Developing a Life Sciences Patent...

Developing a Life Sciences Patent PortfolioProsecution, Orange Book /Purple Book Listing, IP Acquisitions,

Licensing, Collaborations, and More

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THURSDAY, MARCH 28, 2019

Presenting a live 90-minute webinar with interactive Q&A

Shana K. Cyr, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Reston, Va.

Steven P. O'Connor, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Reston, Va.

M. David Weingarten, Ph.D., Attorney, Finnegan Henderson Farabow Garrett & Dunner, Atlanta

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Our Program

Importance of Patents,

Pre-Filing Considerations, How to Obtain

Patents

Patents That Can Withstand

Validity Challenges

Patents That Matter,

Supplementing Your Patents,

Other Considerations

5

IMPORTANCE OF PATENTS,PRE-FILING CONSIDERATIONS,

HOW TO OBTAIN PATENTSSteven P. O’Connor, Ph.D., J.D. | Partner

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

[email protected]

Importance of Patents

Aligning IP Strategy with

Business Objectives

IP Lifecycle Management

Pre-Filing Considerations

Controlling Disclosures

Obtaining Patents

Prosecution

Licensing or Purchasing

7



Business Objectives




Obtaining Patents

Prosecution


8

Why Does The Patent Portfolio Matter To Current Business Objectives?

• Aligning IP strategy with R&D and business development strategy.

• Reasons to have a patent portfolio:

A. Protect R&D;

B. Bargaining chip;

C. Revenue streams; and

D. Start-ups – where does the company’s value come from?

• Investor due diligence/big pharma due diligence (what are they looking for?)

A. The company looks more attractive if it can show:

✓ It is organized and has considered issues/questions typically raised by

investors/acquirers.

✓ That it has a prudent, developed IP strategy.

9

Source: https://medium.com/dissected-by-propel-x/3-reasons-top-startup-investors-want-more-ip-in-their-portfolios-e4c883760c02

Why Is IP So Important to Start-Ups?

• Can provide competitive advantages.

• Can increase valuation and profit potential.

• Can render it an appealing acquisition target.

“High quality, investment-grade patents can have spectacular impact on a

startup’s valuation. In the early stages of a company, especially when

technology risks and market risks abound, the patents may be the most

valuable asset the company has. An investment in a single, well-crafted,

defensible patent that matches a company’s business prospects can easily

raise the value of the company by the cost of the patent multiplied 10x – if

not more.” https://ip.education/startup-company-valuation/

10

Preparing Your Portfolio for IP Due Diligence

1. Freedom to operate (“FTO”)― Knowledge of competitive landscape.

― Know where problem areas are, and have positions worked out when/if asked.

― Determine how much information to give to suitor on technical details, opinions.

― Have necessary licenses for freedom to operate.

2. Scope/validity/enforceability• Determination of the scope, validity, and enforceability of the target’s IP.

3. Ownership/Transferability• Clear title to the IP.• Transferability of in-licensed technology.

11

Keep a Clean House

• Are information disclosure statements submitted?

• Assignments recorded?

• Maintenance fees and annuities paid?

• Have employees signed over all ownership rights?

• Employment agreements signed by key employees providing assignment of present and future inventions?

• Are policies in place regarding publication clearance, laboratory notebooks, and record retention?

12

Contribution of IP to Corporate Value

• IP is often the single most valuable asset of a company

Source:

http://www.oceantomo.com/

intangible-asset-market-

value-study/

13


14


15


16

Licensing Technology As Input to Revenue Stream

• Make money from royalties.

1. Competing & non-competing uses.

• Expand sales.

• Develop a market for new technology.

• Cross-licensing.

17



Business Objectives




Obtaining Patents

Prosecution


18

Life Cycle of Patent Value

Nature Biotechnology, 29(9):298-801 (Sept. 2011)

19



Business Objectives




Obtaining Patents

Prosecution


20

• Control disclosures

• Publications, presentations.

• Collaborations/investors/other 3rd party

disclosures.

• Limit disclosures and then only under NDA.

What To Do Before You File Your Patent Application:

Pre-Filing Concerns

21

§102 Conditions for patentability (a) NOVELTY; PRIOR ART

[teaching edits added]

A person shall be entitled to a patent unless—

(1) the claimed invention was patented [anywhere in the world],

described in a printed publication [anywhere in the world],

or in public use [anywhere in the world],

on sale [anywhere in the world],

or otherwise available to the public [anywhere in the world]

before the effective filing date of the claimed invention;

35 U.S.C. § 102(A)(1) –Defines Prior Art Under AIA

22

§102 Conditions for patentability (a) NOVELTY; PRIOR

ART

(2) the claimed invention was described in a patent

issued under section 151, or in an application for

patent published or deemed published under section

122(b), in which the patent or application, as the case

may be, names another inventor and was effectively

filed before the effective filing date of the claimed

invention.

35 U.S.C. § 102(A)(2) –Defines Prior Art Under AIA

23

§102 Conditions for patentability (b) EXCEPTIONS

(1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE FILING

DATE OF THE CLAIMED INVENTION.—A disclosure made 1 year or less

before the effective filing date of a claimed invention shall not be prior

art to the claimed invention under subsection (a)(1) if—

(A) the disclosure was made by the inventor or joint inventor or by another

who obtained the subject matter disclosed directly or indirectly from the

inventor or a joint inventor; or

(B) the subject matter disclosed had, before such disclosure, been publicly

disclosed by the inventor or a joint inventor or another who obtained the

subject matter disclosed directly or indirectly from the inventor or a joint

inventor.

35 U.S.C. § 102(B)(1) –Defines Exceptions to Prior Art Under AIA

24

I. AIA: Publishing is not a substitute for filing to obtain strong patent

position on the invention. An inventor who has publicly disclosed

should file a patent application promptly or better yet, before

disclosure.

II. Tension between early non-patent disclosure and patent filing.

Try to File Before Disclosure!

25

If Discussing Portfolio a Non-Disclosure Agreement Be Considered

• Required for discussion of confidential information.

― Confidential information

― Filed but unpublished applications

― Inventions without patent filings

― Trade Secrets

― “Know How”

26

Protect as Trade Secret or Patent?

• Trade secrets can advantageously protect:― un-patentable ideas / inventions

― non-patentable subject matter (e.g., business information)― ideas / inventions < standard of patentability

― improvements on patentable inventions― keep improvement as TS after patenting (and disclosing) “basic” invention

― more effectively for some ideas / inventions ― no disclosure to competitors ― protection available immediately― unlimited term― scope: protects against acquisition, disclosure or use

27



Business Objectives




Obtaining Patents

Prosecution


28

• Obtaining patents through filing/prosecution.

• When to file your applications (relative to product development,

timing tension, filing date vs. expiration date).

• Which applications to file (provisional/non-provisional/PCT etc.

strategy – application content).

