Whether to Pursue Enforcement at the ITC and/or District Court; and

Preparing for PTAB Challenges to Pre-AIA and Post-AIA Patents

JOINT BIOTECH-ITC COMMITTEE PRESENTATION

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INTRODUCTIONS

• Brian Koo, Investigative Attorney with the Office of Unfair Import Investigations (OUII) at the U.S. International Trade Commission, in a cameo role

• Kwame N. Mensah, Intellectual Property Counsel at AstrZeneca/MedImmune, featured as “Soteria’s General Counsel”

• Vicki G. Norton, Co-Leader, Global Life Sciences at Duane Morris LLP featured as “Soteria’s Director of IP”

Soteria BiosciencesDiscovered and commercialized its NoPainNoGain drug based on an extract from Humor plantsDeveloped a second generation therapeutic, Soterigen® NPGB, a biologic drug (polypeptide) with pain relieving effects, which does not cause weight gain or memory loss (NoPain/NoGain/Better Brain (NPGB)). Soterigen ® NPGB received approval 10 years ago.

Find out more about Soteria athttp://www.aipla.org/committees/committee_pages/Biotechnology/Soteria/SitePages/Home.aspx

Disclaimer: Soteria Biosciences is a hypothetical biotech company. Fact patterns and legal issues relating to Soteria Biosciences are for educational and entertainment purposes only. All entities, characters, and fact patterns presented herein

are fictitious. Any resemblance to real entities, persons, and/or facts is purely coincidental.

SOTERIA PATENT ENFORCEMENTWhether to Pursue Enforcement at the ITC

and/or District Court; and Preparing for PTAB Challenges to Pre-AIA and

Post-AIA Patents

OCTOBER 22, 2015 MEETING WITH OUTSIDE COUNSEL3:30-5:30 pm

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INTRODUCTIONS

• Maximilienne Giannelli, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP as Soteria’s outside ITC/litigation counsel

• Dallin G. Glenn, Stern Kessler Goldstein Fox as Soteria’s outside ITC/litigation counsel

• Herbert D. Hart III, partner at McAndrews Held & Malloy as Soteria’s outside PTAB counsel

Patent Family

Claimed Subject Matter Filing Date

Term (+PTE)

NPGB Main (Pre-AIA)

NPGBCompositions; formulations

3/17/01 3/17/241

NPGB Main NPGB Gene; constructs; methods of making construct; recombinantly expressed NPGB; mammalian expression systems

3/17/01 3/17/21

NPGB Humor(Post AIA)

NPGB-BG (Track One)Methods of expressing in plants

3/17/13 3/17/33

NPGB Humor Methods of expressing NPGB in plants 3/17/13 3/17/33

NPGB Neuro(Post AIA)

Methods of treating neurodegenerative diseases

3/17/13 3/17/33

1 Soteria secured 3 years PTE for its NPGB composition patent

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SameGene Activities

SG

• SameGene announced it filed its Biosimilar Application a few months ago and recently issued a press release saying that has a meeting scheduled with an FDA Advisory Committee in a few months

• SameGene didn’t give us a copy of its aBLA or provide any manufacturing information

Brian Koo, US International Trade Commission, Washington, DCMaximilienne Giannelli, Ph.d., Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC

Dallin Glenn, Sterne Kessler Goldstein & Fox, Washington, DC

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Whether to Pursue Enforcement of Soteria Bioscience’s Patents before the ITC

[Biotech-image – polypeptide/membrane?]

Brian Koo – Maximilienne Giannelli – Dallin Glenn

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Blocking Importation

(1) Likelihood of success(2) Irreparable harm(3) Balance of equities(4) Public interest

• Timeline – 1 to 6 months

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Blocking Importation

• Irreparable harm: imminent• BPCIA 180-day notice• Likelihood of success: discovery

BPCIA 180-day notice

Amgen Inc. v Sandoz Inc., C.A. App. No. 2015-1499 (July 21, 2015).

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Blocking Importation

• ITC: Temporary exclusion order • Comparable to a preliminary injunction in district court

Temporary Relief: 4 – 6 months

(case continues to hearing on final relief)

Complaintrequesting temporary

relief Institution

1 month

TEO ID

70 days or 120 days

Final ID on TEO(unless Commission

modifies)

20 days or 30 days

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Blocking Importation

35 USC 271(e)(1) 35 USC 271(e)(2)

It shall not be an act of infringement … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

It shall be an act of infringement to submit … an application seeking approval of a biological product, … if the purpose of such submission is to obtain approval … to engage in the commercial manufacture, use, or sale of a … biological product claimed in a patent or the use of which is claimed in a patent

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Blocking Importation

TrialInitial

Determination

Final Commission

Decision

9 months 3 months 4 months

Complaint filed Institution

1 month

• ITC: Final resolution in less than 18 months

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Blocking Importation

Amgen v. ITC (2009)

Federal Circuit vacated summary determination based on safe harbor defense. • Held that Section 271(e)(1) safe harbor can

apply at the ITC, • but remanded for more facts

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Blocking Importation

Temporary Relief: 4 – 6 months

(case continues to hearing on final relief)

Complaintrequesting temporary

relief Institution

1 month

TEO ID

70 days or 120 days

Final ID on TEO(unless Commission

modifies)

20 days or 30 days

• ITC: Temporary exclusion order • Comparable to a preliminary injunction in district court

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Jurisdiction

• ITC: in rem jurisdiction

Products Ñ Imported by or on behalf of named respondentsÑ Respondents subject to discovery, regardless of ties

to the United StatesÑ Certain Gemcitabine, Inv. No. 337-TA-766

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Jurisdiction

• ITC: in rem jurisdiction

Ñ Certain Gemcitabine, Inv. No. 337-TA-766

D. Conn.N. D. Ill.

Canada U.K.Denmark

Singapore

Australia

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IPR Considerations

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IPR Considerations

District Court Stays Post-Institution

GrantedDeniedPartial

~ 65%~ 25%

~ 10%

• ITC: no stays granted; few requests filed

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Joint Committee CLE SessionBiotechnology and ITC Committees

American Intellectual Property Law Association 2015 Annual Meeting

Facing The New Wolf Pack:Preparing For Post-Grant Challenges At The Patent Trial And Appeal Board

Herb HartMcAndrews, Held & Malloy Ltd.

