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7 Key Takeaways - The Federal Circuit's New § 112 Attack on Biotechnology: Diagnosis and Prescription

Kilpatrick attorneys Yifan Mao and Stuart Pollack recently attended the 20th annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) to discuss the “The Federal Circuit’s New § 112 Attack on Biotechnology: Diagnosis...more

10 Key Takeaways - Navigating Litigation Under the Biologics Price Competition and Innovation Act BPCIA

On January 11, 2024, Kilpatrick Partner April Isaacson and Counsel Yifan Mao presented “Navigating Litigation Under the Biologics Price Competition and Innovation Act (BPCIA)” to entrepreneurs in the Chinese life science...more

5 Key Takeaways | Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen [Video]

On December 8, Partner Nena Bains and Counsel Yifan Mao presented “Best Practices in Patent Drafting: Addressing 112 and Enablement After Amgen” at the 24th Annual Berkeley-Stanford Advanced Patent Law Institute organized by...more

5 Key Takeaways - Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen

On December 8, Partner Nena Bains and Counsel Yifan Mao presented “Best Practices in Patent Drafting: Addressing 112 and Enablement After Amgen” at the 24th Annual Berkeley-Stanford Advanced Patent Law Institute organized by...more

Enabling Biotech Genus Claims Defined Only by Function — A Nearly Impossible Goal — Baxalta Incorporated v. Genentech Inc. (Fed....

In the aftermath of Amgen v. Sanofi, courts continue to invalidate genus claims for lacking enablement. Baxalta Incorporated v. Genentech Inc.2 shows that it is nearly impossible to meet the enablement requirement for claims...more

5 Key Takeaways | Hot Topics in Biopharma [Video]

Kilpatrick Townsend recently held its semi-annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) in California. Firm attorneys led two days of interactive discussions with clients on the latest developments in...more

5 Key Takeaways - Hot Topics in Biopharma: From Enablement to Written Description, Section 101 Challenges, and The Patent...

Kilpatrick Townsend recently held its semi-annual KTIPS (Kilpatrick Townsend Intellectual Property Seminar) in San Francisco. Firm attorneys led two days of interactive discussions with clients on the latest developments in...more

5 Key Takeaways - A Cost-Effective Patent Strategy for Startups

Kilpatrick Townsend’s Yifan Mao, MSc, and Joseph Snyder, Ph.D., JD, recently provided a presentation at Daybreak Labs on the topic of “A Cost-Effective Patent Strategy for Startups.” The presentation covered intellectual...more

Sound of Silence: Petition to the Supreme Court, Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc

Novartis and Accord Healthcare, Inc. are embroiled in a patent infringement suit concerning Novartis’ blockbuster multiple sclerosis drug Gilenya. Our previous articles Sound of Silence: Claiming Negative Limitations, and...more

Protecting Antibody Innovations: Searching for Equivalents under The Doctrine of Equivalents —A Discussion of Teva v. Eli Lilly...

United States courts have recently tightened the written description requirements for antibody claims. The scope of issued claims is now often limited to antibodies with specific sequences of the CDR and the heavy chain and...more

The Fast and the Furious: Article 76 Proceedings in China Proceed with Speed

Article 76 of the Fourth Amendment1 to the Chinese Patent Law links regulatory approval of a generic drug and patent protection of the brand-name drug. It establishes a legal framework for resolving drug patent disputes...more

Utility Models: Economical, Efficient, and Enforceable Patent Protection

Obtaining a traditional utility patent is often a long and strenuous process. Although fast track prosecution procedures may be available, they are often costly and cumbersome. But entrepreneurs often want to obtain patent...more

Pushing Boundaries When Patenting Ranges

Inventions with numerical ranges are valuable across different technologies. Obtaining claims with numerical ranges provide competitive advantages to patent owners. Frequently, a claimed range in an application may need to be...more

Drug Discovery Catch-22: A Healthy Dose of Written Description

To satisfy the written description requirement under 35 U.S.C. 112, a patent specification must describe the claimed invention in such sufficient detail that a person of skilled in the art (POSA) can reasonably conclude that...more

The Sound of Silence: Claiming Negative Limitations

The specification shall contain a written description of the invention. To meet the written description requirement, the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date...more

Statement of Invention or “Hunting Expedition”?: Written Description for Claimed Ranges

“A written description . . . requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.” For claims reciting ranges,...more

Federal Circuit Decides Teva-Lilly Spat for Antibody Compositions and Methods

On August 16, 2021, the Federal Circuit handed down two rulings related to patents issued to Teva, which involve therapeutic antibodies targeting a calcitonin gene-related peptide (“CGRP”). In both cases, the Federal Circuit...more

PTAB Denies Petitioner Request to Withdraw PGR as “Too Late”

37 C.F.R. § 42.71(a) provides that “The Board…may grant, deny, or dismiss any petition or motion” but does not provide other specifics. The Board therefore has broad discretion in considering requests to withdraw...more

Navigating Key Differences in Therapeutic Antibody Patent Protection Strategies Between the United States and Europe

Many of today’s top-selling drugs worldwide are therapeutic antibodies thus antibody-related inventions can be extremely valuable. Developing antibody therapeutics requires significant resources and time, so it is paramount...more

Late But Not Too Late | Submitting Post-Filing Data During Patent Prosecution in Selected Jurisdictions

Intellectual Property counsel often face the dilemma of when to file a patent application: as soon as possible, or wait and gather more support? Filing an application “early” helps to avoid anticipatory prior art but if the...more

Drug to Biologic Transition: Is Purple The New Orange?

Approval Processes - The regulatory approval pathway for a new “biological product” submitted as a Biologics License Application (BLA) under the Biologics Price Competition and Innovation Act (BPCIA), is now separate from...more

5 Takeaways: How Do We Ensure Effective Protection of Antibodies?

As part of the Life Sciences Patent Network’s 2018 NORTH AMERICA-FALL Conference, Chemistry & Life Sciences Associate Yifan Mao led a roundtable discussion group on “How Do We Ensure Effective Protection of Antibodies?” Well...more

Obviousness Requires Articulation; Routine Optimization Insufficient Alone

In Re Stepan Company , No. 2016-1811 (Fed. Cir. Aug. 25, 2017) - The Federal Circuit vacated a Patent Trial and Appeal Board’s obviousness decision for failing to adequately articulate its reasoning. The Stepan Company...more

“Patents 4 Patients”: A New Cancer Immunotherapy “Fast Track” for U.S. Patent Applicants

In connection with the White House Cancer Moonshot Initiative, the United States Patent and Trademark Office (“USPTO”) announced on June 29 that it is “Teaming Up to Cure Cancer” by establishing a new accelerated process for...more

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