• How many applications to file.

• Where to file (global protection would be great, but…).

• Who to list as inventors.

• Making sure you own the patents.

How To Develop a Patent Portfolio

29

Patent Timeline

Provisional application filing

date

Jan 15, 2019

Nonprovisional application filing

date

Jan. 14, 2020

Patent issuesDec. 13,

2021

Patent expires (excluding any PTA or PTE to

which patent is eligible)

Jan. 14, 2040

*Total average pendency for TC1600 is 22.9 months.

Source: https://www.uspto.gov/about-us/performance-and-

planning/uspto-annual-reports

30

When To File Patent Application?

I. Quick patent needed? File in national patent officesimmediately.

II. File early to obtain early filing date?1. Risk: Application could be rejected as failing to disclose how to

make and use the invention.

III. Delay filing in order to generate data to support invention.1. Risk: Competitors may get in ahead.

IV. Don’t know if invention will pan out? Delay costs and decisions.1. Pharmaceuticals and biotechnology are both uncertain and slow.

31

Complete Invention

• Is your invention complete

― What additional research will be done?

― Would the research form the basis of follow-up inventions or is it

necessary to prove your concept or provide details to distinguish from the

prior art?

― Consider issues related to the Paris Convention

― Limitations to right of priority

― Can’t necessarily drop one priority claim in favor of a later one

― First application must be fully abandoned before second application is filed

32

35 U.S.C. § 119

(a) An application for patent for an invention filed in this country by any person

who has, or whose legal representatives or assigns have, previously regularly

filed an application for a patent for the same invention in a foreign country

which affords similar privileges in the case of applications filed in the United

States or to citizens of the United States, or in a WTO member country, shall

have the same effect as the same application would have if filed in this

country on the date on which the application for patent for the same

invention was first filed in such foreign country, if the application in this

country is filed within twelve months from the earliest date on which such

foreign application was filed.

(b) ******

(c) In like manner and subject to the same conditions and requirements, the

right provided in this section may be based upon a subsequent regularly filed

application in the same foreign country instead of the first filed foreign

application, provided that any foreign application filed prior to such

subsequent application has been withdrawn, abandoned, or otherwise

disposed of, without having been laid open to public inspection and

without leaving any rights outstanding, and has not served, nor thereafter

shall serve, as a basis for claiming a right of priority.

33

Know the Landscape

• Identify other players in your space

― Who is the competition?

― Are they trying to solve the same problem you are in the same way?

• Identify the relevant prior art

― Do you have enough distinguishing features to avoid it?

• Understand the law on written description and enablement in order to make

sure your invention is complete before filing

34

Self-Collision

• Filing too early

― Earlier applications may not be patentable, but might still become prior

art against later inventions

• Filing too broadly

― May again result in prior art problems

― May negate selection inventions

• Filing too narrowly

― Species vs genus

• Lesson?

― Strategic planning—

the earlier, the better

35

Where To File Patent Applications?

I. Based on business strategy and markets.

A. File where competitors are located.

B. File where infringing products are likely to be manufactured.

C. File where major markets are located.

D. Is effective protection available?

1. Will you ever litigate? Roll into global settlement deal?

36

Filing Patent Applications Internationally

1. File a patent application directly in the patent office of each country

where patent protection is desired.

2. File an international patent application under the Patent Cooperation

Treaty (PCT) followed by national phase applications in each country

of interest.

A. Right of Priority applies to a regular national filing (a filing adequate to establish a filing date),

whatever may be the subsequent fate of the application.

B. 12-month period starts from the date of first filing.

C. Priority can only be claimed from first application for protection of the invention, so be careful

when claiming from any but the first of a chain of US continuations or CIPs.

3. File a patent application in a regional patent office (e.g., EPO).

4. Combination of 1, 2 and 3.

37

Quality Patent Drafting

• Know the invention(s)– Know the science / technology

– Know the state of the art― Investment in pre-filing searches / analysis

– Know the business (commercial landscape / objectives) ― Detailed, critical and extended dialog with counsel

• Draft claims that matter – Prepare multiple independent claims (within each category)

― Claim various combinations of features / scope -> breadth of protection

― Consider functional and structural orientations, and combinations

– Prepare multiple dependent claims (off of each independent)― Claim several tiers of subgeneric scope -> depth of protection

– Draft for novelty (first); but also for inventive step (fall-back; spec)

38

Quality Patent Drafting

• Draft claims with accuracy and precision – Be unrelenting on details

― Work, rework, rework, rework claim sets

― Question the meaning and scope of every word

― Identify and scope-out commercially important features

― Challenge the constructs; scrutinize the syntax

• Draft robust specifications, with strategic focus – Include multi-layer fall-backs (esp. commercially-relevant features)

― Feature by feature; create support for various permutations

― Preferred combinations of features (subgeneric tiers)

― Consider, selectively, to provide basis for expanding scope of certain features

– Describe why the invention matters (commercial importance)― Include advantages / benefits (KSR), but with consummate care (Scimed Life)

– Draft defensively to avoid import of features from specification to

claims

39

Ownership Starts With Inventorship!

40

Inventorship—General Considerations

• Who contributed to the complete concept of the invention as defined by the claims?― Who developed specific screening concepts?

― Who identified trends in data that led to recognition of claimed concepts?

• Who contributed to reducing the invention to practice?― Was contribution independent, or merely the work of a technician

done under direction and control of another?

― Were there any special technical skill required to reduce to practice?

• General― Consider each claim of the application

― An inventor needs to contribute only to one claim

― Differences in timing or place or amount of contribution do not matter for purposes of determining inventorship

• “The exact parameters of what constitutes joint inventorship are quite difficult to

define. It is one of the muddiest concepts in the muddy metaphysics of the patent

law.” Mueller Brass Co. v. Reading Industries, Inc., 352 F.Supp. 1357, 1372 (E.D.Pa.

1972)

• Conception is touchstone of invention.― Only inventors conceive, others can reduce to practice.

― Conception must be complete.

― Recognize the ultimate result desired and develop means to accomplish.

― Communicate completed thought so that one of skill in the art can make the invention.

• 35 U.S.C. § 116― Inventors may apply for a patent jointly even though:

― They did not physically work together or at the same time;

― Each did not make the same type or amount of contribution; or

― Each did not contribute to the subject matter of every claim.

Inventorship

42

Effect of Incorrect Inventorship

• US Patent Law:― 35 U.S.C. 111: “An application for patent shall be made… by the

inventor…”

― 35 U.S.C.101: “Whoever invents [an invention] may obtain a

patent therefore…”

― 35 U.S.C.102(f): “A person shall be entitled to a patent unless he

did not himself invent the subject matter sought to be

patented…”

• Effect of Incorrect Inventorship:― Litigation challenge re validity or enforceability

― e.g., higher potential with inventions from collaborative research

― Potential Avenue of Defense to Infringement ― e.g., license from unnamed inventor

•35 U.S.C. §262: “In the absence of any agreement to the contrary,

each of the joint owners of a patent may make, use, offer to sell, or

sell the patented invention within the United States, or import the

patented invention into the United States, without the consent of

and without accounting to the other owners.”

