Coordinating Post-Grant Patent Opposition in...

Coordinating Post-Grant Patent Opposition in Europe and the U.S. Navigating Timing, Grounds for Opposition, Discovery, and Amendments to Maximize Protection in Both Jurisdictions

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THURSDAY, FEBRUARY 26, 2015

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

Michael J. Flibbert, Partner,

Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Leythem A. Wall, European Patent Attorney,

Finnegan Henderson Farabow Garrett & Dunner, London

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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Coordinating Post-Grant Patent Opposition

in Europe and the U.S.

February 26, 2015

Presented by Michael J. Flibbert and Leythem A. Wall

6 6

‘The European Patent’

• 38 EPC Member States as of 1 January 2014

• 28 EU States, 10 non-EU States

• Centralized prosecution

• Bundle of national patents

• Articles 69 EPC and 138 EPC - National Law ‘largely’ harmonized

• Theoretically, same results for parallel national proceedings

• In practice, can be very different results and very expensive

7 7

Overview • What is an Opposition? - Post-grant inter-partes procedure at the EPO (administrative, not litigation) - Allows public to challenge grant of European patent - No limit to number of opponents - No commercial or other interest whatsoever need be shown - May result in limitation or revocation of patent

• Reasons for opposing a patent - Infringement - Licensing/cross-licensing - Strategy - Patent intelligence - Political/ethical reasons

8 8

Who Can File

- “Any person” may have an Opposition filed on their behalf

- Have to be represented by a European Patent Attorney

- Opponent cannot be anonymous but can be “straw man”

- No limit to the number of Opponents per patent, automatically consolidated into single Opposition proceedings

9 9

Grounds • Grounds of Opposition

- lack of novelty

- lack of inventive step

- invention is insufficiently described

- added matter

- non-patentable subject matter

- not susceptible to industrial application

- clarity and unity are not available grounds of opposition

10 10

Filing the Opposition

• Opposition must be filed in writing at EPO (Munich, The Hague, Berlin) within 9 months from publication of mention of grant of patent. No extension available even if patent republished after voluntary post grant limitation or correction

• Must set forth fully the Opponent’s case, including “an indication of the facts, evidence and arguments”. At least one ground must be cited

• No page limits

• Needs to be in an EPO Official Language (English, French, German)

• Opposition Fee is 775 EUR

• All oppositions instituted if the above requirements satisfied

• All reasoned grounds considered. No concept of redundant grounds

• On public file

11 11

Opposition Written Procedure

The Opposition Division

• 3 EPO Examiners including Examiner who conducted examination

Written Proceedings

• Patentee given a 4-6 month period to reply to opposition once ‘instituted’

• No further formal written deadlines until Summons to Oral Hearing

- Summons includes Opposition Division non-binding preliminary opinion

- Summons sets a deadline for final written submissions, including Auxiliary Claim Requests from the patent proprietor, for 1 month before Hearing

• No Discovery

• Expert declarations rare

12 12

Claim Amendments Formal

• Theoretically no limit to number of Auxiliary claim sets (3 to 10 is typical)

• Can be filed in reply to opposition and summons to Oral Hearing (and also during hearing but no guarantee will be admitted)

Substantive

• Must satisfy EPC requirements including added matter. Strict assessment, express basis often requested

• Must not broaden scope of granted claims

• Added Matter is a ground of Opposition and claim broadening after grant not permitted – “The Inescapable Trap” (G1/93)

13 13

Claim Construction

Article 69 EPC:

“the extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.”

The Protocol on Article 69 EPC

“Article 69 EPC should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties”

14 14

Oral Proceedings - Inter-partes Oral Hearing takes place in Munich, The Hague or Berlin

- Language of the patent (English, French or German). Interpreters provided.

