1. Inter Partes Review and District Court
February 2017
By:
SERENA FARQUHARSON-TORRES

2. Inter Partes Review (IPR) 35 USC§311-319
Trial proceeding at the US Patent Trials and Appeals Board (PTAB) to review patentability on grounds raised under §§102 or 103, on basis of prior art consisting of patents or printed publications
IPR may be instituted: showing of reasonable likelihood petitioner would prevail with respect to at least one claim challenged
Third party may file petition to request IPR 9 months after issue/ reissue date, after post grant review and not more than a year after being served with a complaint of infringement
Optional Preliminary Response is filed by patent owner no more than 3 months after filing date of petition, as of May 2016 can file new testimonial evidence such as an expert declaration with preliminary response
IPR can proceed on all or some of challenged claims.
Final determination no more than 1 year after initiation of post grant review (extensions by 6 months for good cause).
Petitioner can move to stay parallel district court litigation in view of pending IPR (for Hatch Waxman cases: possibly shorten time to resolve litigation, thereby eating into the 30 month stay of product approval).

3. IPRs Filed through March 2016 & Orange Book IPRs / Different Types of Petitioners) From Prof. Jacob Sherkow of New York Law School at BIO IPCC Spring 2016 Meeting

4. IPRs Are Dangerous for Patent Owners

5. Patents at risk
A claim “shall be given its broadest reasonable construction in light of the specification of the patent in which it appears.” CFR (b)
Possibly opens a larger universe of p/a?
Patents are presumed valid in district court, in an IPR there is no presumption of validity
In an IPR petitioner bears lower burden of proof by a “preponderance of the evidence” in district court there is a higher burden of proof by “clear and convincing evidence”

6. IPR Appeals 2016: 79% CAFC Affirmance Rate
IPR Appeals January 1-December 31, 2016:
140 IPR Decisions
All Issues affirmed in 110 cases (79.1%)
Partial Affirmance in 12 cases (8.6%)
Complete reversal/ vacation in 12 cases (8.6%)
Dismissal in 5 cases (3.6%)

7. IPR and District Court Appeals Have Comparable Affirmance Rates
CAFC affirmances January 1-June 30, 2016*:
78% of district courp patent appeals
80% of IPR appeals
Source: IPLaw360, August 12, 2016

8. Appellate Review Standard
Federal Circuit reviews the PTAB’s factual findings under the deferential “substantial evidence” standard
Substantial evidence means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.
Federal Circuit reviews a district court’s factual findings under the less rigorous “clear error” standard
Whether the reviewing court has a definite and clear conviction that a mistake has been made.

9. Standing (IPR & Federal Circ.)
Federal circuit dismissed appeal from IPR decision upholding patent due to lack of standing:
Apellant must supply proof of actual or imminent injury in fact.
Increase in competition and encumbered licensing efforts and estoppel of future IPR proceeding is not sufficient,
Apellant was not engaged in activity that would give rise to possible infringement by patent holder.
Phigenix v ImmunoGen Fed. Circ. 1/9/2017
Note: If patent is upheld in IPR, Patent trolls, investors and other consumer interest groups would not be able to appeal the decision.

10. IPR: Multiple Petitions
35 USC 325(d) Director can reject petition because same or substantially the same prior art or arguments previously have been presented.
Neptune Generics v Eli Lilly IPR & petitions, same claims, two different grounds of obviousness (PTAB instituted both petitions)
Dr Reddy’s Lab v Galderma Labs (IPR , 778, 782) 3 Petitions, same claims, 3 different grounds of obviousness (PTAB denied institution of all 3 petitions)

11. Estoppel 35 USC §315 (e)1& 2
Petitioner is precluded from proceeding in the PTO on any ground that the petitioner raised or reasonably could have raised during IPR
Petitioner is precluded from asserting in a district court or ITC proceeding that a claim is invalid on any ground that the petitioner raised or reasonably could have raised during IPR

12. Recent Decisions Limit the Preclusive Effect of IPR Invalidity Contentions
Invalidity contentions that are not adopted by the PTAB do not become part of the IPR. Shaw Industries Group v. Automated Creel Systems, 817 F. 3d 1293, 1300 (Fed. Cir )
“The validity of claims for which the [PTAB] did not institute inter partes review can still be litigated in district court.” Synopsis, Inc. v. Mentor Graphics Corp., 814 F. 3d 1309, 1316 (Fed. Cir. 2016)

13. Two bites at the apple First bite:
District court held validity of 2 formulation patents after challenge by first ANDA filer, Fed. Circ. Affirmed decision (Novartis Pharms corp v Par Pharmc 48 F. Supp. 3d 733 D. Del. 2014)
one patent upheld again after challenge by 2nd ANDA filer (Novartis Pharms Corp. v. Noven Pharm 125 F. Supp. 3d 474 (D. Del 2015).
Second bite:
PTAB found both of the same patents obvious District court opinion on same prior art was not binding, Fed. Circ. did not control b/c petitioner presented additional prior art