•May license without accounting to others (absent contract

provision).

• May grant immunity from suit by other owner.

• Need not share license royalties!

•Each inventor has equal rights as a co-owner even if he or she

contributed to only one claim of a multi-claim patent.

Ownership

44

Ownership: All Listed Inventors Have An Obligation To Assign?

• Review copies of all employment contracts of inventors.

• Review any evidence that listed inventors were hired to invent.

• Review copies of any assignments not available through USPTO.

• Did inventor(s) assigned their rights to later-filed improvements, divisional, continuation, continuation-in-part, and reissue applications?

• Did inventor(s) agree to assist in prosecution of pending applications?

• Is there any documentation pertaining to potential obligations the inventors may have had to third parties?

45



Business Objectives




Obtaining Patents

Prosecution


46

• Issues relating to performing your IP DD before

closing the deal

• Licensing – getting access to all the IP you need?

• Right to control prosecution.

• Right to control litigation and enforcement.

Supplementing By Licensing Or

Purchasing Patents

47

PATENTS THAT CAN WITHSTAND VALIDITY CHALLENGES

M. David Weingarten, Ph.D., J.D. | Associate


[email protected]

48

Types of Challenges

District Court Counterclaims

Post-Grant Challenges

Patent Statute

Patent Eligibility

Written Description,

Enablement, and Definiteness

Anticipation and Obviousness

Obviousness-Type Double

Patenting

PTA/PTE Issues?

Restriction Requirements

Terminal Disclaimers

49

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



50

Types of Challenges: Validity

• District court declaratory judgment action of invalidity.

• Factors usually important to an alleged infringer:

― low historical patent owner win rate;

― slow time to trial;

― low damage awards;

― high rate of granting summary judgment;

― high rate of granting stay pending administrative proceeding;

― low chance that case will go to trial;

― low chance of getting request for preliminary injunction

granted.

• District court defenses/counterclaims in infringement action.

51

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



52

Types of Challenges: Patentability

• Post-grant administrative challenges • Post-grant review (PGR)

― May file only within 9 months of patent issuing;

― On “any ground that could be raised under paragraph (2) or (3) of section 282(b) (relating to invalidity of the patent or any claim).”

• Inter partes review (IPR)

― May file after 9 months of patent issuing;

― May file within 1 year of being sued for infringement;

― On “102 or 103 and only on the basis of prior art consisting of patents or printed publications.”

• Ex parte reexamination

― May file anytime;

― Raise “a substantial new question of patentability.”

53

Factors Influencing Applicant’s Decisionto File IPR or Challenge in DC

54

ISSUE PGR/IPR DISTRICT COURT

Burden of proof Preponderance of the evidence Clear and convincing evidence

Cost $$ $$$

Presumption of Validity? No Yes

Time statutory 12-month deadline from institution

(may be extended to 18 months; so far, very rare

to extend)

Pharma litigation

D. Del. 31.8 months*

D. NJ 34.8 months*

Claim construction Phillips/Markman framework: analyze claims,

specification, and prosecution history to

determine how claims would be understood by

one of ordinary skill in the art

Phillips/Markman framework: analyze claims, specification,

and prosecution history to determine how claims would be

understood by one of ordinary skill in the art

Decision maker Patent Trial and

Appeal Board (APJs)

District court judge or jury

Success rate for challenger/alleged

infringer

49.5% (claims from TC1600)**

(plus an institution rate of 59% (455/769)*** and

institution decisions are not appealable

pharma litigation

Bench trial win rate

D. Del. 33.1%*

D. NJ 39%*

*Source: LegalMetric Nationwide Pharma Patent Litigation Report, January 1991 to December 2017.

** Source: Finnegan, aiablog, as of Jan. 1, 2019.

*** USPTO stats, as of Feb. 28, 2019.

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



55

Subject Matter Eligibility

56

Section 101:

“Whoever invents or discovers

any new and useful process,

machine, manufacture, or composition

of matter, or any new and useful

improvement thereof, may obtain a

patent therefor, subject to the

conditions and requirements of this

title.”

Judicial Exceptions:

Abstract ideas, laws of nature,

natural phenomenon

Patent Ineligible

• Claim 1. A method for detection of at least one coding region allele of

a multi-allelic genetic locus comprising: a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said

primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and

contains a sufficient number of non-coding region sequence nucleotides to produce an

amplified DNA sequence characteristic of said allele; and

b) analyzing the amplified DNA sequence to detect the allele.

• Ineligible - claim directed to a law of nature• Describes a natural phenomenon

• No sufficient “inventive concept” in additional claim elements to provide subject

matter eligibility

• “Amplifying” and “analyzing” were well known, routine, and conventional

57

Genetic Technologies v. Merial, LLC, 818 F.3d 1369 (Fed. Cir. 2016).

Patent Ineligible

• 4 patents in suit:• 3 patents directed to methods of diagnosing cardiovascular disease based on testing for

myeloperoxidase

• District court held that testing patents were patent ineligible

• Ineligible - claim directed to a law of nature• “The claims of the testing patents are directed to multistep methods for observing the

law of nature that MPO correlates to cardiovascular disease.”

• “[W]ell-known technique to execute claimed method”

• Claim steps merely tell those interested in the correlation

• “[T]he testing patents here do not extend their discovery that MPO correlates to

cardiovascular risk to a patentable method.”

58

Cleveland Clinic v. True Health Diagnostics, LLC, 859 F.3d 1352 (Fed. Cir. 2017).

Patent Eligible

Claim 1. A method for treating a patient with iloperidone, wherein the patient is suffering

from schizophrenia, the method comprising the steps of:

determining whether the patient is a CYP2D6 poor metabolizer by:

obtaining or having obtained a biological sample from the patient; and

performing or having performed a genotyping assay on the biological sample to

determine if the patient has a CYP2D6 poor metabolizer genotype; and

if the patient has a CYP2D6 poor metabolizer genotype, then internally administering

iloperidone to the patient in an amount of 12 mg/day or less, and

if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering

iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,

wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is

lower following the internal administration of 12 mg/day or less than it would be if the

iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day.

59

Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018).

Patent Eligible (continued)

• “Claim 1 requires specific steps: (1) determining the patient's CYP2D6 metabolizer genotype by

(a) obtaining a biological sample and (b) performing a genotyping assay; and (2) administering

specific dose ranges of iloperidone depending on the patient's CYP2D6 genotype.”