- Hearing is very rarely more than a day

- Opposition Division issue Decision at the end of the Hearing i.e. same day

- Decision will either: • revoke the patent (‘kill’) • uphold the patent (‘miss’) • maintain patent in amended form (‘wound’)

- Written Decision with full and detailed reasoning issued within a few months - Appealable only at the EPO

- Whole Process 18-30 months, sometimes quicker

15 15

Opposition Timeline

16 16

EPO Stats – Technical Areas Opposed

• Industrial Chemistry, Polymers and Organic Chemistry account for over a third of all oppositions*

* “The Opposition Procedure and limitation and revocation procedures”, Daniel Closa, Beauce Gaetan, European Patent

Office 30 November 2012

17 17

EPO Stats – Opposition Outcome

• Approximately 5% of all EP patents granted are opposed

• Approximately 70% of patents at least wounded, over a quarter killed*

* European Patent Office “Facts and Figures 2014”

18 18

Reasons for Revocation

• Revocation mainly on grounds for lack of inventive step

• Added matter revocation relatively high at 11%*

* van de Kuilen, Aalt (2013) ” Successful European Oppositions: Analysis for the patent information professional”. World Patent

Information (Elsevier) 35 (2): 126–129

19 19

Appeals - Notice of Appeal must be filed at EPO within 2 months of Written Decision

- Grounds of Appeal must be filed at EPO within 4 months of Written Decision

- Board of Appeal is entirely independent of Opposition Division. 3 members, an EPO in-house lawyer and two technical EPO members (ex-Examiners or ex-patent attorneys)

- Written Procedure similar to Opposition

- Hearing similar nature to Opposition Hearing. Decision will either: • remit case back to Opposition Division • revoke the patent • uphold the patent • maintain patent in amended form

- Decision is not appealable (unless procedural violation by Board of Appeal). Points of Law can be referred to Enlarged Board of Appeal

- Whole Process 18-30 months, sometimes quicker, can request acceleration

20 20

Appeals • Board of Appeal (BoA) increasingly strict on admissions into the proceedings:

• Article 12(4) of the Rules of Procedure of the Boards of Appeal refers to “the power of the Board to hold inadmissible facts, evidence or requests which could have been presented or were not admitted in the first instance proceedings”

• T 23/10 – BoA did not admit Auxiliary Claim Requests 8-15. Only 1-7 filed with Opposition

• T 144/09 – BoA did not allow simple change to the claim to remove added matter. The proprietor had the chance during Opposition

• T 361/08 – BoA did not allow requests withdrawn during opposition

21 21

Settlement and Stays Settlement

- Opposition Division can continue opposition proceedings, regardless of when settlement made or opponent withdrawing opposition

- Appeal proceedings are terminated if appeal is withdrawn

Stays and concurrent litigation

- In some states national proceedings automatically stayed pending opposition outcome (e.g. Germany, France)

- In some states decision based on whether national or EPO decision likely to be issued more quickly (e.g. UK)

22 22

Observations Third Party Observations

- opportunity to file arguments if opposition deadline is missed but another party has filed an opposition

- can also be filed by “straw man”

- goes on public record

Intervention

- if accused of infringement then can become party of the opposition proceedings even if you did not file an opposition

23 23

Estoppel

• Patent Revocation has final effect across Europe

- even if there are parallel national proceedings or decisions, effect of EPO revocation is final and retroactive

• National Proceedings still available if patent maintained

- if EPO opposition not successful, patent can still be attacked nationally

- National Courts not bound by EPO reasoning for patent maintenance or amendment

- No litigation estoppel and same grounds and prior art can be used

24 24

Opposition Pros

• ~70% chance of at least diminishing scope of the patent

• ~30% chance of revoking patent

• Successful opposition (and appeal) means irreversible revocation

• Significantly lower cost than parallel national proceedings

• In some states national proceedings automatically stayed pending opposition outcome (e.g. Germany, France)

• Consistent decision across Europe

• No litigation estoppel

• No litigation in the press!

25 25

Opposition Cons

• Process can be slow, several years. Some courts e.g. UK can be quicker

• EPO is less able to judge oral evidence than the Courts. For prior use case this may be significant

• EPO is less likely to revoke a patent it has granted over the same prior art (national courts are not bound by EPO reasoning)

26 26

The Wildly Popular IPR Proceeding

• America Invents Act (AIA): September 2011

• New post-grant challenges: September 2012

• As of February 20, 2015:

– 2,522 inter partes review (IPR) petitions

– 299 covered business method review (CBM) petitions

– 3 post-grant review (PGR) petitions

– Patent Trial and Appeal Board (PTAB) instituting at high

rate and holding claims unpatentable at high rate

– Related district court litigation is common

27 27

EP Oppositions Compared with IPRs

EPO Opposition IPR

Who can file? Any member of the

public other than the

patent owner

No bar if already

challenged patent in

national court

Any member of the public other

than the patent owner

If already challenged patent in civil

suit, may be barred

28 28


EPO Opposition IPR

Filing Deadline Within 9 months of grant Can file at any time for patents with

effective filing date before March

16, 2013

Otherwise, can file after 9 months

of patent issuance

29 29


EPO Opposition IPR

Where does one

file?

