Patents and the Expectation of Success...
Transcript of Patents and the Expectation of Success...
Patents and the Expectation of Success DoctrineWhat is Reasonable, Tension With Enablement, Best Practices for Patent Drafting and Patent
Prosecution
Today’s faculty features:
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
The audio portion of the conference may be accessed via the telephone or by using your computer's
speakers. Please refer to the instructions emailed to registrants for additional information. If you
have any questions, please contact Customer Service at 1-800-926-7926 ext. 1.
WEDNESDAY, JANUARY 8, 2020
Presenting a live 90-minute webinar with interactive Q&A
Alissa K. Lipton, Partner, Finnegan Henderson Farabow Garrett & Dunner, Boston
Jill K. MacAlpine, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Leslie A. McDonell, Partner, Finnegan Henderson Farabow Garrett & Dunner, Boston
Sara A. Leiman, Ph.D., Attorney, Finnegan Henderson Farabow Garrett & Dunner, Boston
Lulu Wang, Ph.D., Attorney, Finnegan Henderson Farabow Garrett & Dunner, Boston
Tips for Optimal Quality
Sound Quality
If you are listening via your computer speakers, please note that the quality
of your sound will vary depending on the speed and quality of your internet
connection.
If the sound quality is not satisfactory, you may listen via the phone: dial
1-877-447-0294 and enter your Conference ID and PIN when prompted.
Otherwise, please send us a chat or e-mail [email protected] immediately
so we can address the problem.
If you dialed in and have any difficulties during the call, press *0 for assistance.
Viewing Quality
To maximize your screen, press the ‘Full Screen’ symbol located on the bottom
right of the slides. To exit full screen, press the Esc button.
FOR LIVE EVENT ONLY
Continuing Education Credits
In order for us to process your continuing education credit, you must confirm your
participation in this webinar by completing and submitting the Attendance
Affirmation/Evaluation after the webinar.
A link to the Attendance Affirmation/Evaluation will be in the thank you email
that you will receive immediately following the program.
For additional information about continuing education, call us at 1-800-926-7926
ext. 2.
FOR LIVE EVENT ONLY
Program Materials
If you have not printed the conference materials for this program, please
complete the following steps:
• Click on the link to the PDF of the slides for today’s program, which is located
to the right of the slides, just above the Q&A box.
• The PDF will open a separate tab/window. Print the slides by clicking on the
printer icon.
FOR LIVE EVENT ONLY
5
Agenda
Reasonable expectation of success doctrine
Obviousness, including OSI v. Apotex
Anticipation
Enablement, utility, and written description
Takeaways and best practices
6
Reasonable Expectation of Success (REOS)
• Courts’ concerns regarding clinical data impact:
– Obviousness
– Anticipation
– Enablement/Utility
– Written Description
7
Reasonable Expectation of Success (REOS)
Obviousness AnticipationEnablement,
UtilityWritten
Description
• Rasmusson v.
SmithKline
• In re ’318
• Lilly v. Actavis
• Impax v. Aventis
• Sandoz v.
Pharmacyclics
• Nuvo v. Dr. Reddy’s • OSI v. Apotex
• Cubist v. Hospira
• Yeda v. Mylan
• Acorda v. Roxane
• Novartis v. West-
Ward
8
Agenda
Reasonable expectation of success doctrine
Obviousness, including OSI v. Apotex
Anticipation
Enablement, utility, and written description
Takeaways and best practices
9
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• IPR challenge to Orange Book-listed patent (US 6,900,221) with claims
to erlotinib, an epidermal growth factor receptor (EGFR) inhibitor to treat
non-small cell lung cancer (NSCLC). Marketed by OSI as Tarceva®.
• PTAB found patent unpatentable for obviousness, finding reasonable
expectation of success for treating NSCLC with the EGFR inhibitor.
• Federal Circuit found PTAB finding of reasonable expectation of
success not supported by substantial evidence and reversed the
obviousness determination.
10
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• “Obviousness determination requires finding that a person of ordinary
skill in the art would have been motivated to combine or modify the
teachings in the prior art and would have had a reasonable expectation
of success [REOS] in doing so.”
11
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• High unpredictability in cancer treatments, including EGFR inhibitors for
cancer treatments.
• Asserted prior art disclosed erlotinib as EGFR inhibitor for the treatment
of cancer, “good anti-cancer activity in preclinical models,” Phase I and
II clinical trials without clinical data.