• The “claims are directed to a method of using iloperidone to treat schizophrenia. The inventors

recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but

that is not what they claimed. They claimed an application of that relationship.”

• “[T]he claims here are directed to a specific method of treatment for specific patients using a

specific compound at specific doses to achieve a specific outcome.”

• “They are different from Mayo. They recite more than the natural relationship between CYP2D6

metabolizer genotype and the risk of QTc prolongation. Instead, they recite a method of treating

patients based on this relationship that makes iloperidone safer by lowering the risk of QTc

prolongation.”

60

Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018).

Meeting § 101: Practice Tips• Strategize for patent eligibility under section 101 based on USPTO guidance documents.

• Anticipate eligibility rejections and plan a deliberate eligibility strategy to overcome.

• If judicial exception (natural phenomenon) is recited:

• Make claims nonobvious over judicial exception

• Adding “conventional” techniques, without more, may not be sufficient

Red Flags: “correlating,” “determining,” “diagnosing”

• “Integrate the exception into a practical application” with specific and detailed

limitations

Vanda: “A method for treating a patient with iloperidone”

• Include claims not reciting judicial exceptions

• Non-naturally occurring materials,

• E.g., cDNA, genetically modified materials

• Specific process, methods of treating

• E.g., cryopreserving under specific conditions, treating a disease condition

with specific drug

61

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



62

Validity/Patentability

• 35 U.S.C. §112• (a) IN GENERAL.—The specification shall contain a written

description of the invention and of the manner and process of

making and using it, in such full, clear, concise and exact terms

as to enable any person skilled in the art to which it pertains, or

with which it is most nearly connected, to make and use the

same, and shall set forth the best mode contemplated by the

inventor or joint inventor of carrying out the invention.

• (b) CONCLUSION.—The specification shall conclude with one or

more claims particularly pointing out and distinctly claiming

the subject matter which the inventor or a joint inventor

regards as the invention.

Omnibus disclosure v. targeted description

63

Indefiniteness

In Court: Nautilus, Inc. v. Biosig

Instruments, Inc., 134 S.Ct. 2120

(U.S. 2014)

standard: “a patent’s claims, viewed

in light of the specification and

prosecution history, inform those

skilled in the art about the scope of

the invention with reasonable

certainty.”

In the USPTO (including PTAB): In re

Packard, 751 F.3d 1307 (Fed. Cir. 2014)

(per curiam)

MPEP §2173.05(e): “A claim is

indefinite when it contains words or

phrases whose meaning is unclear.”

“If the scope of a claim would be

reasonably ascertainable by those

skilled in the art, then the claim is not

indefinite.”

64

Indefiniteness: Terms with Multiple Meanings

65

• Claim 1. A method of administering pemetrexed disodium…, [and a] methylmalonic acid lowering agent… selected from the group consisting of vitamin B12….

• “’vitamin B12’ can be used in the art to refer either to ―cyanocobalamin specifically or―more broadly, to a class of compounds including

pharmaceutical derivatives of cyanocobalamin…

• the... patent uses the term both ways.”

― OB-Listed U.S. Pat. 7,772,209 (Alimta®)

― Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017)

Are there multiple ways to measure?

66

Are the measurement methods outcome-determinative?

67

Measures to Counter Indefiniteness Attack

68

• Consider expert declaration to support what a POSITA would understand.

• Consider expert declaration explaining the degree of precision available (or

lack thereof) in the relevant art at the relevant time.

• Try to avoid ambiguous claim language, e.g., relative terms, words of degree,

ranges without end points at both ends, inconsistently used terms, undefined

terms.

• Try to avoid describing more than one way to measure without identifying

which one to use.

• Breadth alone is not indefiniteness.

• Consider reissue possibilities.

• Consider continuation possibilities.

Written Description

69

“The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same,….”

An invitation for further research is insufficient

70

Measures to Counter Written Description Attack

• Consider expert declaration to support what a POSITA would understand.

• Try to avoid describing result without means of achieving (just a hope or

plan).

• Try to avoid unsupported claim limitations.

• Try to be vigilant about priority chain support.

• General considerations: broad claims require broad disclosure

71

Enablement

In Court: Claims are not enabled

when, at the effective filing date of

the patent, one of ordinary skill in

the art could not practice their full

scope without undue

experimentation. MagSil Corp. v.

Hitachi Global Storage Techs., Inc.,

687 F.3d 1377, 1380–81 (Fed. Cir.

2012).

In the USPTO: MPEP 2164.01 Did the “disclosure, when filed, contain[] sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention[?]”“The standard for determining whether the specification meets the enablement requirement…: is the experimentation needed to practice the invention undue or unreasonable? … In re Wands, 858 F.2d 731, 737, …(Fed. Cir. 1988).”

72

How to make and use?

73

What is well known is not a substitute for a basic enabling disclosure

74

Measures to Counter Enablement Attack

• Consider expert declaration to support what a POSITA would

understand.

• Try to make sure claim enabled throughout scope.

• Be careful about incorporation by reference.

• Consider reissue possibilities.

• Consider continuation possibilities.

75

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



76

AIA §102

35 U.S.C. §102. Conditions for patentability; novelty

(a) NOVELTY; PRIOR ART.—A person shall be entitled to a patent unless—

(1) the claimed invention was patented, described in a printed publication,

or in public use, on sale, or otherwise available to the public before the

effective filing date of the claimed invention; or

(2) the claimed invention was described in a patent issued under section

151, or in an application for patent published or deemed published under

section 122(b), in which the patent or application, as the case may be,

names another inventor and was effectively filed before the effective

filing date of the claimed invention.

77

AIA §102

• “the anticipating invention [must] be ‘described in a printed

publication,’ [and] must also disclose those elements ‘arranged as in

the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed.

Cir. 2008); see also, Impax Laboratories Inc. v. Aventis Pharms. Inc.,

545 F.3d 1312 (Fed. Cir. 2008).

• “The way in which the elements are arranged or combined in

the claim must itself be disclosed, either expressly or

inherently, in an anticipatory reference.” Therasense, Inc. v.

Becton, Dickinson & Co., 593 F.3d 1325 (Fed. Cir. 2010).

• Cannot simply combine different parts of the reference.

• Reference must be enabling to be anticipating.

78

Inherent Anticipation

Schering held now-expired patent on the antihistamine loratadine and a current

patent covering a metabolite of loratadine called descarboethoxyloratadine (DCL).

DC: Construed claims of DCL patent to cover DCL in all its forms.

• DCL necessarily formed as a metabolite by carrying out the process disclosed in the

loratadine patent.

• Loratadine patent anticipated the claims of the DCL patent.

• SJ of invalidity.

FC: Affirmed

• Rejected “the contention that inherent anticipation requires recognition in the prior art”

and cited In re Cruciferous Sprout Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002), as the

precedent to be followed.

• DCL necessarily and inevitably formed from loratadine under normal conditions.

