We have reviewed a sub-group of 111 IPRs filed by generic drug companies against pharmaceutical patents to assess outcomes and trends. While our survey was not intended to capture every IPR filed by a generic drug company, it...more
The Supreme Court of the United States heard oral argument today on claim construction in inter partes review (IPR) proceedings and the reviewability of institution decisions. On the claim construction issue, the Justices...more
4/29/2016
/ Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Cuozzo Speed Technologies v Lee ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Mandamus Petitions ,
Patent Infringement ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
SCOTUS ,
USPTO
A common deficiency highlighted in recent PTAB decisions denying institution of an IPR petition is that an expert declaration offers only “conclusory” statements in relation to one or more key aspects of the alleged ground of...more
On May 2, 2016, the amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board go into effect, and apply “to all AIA petitions filed on or after the effective date and to any ongoing AIA...more
4/6/2016
/ America Invents Act ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Covered Business Method Proceedings ,
Duty of Candor ,
Expert Testimony ,
Final Rules ,
Genuine Issue of Material Fact ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Post-Grant Review ,
USPTO
On March 31, 2016, the USPTO released its long-awaited package of rules for AIA post-grant proceedings. The final rules largely track the proposed rules (see “USPTO Proposes Extensive Changes to AIA Post-Grant Proceedings” to...more
An obvious but sometimes overlooked item when conducting patent due diligence is to check for PTAB proceedings (CBM, IPR, or PGR). Although the Patent Application Information Retrieval System (PAIR) does show whether patents...more
Kyle Bass has filed numerous prior IPR petitions against pharmaceutical patents, some of which have been denied due to use of prior art references that were not sufficiently proven to be “publicly accessible” (see “Clinical...more
On March 7, 2016, the Federal Circuit issued a temporary stay to permit briefing by the parties on the question of whether the PTAB properly ruled that Apple could use the joinder process in Mangrove Capital’s IPR against...more
In IPR2014-00614, Microsoft filed a petition for IPR against US Patent No. 7,418,504 (“the ‘504 patent) owned by VirnetX, which was instituted based upon anticipation grounds over Kiuchi (see institution decision). This IPR...more
On February 11, 2016, in Nike v. Adidas (Fed. Cir. 2016), the Federal Circuit partially relaxed the hurdle for a patent owner to amend claims during an IPR or other AIA proceeding. This follows the PTAB’s own earlier partial...more
A Texas jury today raised the stakes even higher in a race involving parallel proceedings between the PTAB and Texas district court when it found that Apple infringed the VirnetX patents and awarded to VirnetX $625.6M in...more
On January 15, 2016, the Supreme Court granted certiorari in Cuozzo Speed v. Lee, which represents the first time the high Court will address an AIA proceeding, in this case an IPR decision. Based on the questions presented...more
In Redline Detection v. Star Envirotech, the Federal Circuit confirmed that the PTAB can decline to consider timely filed “supplemental” information from a petitioner (after filing its petition) pursuant to 37 C.F.R. §...more
On December 3, 2015, in MCM Portfolio LLC v. Hewlett-Packard Co., a panel of the Federal Circuit unanimously upheld the constitutionality of IPR proceedings, finding that delegation of patent invalidity determinations to a...more
A recent decision by the PTAB, Inguran v. Premium Genetics, demonstrates that a Petitioner may subject an apparent “pre-AIA” patent, having at least one priority date before and at least one priority date after March 16,...more
On December 17, 2015, in Merck v. Gnosis, the Federal Circuit affirmed the PTAB’s IPR Decision finding a pharmaceutical patent invalid for obviousness. Justice Newman vigorously dissented from the majority’s view (Justices...more
On December 3, 2015, the Federal Circuit issued a notice of proposed changes to its Rules of Practice, many of which relate to IPR practice under the AIA... Some of the proposed changes impact the manner by which appeals from...more
Following a string of denials, the PTAB has recently instituted IPR against several pharmaceutical patents where the petitions were filed by entities linked to hedge funds. Prior to these recent institution decisions, there...more
The PTAB has denied petitions filed by the same petitioner against the same claims, even where the subsequent petition relied upon completely different prior art (IPR2014-00506), reasoning that a petitioner should not hold...more
On Sept. 1, 2015, the PTAB issued an order in Coalition for Affordable Drugs (CFAD) v. NPS Pharmaceuticals for the parties to brief the following questions in 7 business days...more
On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826,...more
8/28/2015
/ Abuse of Process ,
Biotechnology ,
Generic Drugs ,
Hedge Funds ,
Information Disclosure Statement ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Real Party in Interest
Among other topics, a recent web conference hosted by George Quillin and Jeff Costakos tackled the latest developments in amendment practice before the PTAB.
The conference addressed the very recent Federal Circuit...more
Today the USPTO released a 113-page set of proposed changes to AIA post-grant proceedings, including IPR, PGR and CBM proceedings. The USPTO has been attempting to address concerns expressed by the public, having implemented...more
8/21/2015
/ America Invents Act ,
Broadest Reasonable Interpretation Standard ,
Covered Business Method Proceedings ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Proposed Regulation ,
Rule 11 ,
USPTO
In three petitions filed on the same day in 2013, styled Amneal v. Supernus, Amneal filed what appears to be the first challenge of Orange Book listed pharmaceutical patents that led to institution followed by a final...more
8/20/2015
/ Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Examiners ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Orange Book ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preponderance of the Evidence ,
Prior Art
The most recent IPR statistics have shown a sharp increase in the number of settlements, both before and after institution decisions.
What is most remarkable is the huge spike in settlements prior to institution. In...more