NewYorkBio Conference May 5, 2015 Large Molecules, Small Proceedings: The Intersection of Biologics...

NewYorkBio Conference May 5, 2015Large Molecules, Small Proceedings: The Intersection of Biologics and IPRs

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The Panel

Larry Coury

Director of Dispute Resolution, Regeneron Pharmaceuticals, Inc.

Peter Waibel

Vice President, Head of Patent Litigation, Novartis Pharmaceuticals

Brian Walsh

Senior Corporate Counsel and Head of the Immunology Patent Group at Bristol-Myers Squibb

Justin Oliver

Partner and Chair of the PTO Contested Proceedings Practice Group at Fitzpatrick Cella Harper & Scinto

Alicia Russo - Moderator

Partner at Fitzpatrick Cella Harper & Scinto


Mechanics of IPRs (35 U.S.C. § 311 et al.)

Replaced Inter Partes Reexaminations

Grounds for request

– §§102 and 103

– Patents and printed publications only

When can it be requested

– Patent filing date on or before March 16, 2013 – any time

– Patent filing date after March 16, 2013 – after the later of:

Nine months after date of issue, or

Termination of a post-grant review, if instituted


Mechanics of IPRs

Timeline – a final decision is rendered within about 18 months from the filing date of the petition

Estoppel – applies to petitioner, real party in interest, and privy of petitioner

– Cannot assert invalidity on any ground that was raised or reasonably could have been raised in an IPR that reached a final decision

Standing

– No requirement for a proof of injury or other interest

If petitioner does not succeed before the PTAB, it will need standing to appeal to the Federal Circuit


Mechanics of IPRs

Claim Amendments

– Claim amendments are allowed, but the burden is on Patent Owner to prove patentability over all prior art and written description support

– Previous grant rate of motion was about 5%

– Via motion to amend

15 page limit – now changed to 25 pages

New rule - appendix for the amended claims permitted


Mechanics of IPRs

IPR PGR

When After nine months of grant Within nine months of grant

Threshold showing Reasonable likelihood of success

More likely than not or novel legal question

Grounds 102, 103 101, 102, 103, 112

Estoppel Issues raised or reasonably could have been raised

Issues raised or reasonably could have been raised

Appeal Both parties may appeal to Federal Circuit (assuming standing)

Both parties may appeal to Federal Circuit (assuming standing)


Mechanics of IPRs

Miscellaneous

– Redundancy

– Conclusory basis for reason to combine

– Statistics

IPR – 73% rate of cancelation/unpatentability for cases reaching final decision

• 16% of analyzed claims were canceled by Patent Owner

• 59% of those cases were computer/electrical/data processing

• 3% were pharma

http://www.postgranthq.com/statistics/


Different Standards at the PTAB v. District Court

Threshold for institution

– PTAB

“reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition” (§ 314 (a))

– District Court

No requirement



Presumption of validity

– PTAB

No presumption of validity

Petitioner has the burden to prove invalidity

• Except for amended claim

– District Court

Patent is presumed valid

Burden is on the party asserting invalidity to overcome the presumption of validity (35 U.S.C. § 282(a))



Burden of proof

– PTAB

Preponderance of evidence

– District Court

Clear and convincing evidence



Claim Construction

– PTAB

“Broadest reasonable interpretation” (In re Cuozzo Speed Technologies, LLC., Fed. Cir. Feb. 4, 2015)

No Markman hearing

– District Court

Federal Circuit – “the meaning that [a] term would have to a person of ordinary skill in the art in question at the time of the invention.” (Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005))

Markman hearing to decide claim construction



Practical effects

– Success rate of § 102 challenge IPR

PTAB – 37.5%

District Court – 31.1%

– Success rate of § 103 challenge IPR

PTAB – 57.5%

District Court – 27.8%

http://www.postgranthq.com/statistics/


Biologics IPR Decisions

BioMarin Pharmaceutical Inc. v. Genzyme Therapeutic Products Ltd. (IPR2013-00534, IPR2013-00537)

BioMarin Pharmaceutical Inc. v. Duke University (IPR2013-00535)

– Genzyme’s Myozyme product is used for the treatment of Pompe disease

– Representative Claim - A method of treating a human patient with Pompe's disease, comprising intravenously administering biweekly to the patient a therapeutically effective amount of human acid alpha glucosidase, whereby the concentration of accumulated glycogen in the patient is reduced and/or further accumulation of glycogen is arrested.