• “inherency places subject matter in the public domain as well as an express disclosure.”

79

Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir. 2003)

Obviousness

35 U.S.C. §103 (obviousness)

“A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.”

80

Lead Compound

81

• Multiple choices faced inventors, unpredictable result when

combining elements, properties do not teach process

• Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008)

• Prior art did not indicate lead compound

• Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed.

Cir. 2007)• Situation was not one with “a finite number of identified, predictable solutions”…prior art disclosed a

broad selection of compounds any one of which could have been selected as a lead compound for

further investigation.”

• Daiichi Sankyo Co., Ltd. v. Matrix Laboratories, Ltd., 619 F.3d 1346 (Fed. Cir.

2010)

• Unpredictable nature, Unique nature, no reasonable expectation [at time of

the invention] that risedronate would be a successful compound, unexpected

results and other secondary considerations of non-obviousness.

• Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989 (Fed. Cir.

2009)

Breakdown of Sanofi

82

• Multiple choices faced inventors (80 acids as candidates for

forming salts with basic drug compounds)

• Unpredictable result when combining elements (whether a

pharmaceutically suitable crystalline salt will form from a

particular acid-base combination is unpredictable)

• Properties do not teach process (“recognition that

stereoisomers may exhibit different properties does not teach

which results may ensue or how to separate any given

enantiomers.”)

Breakdown of P&G

83

• Unpredictable nature (“extremely unpredictable nature of

bisphosphonates at the time of the invention”; “properties of

bisphosphonates could not be anticipated based on their structure.”)

• Unique nature (“every compound, while remaining a

bisphosphonate, exhibits its own physical-chemical, biological and

therapeutic characteristics, so that each bisphosphonate has to be

considered on its own. To infer from one compound the effects in

another is dangerous and can be misleading.”

• No reasonable expectation [at time of the invention] that

risedronate would be a successful compound.

• Unexpected results of risedronate's potency and toxicity and

secondary considerations of non-obviousness.

Hindsight Not Allowed

84

Federal Circuit in Daiichi:

“These cases illustrate that it is the possession of promising useful

properties in a lead compound that motivates a chemist to make structurally

similar compounds. Yet the attribution of a compound as a lead compound

after the fact must avoid hindsight bias; it must look at the state of the art

at the time the invention was made to find a motivation to select and then

modify a lead compound to arrive at the claimed invention.”

“While the lead compound analysis must, in keeping with KSR, not rigidly

focus on the selection of a single, best lead compound, …the analysis still

requires the challenger to demonstrate by clear and convincing evidence

that one of ordinary skill in the art would have had a reason to select a

proposed lead compound or compounds over other compounds in the prior

art. ”

Arguing No Prima Facie Case

• No reasonable expectation of success.

• Argue lack of predictability (i.e. invention not “predictable”).

• Teaching away

• Prior art (particularly file history) may support lack of predictability argument(s) and teaching away arguments.

• Consider level of ordinary skill in art evidence; what was the direction of the art as a whole? Remember duty of candor.

• Consider arguing missing claim limitations.

85

Arguing No Prima Facie Case (continued)

• If non-obviousness works for genus, works for dependent claims directed to subgenus and species.

• See, MPEP 2142-2144.04

• Advocate no need to show surprising or unexpected properties or other objective evidence of non-obviousness because properties are irrelevant if no prima facie case of obviousness established.

• And make sure that allowance is based on post-KSR principles, particularly now that you may end up back before USPTO post-grant.

86

Rebutting Prima Facie Case

• Consider submitting comparative data—i.e. determine closest prior art, and compare against it.

• Consider pros and cons of defeating prima face case by showing unpredictability or other objective evidence of

patentability.

• Property or result not “predictable.” Careful?

• Unpredictability, objective evidence: commensurate in scope?

• Consider interview with examiner to agree on testing compounds or scope of claim allowable based on

objective evidence.

• Consider In re Hollingsworth, 253 F.2d 238 (CCPA 1958), cited in MPEP §716.03(a).

• Commercial success: commensurate in scope and nexus with the claimed invention: generally harder for genus

but your facts may work!

• See Hollingsworth. In re Glatt, 630 F.3d 1026 (Fed. Cir. 2011) and Applied Materials, Inc. v. Adv.

Semiconductor Materials Am., Inc., 98 F.3d 1563 (Fed. Cir. 1996)

87

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



88

Validity/Patentability

• Obviousness-type double patenting

• Claims in a later-expiring patent or application are

patentably indistinct from claims in an earlier-

expiring patent or application.

• Doctrine of obviousness-type double patenting:• To prevent the “unjustified extension of patent

exclusivity beyond the term of a patent.”

• Expectation of public that upon the expiration of the

patent it will be free to use the claimed invention and

obvious modifications or variants.

89

• Even though there is neither a common inventor nor a

common applicant, double patenting rejections are

authorized where the patents/application are

“commonly owned” or assigned pursuant to pre-AIA 35

U.S.C. § 103(c)(1) or AIA 35 U.S.C. § 102(b)(2)(C).

• 100% required.

• At time of invention (pre-AIA) or time of filing (AIA).

Commonly Assigned/Owned --Double Patenting Implications

90

Later-issuing, Earlier-expiring

91

Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208

(Fed. Cir. 2014)

― Prior to Gilead, double patenting was based on which patent issued first, and invalidated only the second-issued patent. (Lilly v. Barr)

― Gilead Issue: Can a patent that issues after but expires before

another patent qualify as a double patenting reference for that

other patent?

― YES!

ODP and PTA

92

Magna Elecs., Inc. v. TRW Auto. Holdings Corp., No. 1:12-

cv-654 (W.D. Mich, Dec. 10, 2015)

• Patents have same priority, term differed due to PTA

• ‘149 patent filed first and issued first; accrued PTA

• ‘786 (CON) filed later and issued later; no PTA

― OTDP used to override statutory grant of PTA under 35 U.S.C. §154

ODP and PTE

Feb. 2014

‘229 original expiration date

Sept. 2017

‘565 expiration date

Feb. 2019

‘229 PTE expiration date

compound fingolimod patent

method of using fingolimod

Novartis AG v. Ezra Ventures, 909 F.3d 1367 (Fed. Cir. 2018)

• Novartis’ ’229 patent filed before June 8, 1995, so patent term was 17 years from issue (Feb. 18, 2014) + PTE (Feb. 18, 2019).

• Novartis’ ’565 patent filed after June 8, 1995, so patent term was 20 years from filing (Sept. 23, 2017).

• Ezra moved for judgment on the pleadings that the ‘229 patent is invalid or otherwise should be terminally disclaimed for time past expiration date of ‘565 patent.

• DC: Denied motion.

93

ODP and PTE (con’t)

FC: Affirmed.

