Patient? It's been almost 3 years and it's at half of what I paid for it. The FDA is the biggest corrupt joke there is. Anyone see what they are doing to Theranos? Sickening.
The U.S. Supreme Court granted certiorari in the patent case of In re Cuozzo Speed Techs., LLC, 115 U.S.P.Q.2D (BNA) 1425, 793 F.3d 1268, (Fed. Cir. 2015), regarding the different claim construction standards in the Patent Trial and Appeal Board (PTAB) and the U.S. District Courts. The Supreme Court also agreed to hear a case addressing the appropriate standard in awarding attorneys' fees to a prevailing party under Section 505 of the Copyright Act in John Wiley & Sons, Inc. v. Kirtsaeng, 713 F.3d 1142, (2d Cir. 2013).
In In re Cuozzo, there was a 2-1 decision (Judge Dyk for the Court, joined by Judge Clevenger, Judge Newman dissenting) which held that the PTAB's use of the "broadest reasonable interpretation" standard for claim construction was proper, and agreed that the three claims in suit were invalid for obviousness, meaning that the standard for claim construction is different at the PTAB than the "plain and ordinary meaning" standard used in the federal district courts.
In the Cuozzo case, the questions to be addressed are: 1) can inter partes review (IPR) proceedings at the PTAB have claims construed according to their broadest reasonable interpretation rather than their plain and ordinary meaning as used in federal court proceedings; and 2) is the PTAB's decision to institute an IPR proceeding reviewable.
In Cuozzo, the Federal Circuit panel decision held that 1) the PTAB can use the broadest reasonable interpretation, while federal courts can use the plain and ordinary meaning standard, and 2) 35 U.S.C. 314(d) bars it from reviewing a PTAB decision to institute an IPR, even if the issue is raised in an appeal of a PTAB final decision, meaning that institutional decision is not reviewable.
While the dual system of claim construction is present in the statutory construct noted above, it will be interesting to see how the Supreme Court addresses the issue which has caused significant debate among patent practitioners. The Supreme Court could find that
WASHINGTON (Legal Newsline) - Next month, the U.S. Supreme Court will hear arguments in a case that questions the U.S. Patent and Trademark Office’s procedures for evaluating challenges to the validity of patents.
The nation’s highest court has set oral arguments for the patent case of Cuozzo Speed Technologies, LLC, v. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director, Patent and Trademark Office for April 25.
The court, after hearing the arguments in Cuozzo v. Lee, must decide whether the U.S. Court of Appeals for the Federal Circuit should handle claims in patent cases arising from the Patent Trial and Appeal Board, or PTAB, the same as claims in cases arising from district courts.
Some argue that regardless of where the cases originated, the Federal Circuit should handle the claims the same.
David Applegate, chair of the intellectual property practice group at Chicago-based firm Williams Montgomery & John Ltd., says that under the America Invents Act’s new inter partes review, or IPR, process, this has not stood true.
IPR is a procedure for challenging the validity of a patent before the PTO. The procedure, which allows third parties to challenge bad patents, is conducted by the PTAB.
The review was enacted in September 2012 as part of the AIA to create a streamlined alternative to district court litigation. Some argue that the new procedure, which replaced a previous review procedure called inter partes reexamination, has been abused.
Applegate, in a recent blog post, points to Cuozzo’s opening petition to the Supreme Court, which notes that IPRs filed since the AIA’s effective date have yielded an “unexpectedly high” rate of patent claim cancellation.
Of the more than 3,400 IPR petitions filed since the AIA’s inception, as of Oct. 6, 2015, nearly 85 percent have resulted in cancellation of some or all the claims under review.
“One reason, petitioners believe, is that the PTAB applies a broader standard of cla
As many are aware, the Supreme Court granted certiorari for Cuozzo Speed Technologies, LLC v. Lee, No. 15-446. The Supreme Court agreed to hear two issues appealed by Cuozzo: (1) whether the PTAB should use the BRI standard for claim construction in IPR rather than the plain and ordinary meaning standard applied in district court; and (2) whether the PTAB decision to institute an IPR proceeding should be judicially reviewable on appeal from a final written decision. Cuozzo has now submitted its merits brief on these issues.