12
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• Schnur: discloses 105 compounds, including erlotinib, as EGFR
inhibitors and treatments for 12 different types of cancer; does not
discuss NSCLC.
• Gibbs: review article discussing cancer therapeutics, including erlotinib;
states that erlotinib is in clinical trials and appears to have “good anti-
cancer activity in preclinical models . . . particularly in patients with non-
small cell lung cancer”; did not cite any references with erlotinib data for
NSCLC.
13
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• OSI’s 10-K: states:
– “[Erlotinib], which targets a variety of cancers including ovarian,
pancreatic, non-small cell lung and head and neck, achieved a
significant milestone with the completion of Phase I safety trials and
the initiation of Phase II clinical trials in the United States in cancer
patients. [Erlotinib] is a potent, selective and orally active inhibitor of
the epidermal growth factor receptor, a key oncogene in these
cancers.”
14
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• PTAB found that the disclosures in OSI’s 10-K that erlotinib targeted a
variety of cancers including NSCLC, and that erlotinib had entered
Phase II clinical trials, would have provided a POSA with a reasonable
expectation of success in view of Schnur’s teachings.
– POSA would understand from the commencement of Phase I studies
that preclinical animal efficacy data had been submitted to FDA.
• PTAB also relied on Gibbs’s statement regarding NSCLC (although
unsupported by any data) as providing a POSA with a reasonable
expectation of success in view of Schnur’s teachings.
15
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• Federal Circuit reversed, finding no reasonable expectation of success:
“When the references are properly read, the Board's finding that the
asserted references provide a reasonable expectation of success also
is not supported by substantial evidence. To be clear, the claims
require only treatment of a mammal with erlotinib—efficacy in humans
is not required. But the asserted references do not disclose any data
or other information about erlotinib's efficacy in treating NSCLC. The
record does not contain any clinical (human) data or pre-clinical
(animal) data. It does not even include in vitro (test tube) data
regarding erlotinib's effect on NSCLC. At the same time, it is
undisputed that NSCLC treatment was highly unpredictable with an
over 99.5% rate of failure for drugs entering Phase II clinical studies.”
16
OSI Pharms., LLC v. Apotex Inc.,
939 F.3d 1375 (Fed. Cir. 2019)
• Federal Circuit reversed, finding no reasonable expectation of success:
- “These references provide no more than hope—and hope that a
potentially promising drug will treat a particular cancer is not
enough to create a reasonable expectation of success in a highly
unpredictable art such as this.”
- “To be clear, we do not hold today that efficacy data is always
required for a reasonable expectation of success.”
17
Cubist Pharms. Inc., v. Hospira Inc.,
805 F.3d 1112 (Fed. Cir. 2015)
• Claims to, inter alia, administering antibiotic daptomycin at an
interval that minimizes skeletal muscle toxicity (4 or 6 mg/kg every
24 or 48 hours) (“dosing patents”).
• District court ruled dosing patents invalid for obviousness.
• Federal Circuit affirmed.
18
Cubist Pharms. Inc., v. Hospira Inc.,
805 F.3d 1112 (Fed. Cir. 2015)
• Daptomycin originally developed by Lilly researchers in 1980s.
While daptomycin was effective, 4 mg/kg doses administered every
12 hours resulted in skeletal muscle toxicity in some patients.
• Lilly abandoned development of the drug.
• Cubist researchers discovered that toxic side effects could be
reduced with less frequent administration.
19
Cubist Pharms. Inc., v. Hospira Inc.,
805 F.3d 1112 (Fed. Cir. 2015)
• Asserted prior art disclosed preclinical testing of daptomycin and
suggested administration of 4 or 6 mg/kg once per day based on the
drug’s long half-life (Woodworth).
– no disclosure of objective of minimizing skeletal toxicity
• District court relied on known properties of daptomycin including that it
is concentration-dependent, suggesting that less frequent and more
concentrated treatments would be more effective
• District court relied on evidence of aminoglycosides, a group of
antibiotics similar to daptomycin
• Would have been obvious to consider doubling the dosage interval (48
hours) for patients with impaired kidney function
20
Cubist Pharms. Inc., v. Hospira Inc.,
805 F.3d 1112 (Fed. Cir. 2015)
• Federal Circuit stated:
“While it is true that the Woodworth reference is predictive in nature, it is
based on extensive laboratory research, and its predictions of the efficacy
of a dosage regimen of 4 mg/kg to 6 mg/kg at daily intervals give rise to a
reasonable expectation that dosages in that amount would be effective in
patients. Moreover, published accounts of Lilly’s clinical trials indicated a
dosage level of 2 mg/kg administered once daily produced no reported
side effects and a dosage level of 3 mg/kg administered twice daily
produced no symptoms of skeletal toxicity, but were not highly effective
against SAE. Those results would have given rise to a reasonable
expectation that somewhat higher doses administered less frequently than
twice daily could be expected to be both safe and effective.”
