit diuretic, removing not act as a desir- anti-bloating able that sets drospi- effect the court filed Circuit Opinion for from apart renone other proges- Dissenting opinion filed Judge MAYER. Therefore, tins. working Judge by Circuit NEWMAN. drospirenone for in an oral use contra- ceptive must be aware and work MAYER, Judge. Circuit the effects that the human around stom- Bayer Schering (“Bayer”) Pharma AG drug ach will have on the to ensure that judgment of the United States appeals the “bioavailability” its amount —the District for the District New Jer- Court drug active into the absorbed blood- 6,787,531 No. sey, holding U.S. Patent to act stream and available (“'531 Patent”) invalid due to obviousness. body enough perform high its con- —is Bayer Schering Pharma AG Barr traceptive function. Labs., Inc., 05-CV-2308, 2008 No. WL 2008). (D.N.J. poorly is sol- Drospirenone March Because also water hold would have hydrophobic composition. we invention uble Because try, we affirm. easily been obvious will not dissolve into volume of
liquid, bioavailability degraded. its To this, pharmaceutical producers combat BACKGROUND “mi- commonly employ technique called cronization,” drug’s whereby particle large pharmaceutical compa- ais reduced, increasing size its overall sur- daily oral contra- ny produces (but always) face Often with a the active in- area. ceptive, Yasmin®. One of area, Yasmin, larger dissolution rate is surface drospirenone, gredients increased, that all ensuring also inhibits Each of progestin that ovulation. that can poorly drug soluble dissolve requires drospire- claims water the invalidated given liquid. will dissolve in a volume of their on beagles studies and women. This dissolved, presented a drug drug complication more of the further With because higher bioavailability. required exhibit to be effec- will In- 99% tive, deed, work on Bayer’s single all women at a expert testified trial that fit dose—“one dose must all.” A normal attempting this would be his first choice in pill variations, may present such but because, to increase the dissolution rate expose will contents the stomach’s among ways the different to increase the highly acidic environment. rate, presents dissolution micronization All commercially best chance of success. Tack, scientist, Dr. Johannes a Bayer *4 contraceptives oral use micron- available began in develop work 1983 to drospire- progestins estrogens, ized so this and/or none an contraceptive. into At the technique known art. was well in the time, Bayer had been working with relat- ed compound, spirorenone, as a diuretic. micronizing poorly While water soluble consumed, When spirorenone metabolizes composition may result in increased bioa- diuretic, into drospirenone, which is still a vailability, micronizing an acid-sensitive (con- but was have progestogenic composition may also increase sensitivi- traceptive) effects. Spirorenone itself had A ty to the drug acid. isomerizes contraceptive some effects that con- Bayer may when to acid thus isomerize cluded were the result the appearance faster rate if it is micronized. of drospirenone when it metabolized. pharmaceutical companies One method Bayer decided to harness the diuretic ef- an acid-sensitivity use to surmount prob- fect of drospirenone isolated to create the with drug lem to be orally taken is to contraceptive. new Tack consulted via drug deliver an pill, enteric-coated Bayer with drospirenone work including in opposed to an pill, immediate release vitro isomerization performed by studies pill.” also called a An “normal enteric scientist, fellow Dr. Werner Krause. coating pH-sensitive is a protects film that performed Krause had also in vivo studies acid, from stomach only re- with spirorenone, publish- about which he the drug leases when it passed has into the ed studies, I, three articles. These Krause less acidic duodenum and small intestine. II, III, included the knowledge that coatings enteric are not without spirore- was a metabolite of drawbacks themselves. Coated in- tablets decided, however, none. Tack that these cluding enteric present coated tablets an in vivo garnered studies little information obstacle to absorption, and thus reduce the practice of drospirenone in vivo. drug’s exhibited bioavailability. Addition- Tack stability tested the of drospirenone ally, as was in time, the art at the in acid at 1pH to simulate the conditions significant delay introduce a in the of the stomach. He found that after 10 of therapeutic response onset while creat- minutes, 21% of had ing a considerable patient-to-patient varia- acid, isomerized and after 45 min- fact, tion of that onset. for even an utes, half had isomerized. He came to a taking individual the drug at different critical conclusion: times, response vary time may consid- erably from dose to dose. If the results obtained in vitro are noticed these intra- and applied conditions, inter-individual vivo it can be bioavailability practice differences in presumed that, an gastric with assumed in a normal 100ml, Bayer developed drospirenone majority juice volume eventually it would receive pill, which (solubility 5-10 the dose the '531 