Laura W. Smalley

Member

“Clients appreciate my thorough approach to finding the most effective solutions to their intellectual property issues. My passion for new technology and my analytical skills aid me in developing a creative strategy that helps my clients protect their most valuable assets.”

Clients’ development of their technology and protecting and enforcing clients’ intellectual property rights are the focus of Laura’s practice. Laura has litigated numerous patent infringement suits involving medical devices, electronic components and imaging technology. She prosecutes patents in the chemical and biotechnology fields and has a technical background in chemistry, including organic and analytical chemistry. Prior to joining Harris Beach, Laura supported the in-house Patent Prosecution Department at Motorola.

RECENT PUBLICATIONS + SPEAKING ENGAGEMENTS

Presented patent CLE webinar "Update: Written Description and Enablement Requirements under 35 U.S.C. § 112", September 2020
Speaker at AIPLA Annual Meeting 2018: Regulatory and IP Issues for Immunotherapies Including Car-T and Antibody Technologies (“Don’t Put The “Car-T” Before the Horse—IP And Regulatory Issues for Immunotherapies”), BIOTECHNOLOGY/FOOD AND DRUG/TRADE SECRET LAW (JOINT SESSION), presented talk on Resolving Patent Infringement Issues for Biosimilars/ Interchangeable Biologics
“The Supreme Court Interprets the Biologics Price Competition and Innovation Act in Favor of Biosimilar Applicants,” American Intellectual Property Law Association Biotech Buzz, June 2017
Speaker, “USPTO’s Subject Matter Eligibility: The Dos and Dont’s in 2017 and Beyond,”
The Knowledge Group, March 20, 2017
Patent Damages Webinar: Discussed the current state of case law on patent damages, including cases on the entire market value rule and apportionment. The webinar also discussed strategies for motion practice prior to trial, including Daubert and summary judgment motions, and how to marshal the proof to support your client’s theory of damages, including the use of expert testimony. November 2016
ACI, Women Leaders in Technology Law, "Creating a Winning Pitch: Implementing Critical Negotiation, Leadership, and Presentation Skills to Make Your Case," May 15, 2015

Laura has published countless articles and written Harris Beach Legal Alerts on a wide range of patent and trademark topics in a number of technical fields, including:

“Examples in Specification Did Not Provide Written Description Support for Bounded or Closed Ranges,” December 2021.
"Patent Trial and Appeal Board Determination of "Reasonable Expectation of Success" Must Be Supported by Substantial Evidence," December 2021.
"Federal Circuit Court of Appeals Reverses $1.2 Billion Verdict in Juno v. Kite Pharma, Invalidating Genus Claims to a Three-Part Chimeric Antigen Receptor," September 2021.
"Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute," Harris Beach Podcast, July 2021.
"IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112," Harris Beach Legal Alert, September 2020
Samsung v. Apple: Supreme Court’s Reversal of the Design Patent Damages Award, December 2016
"Will Nanotechnology Products be Impacted by the Federal Courts' 'Product of Nature' Exception to Subject-Matter Eligibility Under 35 U.S.C. 101?," The John Marshall Law School Review Of Intellectual Property Law, April 2014
“Using the Term ‘The Invention’ to Describe the Preferred Embodiments May Limit the Claims,” Intellectual Property Today, March 2014
“Extending the Terms of Patents,” Harris Beach Legal Alert, February 2010

Laura has also published numerous articles for American Intellectual Property Law Association’s Biotech Buzz newsletter, including:

AbbVie Files Suit Against Amgen Asserting Patent Infringement by Amgen's Biosimilar to AbbVie's HUMIRA® Biologic. October 2016
Amgen Inc. v. Apotex Inc.: United States District Court for the Southern District of Florida Finds that Apotex Pegfilgrastim and Filgrastim Biosimilars Do Not Infringe Amgen's Patent on Protein Refolding. September 2016
U.S. District Court for the District of Delaware Holds that Discovery under the Biologic Price Competition and Innovation Act is Limited to Information Relevant to the Patents Asserted in the Litigation.
August 2016
Amgen Inc. v. Apotex Inc.: Federal Circuit Holds that 180-Day Notice Must be Given After Biosimilar is Licensed Even if the Biosimilar Applicant Complies with the Information-Exchange Procedures of the Biologics Price Competition and Innovation Act. July 2016
Amgen Sues Sandoz for Patent Infringement Over Pegfilgrastim Biosimilar. May 2016