The PTAB determined that all of the challenged claims of the patents were obvious in view of various combinations of several references

BioMarin is currently conducting clinical trials on a competing product for the treatment of Pompe disease



Biologics decisions since BioMarin

– Baxter/Apatech v. Millenium Biologix (IPR2013-00590; IPR2013-00582)

On March 18, 2015, PTAB determined that Petitioner has shown by a preponderance of evidence that the challenged claims were obvious

– Aker Biomarine/Enzymotec v. Neptune/Bioressources (IPR2014-00003)

On March 23, 2015, PTAB determined that the Petitioner has established by preponderance of evidence that all but two of the challenged claims are unpatentable under both 102 and 103 grounds



Often, Patent Owner cancels challenged claims or reaches settlement

– CroFab – Laboratories Silanes v. BTG Int’l (IPR2014-01269)

Laboratories Silanes filed petition in August 2014

BTG announced settlement, IPR terminated in December 2014

– Eprex – Hospira v. Janssen (IPR2013-00365)

Hospira filed IPR but Janssen disclaimed all challenged claims

Pending

– Herceptin – Phigenix v. Immunogen/Genentech (IPR2014-00676)

Decision to institute reached in October 2014



Effects of IPR decisions on Biologics/Pharma products

– The BioMarin decisions mark one of the first times that the PTAB has invalidated a biologics patent in the context of an IPR

– In light of the recent decisions, IPR proceedings warrant the attention of Patent Owners and would-be Petitioners alike

103 ground for invalidation should be considered in light of the recent decisions from the PTAB

“Preponderance of evidence” standard may be easier to meet

“Broadest reasonable interpretation” of claim scope potentially increases the prior art available for anticipation and obviousness arguments


Rule Changes/Proposed New Rules – Impact on IPRs

USPTO Rule Changes/Proposed New Rules (1st Quick Fix)

– Petitioner’s Reply Brief and PO’s Motion to Amend

Old Rule: 15-Page limit

New Proposed Rule: Increase page limit to 25 pages

http://www.uspto.gov/blog/director/entry/ptab_s_quick_fixes_for



USPTO Rule Changes/Proposed New Rules (2nd Rule Package)

– Motion to Amend

Old Rule: Patent Owner required to prove patentability over all prior art

New Proposed Rule: Patent Owner will be required to prove patentability of the amended claims over the art of record before the Office




USPTO Rule Changes/Proposed New Rules (2nd Rule Package)

– Patent Owner’s Preliminary Response

Old Rule: No new testimonial evidence allowed

New Proposed Rule: Supporting evidence will be allowed

– Establishing the real party-in-interest (RPI)

Old rule: limited discovery by Patent Owner to establish RPI

New Rule: ample discovery to determine RPI




USPTO Rule Changes/Proposed New Rules (3rd Pilot Program)

– PTAB Panel

Old Rule: Judges participating in a decision to institute a trial also part of the panel deciding the case on its merits

New Proposed Rule: A pilot program where a single judge would make the decision on whether to institute a trial and two new judges would be added to the panel only when and if a trial is instituted


Proposed Legislation – STRONG Patents Act

STRONG Patents Act - Spearheaded by Senator Christopher Coons (DEL) and introduced 03/03/2015

Proposed changes (http://patentlyo.com/patent/2015/03/strong-patent-senator.html)

– Claim Construction standard will:

Be “ordinary and customary meaning”

No longer use “broadest reasonable interpretation”

– Claim amendments to be allowed if “reasonable”

– Presumption of validity – burden of proof is “clear and convincing evidence”

– Patent Owner’s Preliminary Response – supporting evidence will be allowed


Proposed Legislation – STRONG Patents

STRONG Patents Act - Proposed changes (cont’d)

– Block anonymous petitions – will allow Patent Owner to discover the RPI associated with the petition

– Standing to file a petition will be limited to only entities charged with infringement

Entities such as the Coalition for Affordable Drugs, a wholly owned subsidiary of Hayman Credes Master Fund, LP, will no longer be permitted to file IPR petitions

• the founder of Hayman Capital, publicly announced his intention to go “activist” against the U.S. pharmaceutical industry and its patents, calling it a “short activist strategy”


Proposed Legislation – Innovation Act

Bill passed the House in 2013 as H.R. 3309 – introduced by Rep. Goodlatte

Bill was re-introduced as H.R. 9 on February 5, 2015, and is the same as H.R. 3309

Proposed changes

– PGR: remove “reasonably could have raised” from the estoppel provisions of § 325(e)(2)

– IPR and PGR: mandate the use of a district court-style claim construction in IPR and PGR proceedings

But Federal Circuit has upheld the USPTO’s use of the “broadest reasonable interpretation” of the claims


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NewYorkBio Conference May 5, 2015 Large Molecules, Small Proceedings: The Intersection of Biologics...

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