during pas- patent. passes into solution mg/1) and conse- through the stomach sage finding drospi- Bayer relied on the isomerization. undergoes rapid quently pill absorb a normal renone would with bioavailability of in the A clear reduction rejection an obviousness in the overcome is to be active substance unchanged During Trademark Office. Patent and a result. expected as rejected the examiner prosecution, progesto- studies on planned a De view of Castro claims as obvious efficacy [drospirenone] should genic reference, taught said which examiner enteric- performed therefore be drugs to in- poorly to micronize soluble coated formulation. bioavailability. Bayer re- crease their art, piece that another sponded into clinical studies with Tack then moved reference, taught mi- Niekisch drospire- formulation of an enteric-coated cronizing drospirenone would increase its *5 Bayer used this years, five none. For exposure highly to the acidic environment studies, reconfirming pill in its even coated stomach, in the which result in in- would an drospirenone needed enter- in 1988 that The examiner al- creased isomerization. quickly it coating isomerized ic because claims, specific giving lowed the reason pH 1 acidic solution. a suggested microniz- 1988, study planned also ing drospirenone would work: “The enteric-coat- effectively how its determine drospirenone degraded micronized will be com- ed tablet delivered formulation rapidly even more because the microniza- injection of the pared to an intravenous drospirenone expose [sic] tion of study would thus same formulation. This (acidic). the stomach There- particles in bioavailability” of measure the “absolute fore, dosage to formulate an oral forms it drug. Bayer added what terms particles, containing drospirenone [sic] study, by element to the “non-routine” gastric which environment exposed (normal) it an unprotected which added dissolution, upon un[o]bvious would be ” drospirenone compared tablet and bioa- presented.... view of the data vailability that of the enteric-coated for- 7, September patent The '531 issued on delivery. the intravenous mulation and representative: 1 is 2004. Claim to find that the enteric- expected Tack produce would a lower bioa- coated tablet composition com- pharmaceutical A injection, vailability an than intravenous prising pill produce an normal would while the 2 4 mg mg to about from about than the enteric- bioavailability even lower particles, drospirenone micronized he coated tablet. mg 0.05 mg 0.01 to about about despite observations that his and or 17.alpha.-ethinylestradiol, one highly in a acidic quickly isomerize acceptable car- pharmaceutically more and his therefore that environment belief riers, necessary to coating an enteric would be in an composition being oral dose bioavailability, pill normal preserve gastric environ- in the form resulted pill and enteric-coated dissolution, upon ment bioavailability. Following study, this same 1346
and composition being whether effective absorbed or isom- contraception
for oral in a with precise human erized in vivo and in vitro female. testing suggested Robert Aul- treatise, ton Pharmaceutrics: The Science (“Barr”) ge- Barr Laboratories makes (1988). Dosage Design Form It then pharmaceuticals, neric filed Abbre- held that under KSR Co. International Drug Application viated New with the Inc., 398, 1727, 127 550 U.S. S.Ct. Teleflex Drug Food and seeking ap- Administration (2007), 167 L.Ed.2d would have proval generic to market a version Yas- been having ordinary obvious to patent min®. promptly filed a in- pharmaceutical skill in formulation to fringement against suit parties Barr. The pill formulating valid, agreed that if the patent '531 Barr oral contraceptive. Bayer as an timely 1, 5, 8, 27, 36, infringes claims appeals ruling; this Barr does not cross- 50. Barr then alleged that these claims appeal its rulings. ju- adverse We have obvious, among invalidity are other pursuant risdiction 28 U.S.C. unenforceability trial, arguments. At 1295(a)(1). § parties agreed two 2-4 mg drospire- art, none was well known in the as well as DISCUSSION
its combination with mg 0.01-0.05 17a-ethi- nylestradiol, a pharmaceutically acceptable § Obviousness under U.S.C. carrier, and a kit containing 21 such tab- the sole appeal. issue Whether ingredients placebos, lets active and 7 *6 an invention would been obvious at to be used as an effective oral contracep- the time ques the invention was made is a tive human females. claimed law, novo, tion of which we review de that its innovation drospire- the facts, on underlying based which we re none could be micronized to increase its view for clear error. Takeda Chem. In bioavailability, and that the micronized dus., Ltd., Ltd. v. Alphapharm, Pty., 492 drospirenone would not need be enteric 1350, (Fed.Cir.2007). F.3d 1355 A district coated for protection against highly finding clearly when, is court’s erroneous gastric acidic environment. despite evidence, some supporting we are
The district court
ruled that
these
“left with the
firm
definite and
conviction
obvious,
claims were invalid
reject-
that a mistake has been
For
committed.”
