How are firms and companies handling ethical and business conflict issues in an increasingly specialized world? This panel will discuss current conflicts and ethics challenges, including the increasingly complicated world of biosimilars and subject-matter conflicts. In addition, the panelists will discuss best practices for drafting and negotiating an advanced conflict waiver that is acceptable to everyone and enforceable.

1. Mercedes Meyer, PhD
Drinker Biddle & Reath LLP
Conflict Issues in 21st Century
Life Sciences Practice
September 10, 2015

2. September10,2015
I am not David Hricik but…
2
≠
+

3. September10,2015
Assorted Topics
• Some 50,000 ft. views with historical
perspectives
• The biotechnology drug landscape
• The ethics landscape – rule and statutory change
• The case law landscape
• Reference Product / Biobetter / Biosimilar / Analogs
• Conflicts of Interest
• Industry consolidation & collaboration
• Word searches / Database robustness
• Multi-party prosecution / litigation
• Contamination
• Staying Sane 3

4. September10,2015
Conflict Questions to Self?
• Could Client A’s subject matter interfere with Client
B’s?
• Could Client A’s subject matter serve as prior art to
Client B’s?
• Could Client A’s subject matter render obvious Client
B’s?
• Could Client A’s subject matter be used in a
comparative example with Client B’s?
• Will I have access to competitor and competitive
information for Client A that could benefit / hurt Client
B?
• Will this information adversely contamination me?
4

5. September10,2015
Drug Approvals
1/30/13
KYNAMRO®(mipomersen sodium)
Isis / Genzyme
antisense drug for hypercholesterolemia
8/26/1998
VITRAVENE™ (fomivirsen sodium)
Antisense drug to
treat CMV retinitis
4/3/2015
PROVENGE® (Sipuleucel-T)
Dendreon Corp.
Autologous cellular
immunotherapy of
metastatic castrate resistant
prostate cancer
6/21/2011
LAVIV® (Azficel-T)
Fibrocell Technologies, Inc.
Treat severe nasolabial fold
wrinkles with autologous
fibroblasts
5/30/2012
HPC (Allocord)
Allogeneic cord blood
hematopoietic progenitor
cell therapy
ANTISENSE DRUGS
CELL/BLOOD PRODUCTS
1990
Ashanti DeSilva treated
for ADA-SCID
2003
Gendicine
Approved in China for
treating some cancers
Expected FDA approval
2015
GLYBERA® by Xenon
Gene therapy for lipoprotein
lipase deficiency
EU approval 10/2012
4/10/2014
MYDICAR by
Celladon
GENE THERAPY
VACCINES & RECOMBINANT PROTEINS (& Abs)
1796
Smallpox vaccine
1982
1st recombinant protein
HUMULIN® - Lilly
2012
18 biopharmaceuticals
approved
3/6/2015 – 1st
biosimilar to Amgen’s
Neupogen
Zarxio (filgrastim-sndz)
5

6. September10,2015
50,000 Foot View – RP /
Biosimilar / BioBetter?
• Reference Product (RP)
• Proof of concept
• ~$1.2B+
• $2.6B estimate now for small
chemical drugs
• BLA
• Data Exclusivity not tied to
the patent
• Biosimilar
• Same as RP – no amino acid
difference or modification
• What about an antisense
biosimilar? Same cost?
• ~$200M+
• Fight to get reimbursement
• 1 yr exclusivity
(interchangibles only)
• BioBetter
• Rides on RP proof of concept
• Requires BLA
• Improved drug, better
reimbursement possibility?
• No time limit 6

7. September10,2015
New Rules & Statutes
• AIA – 2011, 2012, 2013
implications
• Change in Statute of Limitations
• Same outcome for Therasense
• New OED Ethics Rules – May 2013
• Facts before May 2013 – apply old rules
• Business as usual?
• Biosimilars legislation enacted 2010
• Biosimilars Guidances – 5/12/15; 4/28/15; 8/4/14; 5/13/14
• Case Law Change? 7

8. September10,2015
Chronological Legal Change
6/8/95
URAA
11/29/99
AIPA
12/10/04 9/16/2011 9/16/2012 3/16/2013
• Best mode
• Virtual & false marking
• OED Stat. of limitations
• Micro entity status
• PTE
9/26/2011
• Oath & Dec
• Preissuance submission
• Supplemental exam
• IPR
• PGR for business
methods (CBM)
• 17 years from grant
to 20 years from
filing
• CONS/DIVS/CIPS
• Claim of benefit – 1.78
• Publication after 18 mos.
• Inter partes reexamination
• RCE v. CPA practice
Prioritized Exam
5/29/00
PTA 154(b)
• CREATE
Act 103(c)
• Final rules for
interferences and
appeals
(9/10/04)
2013
Myriad
• FITF
• Derivation
• Loss of interference
• Repeal of statutory
invention registration
• PGR2012
Prometheus
New PTO Ethics Rules
2 sets of statutes next 20 yrs.
2014
Alice
In re Roslin Inst.
2009
Bilski
2011
Classen
2007
KSR
2010
Ariad
1997
Lilly
2003
Dayco
2007
McKesson
2009
Larson
2011
Therasense
2014
Nautilus
2014…
Akamai
8
2004
Noelle v.
Lederman
2011
Centocor v. Abbott
2013
Novozymes

