JANSSEN PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. - Before Prost, Reyna, and Taranto. Appeal from the United States District Court for the District of New Jersey. The Federal Circuit found that claims reciting a...more
In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 25-1228, The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of...more
INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD. - Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey. A district court erred in issuing a preliminary...more
ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. - Before Taranto, Chen, and Hughes. Appeal from the United States District Court for the District of Delaware. Once the high threshold for lexicography is met, there must be a...more
6/30/2025
/ Appeals ,
CAFC ,
Claim Construction ,
Intellectual Property Litigation ,
Life Sciences ,
Moderna Inc. ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
In Jazz Pharmaceuticals, Inc. v. Avadel Cns Pharmaceuticals, LLC, Appeal No. 24-2274, the Federal Circuit held that injunctions prohibiting the initiation of new clinical trials for paper NDA drugs before patent expiration...more
AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more
IMMUNOGEN, INC. v. STEWART - Before Lourie, Dyk, and Prost. Appeal from the United States District Court for the Eastern District of Virginia. A solution to a problem can be obvious even when the problem itself was unknown in...more
Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more
7/2/2024
/ Alice/Mayo ,
Appeals ,
Damages ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Google ,
Labeling ,
License Agreements ,
Lump Sum Payments ,
Motion to Dismiss ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Royalties ,
Sports Gambling
Obviousness Analysis Does Not Consider Unclaimed Limitations - In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals Usa, Inc., Appeal No. 22-1258, the Federal Circuit held that district court erred by adding unclaimed...more
Federal Circuit Orders District Court to Consider Extrinsic Evidence in Claim Construction -
In Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., Appeal No. 22-1889, the Federal Circuit held that where a...more
12/5/2023
/ Article III ,
Claim Construction ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Purdue Pharma ,
Standing
Objective Evidence in Determining Obviousness -
In Medtronic, Inc. v. Teleflex Innovations, Appeal No. 21-2357, the Federal Circuit held that a close prima facie case of obviousness can be overcome by strong evidence of...more
7/20/2023
/ Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Medical Devices ,
Medtronic ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
避而不谈可能支持否定性权利要求限定 -
在 Novartis Pharmaceuticals 诉 Accord Healthcare Inc. 一案（上诉案件编号：21- 1070）中，联邦巡回上诉法院认为，一项对药物“速效剂量”避而不谈的专利申请，为要求不存在此类剂量的否定 性权利要求限制提供了书面说明支持。
...more
2/10/2022
/ Claim Construction ,
Indefiniteness ,
Intellectual Property Protection ,
Novartis ,
Patent Applications ,
Patent Examinations ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
記述がないことがクレームの否定的限定のサポートと解釈できる場合がある
Federal Circuit は、Novartis Pharmaceuticals v. Accord Healthcare Inc. (Appeal No. 21-1070) に おいて、薬剤の「初回負荷用量」についての記述がない特許出願は、そのような用量がないことを要 求するクレームの否定的限定に記述によるサポートを提供していることになると判示した。
...more
2/10/2022
/ Claim Construction ,
Indefiniteness ,
Intellectual Property Protection ,
Novartis ,
Patent Applications ,
Patent Examinations ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
January 2022 Federal Circuit Newsletter (Japanese) January 2022 Federal Circuit Newsletter (Chinese) Silence May Support Negative Claim Limitation In Novartis Pharmaceuticals v. Accord Healthcare Inc. Appeal No. 21-1070, the...more
2/9/2022
/ Claim Construction ,
Indefiniteness ,
Intellectual Property Protection ,
Novartis ,
Patent Applications ,
Patent Examinations ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
Ranges for Interdependent and Interactive Components Can Be Tricky to Derive -
In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on...more
1/11/2022
/ AstraZeneca ,
Generic Drugs ,
Instrinsic Evidence ,
Intel ,
Inter Partes Review (IPR) Proceeding ,
Moderna Inc. ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Qualcomm
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
12/9/2021
/ Abbreviated New Drug Application (ANDA) ,
Apple ,
Article III ,
Biogen Idec ,
Dr. Reddy’s Labs. ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Qualcomm ,
Standing ,
Written Descriptions
Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent
In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
10/6/2021
/ Deceptive Intent ,
Evidence ,
Failure To Disclose ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Hospira ,
Inequitable Conduct ,
Intellectual Property Protection ,
Motion to Transfer ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patent Prosecution ,
Patents ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prior Art ,
USPTO ,
Venue
It’s No Secret That a Related Company’s Physical Presence in a Jurisdiction May Not Be Enough For Proper Venue -