21
Cubist Pharms. Inc., v. Hospira Inc.,
805 F.3d 1112 (Fed. Cir. 2015)
• Federal Circuit found obviousness finding supported by evidence of
aminoglycosides, a group of antibiotics similar to daptomycin
22
Yeda Research & Dev. Co. v. Mylan Pharms., Inc.,
906 F.3d 1031 (Fed. Cir. 2018)
• Claims to dosing regimen of 40 mg glatiramer acetate (GA) in three
subcutaneous injections over seven days for the treatment of relapsing-
remitting multiple sclerosis (RRMS); marketed as Copaxone® 40 mg/mL.
• IPR final written decisions found claims obvious over prior art including
disclosure of dosing regimen of 40 mg GA every other day (Pinchasi).
• Federal Circuit affirmed.
23
Yeda Research & Dev. Co. v. Mylan Pharms., Inc.,
906 F.3d 1031 (Fed. Cir. 2018)
• On appeal, Yeda argued that Board erred in finding REOS by
disregarding uncertainties associated with GA, e.g., unknown pk/pd
profile, mechanism of action, optimal dose, active species.
• In In re Cyclobenzaprine, the Federal Circuit held that in the absence of
a known pk/pd profile, bioequivalence alone could not establish
obviousness because “skilled artisans could not predict whether any
particular PK profile, including a bioequivalent one, would produce a
therapeutically effective formulation.” 676 F.3d 1063, 1070 (Fed. Cir.
2012).
24
Yeda Research & Dev. Co. v. Mylan Pharms., Inc.,
906 F.3d 1031 (Fed. Cir. 2018)
• Declined to “read [In re Cyclobenzaprine] as establishing a rigid rule
categorically precluding obviousness determinations without pk/pd data.
There, the court's error was relying on bioequivalence alone, without any
evidence in the prior art teaching or suggesting a therapeutically
effective formulation to one skilled in the art, such as pk/pd data. Here,
however, the Board committed no such error; the record is replete with
prior art that would have taught or suggested a therapeutically effective
formulation to a POSITA.”
• Federal Circuit noted that only difference between the claimed invention
and the prior art is one dose per two-week period.
25
Acorda Therapeutics, Inc. v. Roxane Labs., Inc.,
903 F.3d 1310 (Fed. Cir. 2018)
• Claims to dosing regimen for improving walking in multiple sclerosis
patients, by orally administering 10 mg sustained release composition
of 4-aminopyridine (4-AP) twice daily
• Immediate release: 4-AP shown safe and effective for MS treatment at
wide dose range since 1980s (little to no discussion of walking)
• Sustained-release:
• 1997: Elan study with 10 MS patients showed improvements in walking at
17.5 mg 4-AP twice a day
– Also in 1997, Elan licensed their sustained-release formulation to Acorda
• 2002/2003: Acorda study with 25 MS patients showed lower extremity
muscle improvement at 10-40 mg 4-AP twice a day and improvement in
walking at 20-40 mg 4-AP once a day
26
Acorda Therapeutics, Inc. v. Roxane Labs., Inc.,
903 F.3d 1310 (Fed. Cir. 2018)
• Federal Circuit determined prior art dose (e.g., 17.5 mg twice daily,
showing “improvement . . . in walking ability”) rendered claimed dose
(10 mg twice daily) obvious, in light of prior art concerns about toxicity
at high doses
• Contrasting with In re Cyclobenzaprine, Federal Circuit found a skilled
person could “draw reasonable inferences about the likelihood of
success even without a perfectly designed clinical trial showing a
statistically significant difference in efficacy between a specific dose and
placebo.”
• Blocking patent considerations: Federal Circuit held Acorda’s exclusive
license from Elan negated objective indicia of nonobviousness
27
Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd.