ed Barr’s other
theories. The court
Labs.,
Labs.,
est
Inc. v. Abbott
339 F.3d
person
found that a
having ordinary skill
(Fed.Cir.2003)
1324, 1328
(quoting United
in the art would have considered the
Co.,
v.
Gypsum
364,
States
U.S.
333 U.S.
I, II,
Krause
and III studies’ results that
395,
525,
(1948)).
S.Ct.
68
nevertheless absorb in vivo because A patent may dros- not be if obtained the pirenone closely is related to spirorenone. subject differences between the matter It also found that while sought the Niekisch ref- patented prior be art are erence did teach that subject isom- such that matter a whole erizes in vitro when to acid sim- would have been obvious at the time the ulating stomach, the human person a person of invention was made having to a ordinary skill would be of ordinary aware skill in the art to which the sub study’s shortcomings, 103(a). ject and would verify pertains. § matter 35 U.S.C.
1347
prior
direction of the
analysis
sever-
field unreduced
is based on
obviousness
An
been
would have
‘obvi
must
art. When “what
A court
examine
inquiries.
factual
al
art,
try’
vary
have been to
all
prior
ous to
content of the
scope and
try
possi
each
numerous
parameters
or
of
prior
art and
between
differences
possibly
one
at a
issue,
ordinary
of
choices until
arrived
and the level
ble
at
claims
result,
gave
where the
art
art. Graham v. John
successful
pertinent
skill
17-18,
684,
parameters
of
no
which
Co.,
1,
86
either
indication
U.S.
S.Ct.
Deere
383
(1966).
critical
no direction as to which of
point,
At that
were
or
545
15 L.Ed.2d
many
likely
choices
to be suc
secondary objective
possible
ev-
may consider
court
non-obviousness,
not
an invention would
have been
such as com- cessful”
idence
O’Farrell,
success,
853
at 903. This
but
obvious.
F.2d
long felt
unsolved
mercial
need,
others,
way
express
another
the KSR prong
and the like.
Id.
failure
among
to be
requiring the field
search
KSR,
Supreme
stated that
Court
of identified” solutions.
“finite number
it
may
found obvious if
an invention
be
1727;
at
127
550 U.S.
S.Ct.