Electronic filing system

(Epoline)

Paper filing at European

Patent Office (Munich,

The Hague, Berlin)

Electronic filing through Patent

Review Processing System (PRPS)

Paper filing even if PRPS and

Board’s email address

([email protected]) are unavailable

US Patent and Trademark Office

(Alexandria, VA)

30 30


EPO Opposition IPR

Filing Fees $1000 $23,000 or more

31 31


EPO Opposition IPR

Anonymity Real party may remain

anonymous (“straw

man”)

Must identify real party in interest

32 32


EPO Opposition IPR

Grounds Patentability,

insufficiency, added

matter, not clarity/unity

Lack of novelty and obviousness

based on prior art patents or

printed publications under 35

U.S.C. §§ 102, 103

Post-grant review (PGR) allows

broader challenges, including on

grounds of enablement, written

description, definiteness, or utility,

but is only available for patents

having an effective filing date on or

after March 16, 2013

33 33


EPO Opposition IPR

Institution rate Effectively 100%

No official “redundancy”

of reasoned grounds

Above 70%

Board will often narrow proposed

grounds of unpatentability based on

“redundancy”

34 34


EPO Opposition IPR

Claim

amendments

Patent owner may file

substitute claims in

response to opposition

‘institution’ and summons

to oral hearing. No

official limit on number of

substitute claims

Very often admitted into

proceedings

Additional claim sets can

be admitted during oral

hearing if resolves

issues identified during

hearing

Patent owner may file one motion

to amend as a matter of right. Limit

on number of substitute claims (1

for 1)

Very few motions to amend have

been granted to date

Additional motions to amend may

be permitted to facilitate settlement

or for good cause

35 35


EPO Opposition IPR

Time to decision Final decision 18-30

months on average. For

some technologies (e.g.

Chemical, 12-18 months

can be typical)

Final decision not later than 1 year

after institution (may be extended

for good cause by up to 6 months)

36 36


EPO Opposition IPR

Experts Expert declarations rare

Cross-examination rare,

but technical experts can

be questioned during

Oral hearings

Evidence is usually presented

through expert declarations

Experts may be cross-examined by

deposition

37 37


EPO Opposition IPR

Discovery None Limited

• Routine discovery: exhibits cited,

inconsistent information, cross-

examination of declarants

• Additional discovery: upon

agreement or if “in the interests

of justice”

38 38


EPO Opposition IPR

Duty of

Disclosure

Patent Office (if not EPO)

search results for priority

application must be disclosed

to EPO for EP application

claiming priority

No requirement to disclose

Patent Office search reports

for corresponding

applications. EPO can

request this

No requirement to disclose

own prior art search results

No requirement that

experimental data included in

application or submitted in

support of application

includes all results obtained

Any individuals substantively involved in

proceedings before the USPTO (e.g.,

inventors, in-house counsel, outside

counsel) have a continuing duty to

disclose material information

Rule 42.51(b)(1)(iii) also requires

service of certain “relevant information

that is inconsistent with a position

advanced during the proceeding” as

part of routine discovery

39 39


EPO Opposition IPR

Claim

construction

Typically broadest

reasonable interpretation

of claims

“a fair protection for the

patent proprietor with a

reasonable degree of

legal certainty for third

parties”

Broadest reasonable interpretation

of claims

40 40


EPO Opposition IPR

Oral argument Must file a request for

oral argument;

automatically granted

Generally no live

witnesses, though

technical experts

presented can be asked

questions

Length and number of

oral arguments vary

depending on facts of

case and claim sets

considered

Must file a request for oral

argument; routinely granted

Generally, no live witnesses

Length of oral argument varies

(e.g., one hour per side)

41 41


EPO Opposition IPR

Settlement Settlement does not

guarantee termination of

proceedings

Opposition Division may

decide patentability

despite settlement based

on public interest

considerations

Can be settled, particularly if still

early in proceeding

Board may decide patentability

despite settlement in some

circumstances (e.g., case has been

fully briefed) based on public

interest considerations

42 42


EPO Opposition IPR

Challenger win rate High ‘wounding’ rate ~ 70%

patents opposed either

revoked (~ 30%) or

maintained in amended form

(~ 40%)

