Intellectual Property Pulse

Biosimilars Patent Challenges at the PTAB: Update and Lessons Learned

LexBlog IP

NOVEMBER 7, 2023

This webinar will explore topics including: Evolving trends of biologic patent challenges at the PTAB; Strategic considerations for biosimilar manufacturers; and Lessons learned from recent filings. The post Biosimilars Patent Challenges at the PTAB: Update and Lessons Learned appeared first on Big Molecule Watch.

Patent

Patent Litigation IP Intellectual Property

CYLTEZO® to Launch on July 1 as the First Interchangeable HUMIRA® Biosimilar

LexBlog IP

JUNE 30, 2023

Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States. In addition to CYLTEZO, the FDA has approved eight additional adalimumab biosimilars over the last six years.

Designs

Designs Design Branding Brands

So You Want To Make A Biosimilar: Top Considerations Before BLA Submission

LexBlog IP

SEPTEMBER 7, 2023

Developing and successfully commercializing a biosimilar is a complex and expensive process. Topics that will be covered include the 271(e) Safe Harbor, peremptory challenges, labelling and timing considerations, and competitive intelligence. Click here to register for the webinar.

Litigation

Litigation IP Intellectual Property

Biosimilars Webinar Series

LexBlog IP

AUGUST 24, 2023

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law.

Marketing

Marketing Marketing Registration Litigation

Goodwin Presents on Hot Topics in 2023 and Beyond in the Healthcare Regulatory Environment at JP Morgan Healthcare Conference

LexBlog IP

JANUARY 4, 2023

If you are at the conference in San Francisco, we hope you will join the team on January 11, 2023 for the Goodwin + KPMG 4 th Annual Symposium which will include a discussion by Matt Wetzel on hot topics in 2023 and beyond in the healthcare regulatory environment. For more information, please click here.

Intellectual Property

FDA Announces Biosimilar Funding Opportunity

LexBlog IP

MARCH 17, 2022

This FOA arises out of the FDA’s proposed commitments in the third proposed Biosimilar User Free Act, through which it intends to “explor[e] ways to enhance biosimilar and interchangeable biosimilar product development and regulatory science.”

Intellectual Property

FDA Testimony Before the U.S. Senate Regarding Reauthorization of the Biosimilar User Fee Act

LexBlog IP

APRIL 29, 2022

Senate regarding reauthorization of the User Fee Acts, including the Biosimilar User Fee Act (“BsUFA”). The BsUFA is a law authorizing FDA to assess and collect fees from drug manufacturers that submit Biological License Applications for biosimilar products. decrease in price (for insulin glargine) to a 42.2%

Licensing

Licensing Law Intellectual Property

Netherlands calling with a 10% discount on C5's Pharma & Biotech Patent Litigation Conference

The IPKat

MAY 12, 2023

The AmeriKat is particularly looking forward to the session on "Managing the Implications of the EPO's Decisions in BOA Referral G 2/21" and, as ever, her favorite favorite topic - SPCs. She will be reporting from the event, so look out for posts for those who are unable to attend.

Litigation

Litigation Patent Reporting

Life Sciences Strategy Summit on IP & Exclusivity returns to Munich with special IPKat readers’ discount

The IPKat

JULY 31, 2023

Readers can also watch this video interview with Thomas Böhmer, Head of IP at Pieris Pharmaceuticals, for a glimpse into his work and the topics that will be covered in October. The IPKat has also negotiated a special discount for readers. To save 10% please use VIP code IPKAT at checkout.

IP

IP Editing Intellectual Property Patent

Back to Life (Sciences) in Amsterdam. A conference report

The IPKat

MARCH 28, 2022

The conference lasted almost three days and with a large number of topics having been discussed. The IPKat reports on some of the trends and topics from the conference below. In fact, manufacturing is key in the biosimilars/biologics/antibodies area, even more than it was in the field of small molecules.

Reporting

Reporting Litigation Patent Confidentiality

SpicyIP Weekly Review (February 26- March 3)

SpicyIP

MARCH 4, 2024

Here is another round of SpicyIP flashbacks by Lokesh, where he looks into a variety of topics ranging from IP and Gaming to Biodiversity and Benefit Sharing! Other Posts Journey Through “Januarys” on SpicyIP (2005 – Present) Image from here Sit back, relax, and sift through the pages of January’s posts on SpicyIP!

Invention

Invention Trademark IP Patent

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

JD Supra Law

OCTOBER 26, 2022

Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. By: Goodwin

Publishing

Publishing Trademark Patent

Biosimilars 2021 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

JANUARY 11, 2022

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also exhibited continued growth, with multiple biosimilar developers reporting strong sales of biosimilars through 2021.

Litigation

Litigation Settlement Patent Marketing

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

LexBlog IP

OCTOBER 25, 2022

Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. The post Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition appeared first on Big Molecule Watch.

Invention

Invention Patent Prosecution Art Patent

A Look Back at India’s Top IP Developments of 2023

SpicyIP

DECEMBER 30, 2023

As in previous years, we have divided these developments into five categories: a) Top 10 IP Judgements/Orders (Topicality/Impact) b) Top 10 IP Judgements/Orders (Jurisprudence/Legal Lucidity) c) Top 10 IP Legislative and Policy Related Developments d) Other IP Developments; and e) Other Notable Developments. RDB and Co.

IP

IP Copyright Trademark Intellectual Property

Executive Order on Promoting Competition in the American Economy

Patently-O

JULY 9, 2021

More to come on this topic. This is largely a construct of Federal Law. Passenger Train : Encourage the Surface Transportation Board to require railroad track owners to provide rights of way to passenger rail and to strengthen their obligations to treat other freight companies fairly.

Licensing

Licensing Intellectual Property Privacy IP

Intellectual Property Pulse

Biosimilars Patent Challenges at the PTAB: Update and Lessons Learned

CYLTEZO® to Launch on July 1 as the First Interchangeable HUMIRA® Biosimilar

Trending Sources

So You Want To Make A Biosimilar: Top Considerations Before BLA Submission

Biosimilars Webinar Series

Goodwin Presents on Hot Topics in 2023 and Beyond in the Healthcare Regulatory Environment at JP Morgan Healthcare Conference

FDA Announces Biosimilar Funding Opportunity

FDA Testimony Before the U.S. Senate Regarding Reauthorization of the Biosimilar User Fee Act

Netherlands calling with a 10% discount on C5's Pharma & Biotech Patent Litigation Conference

Life Sciences Strategy Summit on IP & Exclusivity returns to Munich with special IPKat readers’ discount

Back to Life (Sciences) in Amsterdam. A conference report

SpicyIP Weekly Review (February 26- March 3)

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

Biosimilars 2021 Year in Review

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

A Look Back at India’s Top IP Developments of 2023

Executive Order on Promoting Competition in the American Economy

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