• “[N]othing in the statute restricts the patent owner's choice for patent term extension among those patents whose terms have been partially consumed by the regulatory review process.”

• Congress left the choice of which single patent term to extend in the hands of the patent owner.

• The patent term extension was obtained by adherence to the relevant law and procedures.

• Any “effective” extension of the ‘565 GATT patent is a “permissible consequence of the legal status conferred upon the '229 pre-GATT patent by § 156.”

• “[I]f a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.”

• “agreeing with Ezra would mean that a judge-made doctrine [ODP] would cut off a statutorily-authorized time extension.” The court “decline[d] to do so.”

94

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



95

Safe Harbor: Restriction Requirements Are Your Friend!

96

• 35 U.S.C. § 121• If two or more independent and distinct inventions are claimed in one

application, the Director may require the application to be restricted to one

of the inventions. If the other invention is made the subject of a divisional

application which complies with the requirements of section 120 it shall be

entitled to the benefit of the filing date of the original application. A patent

issuing on an application with respect to which a requirement for restriction

under this section has been made, or on an application filed as a result of

such a requirement, shall not be used as a reference either in the Patent

and Trademark Office or in the courts against a divisional application or

against the original application or any patent issued on either of them, if

the divisional application is filed before the issuance of the patent on the

other application. The validity of a patent shall not be questioned for

failure of the Director to require the application to be restricted to one

invention.

• Can only file TD if common owner.

Safe Harbor

97

• Applies to DIV of DIV (if consonance is maintained and if filed before the

issuance of the reference patent).

Boehringer Ingelheim Int’l. v. Barr Laboratories, 592 F.3d 1340 (Fed. Cir. 2010)

• Applies to CON deriving from DIV filed as a result of a restriction requirement.

Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991)

• Does not apply to straight CONs.

Amgen, Inc. v. Hoffman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009)

• Does not apply to CIPs

Janssen Biotech, Inc. v. Celltrion Healthcare Co. Ltd., 211 F.Supp.3d 364 (D. Mass.

Sept. 29, 2016)

• Cannot retroactively create DIV by reissue or reexam.

G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015)

In re Janssen Biotech, Inc., 880 F.3d 1315 (Fed. Cir. 2018)

Types of Challenges



Patent Statute

Patent Eligibility





Patenting

PTA/PTE Issues?



98

Try to avoid filing terminal disclaimers over pending applications

Claims can change; consider amending or canceling claims in copending

application to avoid filing a terminal disclaimer in an otherwise allowable

application.

Do not file a TD if the ODP rejection is over a later-filed pending

application.

MPEP § 804.

Do not file a TD if the ODP rejection is over a patent or (published)

application that is “102(b)” prior art.

ODP rejection should be overcome by the same arguments as the 103 rejection.

Defeating Double Patenting Rejections

99

If the ODP rejection cannot be overcome:

1. Remember: claims can change! Do not file TD until

claims are otherwise allowable.

2. Hold in abeyance until end of prosecution.

Be practical. Don’t panic!1. Consider whether TD is a big deal in this case.

a. Do the application and reference patent have

different terms?

b. Are you giving up any PTA?

c. Are you likely to request PTE on one of the patents?

Filing A Terminal Disclaimer

100

PATENTS THAT MATTER, SUPPLEMENTING YOUR PATENTS,

OTHER CONSIDERATIONSShana K. Cyr, Ph.D., J.D. | Partner


[email protected]

101

Patents that Matter

Commercially Viable

Enforceable

Supplementing Your Patents

Regulatory Exclusivities

Trade Secrets


Third Party Patents

Continuous Process

102

Patents that Matter

Commercially Viable

Enforceable



Trade Secrets


Third Party Patents

Continuous Process

103

Pursue Commercially Viable Claims

Your Products

Your Future Products

Competitors’ Products

Competitors’ Future

Products

104

Varied Claim Type

105

• Compound

• Composition

• Formulation

• Method of Treatment

• Method of Making

• Product-by-Process

• Means-Plus-Function

Varied Claim Scope

Exact Embodiment

Other Embodiments that Will Work

•Consider necessity of each element

•Consider variants for each element

•Consider different transition phrases

106

A Careful Balance

Validity

• Sufficient support

• Use terms consistently

• Avoid prior art

Infringement

• Cover products

• Prevent design arounds

107

Patents that Matter

Commercially Viable

Enforceable



Trade Secrets


Third Party Patents

Continuous Process

108

Pursue Enforceable Claims

• Who will infringe the claims?

• How will you prove it?

• Hatch-Waxman litigation

• BPCIA litigation

• Other litigation

• Direct and indirect

• Divided

• Literal and DOE

109

Drug or Biologic Application Infringement

“(2) It shall be an act of infringement to submit—(A) an application under section

505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of

such Act for a drug claimed in a patent or the use of which is claimed in a patent,…

(C)(i) with respect to a patent that is identified in the list of patents described in

section 351(l)(3) of the Public Health Service Act (including as provided under section

351(l)(7) of such Act), an application seeking approval of a biological product, or (ii)

if the applicant for the application fails to provide the application and information

required under section 351(l)(2)(A) of such Act, an application seeking approval of a

biological product for a patent that could be identified pursuant to section

351(l)(3)(A)(i) of such Act,

if the purpose of such submission is to obtain approval under such Act to engage in the

commercial manufacture, use, or sale of a drug…or biological product claimed in a

patent or the use of which is claimed in a patent before the expiration of such

patent.”

110

35 U.S.C. § 271(e)(2)(A), (C).

Hatch-Waxman Litigation

NDA holder lists patents in FDA’s

Orange Book

Applicant files ANDA or 505(b)(2) with

paragraph IV certification

(20 days)

Applicant provides notice to NDA holder

and patent owners

(45 days)

NDA holder and patent owners file suit

111

BPCIA Litigation

aBLA filed FDA accepts aBLA for review

1, 2(20 days)

Applicant provides confidential info to reference

product sponsor (RPS)

3A(60 days)

RPS provides patent list

3B(60 days)

Applicant provides patent list and detailed statement

3C(60 days)

RPS provides detailed statement

4

RPS and applicant negotiate final list of patents

5

[[OR - no agreement after 15 days, applicant identifies

number of patents; simultaneous exchange]]

6(30 days)

RPS files suit

8A(180 days before first

commercial marketing)

Applicant provides notice

8B, 9A

RPS can seek injunction as to patent on 3A or 3B list but not 4 or 5; applicant or RPS can file DJ action on same

112

42 U.S.C. § 262(l).

Hatch-Waxman Versus BPCIA Litigation

Hatch-Waxman Litigation

BPCIA Litigation

How does applicant provide notice of its application?

Paragraph IV noticePatent dance –

confidential information

When does applicant provide position?

Paragraph IV noticePatent dance –

statement

Which patents are litigated? Orange BookPatent dance –

patent lists

Does suit automatically stayapproval?

