Description
Diagnostic methods lack patent eligibility, except when they possess some unconventional or non-routine steps. The nebulous nature of what qualifies as unconventional or non-routine has created uncertainty for patent applicants.
Method of treatment claims are patent-eligible, but they must include an affirmative administration step, and the claimed treatment must include specificity and be directed to achieving a specific outcome. Further, in its decision in Illumina v. Ariosa (Fed. Cir. 2020), the court confirmed methods of preparation claims are patent-eligible, providing a new opportunity for patent eligibility of diagnostic method claims.
In view of current guidance from the courts, patent practitioners should avoid typical diagnostic claim language and incorporate a sufficiently inventive concept into the claims, ideally based on unconventional elements or steps.
Listen as our authoritative panel of patent attorneys examines diagnostic method inventions and the challenges involved in getting patent protection for them. The panel will discuss the evolving court treatment of diagnostic patents and the USPTO guidance. The panel will offer best practices for getting patent protection for diagnostic methods.
Presented By
For over 25 years, Ms. Mueller has provided strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology, and chemistry sectors. She brings in-depth knowledge and extensive experience to her work, advising clients on the global patent protection, freedom to operate, and validity of blockbuster drugs they aim to produce and distribute. With a background in chemistry and biology, she provides advice on the full spectrum of global intellectual property portfolio management, including patent prosecution, opposition, and other post-grant proceedings, and diverse regulatory matters. Since 2001, she has worked closely with in-house legal departments of global pharmaceutical firms regarding their patent development and enforcement strategies. In this partnership, Ms. Mueller provides training to new in-house counsel. She meets with scientists and other business development to anticipate and resolve a wide array of problems, including navigation of FDA approval. A thought leader on pharmaceutical and biopharmaceutical patent law, Ms. Mueller frequently speaks to legal and industry groups and publishes widely.
Dr. Scarpati’s practice spans all major areas of intellectual property law, including patent prosecution, due diligence investigations, district court litigation involving patents, trademarks, and copyrights, and post-grant proceedings before the U.S. Patent and Trademark Office. He has extensive experience drafting patent invalidity, non-infringement and freedom-to-operate opinions, conducting prior art searches, and analyzing patent portfolios. Dr. Scarpati has advanced degrees in the areas of molecular biology, which he leverages to draft and prosecute patent applications related to biotechnology, pharmaceuticals, diagnostics, agricultural products, medical devices, and related life sciences subject matter. He also has a degree in computer science, providing cross-disciplinary expertise necessary for the prosecution of software patents. In that regard, he has experience drafting and prosecuting patents directed to software and business methods that implement machine learning, blockchain-based ledgers and other cutting-edge technologies. In addition to the above, Dr. Scarpati also has several years of experience prosecuting and litigating utility and design patents related to consumer products technology, and has counseled clients regarding intellectual property issues at all stages of the product development life cycle.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Thursday, February 3, 2022
- schedule
1:00 p.m. ET./10:00 a.m. PT
- Diagnostic method inventions
- Method of treatment claims
- Methods of preparation claims
- Unconventional/inventive steps
- Court treatment and USPTO guidance
- Best practices for patenting diagnostic methods
The panel will review these and other key issues:
- How the courts have addressed the issue of patent eligibility for diagnostic methods
- USPTO guidance for patenting diagnostic methods
- Best practices for protecting diagnostic methods
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