Lessons Learned From the 1st Successful Pharmaceutical IPR Defense of Orange...
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...
View ArticleUSPTO Proposes Extensive Changes to AIA Post-Grant Proceedings
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...
View ArticleWhat Is the Latest on Amendments in PTAB Proceedings?
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...
View ArticleKyle Bass Loses Round 1 of IPR Attack Against Pharma/Biotech Patents
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....
View ArticlePTAB Requests Additional Briefing on Hedge Fund IPR Questions: A Decision May...
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......By: Stephen B. Maebius
View ArticleEstoppel Versus Discretion: How is the PTAB Deciding Multiple Petitions...
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...
View ArticleSeveral hedge fund-linked IPR Petitions Instituted: PTAB Finds No Abuse of...
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...
View ArticleProposed Rule Changes For IPR Appeals
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...
View ArticleFederal Circuit Affirms PTAB's IPR Decision Invalidating A Pharmaceutical Patent
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...
View ArticleUse of Priority Denial to Subject Apparent "Pre-AIA" Patents to PGR: Inguran...
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...
View ArticleFederal Circuit Confirms Constitutionality of IPR Proceedings
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...
View ArticleFederal Circuit Backs PTAB Decision Curtailing A Party's Use Of...
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)...
View ArticleSupreme Court Accepts 1st IPR Appeal: Cuozzo Could Mark Turning Point for...
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...
View ArticleHigh Stakes Race Between Apple and VirnetX: Will PTAB Trump The Texas Jury's...
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...
View ArticleCAFC Partially Relaxes IdleFree Requirements for Amendments During IPR
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...
View ArticleVirnetX Faces Follow-on IPR Petition from a Different Petitioner After...
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...
View ArticleThe Latest Twist In The Apple v. VirnetX IPRs: Appeals Court Issues Temporary...
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...
View ArticlePTAB Institutes Kyle Bass IPR Against Pharmaceutical Patent Based On SEC...
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...
View ArticlePatent Due Diligence: All That Glitters May Not Be PTAB Gold
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)...
View ArticleUSPTO Releases New Rules For AIA Post-Grant Proceedings
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...
View ArticleThe New AIA Rules May Help Patent Owners Avoid Trial
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...
View ArticleGuarding Against Conclusory Statements & Why It Matters Even More Under The...
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...
View ArticleReading The Cuozzo Tea Leaves: Best Practices Pending The Supreme Court's...
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...
View ArticleSurvey of Pharmaceutical IPRs Filed By Generic Drug Company Petitioners
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...
View ArticleMagnum Offers New Path for Challenging AIA Decisions: Burden of Production
On July 25, 2016, the Court of Appeals for the Federal Circuit (CAFC) held in In re Magnum Oil Tools International (Newman, O’Malley & Chen) that the burden of production to show unobviousness does...
View ArticleKeeping Up To Date On CRISPR – July 2016
CRISPR is a gene editing technique that promises to revolutionize genetic engineering, but already is raising ethical, business, and legal issues. This is the first in a monthly series of articles on...
View ArticleEstoppel Prevents Second IPR Petition Even When New References Were Missed By...
In a case that appears to be a case of first impression, the PTAB found in its decision denying institution in IPR2016-00781 that a final written decision in an earlier IPR created estoppel under 35...
View ArticleSovereign Immunity of State Universities: Can It Shield Them from AIA Patent...
In what appears to be a case of first impression, the PTAB is poised to rule on the question of whether state sovereign immunity prevents an IPR challenge from being maintained against a University of...
View ArticleFederal Circuit Finds IPR Petitioner Lacks Standing To Appeal
On January 9, 2017, in Phigenix, Inc. v. Immunogen, Inc., the Federal Circuit held that petitioner Phigenix lacked standing to appeal an adverse final written decision in an IPR. While acknowledging...
View ArticleFederal Circuit Again Reverses PTAB Obviousness Determination
In what is becoming a familiar basis for reversal of PTAB decisions, the Federal Circuit yet again reversed the PTAB for its failure to adequately explain the basis for combining multiple prior art...
