"The biochemistry PhD has seen applications through to grant hundreds of times, furnished vital support to litigation teams and represented parties before the PTAB – a diversity that has elevated his strategic thinking beyond his years.”
- 2021 IAM Patent 1000: The World's Leading Patent Professionals

Overview

Dr. Aydin Harston integrates scientific expertise with legal experience to help his clients grow, protect, and defend the intellectual property that powers their businesses. Aydin counsels and advocates for his clients in both prosecuting patents and managing patent portfolios and in the courtroom, where he is an experienced litigator who handles every aspect of patent-related cases, from discovery and claim construction issues to writing briefs, working closely with expert witnesses, conducting trial and, when necessary, appealing the outcome. 

As a practitioner, he is highly responsive when communicating with clients, beginning with making a point of responding promptly to emails and phone calls. It’s a seemingly simple thing, but makes an enormous difference in the attorney-client relationship. He thoroughly analyzes and communicates possible options and strategies, including the opportunities and risks each presents. An innovative thinker, he is exceptionally creative in devising potential solutions and arguments, directed towards a definitive and advantageous resolution for his clients. He strives to understand their businesses, markets, and goals, and tailors solutions to individual situations. In a complex, difficult intellectual property matter, he is both a formidable adversary and a highly effective ally. Said one client, “I have found his attention to detail and willingness to provide his professional opinion and guidance to be first class. He is someone who genuinely cares and understands the importance of a successful outcome. We feel extremely fortunate to have him as a member of our team.”

Originally a scientist with a Ph.D. in biochemistry, he has devoted his career to studying and working with various aspects of science and technology. Based on his own research path and obtaining both novel and non-obvious results, he now focuses on helping inventors protect their discoveries. He devises creative and simple solutions and explanations for complex situations that enable clients in fields ranging from pharmaceuticals to food science to chemical, mechanical, electronic, and mechanical devices achieve their goals as efficiently as possible. 

In addition to his U.S.-based clients, a significant part of Aydin’s work includes representing international clients from major technology hubs around the world, including South Korea, Europe, Israel, Japan, Australia, Canada, China, and Singapore. His work is concentrated in pharmaceutical, biotechnology, medical device, health technology, and chemical companies, as well as companies manufacturing mechanical devices and materials such as layers of glass, films, coatings, inks, etc.

Since joining the firm in 2007, Aydin has attained an exceptionally in-depth and hands-on knowledge of every aspect of the patent process. In addition, his formal training as a scientist, including authoring numerous publications in high-impact journals, equips him to both quickly grasp and effectively communicate the nuances of what can be extremely complex technologies. Prior to joining Rothwell Figg, he researched protein structures, interactions, and dynamics using nuclear magnetic resonance (NMR) and other biochemical techniques. He also investigated and used novel protein expression and purification techniques, particularly for increasing the purified yield of isotope-labeled proteins.

Experience

Aydin has prosecuted over a thousand patent applications in chemical, pharmaceutical, biotechnology, and mechanical fields and handled numerous IP diligence projects. He has participated in litigation teams representing clients in Federal district courts and at the Court of Appeals for the Federal Circuit. Aydin has also represented clients in inter partes review, appeal, and reexamination proceedings before the U.S. Patent and Trademark Office.

Representative cases:

