Stephen is a patent litigator whose practice is primarily focused on pharmaceuticals and Paragraph IV disputes under the Hatch-Waxman Act. He has acted as lead counsel for clients in numerous pharmaceutical patent litigations, including cases relating to drugs for the treatment of migraine, sepsis, epilepsy, bipolar disorder, acne, Alzheimer's, ADHD, and pain. He has experience in all phases of Paragraph IV disputes, including the cost-effective management of cases, from pretrial through trial and appeal.
With a strong technical background in life sciences and a particular focus on immunology and molecular biology, Stephen has also handled cases in a variety of other areas, including DNA sequencing, research tools, diagnostics, medical devices, agricultural products, consumer products, and food products.
- (D.NJ) — As lead counsel, tried Hatch-Waxman case in which a pharmaceutical company defended its patents relating to a treatment for pain
- (E.D. Tex.); (Fed. Cir.) — Served as lead counsel in Hatch-Waxman litigations in which a pharmaceutical company defended its patents covering a migraine therapy in the first Paragraph IV litigations tried in the Eastern District of Texas; affirmances of judgment were granted in two separate appeals
- (D.NJ) (D.Mass.) (D. Del.) (N.D. Tex.) — Served as lead counsel in Hatch-Waxman litigations relating to numerous pharmaceutical products including those for the treatment of pain, epilepsy, bipolar disorder, acne, Alzheimer's, ADHD, end stage renal disease and cancer
- (E.D. Tex.) — Represented a food products manufacturer in a patent litigation and attendant inter partes reexamination that included an appeal to and argument before the PTAB; the PTAB reversed the examiner and entered a new rejection of all pending claims
- (D. Me.) — Served as lead trial counsel for a dry groceries manufacturer in a patent infringement case involving plant sterols; sought transfer of the case from its originally filed jurisdiction to the defendant's home forum, and meanwhile, filed an ex parte reexamination request with the USPTO; the Court in the transferee forum then stayed the case pending reexamination, resulting in the cancellation of all of the asserted patent's claims
- (D. MN) — Represented a consumer products company in a litigation relating to dental materials
- (D. MN) — Represented a consumer products company in a litigation relating to an automotive after-market product
- (D. D.C.) — Represented a plant biotechnology company in patent litigations relating to genetically modified plants
- (E.D. Tex.) — Represented a biotechnology company in a multipatent infringement litigation filed in the Eastern District of Texas, relating to the use of labeled oligonucleotide primers in PCR
- (E.D. Wis.) — Represented a Swedish medical device company in litigations relating to medical imaging and patient data management
- (E.D. Tex.) — Represented a grocery retailer in a design patent and trade dress case relating to a children's product
- (E.D. Tex.); (Fir. Cir.) — Represented a media company in a patent infringement case related to photographic images and information displayed on the floor—which is a significant source of revenue for the client—favorable ruling on claim construction; subsequently, the plaintiff conceded that it could not prove infringement, and the court entered a final judgment of dismissal
- (W.D. Wis.) — Represented a Danish bio-based company in a patent infringement case relating to genetically-engineered enzymes used to make fuel ethanol; the patent was held invalid for lack of written description at the trial court level and affirmed on appeal
International Trade Commission Litigation
- (ITC) — Representing a DNA sequencing company in patent investigation before the ITC, securing an MSD of noninfringement
- (ITC) — Represented a DNA sequencing company in patent investigation before the ITC relating to nanopore sequencing technology, resulting in a favorable settlement for the client
- (ITC) — Represented a large retail grocery in patent investigation before the ITC relating to multiple mode (solid and gas fueled) outdoor grills, resulting in a favorable settlement for the client
Patent Post-Grant Proceedings
- Represented a pharmaceutical company in 8 IPR proceedings related to challenges to patents covering pharmaceutical products, successfully avoiding institution in 6 of the cases, and prevailing at trial on the other 2
- Represented a research tools company in four inter partes reexaminations related to high-throughput sequencing that resulted in rejections of all challenged patent claims through Actions Closing Prosecution in less than 12 months from filing of initial requests
- Represented a global manufacturer and marketer of differentiated chemicals in an arbitration involving patents directed to photocurable resins for use in stereolithography; resulting in a favorable settlement for the client
Awards & Community
Named an "IP Star" by Managing Intellectual Property, 2014-2017
Recognized as a Texas Super Lawyer (Thomson Reuters), 2014-2018
Publications, Speeches & Presentations
Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Second EditionExternal Articles
American Bar Association
The Federal Circuit Holds BPCIA’s 180-Day Notice of Intention to Commercially Market can Only be Provided After Product is ApprovedExternal Articles
Baker Botts will be hosting a private reception at the JW Marriott located in San Francisco Union Square on Tuesday January 8, 2019.
On April 23-24, join partners Stephen Hash and Michael O'Shaughnessy for ACI's 12th Annual Paragraph IV Disputes Conference in New York, NY.