Tasha Francis, Will Orlady and Dorothy Whelan Author NYIPLA Article, “Recent Developments in Biopharma PTAB Practice”
In 2016, the Patent Trial and Appeal Board (PTAB) was once again the busiest forum for challenging patent validity, surpassing other leading venues such as the Eastern District of Texas and the District of Delaware. Although the overall number of petitions for inter partes review (IPR) has started to plateau, the percentage of biopharma petitions— defined as those petitions involving Group 1600 patents— continues to grow. More specifically, in 2016, biopharma petitions accounted for 13% of all IPR petitions filed at the PTAB—representing a 4% increase over 2015 and a 7% increase over 2014. Further, the IPR biopharma petitions expanded from small molecules to biologics. This article reports developing trends in biopharama PTAB practice. More particularly, we discuss (1) which biopharma entities played significant roles in biopharma IPRs in 2016, (2) statistics including petition numbers, institution rates, and settlement rates in the biopharma space, and, finally, (3) an analysis concerning the PTAB’s evaluation of objective indicia of nonobviousness in the biopharma space.
I. Biopharma Entities Involved in IPRs
As can be seen in Table 1, the most active IPR petitioners in 2016 were Mylan Pharmaceuticals (59 petitions), the Coalition for Affordable Drugs (28 petitions), and Amneal Pharmaceuticals (23 petitions). This list reveals that both pioneers and generics filed petitions challenging patent validity. Notably, the Coalition for Affordable Drugs, run by hedge fund manager Kyle Bass, was the second-most active participant and is neither a patent owner nor a biopharma manufacturer. As also can be seen in Table 1, the most targeted patent owners in the biopharma space in 2016 were Allergan (16 validity challenges), AstraZeneca (15 validity challenges), and Senju Pharmaceutical (15 validity challenges).
Table 1: Most Active Biopharma Entities at the PTAB
|Top 2016 Biopharma IPR Petitioners||Top 2016 Biopharma IPR Patent Owners|
|Mylan Pharmaceuticals (59 petitions)||Allergan (16 validity challenges)|
|Coalition for Affordable Drugs (28 petitions)||AstraZeneca (15 validity challenges)|
|Amneal Pharmaceuticals (23 petitions)||Senju Pharmaceuticals (15 validity challenges)|
|Apotex (23 petitions)||Cubist Pharmaceuticals (13 validity challenges)|
|Lupin (18 petitions)||Genentech (13 validity challenges)|
|Dr. Reddy’s Laboratories (14 petitions)||Myriad Genetics (12 validity challenges)|
|GeneDx (12 petitions)||Proctor & Gamble (12 validity challenges)|
|Praxair Distribution (10 petitions)||Novartis (11 validity challenges)|
|Agila Specialties (9 petitions)||Depomed (9 validity challenges)|
|Fresenius Kabi USA, Illumina, and Teva Pharmaceuticals (three-way tie) (8 petitions each)||Pozen (9 validity challenges)|
(Source: LegalMetric, current data as of November, 2016)
In addition to IPR challenges focused on small molecules, petitioners continued to challenge patents covering biologic products in 2016. Specifically, the data show that from 2013 to 2015, the number of IPR petitions concerning biologics increased severalfold. In 2013, for example, the PTAB received only four IPR petitions concerning biologics; in 2015, it received 17; and, in 2016, 16 petitions were filed. As it stands, the most challenged biologics patents relate to Abbvie’s Humira® (adalimumab) (12 petitions to date), and Genentech’s Herceptin® (trastuzumab) (8 petitions to date) and Rituxan® (rituximab) (7 petitions to date). These challenges suggest that, at least in some cases, the IPR process may form part of a “freedom to operate” strategy to clear out patents in the early stages of biosimilar development to avoid patent issues arising later in the development process.
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