923 F.3d 1051 (Fed. Cir. 2019)
• Claims recite a method of inhibiting growth of solid excretory system
tumors (e.g., treating advanced renal cell carcinoma (RCC)) by
administering an effective amount of everolimus.
• West-Ward challenged the claims as obvious in view of references
teaching successful Phase I trials with another mTOR inhibitor
(temsirolimus) and patents claiming everolimus.
• Federal Circuit affirmed the district court’s holding that there was no
reasonable expectation of success that everolimus would effectively
treat RCC. There was high uncertainty in the field, notable
pharmacological differences (e.g., different half-lives, different binding
affinities) between everolimus and temsirolimus, and important
limitations (design, sample size) of the studies on temsirolimus.
28
Novartis Pharms. Corp. v. West-Ward Pharms. Int’l Ltd.
923 F.3d 1051 (Fed. Cir. 2019)
• “Numerous clinical trials investigating a wide range of treatment
strategies for advanced RCC failed. . . . Cancer drugs in general had
high failure rates for treatment of advanced RCC in clinical trials, with
more than 70% of cancer drugs failing during phase II, and a majority of
cancer drugs failing during phase III.” Id. at 1054
• Despite prior art teachings, “[t]here was no data on the efficacy of
everolimus to treat any type of cancer, let alone to treat advanced
RCC.” Id. at 1054-55
• West-Ward’s expert admitted “that a person of skill in the art would not
have reasonably expected a drug to work based only on phase I clinical
trial results, or on the fact that a drug had entered phase II clinical
trials.” Id. at 1058
29
Agenda
Reasonable expectation of success doctrine
Obviousness, including OSI v. Apotex
Anticipation
Enablement, utility, and written description
Takeaways and best practices
30
Impax Labs., Inc. v. Aventis Pharms. Inc.,
468 F.3d 1366 (Fed. Cir. 2006)
• Claims recite a method of treating ALS by administering an effective
amount of riluzole.
• Prior art patent disclosed compounds, including riluzole, and suggested
they may be used to treat ALS.
• Riluzole was not listed as “especially advantageous” in the prior art
patent and the disclosure noted “substantial uncertainty regarding the
effectiveness of treating ALS with glutamate inhibiting compounds.” Id.
at 1380
31
Impax Labs., Inc. v. Aventis Pharms. Inc.,
468 F.3d 1366 (Fed. Cir. 2006)
• Federal Circuit found the prior art patent anticipated the asserted claims
– The enablement requirement for anticipation does not require
utility/effectiveness.
– The proper issue is whether the prior art patent describes the claimed
invention sufficiently to enable an ordinarily skilled person to carry out the
invention
– Found a similar reference was not enabling because it did not identify
riluzole by name from a large genus of compounds. (“[W]ith the large
number of compounds included in formula I and no specific identification of
riluzole . . . [the reference] does not disclose riluzole, and therefore, cannot
enable treatment of ALS with riluzole.” Id. at 1383)
• See also Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325,
1326 (Fed. Cir. 2005) (“A patent claim cannot be anticipated by a prior art
reference if the allegedly anticipatory disclosures cited as prior art are not
enabled”; “a prior art reference need not demonstrate utility in order to serve
as an anticipating reference.”)
32
Sandoz Inc. v. Pharmacyclics LLC,
IPR2019-00865, Patent 9,795,604, Paper No. 8
• Claims recite a method of treating chronic graft versus host disease
(GVHD) by administering a therapeutically effective amount of ibrutinib.
• Sandoz (Petitioner) alleged the claims were anticipated by a prior art
publication that discloses pharmaceutical formulations of ibrutinib and
their uses for treating autoimmune diseases, e.g., GVHD.
• As there are just two forms of GVHD (acute and chronic) and the prior
art publication provided general guidance for therapeutic amounts of
ibrutinib, Sandoz alleged an ordinarily skilled person would have
envisioned treating chronic GVHD.
• The prior art did not include preclinical or clinical data for ibrutinib.
33
Sandoz Inc. v. Pharmacyclics LLC,
IPR2019-00865, Patent 9,795,604, Paper No. 8
• Pharmacyclics (Patent Owner) argued chronic GVHD was “poorly
understood” and “exceedingly difficult to treat, with numerous agents
failing in the clinic,” and thus the prior art publication was not enabled.
• PTAB granted institution of IPR (Sept. 2019)
– Noted that prior art publications and patents are presumed to be enabled.
