Alyson Wooten, PharmD (Doctor of Pharmacy), focuses her practice on patent litigation with a special emphasis on pharmaceutical patent litigation under the Hatch-Waxman Act. She has experience at all stages of the litigation process includes pre-filing investigations, discovery, expert witness preparation, Markman proceedings, dispositive motions, and settlement negotiations. She has argued Markman hearings, summary judgment, and discovery-related hearings in various United States courts. She also has experience in filing and conduct of Inter Partes Review proceedings, including proceedings co-pending with district court actions.
Registered as a patent attorney and pharmacist, Dr. Wooten also has broad experience in counseling clients on FDA regulatory matters, clinical trial management, early commercialization strategies, patent settlements and licenses regarding pharmaceuticals, drug product liability, and antitrust issues bearing on pharmaceutical patent settlements. Prior to joining Kilpatrick Townsend, Dr. Wooten worked for a leading pharmaceutical company focusing on FDA regulatory matters, clinical trial program for investigational new drugs, and patent litigation under the Hatch-Waxman Act.
Dr. Wooten was recognized in 2016 and the five years immediately preceding as a Georgia “Rising Star” in the area of Intellectual Property Litigation by Super Lawyers magazine. She is also a frequent contributor to Kilpatrick Townsend’s FDA ConneKTion blog.
Professional & Community Activities
Georgia Law Center for the Homeless, Supplemental Board of Directors
American Bar Association, Financial Committee
American International Property Law Association, Member
Metropolitan Counseling Services, Board of Directors, Chairman
Temple University Law School, Student Bar Association, Past Class Division Vice President
Temple University Law School, J.D. (2007)
Campbell University, Pharm.D., magna cum laude (2001)
Campbell University, M.B.A. (2000)
New Jersey (2007)
U.S. Patent and Trademark Office (2005)
Georgia Court of Appeals
Georgia Supreme Court
U.S. District Court for the Northern District of Georgia (2008)
U.S. Court of Appeals for the Federal Circuit (2012)
Javelin Pharmaceuticals, Inc. and Janssen Pharmaceuticals Inc. v. Mylan et al.
Representing Mylan in ANDA litigations over the generic version of Dyloject®. The case involves two patents and is tentatively set for trial in April 2018.
Janssen Pharmaceuticals, Inc, et al. v. Mylan Laboratories Limited, et al., No. 16-224 (D. Del. filed April 4, 2016) and Janssen Pharmaceuticals, Inc., et al. v. Mylan Laboratories Limited, et al., No. 16-59 (N.D. filed April 6, 2016).
Pfizer Inc. et al. v. Mylan et al.
Representing Mylan in ANDA litigations over the generic version of Toviaz®. Both litigations, brought within days of each other in differing jurisdictions, involve the same five patents. The cases are set for trial in January 2017.
Pfizer Inc. and UCB Pharma GMBH v. Mylan Pharmaceuticals Inc., No. 15-0079 (D. Del. filed Jan. 23, 2015) and Pfizer Inc. and UCB Pharma GMBH v. Mylan Pharmaceuticals Inc., No. 15-0013-IMK (N.D.W.Va. filed Jan. 27, 2015).
Medtronic v. Edwards Lifesciences
Defended Edwards Lifesciences in a four patent case Medtronic brought involving Edwards’ flagship prosthetic surgical heart valves. Furthermore, Kilpatrick Townsend led the countersuit asserting Edwards patents infringed by Medtronics’ valve reconstruction products. The team successfully challenged the validity of three of the four Medtronic patents-in-suit and two other threatened patents in proceedings before the U.S. Patent and Trademark office, winning cancellations of virtually all pertinent claims. The case settled as part of a global settlement of multiple cases with an exchange of cross-licenses and license payments by Medtronic of over $1 billion.
Medtronic, Inc. et al. v. Edwards Lifesciences Corp, et al., No. 11-cv-01650 (D. Minn. filed June 24, 2011).
Patent counseling services for leading pharmaceuticals manufacturer
Provided patent counseling services including patent license review, dispute resolution and pre-litigation counseling to leading pharmaceuticals manufacturer related to reexamination and reissue applications for large and small molecule therapeutics.
Biopolymer Engineering Inc. v. Immunocorp
The firm served as lead counsel for Biotec Pharmacon, ASA, a Norwegian pharmaceutical company, in patent infringement litigation initiated by patent owner Biothera, a Minnesota corporation, in the District of Minnesota in Minneapolis. The 14 patents involved in the litigation relate to, among other things, beta glucan compositions for immunotherapy. The District Court granted summary judgment of non-infringement as to 12 of the 14 patents, and the case subsequently settled.
Biopolymer Eng’g, Inc. v. Immunocorp, No. 05-536 (D. Minn. filed Mar. 14, 2005).