9. September10,2015
REFERENCE PRODUCT / BIOSIMILAR 9
Biobetter?

10. September10,2015
Biosimilars
Difficult & Expensive
• Consistent batch production is difficult:
10
EPO KR KR KR KR KR KR AR AR CN CN EPO EPO IN

11. September10,2015
BioBetters – Another Option
• Biobetters contain similar active
ingredients, e.g., an antibody that
targets the same protein as a
reference product, but possess:
• Any new indication, route of administration, dosing schedule,”
etc.; or
• A modification to the structure of the biological product that
[results] in a change in safety, purity, or potency.
11

12. September10,2015
BioBetters
• Licensure of a biobetter would be
through a BLA, rather than the
biosimilar pathway
• Data protection: Biobetters would enjoy the same market
exclusivity and data protection under a BLA as a reference
product
• The biobetter manufacturer would not have to disclose data to a
competitor
• The biobetter manufacturer may face less risk and lower costs in
developing and improving a product already approved by the FDA
for a validated indication 12

13. September10,2015
BioBetters v. Biosimilars
• Does the story of insulin portend the future?
13
Product(s) Biosimilars Biobetters
Enbrel 16 8
Avastin 6 8
Rituxan 21 15
Remicade 6 4
Herceptin 14 11
Humira 5 3
Lantus 5 2
Neulasta 11 9
Lucentis 2 2
Aranesp 4 2
Insulins (all) 33 51
TNF inhibitors 28 16
G-CSF 55 22
mAbs/antibody-like 98 82
Interferons alfa 44 33
Interferons beta 19 21
EPO/epoetins 60 25

14. September10,2015
OTDP – The Legal Forecast?
14

15. September10,2015
Conflict of Interest 15

16. September10,2015
So what’s the problem?
• Industry consolidation?
• Industry collaboration?
• Law Firm consolidation?
• Target v. Ligand?
• Disease?
• Genus / Species & Laundry Lists?
• Term synonyms?
• Landmark patent technology? 16

17. September10,2015
37 CFR §11.106(c):
Confidentiality of Information
• (a) A practitioner shall not
reveal information relating to
the representation of a client
unless the client gives
informed consent, the
disclosure is impliedly
authorized in order to carry
out the representation, the
disclosure is permitted by
paragraph (b) of this section,
or the disclosure is required
by paragraph (c) of this
section.
• (c) A practitioner shall
disclose to the Office
information necessary to
comply with applicable duty
of disclosure provisions.
• §11.106(c) is not present in
MRPR 1.6. It differs from old
§10.57(c) which recited “may
reveal”.
• ISSUE: Can you OR must you
cite a confidential document
of one client that pertains to
the patentability of another
client’s claims under §11.106?
• See J. Nies dissent in Molins PLC
v. Textron Inc., 48 F.3d 1172
(Fed. Cir. 1995).
• Noisy withdrawal?
17

18. September10,2015
Conflict of Interest
• ABA Cmt. 24 / Rule 1.7
Ordinarily a lawyer may
take inconsistent legal
positions in different
tribunals at different times
on behalf of different
clients. The mere fact that
advocating a legal position
on behalf of one client
might create precedent
adverse to the interests of
a client represented by the
lawyer in an unrelated
matter does not create a
conflict of interest.
• So…we can claim
genus for one client
and a species for
another and still be
okay? Can we claim
around another client’s
product?
18

19. September10,2015
Duties
• Confidentiality – 1.6 & 11.106
• Conflict of Interest / Current Clients –
1.7-1.8 & 11.107-11.108
• Former Clients – 1.9 & 11.109
• Imputation of Conflicts – 1.10 &
11.110
• Competence? 1.1 19

20. September10,2015
Industry Consolidation &
Conflicts
• Pharma continues to consolidate
• Mergers, Assets Trades, Collaborations:
• Novartis sells animal health to Lilly; Organon / Schering-
Plough/Merck; Bayer AG with Schering; AstraZeneca/Medimmune;
Pfizer/Wyeth; Sanofi-Aventis; Roche / Genentech; Forest / Watson /
Actavis
• Keeping your representations straight in Big Law
20

