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Written Descriptions Pharmaceutical Patents

MoFo Life Sciences

The PTAB Axes Skin Treatment Patent Under Amgen

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The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v....more

Venable LLP

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

Venable LLP on

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

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

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...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

Bradley Arant Boult Cummings LLP

Is SCOTUS Looking to Change the Enablement Requirement for Patents?

The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more

McDonnell Boehnen Hulbert & Berghoff LLP

Regents of the University of Minnesota v. Gilead Sciences, Inc. (Fed. Cir. 2023)

The Supreme Court's (re)consideration of the enablement requirement expected in its decision later this year in Amgen v. Sanofi may be the most closely watched patent case since AMP v. Myriad Genetics.  But in a decision...more

Robins Kaplan LLP

Novartis Pharms. Corp. V. Accord Healthcare, Inc. - Gilenya® (Fingolimod Hcl)

Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022) (Circuit Judges Moore, Linn, and Hughes presiding; Opinion by Moore, J.; Dissenting Opinion by Linn, J.)...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

Haug Partners LLP

Federal Circuit Rehearing Panel Vacates its January Decision and Reverses District Court Finding of Sufficient Written Description...

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On June 21, 2022, the Court of Appeals for the Federal Circuit (“CAFC”), in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., granted petition for panel rehearing, vacated its prior decision, and reversed the...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

McDonnell Boehnen Hulbert & Berghoff LLP

Junior Party Broad Files Reply to Sigma-Aldrich Opposition to Broad Contingent Motion No. 2

On December 3rd, Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) filed its Contingent Preliminary Motion No. 2 in Interference No. 106,133 (which names Sigma-Aldrich as Senior Party),...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

Robins Kaplan LLP

Novartis Pharms. Corp. v. Accord Healthcare, Inc.

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Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore,...more

Haug Partners LLP

Federal Circuit Denies Rehearing in Biogen v. Mylan: Dissent Raises Four Written Description “Points of Error” That En Banc Court...

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On March 16, 2022, the Court of Appeals for the Federal Circuit denied Biogen International GmbH and Biogen MA, Inc.’s (“Biogen”) combined petition for panel rehearing and rehearing en banc in Biogen International GmbH v....more

Rothwell, Figg, Ernst & Manbeck, P.C.

Rehearing Denied in Federal Circuit’s Ruling Against Tecfidera® Patent for Lack of Written Description

On March 16, 2022, the Federal Circuit denied Biogen’s petition for rehearing of its November 2021 decision in Biogen Int’l GmbH v. Mylan Pharms., Inc., 18 F.4th 1333, 1343 (Fed. Cir. 2021), which found that Biogen’s patent...more

McDermott Will & Emery

Outlier? Split Federal Circuit Denies En Banc Review of Written Description Requirement

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit denied a patent owner’s request for en banc rehearing of a panel decision that invalidated a patent for lack of written description on the basis that a person of skill in the...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

White & Case LLP

Biogen rehearing denied: Is SCOTUS the next step?

White & Case LLP on

On March 16, 2022, the Court of Appeals for the Federal Circuit denied Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc. ("Petition Denial"), in which a Federal Circuit...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Denies Petition for Rehearing en Banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.

On March 16th, the Federal Circuit denied Biogen's petition for panel rehearing and rehearing en banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.  Judges Cunningham and Stoll did not participate in the decision, which...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

Rothwell, Figg, Ernst & Manbeck, P.C.

Is Silence Disclosure?

On January 3, 2021, The Federal Circuit held in a 2-1 decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022) that the claims of Novartis’ U.S. Pat. No. 9,187,405 (“the ’405 patent”) met the...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

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