30-Month stayMay seek preliminary

injunction

113

Orange Book Listable Patents

Listable:

• Drug substance (active ingredient)

• Drug product (formulation, drug-delivery systems)

• Method-of-use

• Product-by-process (novel products)

Not listable (but still may be valuable):

• Method of making

• Metabolites

• Intermediate

• Packaging

114

21 U.S.C. § 355; 21 C.F.R. § 314.53; 68 Fed. Reg. 36,676; 67 Fed. Reg. 65,448.

Direct Infringement

“Except as otherwise provided in this title, whoever without authority makes, uses,

offers to sell, or sells any patented invention, within the United States or imports into

the United States any patented invention during the term of the patent therefor,

infringes the patent.”

115

35 U.S.C. § 271(a).

Proving Direct Infringement

Claim

116

Proving Direct Infringement

• “The infringement determination is…based on consideration of all the relevant

evidence, and ‘[b]ecause drug manufacturers are bound by strict statutory

provisions to sell only those products that comport with the ANDA's description of

the drug,’ the ANDA itself dominates the analysis.”

• “In cases in which the ANDA specification does not resolve the infringement question

in the first instance, we have endorsed the district court’s reference to relevant

evidence, including biobatch data and actual samples of the proposed generic

composition that the ANDA filer had submitted to the FDA.”

117

Ferring B.V. v. Watson Laboratories, Inc., 764 F.3d 1401 (Fed. Cir. 2014).

Case Example | LYSTEDA

1. A tranexamic acid tablet formulation, comprising:

tranexamic acid or a pharmaceutically acceptable salt thereof;

and a modified release material…present in the formulation in an amount from about 10% to about 35% by weight of the formulation;

wherein the formulation provides an in-vitro dissolution release rate of the tranexamic acid or pharmaceutically acceptable salt thereof, when measured by the USP 27 Apparatus Type II Paddle Method @ 50 RPM in 900 ml water at 37±0.5°C., of less than about 70% by weight tranexamic acid or pharmaceutically acceptable salt thereof released at about 45 minutes, and about 100% by weight tranexamic acid or pharmaceutically acceptable salt thereof released by about 120 minutes; and

wherein each tablet of the formulation provides a dose of about 650 mg of tranexamic acid.

118

Ferring B.V. v. Watson Laboratories, Inc., 764 F.3d 1401 (Fed. Cir. 2014).

• Reversed infringement finding

% at 45 min

% at 120 min

Claim < about 70 About 100

ANDA Data 16 37

Testing During

DiscoveryN/R 33-52

Doctrine of Equivalents

Function-Way-Result Test

• “Whether the accused product performs substantially the same function in

substantially the same way to obtain the same result”

Insubstantial Differences Test

• “Whether the accused product or process is substantially different from what

is patented”

119

Mylan Institutional LLC v. Aurobindo Pharma Ltd., 857 F.3d 858 (Fed. Cir. 2017).

Case Example | FINACEA

1. A composition that comprises:

(i) azelaic acid…in a concentration of 5

to 20% by weight,

(ii) at least one triacylglyceride in a

concentration of 0.5 to 5% by weight,

(iii) propylene glycol, and (iv) at least

one polysorbate, in an aqueous phase

that further comprises water and salts,

and the composition further comprises

(v) at least one polyacrylic acid, and (vi)

lecithin,

wherein the composition is in the form of

a hydrogel.

• No clear error in district court’s

finding of infringement under DOE

• Glenmark’s ANDA

• “Isopropyl myristate was

selected as [a] penetration

enhancer instead of lecithin and

medium chain triglyceride”

120

Intendis GMBH v. Glenmark Pharmaceuticals Inc., USA, 822 F.3d 1355 (Fed. Cir. 2016).

Divided Infringement

One actor liable for infringement involving actions by two actors if:

• Actors form a joint enterprise

• One directs or controls the other’s performance

― Conditions participation or receipt of a benefit on performance of one or

more steps of patented method, and

― Establishes the manner or timing of that performance

Physician-patient relationship is not enough

121

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017).

Case Example | ALIMTA

• “A method of administering pemetrexed disodium…comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed byadministering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12….”

• Physicians directed or controlled patients’ performance

• Condition treatment on folic acid administration

• Specify dose of folic acid and that patients must ingest it daily for period

Physician

Administers B12 and pemetrexed

Patient

Self-administers folic acid

122

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017).

Case Example | ZOHYRDO ER

• “A method of treating pain in a patient

having mild or moderate hepatic

impairment…comprising: Administering…a

starting dose of an oral dosage unit having

hydrocodone bitartrate as the only active

ingredient, wherein the dosage unit

comprises an extended release formulation

of hydrocodone bitartrate, and wherein

the starting dose is not adjusted relative

to a patient without hepatic impairment.”

• Physicians directed or controlled patients’

performance

• Condition treatment on self-

administration

• Give dosing instructions on frequency

and amounts

Patient

Self-administers drug per prescription

Physician

Prescribe dose that is not reduced relative to dose for patient without hepatic

impairment

123

Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd., 323 F. Supp. 3d 566 (D. Del.

2018), appeal docketed, No. 18-2361 (Fed. Cir. Sept. 14, 2018).

Indirect Infringement

“(b) Whoever actively induces infringement of a patent shall be liable as an infringer.

(c) Whoever offers to sell or sells within the United States or imports into the United

States a component of a patented machine, manufacture, combination or composition,

or a material or apparatus for use in practicing a patented process, constituting a

material part of the invention, knowing the same to be especially made or especially

adapted for use in an infringement of such patent, and not a staple article or

commodity of commerce suitable for substantial noninfringing use, shall be liable as a

contributory infringer.”

124

35 U.S.C. § 271(b), (c).

Proving Induced Infringement

Requirements Hatch-Waxman BPCIA Other

Underlying infringement

Proposed label, ANDA or 505(b)(2)

Proposed label, aBLA

Evidence of making, using,

selling, importing

Knowledge of patent

Orange Book, paragraph IV certification

Patent dancePatent marking, communications

Knowledge that induced acts constitute infringement

Proposed label Proposed labelActual knowledge or willful blindness

125

35 U.S.C. § 271(b); Commil USA, LLC v. Cisco Systems, Inc., 135 S. Ct. 1920 (2015);

Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011).

Case Example | FANAPT

“A method for treating a patient…suffering from schizophrenia…comprising the steps of: determining whether the patient is a CYP2D6 poor metabolizer by: obtaining or having obtained a biological sample from the patient; and performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day….”

126

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d

1117 (Fed. Cir. 2018).

Case Example | FANAPT (continued)

“A method for treating a patient…suffering from schizophrenia…comprising the steps of: determining whether the patient is a CYP2D6 poor metabolizer by: obtaining or having obtained a biological sample from the patient; and performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day….”