21. September10,2015
An Industry Consolidation
Problem
• Who’s the client? Chap. 4
• Does the current corp. client have a belief that its affiliate has de
facto become a current client of the law firm?
• Does the corp. client share the same directors, officers, management
as affiliate?
• Does the corp. client share the same offices with the affiliate?
• Does the corp. client share the same legal department with affiliate?
• Does the corp. client and affiliate share a substantial number of
corporate services?
• Is there substantial integration infrastructure between the current
corp. client and affiliate (e.g. computer networks, e-mail, intranet,
letterhead, etc.)
• Will representation of corp. client materially limit adverse
representation of affiliate?
• N.Y.C. Ethics Op. 2007-03 (Sept. 2007)
21

22. September10,2015
Law Firm Mergers 2014-15
• Dentons with McKenna Long & Aldridge, 2015
• Greenberg Traurig & Michaels Ward & Rabinowitz,
2015
• Nixon Peabody & Ungaretti & Harris, 2015
• DLA Piper & Davis LLP, 2015
• Dykema & Cox Smith Matthews, 2015
• Stinson Morrison Hecker & Leonard Street Deinard,
2014
• Cooley LLP & Dow Lohnes, 2014
• BakerHostetler & Woodcock Washburn, 2014
• Squire Sanders & Patton Boggs, 2014
• Locke Lord & Edwards Wildman, 2014 22

23. September10,2015
A Big Law Problem?
• In the matter of Certain Laser
Abraded Denim Garments, Order No.
43, Inv. No. 337-TA-930 (5/7/2015)
• Can you solve this by style of business organization? Maybe No.
• Dentons (aka Swiss verein Dentons) was disqualified in the ITC
proceeding for being adverse to Gap while representing Gap on
14 open matters elsewhere.
• Dentons had access to US importation, exportation, financial, and
taxation structure, records, and information and accused
products.
• FIRM DISQUALIFIED. 23

24. September10,2015
Industry Collaboration &
Conflicts
• University collaborations for pipelines
& diagnostics:
• Who do you represent?
• Novartis / U. Penn; GSK / Yale; Sanofi / UCSF
• Keeping your power of attorney straight
• Generics v. Brands –
• Keeping your opinions straight?
• Companies having a branded and generic side (e.g., Sanofi)
24

25. September10,2015
Bender v. Dudas
490F.3d1361,83USPQ2d1065(Fed.Cir.2007)
• AIC gave a money-back guarantee of
“a patent” to inventors.
• Only design patents were sought.
• Neither Gilden nor Bender spoke to
an inventor – AIC discouraged that
practice.
• AIC paid Gilden and Bender.
• Attorney-client relationship is
between the attorneys and the
inventors with payment coming from
a 3rd party.
• What is the impact of the payment
by the 3rd party to the attorney?
• Does it alter the duty of loyalty
owed to the client?
• ADVICE: Know who your client is.
State in writing who is not your
client.
Promotion Company
American Inventors
Corporation (AIC)
Leon Gilden
Michael Bender
1000+ Inventors
AIC pays
attorney
Inventors
hire AIC
to get them
a patent
Attorney-Client
Relationship
25

26. September10,2015
Max-Planck-Gesellschaftv.Wolf Greenfield& Sacks
661F.Supp.2d125(D.Mass2009)and650F.Supp.2d114(D.Mass.2009)
• WGS “represented” Whitehead
Institute in technology involving
MIT, Whitehead, UMass, and MPG.
• MPG’s complaint only states that
the Powers of Attorney confirms
the existence of attorney-client
relationship among all the parties.
• MIT, MPG, and Whitehead are in a
joint-invention and joint-marketing
agreement, with Whitehead
responsible for managing the
prosecution, but all could advise on
prosecution.
• WGS allegedly had included
inventions from the Tuschl II patent
(MPG only) into Tuschl I (joint).
• MPG argues that TII may not issue
because of OTDP.
• TII arguably is a species and TI a genus. 26
MPG
MIT
Whitehead
WGS
UMass
Power
Of Atty Attorney-Client
only??

27. September10,2015
Best Mode
• It is still required under 35 USC 112
• If your client doesn’t want to reveal it:
• Keep it as a trade secret and do not file a patent application,
• Maybe see if it is required for the claims (e.g., small v. industrial
size batches) OR
• Tell client to find a new lawyer
• To omit it is fraud
27

28. September10,2015
28

29. September10,2015
What’s in a name?
• Amgen / Sandoz-Novartis
• Neupogen® (filgrastim) / Zarxio™ (filgrastim-sndz) – Neupogen ®
and Zarxio ™ are the brand names.
• Granulocyte colony-stimulating factor (G-CSF) analog
• Other brand names are as follows:
29
Company Brand
Cadila Pharmaceuticals Filcad
Abbott Laboratories Imu-Max
Dr. Reddy’s Laboratories Grafeel
Intas Biopharmaceuticals Neukine
Emcure Pharmaceuticals Emgrast
Reliance Life Sciences Religrast®
Biocon Nufil