High petitioner win rate: in

over 70% of cases no

claims have survived

43 43


http://www.aiablog.com/

44 44


http://www.aiablog.com/ European Patent Office “Facts and Figures 2014”

45 45


EPO Opposition IPR

Appeal Forum EPO Board of Appeal

Either party may appeal an

adverse decision

US Court of Appeals for the

Federal Circuit

Either party may appeal an

adverse decision

46 46


EPO Opposition IPR

Effect of later

enforcement

No estoppel Litigation estoppel as to grounds of

unpatentability that were raised or

reasonably could have been raised

Estoppel applies in courts and

USPTO after the Board issues a

final written decision

Courts and USPTO have not yet

interpreted the estoppel provision

47 47


48 48

Real-Life Example: Smith & Nephew v Convatec • Smith & Nephew Inc. filed IPR in December 2012 against US7,267,828 of Convatec

Technologies Inc. • PTAB’s written decision (IPR2013-00102) entered 29 May 2014 held that all 32 challenged

claims of Convatec’s US patent were unpatentable for anticipation or obviousness.

• It further rejected ConvaTec’s attempt to amend the claims. • Smith & Nephew also filed an opposition in November 2011 against Convatec’s

corresponding European patent (EP1343510).

• Same prior art as cited in US proceedings “Kreidl” and “Gibbins”

• Amended Claims admitted into proceedings

• EP patent successfully maintained in amended form by Opposition Division December 2012. Subsequent appeal/opposition in October 2014 led to patent revocation.

• Corresponding UK litigation considered UK patent valid in amended form in June 2012, confirmed on appeal December 2012

49 49

Strategic Considerations

EP Oppositions: • Extremely cost effective • Typically leads to proprietor filing amended claims • No redundant grounds, hence can test different arguments to see which one

has best chance of success • High ‘wounding’ rate • Technically trained Opposition Division and Board of Appeal • Can oppose in name of “straw man” • Consistent decision across Europe • No litigation estoppel • Potential stay of related litigation, in some states automatically stayed

50 50

Strategic Considerations

IPRs: • Quick (decision within about 12-18 months) • Lower cost than litigation • No presumption of validity • Lower burden of proof than litigation: preponderance of evidence (i.e., 51%) • Broadest reasonable interpretation of claims • Technically trained Administrative Patent Judges (APJs) • Expert testimony routine • High institution and “kill” rates • Litigation estoppel – uncertain scope/untested in courts • Potential stay of related litigation • Immediate Federal Circuit appeal

51 51

Finnegan Resources

• http://www.aiablog.com/blog/global-harmonization/

• "Coordinating European and U.S. Post-Grant Patent Opposition" -

Corporate Counsel, November 2014

http://www.aiablog.com/blog/global-harmonization/






http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=487d09f1-1815-4471-8671-437c8c296b84






52 52

Questions?

53 53

Thank You!

Leythem A. Wall Finnegan Europe LLP 16 Old Bailey London EC4M 7EG United Kingdom Tel +44 (0)20 7864 2814 [email protected]

Michael J. Flibbert Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 Tel +1 202 408 4493 [email protected]

54 54

Speaker Information

Leythem Wall is a chartered UK patent attorney, a

European patent attorney and a European trademark and

design attorney. His practice involves patent drafting,

prosecution, opinions on infringement and validity, and

portfolio management. He has extensive experience in

Oppositions and Appeals including representation in Oral

Proceedings before the EPO.

Mike Flibbert is a partner is Finnegan’s Washington, DC office and chairs the firm’s chemical practice group. He represents clients in patent disputes before federal district courts and the Federal Circuit and also serves as lead counsel in IPR and other contested proceedings before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office. He lectures frequently in the United States and abroad on patent law topics, including the America Invents Act (AIA).

55 55

Disclaimer

These materials have been prepared solely for educational and

entertainment purposes to contribute to the understanding of U.S. and

European intellectual property law. These materials reflect only the

personal views of the authors 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, the authors, Finnegan,

Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe

LLP, and Fei Han Foreign Legal Affairs Law Firm) 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 these authors. While every attempt was made to ensure that these

materials are accurate, errors or omissions may be contained therein, for

which any liability is disclaimed.

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