  • In Fresenius Kabi USA Inc. v. Coherus BioSciences, Inc. (PGR2019-00064), Aydin represented Coherus in defending its adalimumab formulation patent number U.S. 10,155,039 covering a biosimilar of the top-selling drug in the world, Humira®. In its Final Written Decision, the Board agreed with the arguments written by Aydin and the team in the Patent Owner’s Response and denied all of the challenges to Coherus’ patent.
  • In Acrux DDS Pty Ltd. v. Kaken Pharm. Co. Ltd. (IPR2017-00190), Aydin represented Acrux in successfully challenging the seminal patent covering the blockbuster drug, Jublia®, in IPR2017-00190 before the Patent Trial and Appeal Board. The Board agreed with Acrux’s challenge and cancelled all of the claims of the patent to help clear the path for generic entry. Since the victory, at least 22 other generic drug makers have filed applications to make generic versions of Jublia®.
  • In Galderma Labs. LP v. Actavis Labs. UT, Inc., No. 1:15-cv-00232 (D. Del.), Aydin represented Actavis in challenging patents leading to settlement on patents covering the rosacea treatment Mirvaso®.
  • In Sunovion Pharm., Inc. v. Watson Pharms., No. 1:12-cv-00993 (D. Del.), Aydin represented Watson (Actavis) in Hatch-Waxman litigation leading to settlement after trial on the patent covering Xopenex® allowing launch of generic versions of the asthma drug.
  • In Sunovion Pharm., Inc. v. Synthon Pharm., Inc., No. 5:08-cv-179-H(3) (E.D.N.C.), Aydin represented Synthon in Hatch-Waxman litigation leading to settlement on patent covering Xyzal® allowing Synthon to launch its generic version of the anti-allergy drug.
  • In Appeal No. 2021-000352 (Appl. No. 16/216,225), Aydin represented Agienic before the Board on its oil field proppant coating technology, resulting in reversal of all rejections and issuance of U.S. Pat. No. 11,352,551.
  • In Appeal No. 2018-005516 (Appl. No. 15/154,458), Aydin represented Agienic before the Board on its oil field proppant technology, resulting in reversal of all rejections and issuance of U.S. Pat. No. 10,208,241.
  • In Appeal No. 2015-007342 (Appl. No. 13/219,394), Aydin represented RegeneRx Biopharmaceuticals before the Board on its dry eye syndrome treatment, resulting in reversal of all rejections and issuance of U.S. Pat. No. 9,821,030.
  • In Appeal No. 2013-006526 (Appl. No. 10/585,970), Aydin represented IHI E&C International before the Board on its recovery of liquefied petroleum gas or natural gas liquids technology, resulting in reversal of all rejections and issuance of U.S. Pat. No. 9,360,249 after many years of erroneous rejections by the Examiner. Aydin’s successful arguments resulted in the Office awarding the patentee more than 8.5 additional years of patent term to compensate for the significant delays caused by the erroneous rejections.
  • In Reexamination Proceeding 90/009,946, Aydin successfully defended against challenges to his client’s wine treatment technology, resulting in issuance of a re-examination certificate that confirmed patentability of all claims without any amendments or cancellations.
  • In Reexamination Proceeding 90/009,947, Aydin successfully defended against challenges to his client’s wine treatment technology, resulting in issuance of a re-examination certificate that confirmed patentability of all claims without any amendments or cancellations.

Prior to joining Rothwell Figg, Aydin researched protein structures, interactions, and dynamics using nuclear magnetic resonance (NMR) and other biochemical techniques. He also investigated and used novel protein expression and purification techniques, particularly for increasing the purified yield of isotope-labeled proteins. Aydin's dissertation focused on the molecular structures and interactions of proteins involved in cellular protein degradation pathways. His research was published in high impact journals including Nature Structural Molecular Biology and Molecular Cell. Aydin also served in scientific, marketing, and business development capacities at a start-up biotechnology firm in Maryland.

Honors & Recognitions

Intellectual Asset Management's (IAM) Patent 1000: The World's Leading Patent Professionals (2021-2022)
Ranked for Prosecution in the D.C. Metro Area

Washington, D.C. Super Lawyers "Rising Star" (2017-2022)

Martindale-Hubbell Client Champion Gold (2018-2022)

Newsroom

News

Publications

Harston, A., and Tian, V., “Takeaways from FDA’s Approval of the First Interchangeable Biosimilar for Humira®,” www.BiosimilarsIP.com, October 25, 2021. 

Harston, A., “Pitfalls of Attorney-Client Privilege and Tips for Corporate Officers and Employees,” www.RFEMerge.com, June 16, 2021.

Harston, A., "How the U.S. Compares to Europe on Biosimilar Approvals and Products in the Pipeline," www.BiosimilarsIP.com, March 8, 2021.

Harston, A., “Cadent Therapeutics Acquired by Novartis for Up to $770 Million,” www.RFEMerge.com, December 18, 2021.

Co-author, “Lessons Learned From Centripetal’s Multi-Billion Dollar Damages Award Against Cisco,” www.RFEMerge.com, November 23, 2020.

Co-author, “Is it Time to Re-evaluate (or Create) Your Document Retention Policy?” www.RFEMerge.com, November 6, 2020.

Harston, A., "How the U.S. Compares to Europe on Biosimilar Approvals and Products in the Pipeline," www.BiosimilarsIP.com, October 12, 2020.

Harston, A., “Biosimilar Approvals Stall During COVID-19 Pandemic, But the Pipeline Grows,” www.BiosimilarsIP.com, June 9, 2020.

Harston, A., “U.S. Biosimilar Launches Accelerate with Five Launches in Q4 2019 and early 2020,” www.BiosimilarsIP.com, January 28, 2020.

Harston, A. and Lee, Alvin, “Time to Rethink ‘Consisting Essentially of’ as a Claim Limitation,” www.BiosimilarsIP.com, November 20, 2019.

Harston, A., “FDA Approves Four Biosimilars During Summer 2019 While Europe is on Vacation,” www.BiosimilarsIP.com, September 17, 2019.

Harston, A., “House Democrats Seek to Remove Biologics Exclusivity Period from USMCA,” www.BiosimilarsIP.com, July 25, 2019.

Harston, A. and Teigen, A.J., “What Pharma Companies Must Do Globally to Benefit From Canada’s Patent Term Extension Framework,” www.BiosimilarsIP.com, July 17, 2019.

Harston, A., “Responding to Growing Criticisms, PTAB Expands Discretion to Deny Institution,” www.PTABLaw.com, May 17, 2019.