30. September10,2015
Search Terms – Ex. Insulin
• INSULIN
• Humalog® (Insulin lispro) (Eli Lilly and Co.) - reverses the C-terminal lysine and proline
residues of the B chain
• NovoLog® /NovoRapid (aspart) (Novo Nordisk) – a faster acting insulin wherein a proline is
substituted with an aspartic acid
• Apidra® (Glulisine) (Sanofi) – fast acting insulin
• Levemir® (Insulin detemir) (Novo Nordisk) – long acting insulin with high affinity of serum
albumin
• Tresiba (Degludec insulin) (Novo Nordisk) – ultra long-acting insulin analogue
• Lantus® (Glargine insulin) (Sanofi) – long lasting insulin with 3 modified amino acids
• CONCLUSION: You likely couldn’t do insulin analog
work for two companies because you would likely have
access to comparative data, financial data, etc. It may
limit your claim strategy. Prior Art problems?
30

31. September10,2015
By Structure? Maybe
31

32. September10,2015
By Structure? - NO
32

33. September10,2015
Another Hypo
• Can you represent RB Co. for RB
product and then also represent
Biosimilar Co. in an unrelated IP
matter even though they make a
biosimilar to RB product? POSSIBLY
• What about representing Biosimilar Co. for the biosimilar to the
RB? 37 CFR 11.107(b)(2), 11.108(a)
• See also ABA Model Rule 1.7, Cmt. 24.
• What about representing Biosimilar Co. for a biobetter on RB
product? 37 CFR 11.108(a)
• 11.108(a) – can’t disadvantage one client for another. 33

34. September10,2015
Should we separate by disease?
CD20(Target) andAutoimmuneDiseases(Genus)
• The Laundry List Problem
• B-Cell disorders – Subgenus
• immune-mediated thrombocytopenias – Sub-subgenus for idiopathic
thrombocytopenic purpura and chronic idiopathic thrombocytopenic
purpura
• Species: myasthenia gravis, lupus nephritis, lupus erythematosus,
and rheumatoid arthritis
• CONCLUSION: Search the terms for a robust database, but unlike
LED displays, restriction of legal practice by disease not practical
34

35. September10,2015
Search by target name?
Just afewsynonyms?
• CD20 (human only)
• MS4A1 (membrane-spanning 4-
domains, subfamily A, member 1)
• B1, B-lymphocyte antigen CD20,
B-lymphocyte surface antigen B1,
• Bp35
• CD20
• CVID5,
• LEU-16, Leukocyte surface
antigen Leu-16
• Membrane-spanning 4-domains
subfamily A member 1,
• MGC3969
• MS4A2
• S7
• CD20L (human only)
• MS4A3 (membrane-spanning 4-
domains, subfamily A, member 3
(hematopoietic cell-specific)
• CD20 antigen-like protein,
• CD20L, Hematopoietic-specific
transmembrane protein 4, HTm4,
HTM4, Membrane-spanning 4-
domains subfamily A member 3
35
QUESTIONS: Do you search by target or by target and ligand
of interest that is being modulated? What about multiple
ligands and promiscuous binding behaviors – what do you
search then? And what if all ligands aren’t known?

36. September10,2015
Search by Target Class –
TNF inhibitors example
Antibody
• Golimumab
(Simponi)
• Certolizumab
pegol (Cimzia)
• Adalimumab
(Humira)
• Infliximab
(Remicade)
Other
• Etanercept
(Enbrel) fusion
protein
36
Compounds
• TAPI-1 – TNF-alpha
protease inhibitor 1, OR
• N-{(2R)-2-[2-
(Hydroxyamino)-2-
oxoethyl]-4-
methylpentanoyl}-3-(2-
naphthyl)-L-alanyl-N-(2-
aminoethyl)-L-
alaninamide
• Xanthine derivatives
(e.g. pentoxifylline)
• Buproprion

37. September10,2015
Is there a conflict?
• Are the different insulin analogs
different enough that you could
prosecute applications for analogs for
two different companies?
• Business / Financial / Competitive information?
• Comparative data?
• Negative statements or disparaging statements?
• Prior art issues?
• Does the insulin analog illustrate the
problem of biobetters? 37

38. September10,2015
Is there a conflict?
• An antisense compound to
hypercholesterolemia and a new statin
for different companies? YES
• Or an antisense compound and an antibody?
• A component vaccine and a adenovirus
vaccine for same virus?
• MAYBE?
• A Dab to CD20 and a scFv to CD20?
• MAYBE NO?
• A stem cell – by differentiation status? 38

39. September10,2015
Combination Drugs &
Drug/Companion Diagnositics
• Areas where companies play
together:
• HYPO: You (IP attorney at Company X) have an antibody drug
(Invincimab) and want to combine with an infinitase inhibitor
(small chemical) of Company A. You also want to collaborate with
Company B with infinitase super inhibitor. Both combinations
would treat the same cancer, Toeleola (cancer of the big toe).
39

