AIPPI 2018: Eli Lilly talks IPRs and biosimilar litigation
The inter partes review (IPR) process has had a huge impact on biosimilar litigation, but it isn’t truly fulfilling its goal of being an alternative to district court litigation.
This is the opinion of Mark Stewart, assistant general patent counsel at Eli Lilly, who spoke yesterday on the “Biosimilar litigation—dissimilar considerations?” panel at the 2018 AIPPI World Congress in Cancún, Mexico.
He noted that almost every biosimilar applicant has been through the IPR process, but that because of concurrent litigations, it is up for debate whether IPRs are truly an alternative.
Manisha Desai, associate general patent counsel at UCB and panel moderator, said she had read that 70% of IPR petitions that have been filed involved a defendant who is also involved in district court litigation.
Stewart added that in June this year, US Senator Orrin Hatch proposed an amendment to the Hatch-Waxman Act. The amendment, called the Hatch-Waxman Integrity Act of 2018, would force a generic company that wishes to challenge a patent to choose between filing a Hatch-Waxman lawsuit or an IPR, rather than having the option to pursue both.
Another difference between the two litigation pathways is the standards to prove invalidity under Patent Trial and Appeal Board proceedings and those at the district courts.
In an IPR, a preponderance of evidence must be demonstrated in order to prove invalidity, while in court, a clear and convincing argument must be made.
In May, in a bid to standardise proceedings, the USPTO proposed to replace the broadest reasonable interpretation standard for construing unexpired and proposed patent claims in America Invents Act trials with the standard that is applied in district court and International Trade Commission proceedings.
Stewart said: “You can have a situation where you can fairly litigate a patent through a district court proceeding, have it affirmed by the US Court of Appeals for the Federal Circuit and then you can have an IPR filed, following successful litigation that may have taken years and millions of dollars.”
Whether the Unified Patent Court (UPC) will actually come into existence was also raised, with Neil Trueman, chief international patent counsel of pharmaceutical company Mundipharma, stating that it was “anyone’s guess”.
“There’s still going to be forum shopping with a local flavour present in each court, in terms of both languages and the judges that sit in those courts,” he added.
Trueman noted that the UPC will be a particularly attractive venue if the patents are “on the shaky side”, as he expects there will be an initial stance to make the court effective and give pro-patent decisions.
Jesús Sepúlveda, technical and legal services manager at Clarke Modet in Mexico, also spoke at the session, where all panellists spoke in a personal capacity.
The 2018 AIPPI World Congress finishes today, September 26.
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