In Andra Group, LP v. Victoria’s Secret Stores, LLC, Appeal No. 20-2009, The Federal Circuit held that an...more
9/20/2021
/ Abstract Ideas ,
Eli Lilly ,
Improper Venue ,
Inter Partes Review (IPR) Proceeding ,
Jurisdiction ,
Nexus ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Physical Presence Test ,
Preamble ,
Principal Place of Business ,
Retailers ,
Teva Pharmaceuticals ,
Victoria Secret
Specification’s Narrow Description of the Invention Results in Disavowal of Claim Scope -
In Techtronic Industries Co. Ltd. v. ITC., Appeal No. 18-2191, the consistent description in the specification of a particular...more
1/27/2020
/ Administrative Law Judge (ALJ) ,
Exceptional Case ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
New Evidence ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art
The PTAB Cannot Approve or Deny Certificates of Correction -
In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
11/25/2019
/ Abbreviated New Drug Application (ANDA) ,
Abuse of Discretion ,
Appeals ,
Certificate of Correction ,
Claim Construction ,
CLS Bank v Alice Corp ,
Cross Motions ,
Enablement Inquiries ,
Indefiniteness ,
Induced Infringement ,
JMOL ,
Judgment As A Matter Of Law ,
Leave to Amend ,
Mayo v. Prometheus ,
Motion for Summary Judgment ,
Nonobvious ,
Partial Reversal ,
Patent Applications ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Post-Grant Review ,
Priority Patent Claims ,
Product of Nature Doctrine ,
Reaffirmation ,
Remand ,
Scope of the Claim ,
Section 101 ,
Section 112 ,
Vacated ,
Written Descriptions
Mere Potential for Future Appeal Does Not Prevent Triggering Estoppel of Inter Partes Reexamination When Party Fails to Seek Relief in the First Instance -
In Virnetx Inc. v. Apple Inc., Appeal Nos. 2017-1591, -1592,...more
10/3/2019
/ Administrative Law Judge (ALJ) ,
Appeals ,
Claim Construction ,
Equivalency Determinations ,
Estoppel ,
Foreign Entities ,
Foreign Sovereigns ,
Indefiniteness ,
Inter Partes Reexamination ,
International Litigation ,
International Trade Commission (ITC) ,
IP License ,
Judgment As A Matter Of Law ,
Nonobvious ,
Novelty ,
Parallel Proceedings ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Reaffirmation ,
Remand ,
Section 101 ,
Subject Matter Jurisdiction ,
Universities ,
Vacated ,
Written Descriptions
Federal Circuit Determines Time-Barred Petitioner Joined to an IPR Has Appellate Standing -
In Mylan Pharmaceuticals Inc. v. Research Corporation Tech., Appeal Nos. 2017-2088, -2089, -2091, the Federal Circuit held that a...more
4/11/2019
/ § 315(b) ,
Affirmative Defenses ,
Appeals ,
Counterclaims ,
Defense Strategies ,
Denial of Rehearing ,
Diagnostic Method ,
Dismissals ,
En Banc Review ,
Google ,
Inter Partes Review (IPR) Proceeding ,
Joinder ,
Mandamus Petitions ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Principal Place of Business ,
Product of Nature Doctrine ,
Reaffirmation ,
Rebuttal ,
Remand ,
Right To Appeal ,
Section 101 ,
Software Patents ,
Sovereign Immunity ,
Standing ,
States Rights ,
Time-Barred Claims ,
Universities ,
Venue ,
Waivers
PTAB May Invalidate Claims on Reconsideration Based on Grounds Raised in the Institution Decision that Were Not Originally Instituted -
In AC Technologies S.A., V. Amazon.Com, Inc., Blizzard Entertainment, Inc., Appeal No....more
3/14/2019
/ Abbreviated New Drug Application (ANDA) ,
Amazon ,
Anticipation ,
Appeals ,
Article III ,
Due Process ,
Final Written Decisions ,
Generic Drugs ,
Hatch-Waxman ,
Hewlett-Packard ,
Inter Partes Review (IPR) Proceeding ,
Motivation to Combine ,
Mylan Pharmaceuticals ,
Obviousness ,
Orange Book ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing ,
Pharmaceutical Patents ,
Reaffirmation ,
Right To Appeal ,
Section 103 ,
Standing
A Post-URAA Patent that Issues After but Expires Before a Related Pre-URAA Patent Is Not a Double-Patenting Reference Against the Pre-URAA Patent -
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.,...more
2/8/2019
/ Abbreviated New Drug Application (ANDA) ,
Abstract Ideas ,
Appeals ,
Declaratory Judgments ,
Dismissals ,
Dispute Letters ,
Double Patent ,
Due Process ,
Improper Venue ,
Long Arm Statute ,
Minimum Contacts ,
Obviousness-Type Double Patenting (ODP) ,
Patent Expiration ,
Patent Infringement ,
Patent Invalidity ,
Patent Term Extensions ,
Patent Terms ,
Patent Validity ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Patents ,
Reaffirmation ,
Reversal ,
Stipulated Judgment ,
Uruguay Round Agreements Act (URAA)
Federal Circuit Finds Claims Directed to Tabbed Spreadsheets Patent Eligible and Claims Directed to Tracking Changes in Documents Ineligible Under Section 101 -
In Data Engine Technologies LLC v. Google LLC, Appeal No....more
12/7/2018
/ Abstract Ideas ,
Appeals ,
CLS Bank v Alice Corp ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Mayo v. Prometheus ,
Mylan Pharmaceuticals ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
POSITA ,
Prior Art ,
Product of Nature Doctrine ,
Reaffirmation ,
Remand ,
Reversal ,
Sandoz ,
Section 101 ,
Summary Judgment ,
Teva Pharmaceuticals