40. September10,2015
Combination Drugs &
Drug/Companion Markers 2
• Corporate team contamination issue?
• Outhouse attorney considerations
• Rule 1.6 – must preserve client confidences even after a client
departs / matter concluded
• Rule 1.7 - Can you represent both Company A and Company B?
Is there a significant risk that the representation of one or more
clients will be materially limited by the lawyer’s responsibilities to
another client, a former client or a third person or by a personal
interest of the lawyer? See 1.7(a)(2)
40

41. September10,2015
Conflict of Interest
• ABA cmt. 24, Rule 1.7
• A conflict of interest
exists, however, if
there is a significant
risk that a lawyer’s
action on behalf of
one client will
materially limit the
lawyer’s effectiveness
in representing
another client in a
different case….
• Disclosing data or
references obtained
from one client for
another client’s
biobetter?
• Disclosing data from
one client for
another for different
drug combinations?
• What about prior
art? 41

42. September10,2015
The Patent Scrum
• Landmark patents & The Pile On
• The Queen patents
• The PCR patents of Cary Mullis
• CRISPR
• Do such patents lead to a patent
scrum?
• Does the field get a wee muddy?
• Where’s the ball?
42

43. September10,2015
Legal Conflict of Interest
Factors
• ABA cmt. 24, Model Rule 1.7
• Where the cases are pending?
• Whether the issue is substantive or procedural?
• The temporal relationship between the matters?
• Think former client / former matter
• The significance of the issue to the immediate and long-term
interests of the clients involved?
• The client's reasonable expectations in retaining the lawyer?
• IF there is significant risk, then informed consent is necessary or
the attorney must withdraw
43

44. September10,2015
Contamination
42USC262(l)(1)(B)
• What does related or
relevant to RP mean?
• What does formally or informally mean
regarding prosecuting attorney?
• How does past prosecution impact work?
• Inhouse v. outhouse counsel contamination?
• How far in the “past”?
• Ethical wall impracticality for combination patents.
• Biosimilar v. Reference Products – an FTO mess.
44

45. September10,2015
OMG, WHAT DO I DO? 45

46. September10,2015
Questions to ask yourself?
• Would there a material limitation in
what data from each client I could
include in the application?
• Would one application serve as prior
art to the other? 102/103 or 112
• Are there interfering claims?
• What are my search terms?
• iHOP – great for synonyms / subject matter conflict
• http://www.ihop-net.org/UniPub/iHOP/ 46

47. September10,2015
Engagement Letters
• Point out when you as attorney would
have to withdraw
• Point out issues of having to cite prior
art
• Indicate who you represent and who
you DO NOT represent
47

48. September10,2015
Conflicts Databases &
Robustness
• Company name, address, Dunn &
Bradstreet
• Drug name, brand name
• Target and ligand to target and their
synonyms
• Claim terms
• Law firm acquisitions & laterals
• Competitors – discuss with client 48

49. September10,2015
Other?
• Even after the conflict check, remain
aware
• GP firms – educate management on
client industry / competitors and conflicts
• Strategic planning to include industry
change
• Landmark patents included strategy
• Waivers / Engagement letters /
collaboration mapping
49

50. September10,2015
I am Not Your Lawyer
• These materials are public information and have been prepared
solely for educational and entertainment purposes to contribute to
the understanding of U.S. intellectual property law and practice.
These materials reflect only the personal views of the speaker and
are not individualized legal advice. It is understood that each case is
fact-specific, and that the appropriate solution in any case will vary.
Therefore, these materials may or may not be relevant to any
particular situation. Thus, Drinker Biddle & Reath LLP, and the
speaker cannot be bound either philosophically or as
representatives of their various present and future clients to the
comments expressed in these materials. The presentation of these
materials does not establish any form of attorney-client relationship
with the firm or the speaker, or any combination thereof. While
every attempt was made to insure that these materials are accurate,
errors or omissions may be contained therein, for which any liability
is disclaimed.
• And nothing represents the views of any sentient life form on the
earth or universe, or any parallel universe, alive or dead, fictitious
or real! This is for entertainment purposes only.
50

51. September10,2015
Thanks for your attention!
Mercedes K. Meyer, Ph.D.
Partner
Drinker, Biddle & Reath LLP
Washington, DC 20005
202.842.8821
Mercedes.Meyer@dbr.com
51