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Pre-AIA patents:

• Ex parte reexamination (anyone)

• Inter partes review (anyone)

• Interference (rival inventor)

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Post-AIA patents

• Ex parte reexamination• Inter partes review

– “ reasonable likelihood”– No “new issue” needed

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Post-AIA patents

• Post grant review– any ground – “more likely than not”.– broad scope of estoppel

• Derivation proceeding

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Timing

• Ex parte reexamination - no time constraints

• Interference – no predictability

– see 35 U.S.C. § 135(b)(1) and (b)(2).

• Inter partes review of pre-AIA patent

– No later than one year from service of complaint

– Otherwise, any time

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Timing

• Inter partes review of AIA patent

– No earlier than 9 months from grant

– No later than one year from service of complaint

• Post grant review of AIA patent

– No later than 9 months from grant

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PTAB Procedure

• Expedited trial schedule

• Unique PTAB trial practice

• Very limited discovery

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PTAB Procedure

• “Discovery” is not discovery defined by Rule 26

• A “trial” is not a live hearing before the PTAB.

• A “deposition” is not a discovery deposition under Rule 26.

• Oral argument is dominated by the technology

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Patentee Concerns about the PTAB

• Speed

• Standard of Proof

• No presumption of validity

• Broadest reasonable interpretation (“BRI”) – not Phillips

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Patentee concerns about PTAB

• Much lower cost than district court

• Scientifically and technically trained decision-makers

• Potential stay of related district court cases

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Preparation for a PTAB Challenge

• Prior Art Searching

• Proactive prosecution

• Reissue application(s)

• Ex parte reexamination

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Preparation for a PTAB Challenge

• Identification and engagement of experts

• Early review of potential vulnerabilities

• Early consideration of potential options for resolution

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Offensive Post-Grant Challenges

• Defensive strategy in district court proceedings

• Freedom-to-operate tool

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• Biotech patents – less than 10% of challenges• Perceived lower success rate than tech patents• New player – Kyle Bass hedge fund

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Key lessons

• It’s never too early to prepare

• Keep the PTO correspondence address current

• Develop and update an objective assessment

• Engage experienced PTAB trial counsel

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Section 101

SOTERIA BIOSCIENCES

19 U.S.C. 1337(c): At the ITC, “All legal and equitable defenses may be presented in all cases.”

September 16, 2015 Notice of Proposed Rulemaking: 100-day proceedings on dispositive issues

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Patent Enforcement

SOTERIA BIOSCIENCES

• Eli Lilly and Co. v. American Cyanamid Co., 82 F.3d 1568 (Fed. Cir. 1996).• Certain Sucralose, Sweeteners Containing Sucralose, and Related Intermediate Compounds Therefor,

337-TA-604, Comm’n Op. (Apr. 29, 2009).• Kinik Co. v. ITC, 362 F.3d 1359 (Fed. Cir. 2004).

• Kinik: § 271(g) does not apply • Certain Sucralose: ITC may enforce claims covering

intermediates

• Eli Lilly: 35 U.S.C. § 271(g) “materially changed” provision may preclude enforcement of claims to intermediates

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Patent Enforcement

SOTERIA BIOSCIENCES

• AIA restricts joinder in district court• claims arising out of the same

transaction(s) or occurrence(s); or• common questions of fact;• 35 USC § 299(a).

• ITC presently has no limits on joinder• But, ITC may amend Rule 210.10:

• technologies, and/or • unrelated patents.

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Patent Enforcement

Suprema v. ITC (Fed. Cir. 2015)

• Commission found induced infringement based on willful blindness

• 2013 Panel: Infringement must occur at time of importation

• 2015 En banc: Deference to Commission • 2015 Panel: Affirmed willful blindness

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Damages

• District court: damages• Stay, 28 U.S.C. § 1659(a)• Record transfers, 28 U.S.C. § 1659(b)

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ITC Litigation

Domestic Industry based on

clinical trials

Investments related to clinical trials and regulatory approval can count toward domestic industry,

but consider Lelo v. ITC

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ITC Litigation

Be ready to file

1. Experienced ITC counsel2. Timing and importation3. Domestic Industry position4. Claim Charts5. Public Interest Statement

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AT THE ITC

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AT THE ITC

• Review of draft complaint with Office of Unfair Import Investigations (OUII)

• OUII has an active role prior to institution of the investigation and in most cases after institution

• OUII is an independent party representing the public interest in the investigations in which it participates

• Active role in discovery, motions practice, Markman, and trial

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ITC Litigation

• Fast pace of the investigation

• Discovery served the day after publication of the notice of institution in the Federal Register

• Answer to the complaint due in 20 days from service (upon institution)

• Markman hearing as early as 3 months of institution

• Trial typically within 9-10 months of institution of investigation

• Administrative Law Judges (ALJs) issue post-trial findings by initial determinations (ID) typically within 12 months of institution of investigation

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ITC Litigation

• Review of IDs by the Commissioners, Office of General Counsel

• Conclusion of the investigation (“target date”) typically within 16 months of institution; can be extended by majority vote of the Commission

• Presidential review (delegated to U.S. Trade Representative) within 60 days of issuance of Commission’s Final Determination

• During the 60 day period, infringing products can enter the United States under bond

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