Mercedes Meyer, PhDDrinker Biddle & Reath LLP

Conflict Issues in 21st CenturyLife Sciences Practice

September 10, 2015

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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 Sane3

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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

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Drug Approvals1/30/13KYNAMRO®(mipomersen sodium) Isis / Genzymeantisense drug for hypercholesterolemia

8/26/1998VITRAVENE™ (fomivirsen sodium)Antisense drug totreat CMV retinitis

4/3/2015PROVENGE® (Sipuleucel-T) Dendreon Corp.Autologous cellular immunotherapy of metastatic castrate resistant prostate cancer

6/21/2011LAVIV® (Azficel-T)Fibrocell Technologies, Inc.Treat severe nasolabial fold wrinkles with autologous fibroblasts

5/30/2012HPC (Allocord) Allogeneic cord blood hematopoietic progenitor cell therapy

ANTISENSE DRUGS

CELL/BLOOD PRODUCTS

1990 Ashanti DeSilva treated for ADA-SCID

2003GendicineApproved in China for treating some cancers

Expected FDA approval 2015GLYBERA® by XenonGene therapy for lipoprotein lipase deficiencyEU approval 10/2012

4/10/2014MYDICAR by Celladon

GENE THERAPY

VACCINES & RECOMBINANT PROTEINS (& Abs)1796 Smallpox vaccine

19821st recombinant proteinHUMULIN® - Lilly

201218 biopharmaceuticals approved

3/6/2015 – 1st biosimilar to Amgen’s NeupogenZarxio (filgrastim-sndz)

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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

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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

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Chronological Legal Change

6/8/95URAA

11/29/99AIPA

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)

2013Myriad

• FITF• Derivation• Loss of interference• Repeal of statutory

invention registration• PGR2012

Prometheus

New PTO Ethics Rules

2 sets of statutes next 20 yrs.

2014Alice

In re Roslin Inst.2009Bilski

2011Classen

2007KSR

2010Ariad

1997Lilly

2003Dayco

2007McKesson

2009Larson

2011Therasense

2014Nautilus

2014…Akamai

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2004Noelle v. Lederman

2011Centocor v. Abbott

2013Novozymes

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REFERENCE PRODUCT / BIOSIMILAR 9

Biobetter?

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Biosimilars Difficult & Expensive• Consistent batch production is difficult:

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EPO KR KR KR KR KR KR AR AR CN CN EPO EPO IN

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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.

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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

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BioBetters v. Biosimilars

• Does the story of insulin portend the future?

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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

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OTDP – The Legal Forecast?

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Conflict of Interest 15

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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?

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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

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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?

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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

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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

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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)

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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

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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

DQed

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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)

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Bender v. Dudas490 F.3d 1361, 83 USPQ2d 1065 (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 CompanyAmerican Inventors Corporation (AIC)

Leon GildenMichael Bender

1000+ Inventors

AIC paysattorney

Inventors hire AICto get them a patent

Attorney-ClientRelationship

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Max-Planck-Gesellschaft v. Wolf Greenfield & Sacks661 F.Supp.2d 125 (D. Mass 2009) and 650 F.Supp.2d 114 (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.

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MPGMIT

Whitehead

WGS

UMass

Power Of Atty Attorney-Client

only??

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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

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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:

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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

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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?

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By Structure? Maybe

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By Structure? - NO

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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.

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Should we separate by disease?CD20 (Target) and Autoimmune Diseases (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

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Search by target name?Just a few synonyms?• 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?

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Search by Target Class – TNF inhibitors example

Antibody• Golimumab

(Simponi)• Certolizumab

pegol (Cimzia)• Adalimumab

(Humira)• Infliximab

(Remicade)

Other• Etanercept

(Enbrel) fusion protein

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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

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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?

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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

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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).

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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)

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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?

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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?

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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

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Contamination42 USC 262(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.

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OMG, WHAT DO I DO? 45

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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

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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

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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

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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 mapping49

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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.

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Thanks for your attention!

Mercedes K. Meyer, Ph.D.Partner

Drinker, Biddle & Reath LLPWashington, DC 20005

202.842.8821Mercedes.Meyer@dbr.com

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Extras 52

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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

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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

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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

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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)

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