52. September10,2015
Extras 52

53. September10,2015
References – Non Case Law
• Kevin Noonan, “Effect of OTDP on Patent Term Loss” ACI Life Science Patents, New York (Jan. 13,
2015)
• Kimberly Baker and Manish Borde, “Precluding Disclosure under FOIA Requests,” DRI Jul 2008
• James Clements and Eric P. Raciti, “A Trap for the Wary: How Compliance with FDA Medical Device
Regulations Can Jeopardize Patent Rights, IDEA-The Intellectual Property Law Review July 2006
• P. Lurie and A. Zieve, “Sometimes the Silence Can be Like Thunder: Access to Pharmaceutical Data
at the FDA,” 69 Law & Contemp. Problems 85-97 (2006)
• Tracy Staton, “Bristol-Myers socks Merck’s Brand-new Keytruda with PD-1 Patent Suit,”
FiercePharma Sept. 8, 2014
• Janene Boyce, “Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information
Act Should Be Restored,” 2005 (3) Duke Law & Tech. Rev.
• Todd E. Garabedian, “Nontraditional Publications and Their Effect on Patentable Inventions,”
Nature Biotechnology 20: 401 (Apr. 2002)
• Gene Quinn, “Patent Abuse or Genius? Is Kyle Bass Abusing the Patent System?” Apr. 8, 2015, IP
WatchDog
• Douglas G. Metcalf, “Therapeutic Antibody Patent Infringement Litigation: Untested and
Uncertain Litigation Strategies Underpin Patents Protecting Multibillion-Dollar Pharmaceuticals,”
19 B.U.J. Sci. & Tech. L. (2013)
• Pharma History - http://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-
learned-and-trends-to-watch/
• Pharma / University Pairings - http://www.fiercebiotech.com/slideshows/20-major-pharma-
academic-alliances-2012
• A $4 Billion Surprise for 45-Person Biotech, WSJ Jan. 10, 2014
• OED FOIA Reading Room: http://e-foia.uspto.gov/Foia/OEDReadingRoom.jsp
53

54. September10,2015
Case Law
• Ariad Pharms., Inc. v. Eli Lilly & Co., 2008-1248, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 560 F.3d 1366; 2009 U.S.
App. LEXIS 6915; 90 U.S.P.Q.2D (BNA) 1549, April 3, 2009, Decided, Vacated by, Rehearing, en banc, granted by ARIAD Pharms., Inc. v. Eli
Lilly & Co., 2009 U.S. App. LEXIS 18981 (Fed. Cir., Aug. 21, 2009)
• Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 186 L. Ed. 2d 124, 2013 U.S. LEXIS 4540, 24 Fla. L. Weekly Fed. S
276, 106 U.S.P.Q.2d (BNA) 1972 (U.S. 2013)
• Bender v. Dudas, 2006-1243 , UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 490 F.3d 1361; 2007 U.S. App. LEXIS
14702; 83 U.S.P.Q.2D (BNA) 1065, June 21, 2007, Decided , US Supreme Court certiorari denied by Bender v. Dudas, 2008 U.S. LEXIS
3813 (U.S., Apr. 28, 2008)
• Bilski v. Kapos, 561 U.S. 593; 130 S. Ct. 3218; 177 L. Ed. 2d 792; 2010 U.S. LEXIS 5521; 78 U.S.L.W. 4802; 2010-1 U.S. Tax Cas. (CCH)
P50,481; 95 U.S.P.Q.2D (BNA) 1001 (2009)
• Biosig Instruments, Inc. v. Nautilus, Inc., 2012-1289, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 2015 U.S. App. LEXIS
6851, April 27, 2015, Decided
• Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 2009-1032, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 592 F.3d
1340; 2010 U.S. App. LEXIS 1624; 93 U.S.P.Q.2D (BNA) 1417, January 25, 2010, Decided, Related proceeding at Mylan, Inc. v. Boehringer
Ingelheim Int'l GMBH, 2010 U.S. Dist. LEXIS 27819 (W.D. Pa., Mar. 24, 2010)Rehearing denied by, Rehearing, en banc, denied by
Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 603 F.3d 1359, 2010 U.S. App. LEXIS 9371 (Fed. Cir., 2010)Related proceeding at FTC
v. Boehringer Ingelheim Pharms., Inc., 2012 U.S. Dist. LEXIS 138854 (D.D.C., Sept. 27, 2012)
• Centocor Ortho Biotech, Inc. v. Abbott Laboratories, 636 F.3d 1341 (Fed. Cir. 2011)
• Classen Immunotherapies, Inc. v. Biogen Idec, 2006-1634, 2006-1649, UNITED STATES COURT OF APPEALS FOR THE FEDERAL
CIRCUIT, 659 F.3d 1057; 2011 U.S. App. LEXIS 18126; 100 U.S.P.Q.2D (BNA) 1492, August 31, 2011, Decided, As Corrected September 12,
2011.Motion granted by, in part, Motion denied by, in part, Claim dismissed by Classen Immunotherapies, Inc. v. Biogen IDEC, 2012 U.S.
Dist. LEXIS 75039 (D. Md., May 29, 2012)Later proceeding at GlaxoSmithKline v. Classen Immunotherapies, Inc., 133 S. Ct. 50, 183 L. Ed.
2d 672, 2012 U.S. LEXIS 4709 (U.S., 2012)US Supreme Court certiorari denied by GlaxoSmithKline v. Classen Immunotherapies, Inc., 2013
U.S. LEXIS 648 (U.S., Jan. 14, 2013)
• Chiron Corp. v. Genentech, Inc., 363 F.3d 1247 (Fed. Cir. 2004)
• CLS Bank Int'l v. Alice Corp. Pty, 2011-1301, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 717 F.3d 1269; 2013 U.S.
App. LEXIS 9493; 106 U.S.P.Q.2D (BNA) 1696, May 10, 2013, Decided, US Supreme Court certiorari granted by Alice Corp. Pty. Ltd. v. CLS
Bank Int'l, 134 S. Ct. 734, 187 L. Ed. 2d 590, 2013 U.S. LEXIS 8777 (U.S., 2013)Affirmed by Alice Corp. Pty. LTD v. CLS Bank Int'l, 2014 U.S.
LEXIS 4303 (U.S., June 19, 2014)
• Dayco Prods. v. Total Containment, No. 99-3042-CV-S-SOW , UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MISSOURI,
SOUTHERN DIVISION, 218 F. Supp. 2d 1129; 2002 U.S. Dist. LEXIS 16769, June 21, 2002, Decided , Vacated by, Remanded by Dayco Prods.
v. Total Containment, 2003 U.S. App. LEXIS 10374 (Fed. Cir., May 23, 2003)
• In re Dinsmore, 2013-1637, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 757 F.3d 1343; 2014 U.S. App. LEXIS 10708;
111 U.S.P.Q.2D (BNA) 1229, June 10, 2014, Decided
• E.I. du Pont de Nemours & Co. v. Cetus Corp., No. C 89-2860 MHP, UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF
CALIFORNIA, 1990 U.S. Dist. LEXIS 18382; 19 U.S.P.Q.2D (BNA) 1174, December 11, 1990, Decided , December 11, 1990, Filed
54