Issue 1: PTAB's Use of the BRI Standard
Regarding the first issue, Cuozzo argues that Congress never authorized the PTO to depart from the ordinary-meaning standard for adjudicating patent validity in IPR proceedings. Cuozzo explains that courts and the PTO have long distinguished between patent adjudication and patent examination. According to Cuozzo, adjudication of patent validity tests the fixed meaning of a legally-operative property right, while examination assesses the meaning of patent claims where the scope is in flux. Thus, Cuozzo argues that the plain meaning standard is appropriate in adjudication while the BRI standard is appropriate for examination.
Cuozzo also argues that the AIA's text, structure, and legislative history show that Congress created IPR as a substitute for district court adjudication of patent validity, rather than as an extension of the examination process, so the plain meaning standard should be used. "Although the PTO has long given claims their broadest reasonable interpretation in examinational proceedings, it has done so to asses and, if necessary, adjust the scope of such claims, which are treated as fluid and amendable at the will of the applicant...The BRI protocol is used before the patent issues to ensure claim language is precise; use of that protocol in post-issuance IPR reintroduces needless ambiguity in determining validity." (Br. at 12-13).
Issue 2: PTAB's Decisions Whether to Institute IPRs Judicially Reviewable
Regarding the second issue, Cuozzo argues that if the PTAB exceeds its statutory authority in deciding to institute an IPR proceeding, the decision is reviewable. Specifically, according to Cuozzo, the AIA grants the PTAB the power to institute IPR proceedings, but it places significant limits on such power, and the PTAB cannot violate these limits with impunity and without judicial oversight. Additionally, Cuozzo argues that the PTAB wrongfully interprets 35 U.S.C. § 314(d) as making its decisions on whether to institute an IPR final and non-appealable, even after a final written decision. Rather, Cuozzo explains, the statute only bars appeal of the PTAB's institution decision itself. Additionally, Cuozzo argues that the PTAB's institution decision is reviewable when it plainly violates the AIA.
Argument is set for April 25, 2016.
I've worked in the healthcare since 1992 and I can tell you our healthcare system is nothing more than a big joke and fraud. M.D. stands for "Masking for Dollars" as they are nothing more than Big Pharmas puppets who started this whole mess by giving out opium pills to anyone and everyone now they are screaming "What?" Medicine treats NOTHING but the symptoms and NOT the cause. A cure for cancer was found years ago but not allowed on the market. Also Google: Cancer drugs thrown away: Why $3 billion in waste?
Big Pharma and the FDA are partners in reaming the public out of every dollar they can get and they could care less about curing anything or saving lives.
The number one abuse is "TAKING TOO D-A-M-N- many pills not snorting, shooting up, alcohol dropping, etc. so all these abuse deterrent formulas are a waste. No if IPCIs PODRAS does ACTUALLY WORK then that will be big. But tell me how are they going to do clinical trials on that? Give someone ten pills and pray it works?
As part of the AIA, Congress created administrative procedures to allow parties to challenge the validity of issued patents before the Patent Trial and Appeal Board (“PTAB”). Although post-grant review procedures before the PTAB were originally designed as a vehicle to weed out low quality patents,1 critics ranging from pharmaceutical companies to former Federal Circuit Chief Judge Randall Rader have all indicated that the PTAB may be too effective at invaliding patents, primarily due to the PTAB’s broad interpretation of claims.
