News & Analysis as of

Written Descriptions Patents Intellectual Property Protection

Kilpatrick

5 Key Takeaways | Rolling with the Legal Punches: Resetting Patent Strategy to Address Changes in the Law

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Kilpatrick partners Tina McKeon, Michael Bertelson, and Michael Turton recently joined Laura Fritts (Vice President, Intellectual Property, Legal, Azurity Pharmaceuticals, Inc.) to present at the annual Kilpatrick...more

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

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We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more

Sunstein LLP

Enablement Enigma: The Supreme Court Weighs In

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In a unanimous decision, the Supreme Court has affirmed the lower court’s ruling that Amgen’s broad genus claims to cholesterol-lowering antibodies are invalid for lack of enablement....more

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Prior Art Disclosure with Same Specificity as Patent Inherently Anticipates Claims

In a recent appeal from the PTAB, the Federal Circuit held that claims of a patent were inherently anticipated where the patent and prior art incorporated the same reference to describe a process for making the claimed...more

American Conference Institute (ACI)

[Event] C5’s 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe - May 23rd - 24th, Amsterdam, Netherlands

Hosted by C5, the 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns 23-24 May, at the DoubleTree by Hilton Amsterdam Central Station, Amsterdam with curated programing for you to gain the knowledge and...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2022 Decisions

As part of the recovery from the global COVID-19 pandemic, the U.S. Court of Appeals for the Federal Circuit took steps to return to normal operations. It began requiring live oral arguments in August 2022 and, by November,...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Master Symposium - September 21st - 22nd, Chicago, IL

ACI’s 8th Annual Paragraph IV Disputes Master Symposium returns in person to Chicago on September 21-22! Join leading pharmaceutical patent litigators for brand name and generic drug companies to receive up-to-the-minute...more

American Conference Institute (ACI)

[Event] 20th Advanced Summit on Life Sciences Patents - June 2nd - 3rd, New York, NY

ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more

McDonnell Boehnen Hulbert & Berghoff LLP

BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)

The consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if...more

Knobbe Martens

Niazi’s Patent Survives on Appeal: Federal Circuit Reverses In Part Lower Court’s Decision

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On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit alleged that St. Jude Medical S.C....more

Knobbe Martens

“Pliable” Language Results in “Resilient” Patent Claims

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NIAZI LICENSING CORPORATION v. ST. JUDE MEDICAL S.C., INC. Before Taranto, Bryson, and Stoll. Appeal from the U.S. District Court for the District of Minnesota. Summary: Providing examples in the claim language and...more

American Conference Institute (ACI)

[Event] 17th Annual Paragraph IV Disputes Conference - April 26th - 27th, New York City, NY

Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more

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

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...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

Proskauer - Life Sciences

“Negative” Patent Claim Limitations—May They be Adequately Described by Omission?

Patent claim limitations that are “negative”—that is, claim limitations specifying the absence of a particular element from the patent claim—can pose a dilemma in the written description context. How much of the specification...more

Harris Beach PLLC

Intellectual Property Law: Year in Review 2021

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Specification and Prosecution History Narrow the Plain Meaning of “0.001%.” The claim at issue included a concentration of 0.001% of PVP. The term’s plain meaning is 0.001% within one significant figure (i.e., 0.0005% to...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

Knobbe Martens

Federal Circuit Review - November 2021

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Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more

Knobbe Martens

Written Description: What Is the Proper “Dosage” to Satisfy This Requirement?

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BIOGEN INTERNATIONAL GMBH V. MYLAN PHARMACEUTICALS INC. Before O’Malley, Reyna, and Hughes. Appeal from the United States District Court for the Northern District of West Virginia. Summary: A specification may not...more

Proskauer - Life Sciences

Juno v. Kite: Written Description and Claiming Antibodies and Chimeric Antigen Receptors—Lessons for Patent Prosecutors

The recently reversed jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Jones Day

Didn’t Cut the Mustard: PTAB Finds Claims Lacked Written Description and Enablement

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A recent post-grant review decision once again reminds patentees of the increasing scrutiny that claims are facing under the written description and enablement requirements under 35 U.S.C. § 112 (a).  In this case,...more

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