While many patent disputes involve high tech components like semiconductors or computers, many concern pharmaceuticals. The U.S. Food and Drug Administration compiles pharmaceuticals into what is called the Orange Book, which contains patents for FDA-approved drug products with therapeutic equivalence evaluations.
The Patent Trial and Appeals Board (PTAB), meanwhile, is an administrative body formed in 2012 as part of the America Invents Act. PTAB hears many patent disputes, including inter partes reviews that challenge the validity of a given patent.
Mylan Pharmaceuticals has filed the most PTAB petitions concerning Orange Book patents since PTAB was formed, according to Docket Alarm’s data. The company, along with others like Apotex, Teva Pharmaceuticals, Dr. Reddy’s, and Amneal, have sought to contest patents in order to have the ability to produce more, primarily generic, pharmaceuticals.
On the other side of PTAB proceedings are patent owners who defend the validity of challenged patents. Both Allergan and AstraZeneca have had a significant number of patent complaints filed against them, but have not filed any of their own petitions challenging other patents..
Some law firms, like Williams & Connolly and Fish & Richardson, have represented exclusively patent owners, while other major law firms filing petitions regarding pharmaceutical patents have represented a mixture of patent owners and companies contesting those patents.
Mylan Pharmaceuticals has filed the most petitions regarding Orange Book patents before the PTAB, with 64. The company produces generic pharmaceuticals, it merged in late 2020 with Pfizer Inc.’s Upjohn and formed Viatris so none of the filings occurred recently.
Almost a quarter of these filings initiated by Mylan occurred in June 2016 when it filed 15 petitions asking for a review of specific patents, claiming that at least some claims of the patent are unpatentable, among other claims. These filings were primarily regarding Allergan’s patents but some petitions addressed patents held by Senju Pharmaceuticals, Janssen Oncology, AstraZeneca, and Research Corporation Technologies.
A majority of these cases, including those filed in June and others, were determined in Mylan’s favor with 34 proceedings ending in termination of the patent. Docket Alarm analytics show that there have been 44 decisions and 39 of those times the company’s petition was instituted and that out of 16 written decisions in the lawsuits 10 were determined in Mylan’s favor.
Apotex, a large Canadian generic drug company, filed 35 patent disputes since 2012, with the large majority of filings occurring in 2015 and 2016 and fewer occurring recently. Multiple filings in 2015 and 2016 were regarding a patent owned by Eli Lilly and Company for antifolate combination therapies.
Apotex’s success rate for its petitions is not significantly different from Mylan Pharmaceuticals.. Of its petitions that came to an institution decision, 13 were instituted out of 18, meaning 72% of its petitions which came to a final decision from were either instituted in full or in part.
Apotex has been represented by multiple law firms, each hired for about 12 lawsuits although there were other law firms hired for fewer. The main law firms retained by Apotex include Rakoczy Molino Mazzochi Siwik; Brinks Gilson & Lione; Carlson, Caspers, Vandenburge, Lindquist & Schuman, Goodwin Procter, and Pillsbury Winthrop Shaw Pittman.
The third highest company for filing petitions against Orange Book patents is Teva Pharmaceuticals, an Isreali-American generic drug company, which has filed 33 filings since 2021. A large majority of these patents were filed in the last quarter of 2015, middle of 2016 and early 2017.
Teva has had a higher success rate than Apotex, although a lower success rate than Mylan Pharmaceuticals. According to Docket Alarm data, 88% of the 16 institution decisions were in Teva’s favor, and 24 percent, or 4 of the 17, written decisions were in its favor. More recently, the decisions on its petitions have been more likely to be in Teva’s favor and the claims it lost occurred in 2016.
A group of law firms have represented Teva in these lawsuits. In the most recent filing it was represented by Goodwin Procter, which has represented them in 15 cases so far. The firm that has represented Teva the most is Carlson, Caspers, Vandenburgh, Lindquist & Schuman, which has represented them in 19 cases. Three other law firms have represented Teva in 12 cases, Brinks Gilson & Lione, Pillsbury Winthrop Shaw Pittman, and Rakoczy Molina Mazzochi Siwik.
Allergan is the company who has had the most petitions filed against concerning Orange Book patents. It makes brand-name pharmaceuticals as well as products like Botox. Although the company has not been a petitioner, it has been involved as the patent owner in 30 different petitions, according to Docket Alarm. Of those 30 petitions, five occurred in June 2015, seven including the three filed by Mylan occurred in June 2016, and the remaining 18 were filed in January 2017.
All but six of the proceedings involving Allergan as the patent owner have ended in a termination of the patent. This pharmaceutical company has had 10 petitions instituted against it, and two written decisions. In each case, all claims were cancelled.
AstraZeneca, Novartis AG, and Opiant are the next three companies in volume of petitions being filed against their patents, but none of these companies had the same rate of claims being determined against them. Of the 18 lawsuits against AstraZeneca’s patents, 11 had a court decision on institution and only one of those was decided against it. Almost half of the claims against Novartis were decided in its favor and a majority of the claims regarding Opiant were decided in its favor. Both Novartis and Opiant received 15 lawsuits against them over Orange Book patents.
Allergan has been represented primarily by Fish & Richardson and sometimes by Shore Chan. Astrazeneca has been represented by O’Melveny & Myers, Finnegan, Henderson, Farabow Garrett, and Dunner, McCarter & English, and others.
Pharmaceutical patents are an important subset of the patent industry, generating significant litigation both inside and outside of PTAB. Perhaps unsurprisingly, it is very rare for a pharmaceutical company to serve as both petitioner and patent owner in different cases before PTAB – either one or the other, with limited exception.