127

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d

1117 (Fed. Cir. 2018).

• Affirmed inducement finding

• Label recommends performing

genotyping assay and dosing based on

the results

Case Example | MULTAQ

“A method of decreasing a risk of cardiovascular hospitalization…comprising administering…an effective amount of dronedarone or a pharmaceutically acceptable salt thereof, twice a day with a morning and an evening meal, wherein said patient does not have severe heart failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month; and (ii) wherein said patient has a history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter; and (iii) wherein the patient has at least one cardiovascular risk factor selected from the group consisting of: i. an age greater than or equal to 75; ii. hypertension; iii. diabetes; iv. a history of cerebral stroke or of systemic embolism; v. a left atrial diameter greater than or equal to 50 mm; and vi. a left ventricular ejection fraction less than 40%.”

128

Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).

Case Example | MULTAQ (continued)

“A method of decreasing a risk of cardiovascular hospitalization…comprising administering…an effective amount of dronedarone or a pharmaceutically acceptable salt thereof, twice a day with a morning and an evening meal, wherein said patient does not have severe heart failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month; and (ii) wherein said patient has a history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter; and (iii) wherein the patient has at least one cardiovascular risk factor selected from the group consisting of: i. an age greater than or equal to 75; ii. hypertension; iii. diabetes; iv. a history of cerebral stroke or of systemic embolism; v. a left atrial diameter greater than or equal to 50 mm; and vi. a left ventricular ejection fraction less than 40%.”

129

Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).

• Affirmed inducement finding

• Label encourages administration to

patients with claimed risk factors

Case Example | YASMIN

“A method of simultaneously achieving,

during premenopause or menopause a

gestagenic effect, antiandrogenic effect,

and an antialdosterone effect in a female

patient in need thereof comprising

administering an amount of

dihydrospirorenone to said female

patient, wherein said amount of

dihydrospirorenone is effective to

simultaneously achieve a gestagenic

effect, antiandrogenic effect and

antialdosterone effect in said patient.”

130

Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316 (Fed. Cir. 2012).

• No induced infringement

• Label did not recommend or suggest

that Yasmin was safe and effective

for inducing the claimed effects

Defense to Induced Infringement

• Reasonable belief of noninfringement is a defense to induced infringement

• Good-faith belief of invalidity is not a defense

131

Section viii Statement

Can omit method of use from label if it does not render the proposed drug product less

safe or effective than the reference listed drug for remaining conditions of use

Can file section viii statement instead of paragraph IV certification

Does the label nonetheless encourage, recommend, or promote the allegedly carved-

out use?

132

21 U.S.C. § 355(b)(2)(B), (j)(2)(A)(viii).

Case Example | PULMICORT RESPULES

• “A method of treating a patient suffering

from a respiratory disease, the method

comprising administering to the patient a

nebulized dose of a budesonide

composition in a continuing regimen at a

frequency of not more than once per day.”

• Apotex omitted once daily language

• But per FDA kept downward-titration

language

• AstraZeneca would likely prove induced

infringement at trial

• Downward-titration language “would

inevitably lead some consumers to

practice the claimed method”

133

AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010).

Case Example | COLCRYS

• “A method of treating a patient having an acute gouty arthritis attack with colchicine consisting of administering 1.2 mg oral colchicine to a human patient having an acute gouty arthritis attack at the onset of the acute gouty arthritis attack, followed by 0.6 mg oral colchicine one hour later.”

• Hikma omitted treatment as indication

• But kept instruction to report gout flares

• No induced infringement

• “No evidence that the label would necessarily lead doctors…to prescribe an off-label use”

134

Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., 785 F.3d 625

(Fed. Cir. 2015).

Patient Counseling Information

Goal for Claims

Draft claims that will be directly and literally infringed

Why?

• Avoid challenges of proving infringement under the doctrine of equivalents

• Deny your competitor the additional defenses to induced and contributory infringement

• Avoid third party discovery, especially from customers and prospective customers

How?

• Coordinate patent, regulatory, and clinical personnel early and throughout patent

prosecution at PTO and label negotiation with FDA

• Maintain consistency between claims and likely or actual label language

• Question who will infringe claims and how you will prove it

135

Patents that Matter

Commercially Viable

Enforceable



Trade Secrets


Third Party Patents

Continuous Process

136


Exclusivity Period Notes

Orphan drug exclusivity (ODE) 7 years

New chemical entity (NCE) exclusivity 5 years

Generating antibiotic incentives now (GAIN) exclusivity

5 years Added to certain exclusivities

New clinical study exclusivity 3 years

Pediatric exclusivity (PED) 6 monthsAdded to certain patents and

exclusivities

Patent challenge (PC) 180 days Exclusively for ANDAs

Competitive generic therapy (CGT) 180 days Exclusively for ANDAs

Reference product exclusivity 12 yearsBiological products filed under

351(a)

137

Patents that Matter

Commercially Viable

Enforceable



Trade Secrets


Third Party Patents

Continuous Process

138

Trade Secrets

139

• Secret, valuable information

• Take reasonable steps to maintain secrecy

• Until no longer secret

Financial

•Pricing strategies

•Budgets

• Information about revenues, profits, losses

Business

•Business plans

•Supply and distribution chains

•Customer lists

•Reimbursement strategies for medical products

•Forecasts

•Customer preferences

Scientific

•Formulas

•Specifications

•Algorithms

•Processes

•Data compilations

•Scientific know-how

Technical

•Source code

•Programmer’s notes

•Manufacturing techniques

•Design specifications

•Vendor information

•Data collection methods

•Data storage methods

Economic

•Cost considerations

•Manufacturing strategies

Engineering

•Prototypes

•Designs

•Testing methods

Protecting Trade Secrets

• Restrict access

• Establish written trade secret policy

• Use confidentiality agreements

• Train employees

• Use legending

• Monitor authorized and unauthorized access

• Enforce

140

Trade Secrets and Patents

Trade Secret

• Not patent eligible

• Commercial value <2 or >20 years

Patent

• Difficult to keep secret

• Can be reverse engineered

• Independent discovery likely

141

Patents that Matter

Commercially Viable

Enforceable



Trade Secrets


Third Party Patents

Continuous Process

142

Freedom to Operate

Why?

• Identify and analyze potential patent roadblocks

― Focus on claims and how they compare to products and future products

― Focus on unexpired patents or pending applications in countries of interest

Then what?

• Design around

• Consider licensing or partnership opportunities

• Consider validity issues

• Consider initiating post-grant proceedings

143

Patents that Matter

Commercially Viable

Enforceable



Trade Secrets


Third Party Patents

Continuous Process

144

Evaluate and Reevaluate

• Throughout patent lifecycle

• Identify additional patents to pursue

• Identify patents no longer of value

― Claims

― Geographic

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Developing a Life Sciences Patent...

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