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Sarah ML Wilkening is an attorney who assists clients in all areas of patent law with a focus in chemical science. She uses her PhD in chemistry and her curious nature to provide exceptional service to her clients.

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A Unique Blend of Science and Legal Knowledge

Sarah focuses her practice on organic and inorganic chemistry, pharmaceuticals, polymer chemistry, nanochemistry, semiconductors, and medical devices. She lends her support in patent prosecution, patent litigation and transactional duties. 

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Her background in science, university research and IP management makes her an indispensable asset who understands the practical details of innovators, researchers and licensing associates with whom she works.&nbsp;

Every day, Sarah delves deeply into patentability, freedom-to-operate, invalidity and IP acquisition issues. She’s closely involved in Hatch-Waxman litigations, producing pleadings, claim charts and other vital documents.&nbsp;

In a world of constant innovation, clients turn to Sarah for her meticulous approach to drafting patent applications. She recognizes the importance of preparing for potential licensing opportunities, acquisitions, or litigation challenges. Sarah crafts applications that are thorough, well-researched and ready to withstand scrutiny.

Sarah’s communication skills shine when counseling corporate, university and individual clients. She understands their needs and offers strategic insights.&nbsp;

Adaptable, Curious and Client-Centric&nbsp;

Sarah’s adaptability ensures that she’s always ready to pivot for her clients. With a knack for viewing challenges from multiple perspectives, she taps into her clients’ mindset while anticipating competitor strategies.

Guided by the principles of client satisfaction and exceeding expectations, Sarah is known for going above and beyond. She uses her innate curiosity and exceptional organizational skills to provide the support her clients need. 

Sarah was born and raised in Indianapolis, Indiana. When not at work, she enjoys running with friends, Tuesday trivia night, traveling with her husband, and trying to train her stubborn dogs.

Manchester University, B.S. Chemistry, 

Emory University, Ph.D. Chemistry

Georgia State University, J.D., 

Alternative Energy

Industrial Chemistry

Manufacturing

Medical Devices

Nanotechnology

Pharmaceuticals

Research Organization Collaborative

Semiconductors

Atlanta

On March 18, 2024, the U.S. District Court for the District of Delaware issued an opinion in <a href="https://www.ded.uscourts.gov/sites/ded/files/opinions/21-1338.pdf">Puma Biotechnology, Inc v. AstraZeneca Pharmaceuticals LP et al, 1:21-cv-1338-MFK</a> granting AstraZeneca&#8217;s motion for pre-issuance damages.



The parties are pharmaceutical companies that commercialize drugs to treat cancer and other illnesses. The suit is trying to block sales of AstraZeneca&#8217;s drug Tagrisso (osimertinib) to treat lung cancer, which AstraZeneca has been selling since 2015. Wyeth has an exclusive license with Puma for developing and commercializing Wyeth&#8217;s drug Nerlynx (neratinib) for treating breast cancer and is currently in clinical trials for treating lung cancer. The patents-in-suit (10,603,314 and 10,596,162) claim a method of treating a certain form of non-small cell lung cancer.



AstraZeneca moved for summary judgement on a variety of issues, including standing, invalidity, non-infringement, and pre-issuance damages, which the court denied with the exception of the pre-issuance damages.



Wyeth argued that a narrow exception exists to the general rule that patent owners can only collect damages for patent infringement that occurs during a patent term. The proposed exception comes from the &#8220;provisional rights&#8221; codified at 35 U.S.C. § 154(d), where a patent owner has the right to obtain a reasonable royalty from:



any person who, during the period beginning on the date of publication of the application for such patent . . . and ending on the date the patent is issued:



(A)(i) makes, uses, offers for sale, or sells in the United States the invention as claimed in the published patent application or imports such an invention into the United States; or



(ii) if the invention as claimed in the published patent application is a process, uses, offers for sale, or sells in the United States or imports into the United States products made by that process as claimed in the published patent application. &nbsp;



&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 35 U.S.C. § 154(d)(1) (emphasis added).



The parties recognized and agreed that § 154(d) does not explicitly include a provision incorporating the induced infringement language of § 271(b); however, Wyeth argued that section 154(d) does not need to expressly mention induced infringement. The court disagreed based on the plain text of § 271(b) being directed to induced infringement of a patent while § 154(d) only extends rights to certain conduct specifically enumerated and not to all post-issuance patent rights. Therefore, the statute does not authorize pre-issuance damages for induced infringement.

Third Circuit Affirms No Pre-Issuance Damages for Induced Infringement

Chemical & Life Sciences

IP Due Diligence

Licensing

Litigation

Attorney

Sarah ML Wilkening, Ph.D.

American Bar Association (ABA), American Intellectual Property Law Association (AIPLA), Patent Agents of Georgia (PaGA), Georgia IP Alliance (GIPA), US IP Alliance (USIPA), Corporate IP Institute (CIPI), Association of University Technology Managers (AUTM)

Professional Affiliations

Bench2Market Talk: Protecting your Innovation (2021 &amp; 2022), Bench2Market Talk: Intellectual Property Basics and Strategy (2021&amp; 2022)

Sarah ML Wilkening

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