– “We acknowledge Patent Owner’s argument that cGVHD is difficult to treat,
poorly understood, and lacking in predictive animal models. We further
acknowledge Patent Owner’s argument that numerous treatment agents
have failed in clinic. At this point in the proceeding, however, we are not
persuaded that the alleged failure to develop an effective treatment prior to
ibrutinib is sufficient to rebut the presumptively enabled teaching of the [prior
art] that ibrutinib can be used to treat GVHD.” Id. at 18
34
Agenda
Reasonable expectation of success doctrine
Obviousness, including OSI v. Apotex
Anticipation
Enablement, utility, and written description
Takeaways and best practices
35
Rasmusson v. SmithKline Beecham Corp.,
413 F.3d 1318 (Fed. Cir. 2005)
• Claims to method of treating prostate cancer using finasteride.
• Board held Rasmusson not entitled to priority in interference.
• On appeal to Federal Circuit, Rasmusson argued priority applications
were enabled and that efficacy only pertains to utility under 101 and is
not relevant to enablement
– “[B]oth parties agree that a person of ordinary skill in the art at the
time of Rasmusson’s applications would have recognized that
finasteride was a selective [enzyme] inhibitor, the parties disagree
as to whether a person of ordinary skill in the art would have
believed [as of the priority date] that finasteride would be effective
in treating prostate cancer.”
36
Rasmusson v. SmithKline Beecham Corp.,
413 F.3d 1318 (Fed. Cir. 2005)
• Rasmusson argued that data was not needed and POSA “would
have believed that administering a therapeutically effective amount
of finasteride could be used in treating human prostate cancer”
• Federal Circuit disagreed, finding that enablement requires
sufficient utility as a drug
– “In order to obtain [priority date], Rasmusson needed to provide
experimental proof that his invention could be effective in
treating cancer. Because Rasmusson failed to do so . . . the
Board was correct to find that all applications prior to [later]
application were not enabled, and that Rasmusson is not
entitled to a priority date earlier than the priority date of
SmithKline’s . . . patents.”
37
In re ’318 Patent Infringement Litigation,
583 F.3d 1317 (Fed. Cir. 2009)
• Claims to method of treating Alzheimer’s disease with galanthamine
• One-page specification with no animal or human testing data
• Later, galanthamine efficacy tested, licensed to Janssen, FDA approved
• Federal Circuit upheld finding of invalidity for lack of enablement and utility
38
In re ’318 Patent Infringement Litigation,
583 F.3d 1317 (Fed. Cir. 2009)
• “Typically, patent applications claiming new methods of treatment are
supported by test results. But it is clear that testing need not be conducted
by the inventor. In addition, human trials are not required for a therapeutic
invention to be patentable.”
• “We have held that results from animal tests or in vitro experiments may
be sufficient to satisfy the utility requirement.”
• “Although no case has been called to our attention where utility was
established simply by analytic reasoning, the [MPEP] has recognized that
‘arguments or reasoning’ may be used to established an invention’s
therapeutic utility.”
• “To reiterate: the question here is whether the written description of the
’318 patent would have illuminated to a person of ordinary skill in the art a
credible utility, not whether actual utility was in fact demonstrated.”
39
Eli Lilly and Co v. Actavis Elizabeth LLC,
435 Fed.Appx. 917 (Fed. Cir. 2011)
• Claims recite a method of treating ADHD by administering an effective
amount of tomoxetine.
• Federal Circuit reversed the district court’s finding of lack of
enablement/utility.
• Federal Circuit affirmed the district court’s finding of nonobviousness,
determining no reasonable expectation of success in the prior art that
tomoxetine would safely and effectively treat ADHD.
40
Eli Lilly and Co v. Actavis Elizabeth LLC,
435 Fed.Appx. 917 (Fed. Cir. 2011)
• At the time of filing:
– tomoxetine was a known compound
– tomoxetine had gone through Phase II trials for treating urinary incontinence
and Phase III trials for treating depression
– very little was known about the causes/mechanisms of treating ADHD, and
all drugs used to treat ADHD “exhibited deficiencies” (e.g., adverse events)
– another potent selective norepinephrine reuptake inhibitor (desipramine) was
known to be effective for treating ADHD, but reportedly caused sudden death
in some children
– Suggestion by inventors that tomoxetine might be an effective treatment for
ADHD was met with skepticism
– Experts for both sides in agreement that they would not have expected that
tomoxetine would be a successful treatment for ADHD
41
Eli Lilly and Co v. Actavis Elizabeth LLC,
435 Fed.Appx. 917 (Fed. Cir. 2011)
• Federal Circuit reversed the district court’s finding of lack of enablement/utility.