55. September10,2015
Case Law
• Genentech, Inc. v. Chiron Corp., No. C-94-3334 CW, UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF
CALIFORNIA, 1995 U.S. Dist. LEXIS 22291, July 19, 1995, Decided , July 19, 1995, Filed; July 28, 1995, Entered in Civil Docket
• Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 02-1439 , UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 349
F.3d 1373; 2003 U.S. App. LEXIS 23795; 68 U.S.P.Q.2D (BNA) 1865, November 21, 2003, Decided
• Gilead Scis., Inc. v. Natco Pharma Ltd., Civil Action No. 11-CV-1455 (SDW-MCA)Consolidated withCivil Action No. 11-CV-4969
(SDW-MCA), UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY, 2012 U.S. Dist. LEXIS 180717, December
21, 2012, Decided, December 21, 2012, Filed, NOT FOR PUBLICATION, Vacated by, Remanded by Gilead Scis., Inc. v. Natco
Pharma Ltd., 2014 U.S. App. LEXIS 7494 (Fed. Cir., Apr. 22, 2014)
• KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 167 L. Ed. 2d 705, 2007 U.S. LEXIS 4745, 75 U.S.L.W. 4289, 20 Fla.
L. Weekly Fed. S 248, 82 U.S.P.Q.2d (BNA) 1385 (2007)
• Larson Mfg. Co. of S.D. v. Aluminart Prods., 2008-1096, 2008-1174, UNITED STATES COURT OF APPEALS FOR THE FEDERAL
CIRCUIT, 559 F.3d 1317; 2009 U.S. App. LEXIS 5572; 90 U.S.P.Q.2D (BNA) 1257, March 18, 2009, Decided, Rehearing denied
by Larson Mfg. Co. of S.D., Inc. v. Aluminart Prods., 2009 U.S. App. LEXIS 10624 (Fed. Cir., Apr. 13, 2009)On remand at Larson
Mfg. Co. of S.D., Inc. v. Aluminart Prods., 2010 U.S. Dist. LEXIS 76917 (D.S.D., July 28, 2010)
• Max-Planck-Gesellschaft Zur Foerderung Der Wissenschaften E.V. v. Wolf Greenfield & Sacks, PC, CIVIL ACTION NO. 09-
11168-PBS, UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS, 736 F. Supp. 2d 353; 2010 U.S. Dist.
LEXIS 95676, September 14, 2010, Decided, September 14, 2010, Filed
• Max-Planck-Gesellschaft Zur Forderung Der Wissenschaften E.V. v. Whitehead Inst. for Biomedical Research, CIVIL ACTION
NO. 09-CV-11116-PBS, UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS, 850 F. Supp. 2d 317; 2011
U.S. Dist. LEXIS 11469, February 7, 2011, Decided, Related proceeding at Univ. of Utah v. Max-Planck-Gesellschaft zur
Forderung der Wissenschaften E.V., 2012 U.S. Dist. LEXIS 80311 (D. Mass., June 11, 2012)
• McKesson Info. Solutions, Inc. v. Bridge Med., Inc., 2006-1517 , UNITED STATES COURT OF APPEALS FOR THE FEDERAL
CIRCUIT, 487 F.3d 897; 2007 U.S. App. LEXIS 11606; 82 U.S.P.Q.2D (BNA) 1865, May 18, 2007, Decided , Rehearing denied by,
Rehearing, en banc, denied by McKesson Info. Solutions, Inc. v. Bridge Med., Inc., 2007 U.S. App. LEXIS 17649 (Fed. Cir., July
10, 2007)
• Meds. Co. v. Kappos, Civil Action No. 01:10-cv-81, UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF VIRGINIA,
ALEXANDRIA DIVISION, 699 F. Supp. 2d 804; 2010 U.S. Dist. LEXIS 25727; 94 U.S.P.Q.2D (BNA) 1748, March 16, 2010, Filed
55