see also
person
to a
hav-
been obvious
would have
Gamble,
996;
Ku
Proctor &
F.3d
con-
ordinary
try
skill
course of
bin,
options within success, vague where does anticipated If this leads guide particular not of innovation an inventor toward a solu product likely A finding of obviousness would not skill and common sense. tion. but *7 try’ ‘obvious that a obtain where “what was the fact combina- that instance technology or might explore gener that was to a new try show tion was obvious promising § to be a approach it was 103. al that seemed obvious under experimentation, prior where field of 421, 127 1727. This 550 U.S. at S.Ct. as gave only general guidance to the art our consistent with methodolo approach is of the claimed invention or particular form (Fed. O’Farrell, in In F.2d gy re 853 894 O’Farrell, at it.” 853 F.2d how achieve Cir.1988). Co. v. See Proctor & Gamble idea expresses This the same USA, Inc., 989, 566 Teva F.3d Pharms. that solu requirement KSR the identified Kubin, (Fed.Cir.2009); In re 996-97 421, “predictable.” be 550 U.S. at tions (Fed.Cir.2009). F.3d O’Farrell 1727; Proctor 127 S.Ct. see also & Gam ob most inventions that are observed that Kubin, ble, 996-97; F.3d 566 F.3d at try, found also obvious to but vious were 1359-60. did that rule thumb two classes where not obtain. Because the use of an con
First, 17á-ethinylestradiol have an would not with invention art, Bayer traceptive prior try when inventor was been obvious mi- represented in a that innovation was possibilities had to all would have cronize the to increase its The fine material often in micronized form larger bioavailability, specific and that the micronized with surface dissolves at a normal improved would absorb with faster rates which can lead to art. pill, against teachings prior drug absorption by passive of the diffusion.” analyzed prior art court acknowledged The district court The district micronizing drospire- prior suggested and determined that art there would be taught, none and that concern about using the dissolution of a poorly try. been pill would have obvious to water soluble drug, acid-sensitive but generally suggests per- first The court determined how that micronization improve could the disso- ordinary having son skill in the art of of drospirenone. lution It concluded that a pharmaceutical formulation consider person having ordinary skill would have in the correlation of vitro and in vivo tests. it as a option. seen viable principally It relied on Robert Aulton’s textbook, pharmacologist Bayer argues Pharmaceutics: this is clear error Dosage Design, The Science of piece Form because the court relied on one which, found, as the court teaches art to show that micronization has “dissolution data rate when combined been to work on shown acid-sensitive com- provide solubility ... an insight pounds. Hargrove The court reviewed the reference, the potential study formulator into in vivo ab- which was a on microniz- sorption characteristics of a Howev- drug. ing progesterone, concluding that “it con- er, only significance vitro tests if firms that not all drugs acid-sensitive re- quire coating.” incorrect, can related results. enteric This vivo agrees, Once relationship progesterone such a has estab- as Barr because been lished, in vitro dissolution can be drug. Bay- tests acid-sensitive (Aulton, used as a quality p. expert, control test. er’s own Dr. McGinity, James testi- 9).” The court concluded that the fied that micronization first choice skill would not vitro accept solution because it presents the best testing as valid without a correlation to chance success. So there remains ade- vivo tests. quate support for the conclusion that mi- option. cronization was a viable
With that knowledge, the then court turned to micronization. It found that district Bayer’s court then moved to ways Aulton cut both point, alleged be- aspect second non-obvious of the *8 invention, cause it both taught micronizing that a whether the formulation should poorly drospi- water soluble like substance use an enteric-coated or tablet de- may rate, renone increase absorption livery. The Bayer’s court considered ar- but may also increase degrada- the rate of that gument prior taught art formulation stated, tion. Aulton and other to employ coating an enteric on corroborated, evidence gen- that “it now drospirenone, argument is and Barr’s that an erally recognized poorly that drugs coating complicated, enteric expen- soluble is so showing limiting sive, a step manufacture, dissolution rate cumbersome to and absorption process readily prone will be more variability only to that it would be finely bioavailable when in a a administered used as last resort formulation scien- subdivided larger working [micronized] form with tists with an acid-sensitive drug. surfaces than the coarse persuasive, material.... The court found side neither (2) center, rates, having phar- the same prior art as the steroids and considered (3) macological properties, It derivatives of focusing on the Aulton textbook. again (4) of necessity drug, the same the same chemical recognizes Aulton found that (5) bond, composition except one and coating to the formulation of an enteric family from the same of substances. The drugs, that an enteric acid-sensitive but drawbacks, then that a of ordi- includ- court concluded coating also introduces nary drugs closely find the tablets have the skill would that enteric coated related, and access bioavailability drug delivery all would therefore these lowest drospirenone. bioavailability drospire- formulating when studies forms. Poor to that major drospire- that Tack He would be led believe problem none is the vivo, none, spirorenone, may like absorb in The court further sought to solve. district is in vitro. Aulton that there but isomerize found that teaches and bioavailability both intra- variability in Bayer argues now that the district court using enteric coated inter-subject when key drospire- between ignored differences tablets, significant is obstacle which spirorenone, none and such that drug that must Bayer’s requirement 40% than lat- former isomerizes faster for women. 99% effective all be ter, and that is more soluble thus could dissolve and isomerize in effect, argued prior that while acid This is irrelevant because the away using micronized faster. art teaches from tablet, art anticipa- Barr ar- Krause series is not drospirenone in a normal It can used to away tory teaches from reference. show gued having ordinary formulator parties using coating. an enteric What however, had a done, present options option viable consider is micronized, unprotected pharmaceutical drospire- formulator with available to none, problem expectation and a reasonable having ordinary skill to solve the similarly hydrophobic drospire- perform but of acid-sensitive (even identically) spirorenone if not none. O’Farrell, in the Krause series. See Barr that the Krause series argued (“Obviousness F.2d 903-904 does controlling because of spirorenone require predictability absolute success similarity spirorenone great between required ... all that reasonable drospirenone. The Krause series tested success.”). expectation of hu- bioavailability spirorenone vivo in Similarly, Bayer argued that Nick- monkeys whether mans and to determine “pharmaceuti- isch article teaches develop there was need vitro, acid in isomerizes when gastric juice.” resistant cal formulation teaching away allowing exposure from spirorenone each found no iso- studies streams, environment, suggest- thus subjects’ gastric blood and the mers coating. ing the for an enteric Barr spirorenone is absorbed be- need concluded *9 Furthermore, study it an in attacked the merits of the fore it isomerizes. practice drospire- to the of drospirenone apply that would comparison vitro found vivo, not noting none in that Nickisch did pH profile in 1 acid with a isomerized in in drospirenone vivo to correlate its The court found test spirorenone. similar to challenged the Barr also closely findings. in that vitro drugs were related (1) grounds Nickisch reference the at similar are both acid-sensitive drospirenone NEWMAN, was to Judge, isomerize slow- dissenting. Circuit ly not and would have isomerized before all respect my colleagues, With I do emptied, the stomach in the vitro not share their view that it would have environment was too to be com- extreme been obvious to do that which was indis- pared practice, to an in vivo that it did putably experienced unobvious for- testing explain protocols. not The assignment mulation scientists whose person ordinary court found that a of skill to formulate the product drospire- in the art recognize would that Nickisch showed, none. The evidence without con- establishes that in isomerizes tradiction, that it was known that micron- vitro, but study’s would be alerted to the drospirenone rapidly degraded ized at the shortcomings when in vivo. used acidity of stomach acid. The evidence point, At this having ordinary showed, contradiction, without in skill the art has reached a crossroads in working scientists this field be- where he must choose between two known lieved that product required an enteric delivery options: drospire- micronized in coating prevent degradation order to by a pill following spirore- none normal stomach, upon ingestion series, analogy none the Krause or de- contraceptive. Yet my colleagues, employ- livery by of drospirenone an enteric-coated expertise, their own hold that pill since the following teaching the Nickisch working needs to this field turned out protected be from the mistaken, stomach. This is a finite number of it identi- would have been obvious fied, predictable solutions. See KSR. 550 that it was necessary steps to take U.S. at prior S.Ct. 1727. The art prevent degradation. acid The court dis- would, have funneled the formulator to- testimony counts the of the scientists options; ward these two he themselves, ignores knowledge con- required possibilities been all in a cerning this product instability and its art, field unreduced thus acid, ignores