– “When priority it not at issue, generally the applicant may provide data
obtained either before or after the patent application was filed [to show
utility].” Id. at 925
– Relied on MPEP 2107.03 (8th ed. 2008) for instruction “to give presumptive
weight to the utility for which human trials have been initiated.” Id. at 924
– Presumption of utility depends on context: “The utility of this product to treat
ADHD is not so incredible as to warrant the special procedures that are
authorized for use when the examiner doubts the described utility, as in . . .
subject matter in once notoriously intractable areas such as cures for
baldness or cancer.” Id. at 924 (also noting that claiming “perpetual motion”
would warrant doubt)
42
Agenda
Reasonable expectation of success doctrine
Obviousness, including OSI v. Apotex
Anticipation
Enablement, utility, and written description
Takeaways and best practices
43
Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy's
Labs. Inc., 923 F.3d 1368 (Fed. Cir. 2019)
• Claims to composition comprising an acid inhibitor without an
enteric coating and an NSAID with an enteric coating
• D.N.J. found Nuvo’s claims to be nonobvious, enabled, and
adequately described
• Federal Circuit reversed, finding claims invalid for lack of written
description
44
Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy's
Labs. Inc., 923 F.3d 1368 (Fed. Cir. 2019)
• Tension between nonobviousness and written description
• District court found nonobviousness because “persons of ordinary skill in the
art were discouraged by the prior art from using uncoated PPI and would not
have reasonably expected it to work”
• Dr. Reddy’s argued if it lost on obviousness, “then the claims lack written
description support for the claimed effectiveness of uncoated PPI because
ordinarily skilled artisans would not have expected it to work and the
specification provides no experimental data or analytical reasoning showing
the inventor possessed an effective uncoated PPI.”
• “It is undisputed that there is no experimental data demonstrating the
therapeutic effectiveness of any amount of uncoated PPI and coated NSAID
in a single dosage form.”
45
Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy's
Labs. Inc., 923 F.3d 1368 (Fed. Cir. 2019)
• Dr. Reddy’s argued “satisfaction of the written description requirement
requires either supporting experimental data, or some reason, theory, or
alternative explanation as to why the claimed invention is possessed by the
inventor, and that mere recitation of claim language in the specification
cannot suffice”
• Specification describing immediate release of uncoated PPI and potential
disadvantages of enteric-coated PPI formulations “in no way provides
support for the claimed efficacy of uncoated PPI”
• “In light of the fact that the specification provides nothing more than the mere
claim that uncoated [drug] might work, even though persons of ordinary skill
in the art would not have thought it would work, the specification is fatally
flawed. It does not demonstrate that the inventor possessed more than a
mere wish or hope that uncoated [drug] would work”
46
Agenda
Reasonable expectation of success doctrine
Obviousness, including OSI v. Apotex
Anticipation
Enablement, utility, and written description
Takeaways and best practices
47
Takeaways and Best Practices
• Properly time patent application filings
– More than a “mere wish” (Nuvo) but less than clinical trial (In re ’318)
– “Analytic reasoning” of utility (In re ’318)
– “Supporting experimental data, or some reason, theory, or alternative
explanation” showing possession (Nuvo)
• Include or exclude characterizations in view of available data and prior art
– Disease characteristics “highly unpredictable” (OSI) or “reasonab[ly]
infer[red]” (Acorda)
– Description of mechanism of action, correlation between animal studies to
human efficacy
48
Takeaways and Best Practices
• Assess scope of claimed subject matter in view of clinical disclosures
– Consider claims of cascading scope
• Monitor clinical data disclosures (e.g., press releases, scientist
presentations)
– Avoid creating own prior art (Acorda)
– Limiting unnecessary subjective statements when disclosure necessary
(In re ’318; Nuvo)
• Balance nonobviousness positions with written description positions in
prosecution and litigation
– Avoid distinguishing prior art based on special features not tested in one’s
own specification (Nuvo)
49
Thank you.
Questions?
Thank You
Sara [email protected]
Alissa [email protected]
Jill [email protected]
Leslie [email protected]
Lulu [email protected]
50