Representative Matters

Patent Litigation

Greatbatch Ltd. v. AVX Corp. et al. (U.S. District Court, D. Del. 2019): Represented patent owner in patent infringement action over key components for pacemakers and implantable defibrillators. Jury verdicts found infringement of three U.S. Patents, and awarded lost profits and price erosion. Judgment on the jury verdict exceeded $27 million in damages. The judgment was affirmed by the Federal Circuit Court of Appeals.
MAX International Converters, Inc. v. Iconex, LLC (U.S. Dist. Court, D. Del.): Counsel in patent infringement action relating to repositionable linerless labels.
Arbitration proceeding (AAA 2014): Trial counsel in confidential arbitration over breach of settlement agreement and patent infringement.
NuClimate v. Airtex (U.S. Court of Appeals, Federal Circuit 2012): Successfully defended judgment of non-infringement on appeal.
Izzo Golf, Inc. v. King Par Golf, Inc. (U.S. District Court, WDNY 2010): Plaintiff’s counsel in a patent infringement action resulting in a jury verdict of over $3 million and finding of willful infringement.
Eastman Kodak v. Apple, Inc. (U.S. District Court, WDNY; 2010): Co-counsel for Kodak in claims for infringement by Apple products of Kodak digital still camera and software architecture patents.
Redcom Laboratories, Inc. v. Cisco Systems, Inc. (U. S. District Court, WDNY; 2006): Counsel in patent infringement case involving telephone switching equipment; multimillion dollar settlement obtained after Markman ruling.
Honeywell vs. Eastman Kodak (U.S. District Court; 2005): Defense of Kodak in patent infringement dispute involving liquid crystal displays for digital still cameras.
Amesbury Products v. Caldwell Manufacturing: Defense counsel in a patent infringement suit involving patents for window hardware balances.
Neutrik AG v. Switchcraft (U.S. Court of Appeals, Federal Circuit): Appeal of a grant of summary judgment on non-infringement.

Additional Trial Experience

Trafalgar Power v. Stetson-Harza (U.S. District Court and U.S. Court of Appeals, Second Circuit): Part of team of Harris Beach attorneys who obtained and defended on appeal a plaintiff’s jury verdict of $11.1 million in an engineering malpractice action.
Jackson v. Guardsmark (Supreme Court Monroe County, 2011): Lead trial counsel where no-cause verdict was obtained in alleged toxic exposure case after two and a half week trial.
In the Matter of JPMorgan Chase (Monroe Co. Surrogate’s Court 2013): Two week trial representing JPMorgan in contested trust accounting matter regarding claim of negligent retention of securities. Judgment unanimously reversed on appeal in client’s favor.
In the Matter of JPMorgan Chase (Westchester Co. Surrogate’s Court 2009): Two and a half week trial representing JPMorgan in contested trust accounting matter regarding claim of negligent retention of securities.
In the Matter of JPMorgan Chase (Monroe County Surrogate’s Court; 2008): Obtained $300,000 award of fees for trust fiduciary resulting from successful defense of surcharge proceeding.

Patent Prosecution

Prepared and prosecuted patents for cancer immunotherapies, medical devices and catalysts, among other technologies.
Participated in post-issuance proceedings, including PTAB and ex parte reexamination proceedings.

Trademark Prosecution and Enforcement

Conduct trademark searches and product clearances.
File and prosecute trademark applications, both domestic and international.
Coordinate foreign associates’ prosecution of trademarks filed directly or under the Madrid protocol.
Advertising, marketing and copyright clearance and counseling.
IP due diligence/M&A support.
Trademark opposition and cancellation proceedings before the Trademark Trial and Appeal Board.
Trademark and trade dress litigation in state and federal court.

Professional and Civic

AIPLA (American Intellectual Property Law Association), member of the Biotechnology Committee and contributor to the Biotech Buzz. Previously served on the committee revising AIPLA’s Model Patent Jury Instructions and on the patentability subcommittee of the Patent Law Committee
RIPLA (Rochester Intellectual Property Law Association), former President and now officer of RIPLA, an organization composed mainly of attorneys actively engaged in the practice of patent, trademark, or copyright law in the Rochester area.
Volunteer Legal Services Project of Monroe County, Inc., former President and Board Member
Monroe County Bar Association, Board of Trustees

Recognition

Best Lawyers, Commercial Litigation, since 2013
Super Lawyers, Intellectual Property Litigation, 2016 – 2019
The Daily Record, Up & Coming Attorneys
Volunteer Legal Services Project, McKnight Award

Legal Practices

Appellate

Business and Commercial Litigation

Intellectual Property

Industry Teams

Photonics

Admissions

New York

U.S. Court of Appeals, Federal Circuit

U.S. Court of Appeals, Second Circuit

U.S. District Court, New York - Northern District

U.S. District Court, New York - Southern District

U.S. District Court, New York - Western District

U.S. Patent and Trademark Office

U.S. Supreme Court

Cornell Law School

1997

University of Florida

1994

June 28, 2022

Federal Circuit Imposes Heightened Standard for Written Description Support of Negative Claim Limitations

In Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held pat

February 10, 2022

Intellectual Property Law: Year in Review 2021

Analyzing the major Federal Circuit decisions that have affected patent law over the past year can spark a change in your procedures or deci

December 15, 2021

Examples in Specification Did Not Provide Written Description Support for Bounded or Closed Ranges

The Federal Circuit Court of Appeals affirmed the Patent Trial and Appeal Board’s determination that a patent specification did not provide

December 15, 2021

Patent Trial and Appeal Board Determination of “Reasonable Expectation of Success” Must Be Supported by Substantial Evidence

The Federal Circuit Court of Appeals reversed a decision of the U.S. Patent Trial and Appeal Board (“Board”), finding a patent on a method o

December 7, 2021

Examples in Specification Did Not Provide Written Description Support for Bounded or Closed Ranges

The Federal Circuit Court of Appeals affirmed the Patent Trial and Appeal Board’s determination that a patent specification did not provide

July 13, 2021

Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute

T-Cell Therapies offer enormous promise in the development of new approaches to treating cancer. A federal appeals court recently heard argu

June 29, 2021

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Att

February 25, 2021

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

November 17, 2020

Claiming a New Manufacturing Method Cannot Impart Novelty to Composition or Method of Treatment Claims

In Biogen MA, Inc. v. EMD Serono, Inc., the Court of Appeals for the Federal Circuit has reconfirmed, and to an extent clarified, that an ex

September 28, 2020

Federal Circuit Construes the Terms “Antibody” and “Antibody Fragment”

The Federal Circuit issued a decision in Baxalta Inc. v. Genentech, Inc., ___ F.3d __, 2020 WL 5048435 (Fed. Cir. Aug. 27, 2020) construing

September 14, 2020

IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112

In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of t

August 13, 2020

Federal Circuit Issues Two Decisions Clarifying Patent-Eligible Subject Matter

One of the murkier areas of patent law is subject matter eligibility—when are patent claims directed to laws of nature, natural phenomenon o

July 23, 2020

Specification References to Publicly Available Databases or Deposits Can Satisfy the Written Description Requirement for a Biological Drug

In Immunex Corp. v. Sandoz, Inc. No. 20-1037 (July 1, 2020), the Federal Circuit Court of Appeals addressed whether references to publicly a

July 17, 2020

New Podcast: Verdict in Cancer Immunotherapy IP Case

One of the most interesting and promising areas of medical research today involves the use of T-Cell therapies, which offer hope and promise

May 21, 2020

Prevent Your Licensee From Instituting Inter Partes Review with a Forum Selection Clause

Courts have a general policy prohibiting licensees from challenging patent validity (even though the licensee may have voluntarily agreed to

April 30, 2020

USPTO Extends Certain Patent-Related Deadlines due to COVID-19 Crisis

The United States Patent and Trademark Office (“USPTO”) has further extended the time to file certain patent-related documents or pay fees d

April 16, 2020

Federal Circuit Ruling in Patent Case Expands ‘Obviousness’ Doctrine

The Federal Circuit held that a prima facie case of obviousness can be established by prior art ranges for solutions of structurally and fun

February 5, 2020

Patent Infringement: Successful Litigation Stays the Course

What happens when your competitors infringe your patent for golf equipment – then declare bankruptcy to avoid paying up? In this episode, Ha

June 7, 2019

Harris Beach Obtains Summary Judgment in Business Defamation Case

Harris Beach attorneys Pamela Goldsmith and Laura Smalley successfully obtained judgment as a matter of law in New York Supreme Court, Queen

May 6, 2019

Recent District Court Decisions Provide Guidance on Written Description Requirement for Antibodies

One of the most difficult aspects of patenting antibodies and other biologics is obtaining sufficiently broad patent protection. In order to

March 4, 2022

Partner Laura Smalley Discusses IP Trends

Partner Laura Smalley of our intellectual property law team recently chatted with Caurie Putnam of the Rochester Business Journal about tren

November 9, 2020

Laura Smalley Highlights Use of Forum Selection Clauses In The Licensing Journal

Laura Smalley, an attorney on the Harris Beach Intellectual Property team, contributed an article to The Licensing Journal focused on preven

August 7, 2020

Federal Appeals Court Upholds $27 Million Judgment after Jury Verdicts on Patents for Greatbatch, Medical Components Manufacturer

A $27 million judgment after three jury verdicts in favor of Greatbatch Ltd., a Buffalo-based medical device manufacturer and subsidiary of

November 12, 2019

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Laura W. Smalley

Member

Cornell Law School

University of Florida

Laura W. Smalley

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