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Expert Testimony Patents Pharmaceutical Patents

Jones Day

Expert Testimony Supporting POPR Can Be An Effective Strategy

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It is relatively uncommon for parties to submit expert declarations in the preliminary-response phase of an IPR proceeding, but recently the Patent Owner in Imperative Care, Inc. v. Inari Medical, Inc. effectively used that...more

Akin Gump Strauss Hauer & Feld LLP

Results from Phase I and II Clinical Trials and Pending Phase III Clinical Trial Insufficient to Render Obvious Method of Treating...

In an ANDA case in the District of Delaware, the court has rejected an obviousness challenge to a patented method of increasing survival in patients having prostate cancer. The court found that early clinical trial results...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Strategies and Insights Newsletter - May 2023: Kyocera and the Brewing Debate Over Expert Qualifications at the PTAB

Technical experts play a key role in patent litigation, including in PTAB litigation. Indeed, experts are often the only witnesses to provide testimony in PTAB proceedings, and final written decisions often hinge on which...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

The Federal Circuit recently granted a panel rehearing and vacated a panel decision between these parties decided earlier this year (see Novartis Pharmaceuticals Corp. v. Accord Healthcare), and rendered a decision that...more

Akin Gump Strauss Hauer & Feld LLP

Discussion of Inventors’ Path in Expert’s Obviousness Opinion Warrants Partial Exclusion in Bench Trial

In the weeks preceding a recent Hatch-Waxman bench trial, a district court excluded portions of an expert’s opinion on obviousness that addressed internal documents and inventor testimony concerning the “inventors’ path” to...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Strategies and Insights: January 2022 - Does the Limit Exist?: Negative Limitations in Novartis v. Accord

In an appeal, Novartis Pharmaceuticals v. Accord Healthcare, Inc., the issue of whether a patent provides sufficient written description of a negative limitation split the panel at the Federal Circuit. Novartis...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

PTAB Strategies and Insights: January 2022

The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return on investment for all stakeholders looking at the entire...more

Haug Partners LLP

Is Silence Disclosure? The Federal Circuit Clarifies its Position on Negative Claim Limitations

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In Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 21-1070, slip op. at 7 (Fed. Cir. Jan. 3, 2022), the defendant posed two distinct written-description challenges to Novartis’s patent claims, regarding (1) a daily...more

Snell & Wilmer

Federal Circuit Upholds a Silent Written Description

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In a precedential opinion this week, the Federal Circuit affirmed a district court judgment in favor of Novartis Pharmaceuticals, in an appeal brought by HEC Pharm challenging the written description in Novartis’s 9,187,405...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim?  This is a question that comes readily to mind...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2021 #5

MLC Intellectual Property, LLC v. Micron Technology, Inc., Appeal No. 2020-1413 (Fed. Cir. Aug. 26, 2021) - For those interested in an important Section 112 written description case, we recommend reading the Juno...more

McDonnell Boehnen Hulbert & Berghoff LLP

Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc. (Fed. Cir. 2020)

Stipulating to infringement after a contrary claim construction is a conventional stratagem for a losing party to have a final judgment that can be challenged before the Federal Circuit.  The risk of course, is that if the...more

Smart & Biggar

Effectively using experts in IP Litigation – Part 2: Practise

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In intellectual property litigation, the outcome of many high stakes cases has turned on expert testimony. It is therefore important for a litigator to spend time and effort to properly identify, select, and prepare the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Actavis Laboratories v. Nalproprion Pharmaceuticals

In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Upholds Application of Dedication-Disclosure Doctrine at the Pleading Stage

On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals...more

McDermott Will & Emery

Equivalent Disclosure Used to Satisfy Written Description Requirement

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Invoking a newly minted equivalent disclosure doctrine, a panel of the US Court of Appeals for the Federal Circuit found that the written description requirement of § 112 was satisfied in the interest of arriving at a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2019

PATENT CASE OF THE WEEK - Elbit Systems Land and C4I Ltd. v. Hughes Network Systems, LLC, Appeal No. 2018-1910 (Fed. Cir. June 25, 2019) - In this appeal from the United States District Court for the Eastern District of...more

Foley & Lardner LLP

The Senate Holds Hearings On The State Of Patent Eligibility In America

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Last week the Senate Judiciary Committee held two of three scheduled hearings on “The State of Patent Eligibility in America.” Many witnesses with prominent roles in the patent field testified in favor of legislative action...more

Foley & Lardner LLP

Claim Construction Of An Enantiomeric Chemical Structure

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In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Patterson Belknap Webb & Tyler LLP

Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more

Akin Gump Strauss Hauer & Feld LLP

PTAB Declines Request to Review Method of Treating Lymphoma Claim

A Patent Trial and Appeal Board (PTAB) panel declined to institute an inter partes review (IPR) of a claim directed to a method for treating low grade B-cell non-Hodgkin’s lymphoma. The challenged method required patients to...more

Jones Day

PTAB Grants Rare Rehearing Due To Insufficient Evidence Of Obviousness

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In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene’s request for rehearing of a final written decision that had found the challenged claims invalid...more

Jones Day

Genentech to Defend 3 of 4 Herceptin® Patents Challenged by Hospira

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At least 19 IPRs have been filed against seven of Genentech’s patents covering its blockbuster antibody drug Herceptin® (trastuzumab). On July 27, 2017, the PTAB instituted IPRs filed by Hospira, Inc. (a subsidiary of Pfizer)...more

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