56. September10,2015
Case Law
• Molins Plc v. Textron, 94-1199, 94-1200, 94-1201, 94-1215 , UNITED STATES COURT OF APPEALS FOR THE FEDERAL
CIRCUIT, 48 F.3d 1172; 1995 U.S. App. LEXIS 2959; 33 U.S.P.Q.2D (BNA) 1823, February 16, 1995, Decided , Rehearing
Denied March 15, 1995, Reported at: 1995 U.S. App. LEXIS 12219
• Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004)
• Pfizer, Inc. v. Teva Pharms. USA, Inc., 2007-1271, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 518 F.3d
1353; 2008 U.S. App. LEXIS 4969; 86 U.S.P.Q.2D (BNA) 1001, March 7, 2008, Decided, Rehearing denied by, Rehearing, en
banc, denied by Pfizer, Inc. v. Teva Pharms. USA, Inc., 2008 U.S. App. LEXIS 12722 (Fed. Cir., May 6, 2008)Rehearing denied
by, Rehearing, en banc, denied by Pfizer, Inc. v. Teva Pharms. USA, Inc., 2008 U.S. App. LEXIS 12718 (Fed. Cir., May 6,
2008)Related proceeding at Mylan Pharms., Inc. v. United States FDA, 23 F. Supp. 3d 631, 2014 U.S. Dist. LEXIS 73448 (N.D.
W. Va., 2014)
• Prometheus Labs., Inc. v. Mayo Collaborative Servs. & Mayo Clinic Rochester, 2008-1403, UNITED STATES COURT OF
APPEALS FOR THE FEDERAL CIRCUIT, 628 F.3d 1347; 2010 U.S. App. LEXIS 25956; 97 U.S.P.Q.2D (BNA) 1097, December 17,
2010, Decided, US Supreme Court certiorari granted by Mayo Collaborative Servs. v. Prometheus Labs., Inc., 131 S. Ct. 3027,
180 L. Ed. 2d 844, 2011 U.S. LEXIS 4764 (U.S., 2011)Reversed by Mayo Collaborative Servs. v. Prometheus Labs., 2012 U.S.
LEXIS 2316 (U.S., Mar. 20, 2012)
• Regents of Univ. of Cal. v. Eli Lilly & Co., 96-1175, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 119 F.3d
1559; 1997 U.S. App. LEXIS 18221; 43 U.S.P.Q.2D (BNA) 1398, July 22, 1997, Decided , Rehearing Denied and Suggestion for
Rehearing In Banc Declined October 24, 1997, Reported at: 1997 U.S. App. LEXIS 31640. Certiorari Denied April 20, 1998,
Reported at: 1998 U.S. LEXIS 2769
• In re Roslin Inst. (Edinburgh), 2013-1407, UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT, 750 F.3d 1333;
2014 U.S. App. LEXIS 8647; 110 U.S.P.Q.2D (BNA) 1668, May 8, 2014, Decided
• Sun Pharm. Indus. v. Eli Lilly & Co., 611 F.3d 1381, 2010 U.S. App. LEXIS 15552, 95 U.S.P.Q.2d (BNA) 1797 (Fed. Cir. 2010)
• Therasense, Inc. v. Becton, Dickinson & Co., No. C 04-02123 WHA Consolidated withNo. C 04-03327 WHA, No. C 04-03732
WHA, No. C 05-03117 WHA, UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA,2012 U.S. Dist.
LEXIS 71446, May 22, 2012, Decided, May 22, 2012, Filed, Motion granted by Therasense, Inc. v. Becton, Dickinson & Co.,
2012 U.S. App. LEXIS 17414 (Fed. Cir., Aug. 17, 2012) Appeal dismissed by, in part Therasense, Inc. v. Becton, Dickinson &
Co., 2012 U.S. App. LEXIS 22189 (Fed. Cir., Oct. 23, 2012) Affirmed by Therasense, Inc. v. Becton, Dickinson & Co., 2014 U.S.
App. LEXIS 4582 (Fed. Cir., Mar. 12, 2014)
56