On January 15, 2016, the Supreme Court agreed to evaluate and address this issue by granting a petition filed by Cuozzo Speed Technologies LLC. The petition argued that the PTAB improperly invalidated Cuozzo’s patent because it had construed the claims by giving them their “broadest reasonable interpretation,” instead of the narrower “Philips Standard” used in district courts. In its petition, Cuozzo described PTAB proceedings as “surprisingly lethal,” and noted that 85 percent of PTAB decisions invalidated some or all of the patent claims reviewed. Cuozzo explained that:
A primary reason for the high cancellation rate is that, although IPR was expressly designed to be a surrogate for litigation, the Board does not use the same claim construction standard as federal courts. Rather than construe the claim in an issued patent according to its plain and ordinary meaning, as a federal court would be required to do, the Board gives the claim its broadest reasonable interpretation, which is a protocol used by examiners in reviewing patent applications. Of course, the broader the interpretation of the claim, the more extensive the array of relevant prior art—and in turn the more likely that the claim will be held invalid in light of that prior art.2
If the large numbers of patents invalidated by the PTAB are in fact due to the broader standard, that number may be reduced by a Supreme Court decision that rejects the “broadest reasonable interpretation” standard. The petition also asks the Court to consider whether the PTAB’s “decision  to institute an IPR proceeding is judicially unreviewable.”3Notably, nine amicus briefs were filed by various industry groups and companies, only one being in favor of the respondent.4
If the PTO starts using the Phillips standard in post-grant proceedings instead of BRI, patent claims will be subject to Phillips' more limiting interpretation, which in turn will make it harder to find invalidating prior art. The U.S. Supreme Court decision in this case may thus be one of the more important patent-related decisions of 2016. •
Major Firms Line Up At High Court To Fight AIA Claim Rules
By Ryan Davis
Law360, New York (March 2, 2016, 10:16 PM ET) -- Exxon Mobil Corp. and Procter & Gamble Co. were among a slew of major companies and drug industry groups that urged the U.S. Supreme Court Monday to change the
patent claim construction standard for America Invents Act reviews, calling the current test unfair to patent holders....
High Court Urged To Throw Out PTAB Claim Construction Test
By Ryan Davis
Law360, New York (February 29, 2016, 9:58 PM ET) -- The claim construction standard used by the Patent Trial and Appeal Board is “manifestly unreasonable” and harms the patent system by allowing the same patent to be
interpreted differently in court and at the PTAB, Cuozzo Speed Technologies LLC has told the U.S. Supreme Court..
Worlds has a chance at winning this IPR coming up? With around 85% of the IPRs going against the patent holders it looks pretty slim for them. Can they appeal the IPR's verdict if they lose?
"Enjoy the ride?" Odds are this ends up in the red today. This stock is a long term hold as they won't have much revenue until they get one of their NDA drugs on the market
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, "FDA approval of our application for a generic version of Keppra XR® is an important milestone for the Company. It is our first approved product developed in house at Intellipharmaceutics without the support or regulatory input of a development partner. We believe that this approval of our generic Keppra XR® product represents a strong validation of our core drug development and regulatory competence and our controlled-release delivery technologies. The approval, under the Generic Drug Fee User Amendments of 2012, or GDUFA, fee regime at the FDA, is perhaps also an indication that the FDA is making progress to clear its backlog of ANDA drug candidates under review. We regard it as hopeful that some of the Company’s other 8 ANDA candidates will be accorded further attention soon. We are actively exploring the best approach to maximize our commercial returns from this new approval.”
Keppra XR®, and the drug active levetiracetam, are indicated for use in the treatment of partial onset seizures associated with epilepsy. According to Symphony Health Solutions, sales in the United States for the 12 months ended December 2015 of the 500 mg and 750 mg strengths of Keppra XR® and all generic equivalents, were approximately $168 million (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price). The Company is aware that other generic versions of this product are currently available in the market. There can be no assurance that the Company’s levetiracetam extended-release tablets for the 500 mg and 750 mg strengths will be successfully
That ruling is why Activision doesn't want this to go to a jury trial. They know they will lose BIG TIME. Hopefully with SCOTUS looking into the IPR #$%$ we can get over that hurdle and get them to a jury trial ASAP!
" Attorneys from the East Texas law firm Ward, Smith & Hill, PLLC, helped Zephyr Cove, Nevada-based VirnetX (NYSE MKT: VHC) win a $625.6 million patent infringement verdict against technology powerhouse Apple Inc. (AAPL). The verdict reportedly stands among the 10 largest jury awards in U.S. history in an intellectual property case.