Oklahoma Med. Research Found. v. Alexion Pharmaceuticals Inc.
The firm served as lead counsel on behalf of Oklahoma Medical Research Foundation in a patent infringement suit brought in the Northern District of Oklahoma against Alexion Pharmaceuticals. The patents related to complement-inhibition technology and their use in a drug marketed by Alexion to treat a rare, debilitating and life-threatening disease. After replacing OMRF’s previous counsel in the matter and soon after claim construction briefing was complete, we obtained a settlement. It included payment to our client as well as public acknowledgement that individuals affiliated with OMRF were the true inventors of the technology at issue.
Oklahoma Med. Research Found. v. Alexion Pharmaceuticals, Inc., No. 07-163 (N.D. Okla. filed Mar. 15, 2007).
Porex Surgical Inc. et al v. Synthes USA Sales LLC et al.
Lead counsel for Porex Surgical, Inc., and Porex Corporation in patent infringement litigation. Soon after filing the suit, we filed a motion for preliminary injunction, engaged in expedited discovery and had a hearing date for an evidentiary hearing on the motion. At the same time the case was proceeding, our client was engaged in confidential negotiations for an asset sale transaction that included the operating business and the patent involved in the litigation that made the resolution of the case an important consideration in closing that transaction. Against that backdrop, we were able to negotiate a settlement of the lawsuit with Synthes on terms that pleased not only our client but the third party with which our client was negotiating and enabled our client to close its significant asset sale transaction. Porex Surgical, Inc. et al v. Synthes USA Sales, LLC et al., No. 3:10-cv-00023 (N.D. Ga. filed Feb. 10, 2010).
Smith & Nephew Inc. v. Synthes (U.S.A.)
Represented Smith & Nephew in a patent infringement suit against Synthes Corp. in the Western District of Tennessee. After a three-week bench trial, the court found Smith & Nephew’s patents to be valid and infringed. The court entered a permanent injunction in September 2006 enjoining Synthes from continuing to sell infringing bone repair devices. This is one the first permanent injunctions entered in a patent case after the Supreme Court’s eBay opinion. After briefing and argument in the Federal Circuit, the parties reached a confidential settlement of the case.
Smith & Nephew Inc. v. Synthes (U.S.A.), 466 F. Supp.2d 978 (W.D. Tenn. 2006).
PatentMarks v. Motorola Mobility LLC
Represents Motorola in patent litigation matter in which several smartphones are accused infringing a patent directed to multi-protocol telecommunications routing optimization. The case has not progressed beyond early discovery and is currently stayed pending resolution by settlement.
PatentMarks v. Motorola Mobility LLC, Case No. 13-998 (D. Del. filed June 4, 2013)
SoftView v. AT&T Mobility LLC et al.
Served as lead counsel for Motorola Mobility in a patent infringement suit filed by Softview in the District of Delaware against several smartphone manufacturers. The asserted patents related to scalable display of internet content on mobile devices. The case is currently stayed pending inter partes review.
SoftView v. AT&T Mobility LLC et al., Case No 12-990-LPS (D. Del. filed July 26, 2012)
Monec Holding AG v. Motorola Mobility, Inc.
The firm served as lead counsel for Motorola Mobility in a patent infringement suit filed by Monec in the District of Delaware. The parties settled the matter during expert discovery.
Monec Holding AG v. Motorola Mobility, Inc.. et al., Civ. No. 11-cv-00798 (D. Del. filed September 9, 2011)
The Use of Inter Partes Review Petitions in Pharma Patent Litigation, China Pharma Intellectual Property Summit, Shanghai, China, November 2016
Interpretation of Patent Dance of BPCIA and Its Influences on Biosimilars and Innovative Drugs, China Pharma Intellectual Property Summit, Shanghai, China, November 2016
PATENT LAW: Patent Law Update, 28th Annual North American Law Summit, Mexico, November 2016
Asserting and Defending Your Rights: Overview of Litigation and Life Cycle Planning for Drugs and Biologics, Pharmaceutical Patent Law Seminar, Shanghai, China, March 2016
Abbreviated New Drug Application (ANDA) with Paragraph IV Certification: Critical Insights in 2015, August 2015
Post-Grant & Covered Business Method Patent Review, November 2014
“Regulatory Exclusivity,” Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, September 2014
“Patent Law Basics: An Overview of Patent Law and Avoiding the Loss of Rights,” Kilpatrick Townsend & Stockton LLP, May 2015
“Negotiating a New Legal Landscape: The Advent of Follow-On Biologics,” University of San Francisco Law Review, Vol. 46, pp. 1029-1074, April 2012
“Protecting the Validity of Your Pharmaceutical Patents After KSR,” 2009 BIO International Convention, May 2009
“Patent Law Basics: An Overview of Patent Law and Avoiding the Loss of Rights,” Intellectual Property Desk Reference, January 2009