Harston, A., “Key Takeaways from a Flurry of Precedential Decision Designations,” www.PTABLaw.com, April 11, 2019.

Harston, A. and Teigen, A.J., “Why the Disconnect? Federal Circuit Reverses Yet Another Inherent Obviousness Decision,” www.PTABLaw.com, March 22, 2019.

Harston, A., “Biosimilars Will Get Special Names – Suffixes are Here to Stay,” www.BiosimilarsIP.com, March 15, 2019.

Harston, A., “Two Asserted Lantus Patents Cancelled – Commercial Success Evidence Insufficient Because of Blocking Patents,” www.PTABLaw.com, January 8, 2019.

Harston, A., “USMCA Assailed as Exacerbating High Drug Prices,” www.BiosimilarsIP.com, November 15, 2018.

Harston, A. (panel member), “Roundtable: Trends in Biosimilars,” https://www.financierworldwide.com/roundtable-trends-in-biosimilars, October 2018.

Harston, A. and Allen, D.L., “Federal Circuit: No Tribal Sovereign Immunity,” www.PTABLaw.com, July 23, 2018.

Harston, A., “Ignore PTAB Precedent at Your Peril,” www.PTABLaw.com, May 30, 2018.

Harston, A., “Challenging Pharmaceutical Patents, New Arrows in the Quiver?” www.PTABLaw.com, April 10, 2018.

Harston, A., “A Rare Successful Challenge of a Patent for a Method of Manufacturing Biologic Drugs,” www.BiosimilarsIP.com, March 12, 2018.

Harston, A., “Federal Circuit Revives Polaris’ Claims After PTAB’s Obviousness Analysis Veers Off Course,” www.PTABLaw.com, February 23, 2018.

Harston, A., “Are Communications with Foreign Patent Agents and Attorneys Privileged in PTAB Proceedings?” www.PTABLaw.com, November 14, 2017.

Co-author, “Reissue Applications During Post Grant Proceedings: To Stay or Not To Stay?” www.PTABLaw.com, October 4, 2017.

Harston, A., “FDA Reauthorization Bill is Enacted–Changes Biosimilar User Fees and Review Model,” www.BiosimilarsIP.com, August 4, 2017.

Harston, A., “An Overview of Important Changes in BsUFA II,” www.BiosimilarsIP.com, June 27, 2017.

Co-author, "How the U.S. Compares to Europe on Biosimilar Approvals and Products in the Pipeline," www.BiosimilarsIP.com, April 25, 2017.

Co-author, "Long-Lived States to Monitor Protein Unfolding by Proton NMR" ChemPhysChem, 12(15), (2011): 2729–2734.

Co-author, Perturbing the Ubiquitin Pathway Reveals How Mitosis Is Hijacked to Denucleate and Regulate Cell Proliferation and Differentiation In Vivo, PLoS ONE, 5(10), (2010): e13331.

Co-Author, Structure of the S5a:K48 Linked Ubiquitin Complex and Its Interaction with Rpn13, Mol. Cell. 35(3), (2009):280-290.

Co-Author, Avid Interactions Underlie the K63-Linked Polyubiquitin Binding Specificities Observed for UBA Domains, Nature Struct. Mol. Biol. 16(8), (2009):883-889.

Haririnia, A. et al., Mutations in the Hydrophobic Core of Ubiquitin Differentially Affect its Recognition by Receptor Proteins, Journal of Molecular Biology 375, (2008):979-996.

Haririnia, A. et al., “Mapping the interactions between Lys48- and Lys63-linked di-ubiquitins and a ubiquitin-interacting motif of S5a” Journal of Molecular Biology 368, (2007):753-766.

Co-Author, “Personal Role Management: Overview and a Design Study of Email for University Students" Kaptelinin, V., Czerwinski, M. (Editors) Beyond the Desktop Metaphor, MIT Press, April 1, 2007.

Co-Author, “Solution conformation of Lys63-linked di-ubiquitin chain provides clues to functional diversity of polyubiquitin signaling” Journal of Biological Chemistry 279, (2004):7055-7063.

Community & Professional

American Bar Association, Co-Chair of the Biotechnology, Healthcare Technology, and Medical Devices Committee of the ABA’s Science & Technology Law Section

American Intellectual Property Law Association

Intellectual Property Owners Association

Federal Circuit Bar Association

PTAB Bar Association

Education

J.D., The George Washington University Law School (with honors)

Ph.D., Biochemistry, University of Maryland, College Park

B.S., Biochemistry, University of Maryland, College Park

Bar & Court Admissions

Bar Admissions

  • District of Columbia
  • Virginia
  • U.S. Patent and Trademark Office

Court Admissions

  • U.S. Court of Appeals for the Federal Circuit
  • U.S. District Court for the Eastern District of Virginia
  • Supreme Court of Virginia
Jump to Page

By using this site, you agree to our updated Privacy Policy and our Terms of Use.