teachings, the textbook avoiding O’Farrell, pitfall the first 853 finds that unlikely process obviously at Additionally, F.2d 903. should have been tried. That is not the vague was not in pointing general toward law of obviousness. approach or area of exploration, but rather The statutory criterion is whether the guided the formulator precisely to the use invention per- would have been obvious pill either a normal anor enteric-coated sons of pill, at the avoiding thus time pitfall the second invention, O’Farrell. Id. not whether is sufficiently Because the selection of mi- cronized in a pill simple to appear led obvious to judges after anticipated by result the Krause made, the discovery finally despite the series, the invention would have been obvi- years contrary among belief the scien- KSR, ous. See U.S. 127 S.Ct. charged tists project. with the At the time that scientists were at- tempting to formulate as an
CONCLUSION oral contraceptive, teaching the textbook Accordingly, judgment of the United micronizing was that prod- acid-sensitive States District Court for the District of ucts would accelerate their acid-induced Jersey New is affirmed. See, degradation. e.g., Aulton’s Pharma- AFFIRMED Design ceutics: and Manufacture of *10 likely in this micronizing to succeed. The evidence (advising against Medicines case a better measure of obviousness it reduces the is drugs because acid-sensitive hindsight judges, than science of colleagues crit- is the bioavailability). My drug’s eventually it who made this rule that the scientists and was specialists, these icize testified, dispute, that discovery without experi- to conduct obvious nonetheless they an uncoated micron- not did not believe would work. that believed ments product demanding ized would meet that scientists should court rules The contraceptive of effectiveness. they believed criteria that which have “tried” fail, The in KSR International Co. v. they eventually Court that when and Inc., formulation, it 550 U.S. S.Ct. unlikely and did this Teleflex (2007) explained that the succeeded, 167 L.Ed.2d to do so. it was obvious try” to standard for “obvious whether behavior of physiological The unusual expectation suc- there was a “reasonable of was not stomach drospirenone undisputed cess” the time. It was that known; knowledge followed scienti- undisputed there not. It that it was was precede it did not explanation; fic reasonably was that uncoated expected not no evidence in suit. There was invention + drospirenone would be 99 % micronized suggest that micronized reasonably to contraceptive as an oral when effective usable, likely was to be drospirenone stomach, ingested into the it acidic when effectiveness, percent consistency of 99+ degrade rapidly was in acid. known degradation from any protection without that A The district court stated microni- contraceptive usable by stomach acid. effectiveness, zation that al- complete option, was “viable” and virtually requires “uncertain,” though in- confronting success was and standard try. vention was obvious to high. Unlike the unrelated scientists was “Viability” panel majority, “viability” contra- is not the standard. by the drugs cited may may complete implies experiment or ceptives require effectiveness. law Previously contraceptives requires such not succeed. What the luck, guesswork, not but a rea- spironolactone and are not dumb progesterone sensitive, presented degree predictability of suc- sonable acid colleagues My depart to the formula- cess. from highly specific challenge standard, ruling that statutory persons The scientists be- tion scientists.' way ordinary skill would have conducted ex- avoiding the known lieved that expected that fail. degradation periments were acid in the art teaches the like- My colleagues, Nothing it acid. how- protect from ever, ingestion lihood of uncoated find it would have been obvious of success acid, drospirenone; taught what expose although it was not micronized it is the likelihood of failure. working on the obvious to the project. invention as a must viewed subject existing knowledge requires that the whole. With
“Obviousness” persons hydrophobic is both matter was obvious acid, degrades rapidly and the exist- law the field of invention. The micronization, although try” ing knowledge that experi- it “obvious to does hold drug’s hydrophobic useful to counteract a ments that contravene conventional knowl- more reasonably properties, renders the even are not edge, deemed *11 susceptible to acid degradation, was
shown that
this field would had a reasonable
expectation achieving complete contra-
ceptive bioavailability and effectiveness drospirenone.
with uncoated micronized contrary view only has surfaced
litigation-induced argument. The exercise judicial expertise clear to override the persons
evidence how of skill in this actually behaved,
field inappropriate.
I respectfully dissent. MARINE, INC.,
WEEKS
Plaintiff-Appellee, STATES,
UNITED Defendant-
Appellant.
No. 2008-5034.
United Appeals, States Court of
Federal Circuit.
Aug.