View Article2017 Mid-Year Statistics Point to Continued Rise in IPR Petitions
March 31st marked the mid-point of the PTAB’s fiscal year and the release of mid-year statistics on AIA proceedings... ...One interesting trend is a continued increase in overall number of IPR...
View ArticleIs The Real IPR Institution Rate Higher When Petitioner Errors &...
We have previously noted that the increasing rate of pre-institution settlement may in part be responsible for the declining institution rate in IPR proceedings because stronger petitions may drive...
View ArticleKey Trends In Pharmaceutical IPRs Filed By Generic Petitioners
We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field....
View ArticlePharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review
As we have previously reported, sovereign immunity of state universities (who are instruments of state government) has been used to avoid IPRs under the immunity clause of the US Constitution...
View ArticleCAFC Eases Amendment Process In IPR Proceedings
Today in Aqua Products, Inc. v. Matal, a fractured Court of Appeals for the Federal Circuit (CAFC) sitting en banc decided to flip the burden of persuasion onto petitioners in IPR proceedings to show...
View ArticlePTAB Grants Rare Request for Additional Discovery In IPR
In Mylan v. Allergan (IPR2016-00127, Paper No. 73), the PTAB granted a rare request for discovery filed be Petitioner in response to summaries of data presented in a Patent Owner Response used to rebut...
View ArticleExpanded PTAB Panel Finds Sovereign Immunity Waived By Patent Enforcement
In a case of first impression, an expanded PTAB panel (including Chief APJ Ruschke) found that a parallel enforcement action by a patent owner waives its sovereign immunity defense against under the...
View ArticleSupreme Court Upholds Constitutionality Of IPRs In Oil States
Today in Oil States v. Greene’s Energy, the Supreme Court upheld the constitutionality of IPR proceedings, finding that they are a permissible second review of patents conducted by the administrative...
View ArticleProposed Legislation Would Require Choice Between ANDA Litigation Or AIA...
On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge...
View ArticleFederal Circuit Affirms PTAB Ruling That Tribal Immunity Does Not Apply To IPRs
On July 20, 2018, the Federal Circuit held in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals that tribal sovereign immunity does not prevent IPR on a patent assigned to a tribe asserting such...
View ArticleRevamped PTAB Trial Practice Guide Holds Surprises
The Patent Trial and Appeal Board (“PTAB”) issued its initial Trial Practice Guide in August 2012, shortly before America Invents Act (“AIA”) post-grant proceedings became available. That Guide had not...
View ArticleNew Estoppel Concern For Petitioners Raised In BTG v. Amneal
The Court of Appeals for the Federal Circuit is poised to decide a case which may create new estoppel concerns for AIA petitioners under 35 USC § 315(e)(2). The appeal resulted from a Hatch-Waxman...
View ArticleDistrict Court Sheds Light on Scope of IPR Estoppel
One area of estoppel arising from an unsuccessful AIA petition that remains poorly understood relates to prior art that is described both in a printed publication or patent and also was in use by...
View ArticlePTAB - 2019 Year in Review
To wrap up 2019 and usher in 2020 for practitioners who handle Patent Trial and Appeal Board (PTAB) matters, Foley partners Jeanne Gills, Steve Maebius, and George Quillin discussed 2019’s major...
View ArticleNew USPTO Pilot Program to Expedite Grant of Small Entity COVID-19 Patents
In an effort to help independent inventors and small businesses bring “important and possibly life-saving treatments” to market more quickly, the United States Patent and Trademark Office (USPTO) is...
View ArticleINSIGHT: Biogen Decision Shows Need for Clinical, Legal Collaboration
In Biogen International GmbH v. Banner Life Sciences LLC, a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the scope of a patent term restoration under 35 U.S.C. §156 only...
View ArticlePTAB’s Motion to Amend Pilot Program: Review of Initial Results
Since the inception of inter partes reviews (IPRs) and post grant reviews (PGRs) under the America Invents Act, the option for a patent owner to file a motion to amend its claims was always present,...
View ArticleWondering if Your Digital Health Product or Service is Subject to FDA...
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel...
View ArticleRevisiting FDA’s Original Guidance on Orange Book Listability in Light of...
The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product...
View ArticleLeveraging USPTO Delays To Maximize Patent Term
Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of...
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