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Articles by Kevin DeJong
Federal Circuit Finds Claims Directed To Host Cells Patent-Eligible
Goodwin Procter LLP are most popular: within Criminal Law, Immigration and Cannabis & Hemp topic(s) On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court's January 2024 decision granting summary judgment of patent ineligibility.
Janssen Files BPCIA Complaint Against Bio-Thera And Accord Related To Golimumab Biosimilar
Christopher Cassella’s articles from Goodwin Procter LLP are most popular: with readers working within the Banking & Credit, Healthcare and Pharmaceuticals & BioTech industries Goodwin Procter LLP are most popular: within Criminal Law, Immigration and Cannabis & Hemp topic(s) On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, "Janssen") filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc.
Genentech Brings Pertuzumab Biosimilar Fight To The ITC
Natasha E. Daughtrey’s articles from Goodwin Procter LLP are most popular: within Food, Drugs, Healthcare and Life Sciences topic(s) in United States Goodwin Procter LLP are most popular: within Criminal Law, Immigration and Cannabis & Hemp topic(s) On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon's proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech's PERJETA®.
Federal Circuit Finds Claims Directed to Host Cells Patent-Eligible
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of patent ineligibility. The Federal Circuit decision makes clear that recombinant, human‑engineered host cells are patent‑eligible, even if their constituent sequences have natural origins.
Federal Circuit Finds Claims Directed to Host Cells Patent-Eligible
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of patent ineligibility. The Federal Circuit decision makes clear that recombinant, human‑engineered host cells are patent‑eligible, even if their constituent sequences have natural origins.
Federal Circuit Finds Claims Directed to Host Cells Patent-Eligible
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of patent ineligibility. The Federal Circuit decision makes clear that recombinant, human‑engineered host cells are patent‑eligible, even if their constituent sequences have natural origins.
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar | JD Supra
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. Janssen’s complaint was filed under seal, with a redacted version due to be filed on March 11.
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. Janssen’s complaint was filed under seal, with a redacted version due to be filed on March 11.
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. Janssen’s complaint was filed under seal, with a redacted version due to be filed on March 11.
Genentech Brings Pertuzumab Biosimilar Fight to the ITC
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same, seeks a permanent limited exclusion order and cease-and-desist orders.
Genentech Brings Pertuzumab Biosimilar Fight to the ITC
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same, seeks a permanent limited exclusion order and cease-and-desist orders.
CareFirst's Class Action STELARA® Antitrust Case Against J&J Will Proceed: Court Grants-in-Part And Denies-in-Part Class Certification And Denies The Parties' Motions For Summary Judgment
Goodwin Procter LLP are most popular: within Transport topic(s) As we have previously reported, a group of health insurers and health insurance administrators (collectively, "CareFirst") filed a class action complaint in 2023 against Johnson & Johnson and Janssen Biotech, Inc. (collectively, J&J), alleging multiple violations of federal and state antitrust laws arising from J&J's STELARA® (utsekinumab) product, as well as violations of state consumer protection laws and unjust enrichment claims.
CareFirst’s Class Action STELARA® Antitrust Case Against J&J Will Proceed: Court Grants-in-Part and Denies-in-Part Class Certification and Denies the Parties’ Motions for Summary Judgment | Goodwin - JDSupra
As we have previously reported, a group of health insurers and health insurance administrators (collectively, “CareFirst”) filed a class action complaint in 2023 against Johnson & Johnson and Janssen Biotech, Inc. (collectively, J&J), alleging multiple violations of federal and state antitrust laws arising from J&J’s STELARA® (utsekinumab) product, as well as violations of state consumer protection laws and unjust enrichment claims.
CareFirst’s Class Action STELARA® Antitrust Case Against J&J Will Proceed: Court Grants-in-Part and Denies-in-Part Class Certification and Denies the Parties’ Motions for Summary Judgment | Insights & Resources | Goodwin
As we have previously reported, a group of health insurers and health insurance administrators (collectively, “CareFirst”) filed a class action complaint in 2023 against Johnson & Johnson and Janssen Biotech, Inc. (collectively, J&J), alleging multiple violations of federal and state antitrust laws arising from J&J’s STELARA® (utsekinumab) product, as well as violations of state consumer protection laws and unjust enrichment claims.
Regeneron Moves To Strike And Dismiss Amgen's Counterclaims In Aflibercept Litigation
Allegra J. Padula’s articles from Goodwin Procter LLP are most popular: with readers working within the Healthcare industries Goodwin Procter LLP are most popular: within Transport topic(s) On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court for the Northern District of West Virginia. The dispute centers on Amgen's aflibercept biosimilar, PAVBLU®.
New FDA Guidance Aims To Simplify The Biosimilar Approval Process
Goodwin Procter LLP are most popular: within Transport topic(s) In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products.
Regeneron Moves to Strike and Dismiss Amgen’s Counterclaims in Aflibercept Litigation | JD Supra
On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court for the Northern District of West Virginia. The dispute centers on Amgen’s aflibercept biosimilar, PAVBLU®.
Regeneron Moves to Strike and Dismiss Amgen’s Counterclaims in Aflibercept Litigation
On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court for the Northern District of West Virginia. The dispute centers on Amgen’s aflibercept biosimilar, PAVBLU®.
New FDA Guidance Aims to Simplify the Biosimilar Approval Process | JD Supra
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Guidance for Industry,” is a long-awaited announcement that could streamline the biosimilar approval process.
New FDA Guidance Aims to Simplify the Biosimilar Approval Process
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Guidance for Industry,” is a long-awaited announcement that could streamline the biosimilar approval process.
New FDA Guidance Aims to Simplify the Biosimilar Approval Process
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Guidance for Industry,” is a long-awaited announcement that could streamline the biosimilar approval process.
Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation | JD Supra
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ‘099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on October 30, 2024.
Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ‘099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on October 30, 2024.
President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs | JD Supra
In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO 273”), titled “Lowering Drug Prices By Once Again Putting Americans First.” Then, on May 12, 2025, President Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (“the MFN EO”).
President Trump Issues Two Executive Orders Concerning the Affordability and Accessibility of Drugs
In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO 273”), titled “Lowering Drug Prices By Once Again Putting Americans First.” Then, on May 12, 2025, President Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (“the MFN EO”).
Introducing AWS CloudFormation Stack Refactoring | Amazon Web Services
AWS DevOps & Developer Productivity Blog Introduction As your cloud infrastructure grows and evolves, you may find the need to reorganize your AWS CloudFormation stacks for better management, for improved modularity, or to align with changing business requirements. CloudFormation now offers a powerful feature that allows you to move resources between stacks.
Amgen Fires Back With Counterclaims In Aflibercept BPCIA Litigation
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen's aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 ("the '099 patent"). The '099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on October 30, 2024.
Year In Review: Top Legal Developments Of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year's recap of 2023, Regeneron's litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024 | JD Supra
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Introducing AWS CloudFormation Hooks invoked via AWS Cloud Control API (CCAPI) | Amazon Web Services
Today we are announcing the integration of AWS CloudFormation Hooks with AWS Cloud Control API (CCAPI). This integration enables the use of hooks to validate the configuration of resources being provisioned through CCAPI. In this blog post, we will explore the integration between CloudFormation Hooks and CCAPI by configuring an existing hook to work with CCAPI and then test that hook using the AWS CLI and Terraform.
Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar
On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz's ENVEEZU (aflibercept-abzv). This is the fifth BPCIA litigation regarding aflibercept, following Regeneron's litigations against Biocon/Mylan, Samsung Bioepis, and Formycon, and Amgen, which have been consolidated for pretrial proceedings in a multi-district litigation pending in the District Court for the Northern District of West Virginia.
Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar | JD Supra
On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv). This is the fifth BPCIA litigation regarding aflibercept, following Regeneron’s litigations against Biocon/Mylan, Samsung Bioepis, and Formycon, and Amgen, which have been consolidated for pretrial proceedings in a multi-district litigation pending in the District Court for the Northern District of West Virginia.
Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar
On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv). This is the fifth BPCIA litigation regarding aflibercept, following Regeneron’s litigations against Biocon/Mylan, Samsung Bioepis, and Formycon, and Amgen, which have been consolidated for pretrial proceedings in a multi-district litigation pending in the District Court for the Northern District of West Virginia.
Preliminary Injunction Issued Against Samsung Bioepis In Aflibercept BPCIA Litigation
In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 ("'865 patent"), generally directed to an ophthalmic formulation with a vascular endothelial growth factor (VEGF) antagonist. A public version of the Court's preliminary injunction order is not yet available.
Update On Aflibercept BPCIA Litigation
In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation.
Preliminary Injunction Issued Against Samsung Bioepis in Aflibercept BPCIA Litigation | JD Supra
In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with a vascular endothelial growth factor (VEGF) antagonist. A public version of the Court’s preliminary injunction order is not yet available.
Update on Aflibercept BPCIA Litigation | JD Supra
In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation.
Update on Aflibercept BPCIA Litigation
In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation.
Celltrion Expands Access to YUFLYMA (adalimumab-aaty) | JD Supra
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.” According to the press release, YUFLYMA (adalimumab-aaty) will be a preferred drug in Ventegra’s formulary.
Celltrion Expands Access To YUFLYMA (Adalimumab-Aaty)
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) "who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM's." According to the press release, YUFLYMA (adalimumab-aaty) will be a preferred drug in Ventegra's formulary.
Celltrion Expands Access to YUFLYMA (adalimumab-aaty)
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.” According to the press release, YUFLYMA (adalimumab-aaty) will be a preferred drug in Ventegra’s formulary.
Celltrion Expands Access to YUFLYMA (adalimumab-aaty)
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.” According to the press release, YUFLYMA (adalimumab-aaty) will be a preferred drug in Ventegra’s formulary.
Genentech Files Lawsuits Against Biogen and Millennium for Past Royalties on the Cabilly Patents | JD Supra
This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221).
Genentech Files Lawsuits Against Biogen and Millennium for Past Royalties on the Cabilly Patents
This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221).
Genentech Files Lawsuits Against Biogen and Millennium for Past Royalties on the Cabilly Patents
This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221).
Genentech BPCIA Trastuzumab Case Against Tanvez Dismissed After Settlement | JD Supra
As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab). On February 9, the court entered an order dismissing all claims in the case. Tanvez’s trastuzumab biosimilar has not yet been approved by FDA. Genentech previously settled cases filed against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis/Merck involving their respective trastuzumab biosimilars.
Genentech BPCIA Trastuzumab Case Against Tanvez Dismissed After Settlement
As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab). On February 9, the court entered an order dismissing all claims in the case. Tanvez’s trastuzumab biosimilar has not yet been approved by FDA. Genentech previously settled cases filed against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis/Merck involving their respective trastuzumab biosimilars.
Genentech BPCIA Trastuzumab Case Against Tanvez Dismissed After Settlement
As previously reported, Genentech and Tanvex reached an agreement in January 2022 to settle BPCIA litigation relating to Tanvex’s biosimilar of HERCEPTIN (trastuzumab). On February 9, the court entered an order dismissing all claims in the case. Tanvez’s trastuzumab biosimilar has not yet been approved by FDA. Genentech previously settled cases filed against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis/Merck involving their respective trastuzumab biosimilars.
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