By James DeGiulio —
One of the highlights of the afternoon sessions at the BIO International Convention was a seminar appropriately entitled "A Brave New World: Patent Litigation Tactics and Strategies for Biosimilars," where an experienced panel of patent attorneys presented their interpretation of the new biosimilars pathway of the Biologics Price Competition and Innovation Act and speculated on some of the potential issues that will arise once the statute is put into practice. The panel consisted of patent counsel from both brand and generic industries, including Mark Bowditch (Sandoz, Inc.), Edward Murray (Merck & Co., Inc.), and Bart Newland (Biogen Idec Inc.), while moderator Eric Marandett of Choate Hall & Stewart LLP supplied the perspective of outside counsel. The panel outlined the various litigation phases of the framework, with each panelist discussing a specific aspect of the statute, often returning to a big-picture view of the timeline of the procedural provisions of the statute. After this thorough discussion of the provisions of the statute (which will not be covered here), the panel described several issues that the statute as written will present in the near future.
The first strategic decision that the biosimilar applicant must make is to decide which pathway it wishes to take toward FDA approval of the biologic. The statute provides two pathways for a biosimilar applicant: the interchangeable pathway, and the biosimilar pathway. Interchangeable biologics are awarded their own exclusivity term, but biologics classified as merely "biosimilar" do not enjoy any exclusivity. However, the standard for interchangeability with the BLA reference product will presumably be much higher, and likely more expensive to achieve, though the FDA has yet to issue its guidelines on these standards. The decision will ultimately come down to the business strategy of the particular product. Interestingly, the panel noted that many of the biosimilar products on the horizon are focused on being "biobetters," in that they wish to distinguish themselves as a better, and thereby different, product than the BLA reference product. How this emphasis will impact FDA approval on particular biosimilars remains to be seen.
The various periods of exclusivity are well known under the new scheme, for they were intensely debated prior to passage of the statute. In light of these various periods of exclusivity, the question arises: when should a biosimilar applicant file their application? On one hand, it may be of interest to file the application as early as possible after the 4-year data exclusivity period. This will provide ample time to resolve any patent disputes before FDA approval. However, unlike the 180-day exclusivity under Hatch-Waxman, the biosimilar scheme lacks a reward for a first-to-file biosimilar application. On the other hand, it may be beneficial for the applicant to wait until the 12-year market exclusivity is set to expire, using more time to perfect the biosimilar application. Since the biosimilar scheme also lacks a 30-month stay, the biosimilar applicant could then launch its product after providing the required 180-day notice to the BLA holder. However, since the patent litigation would still be unresolved, this would be equivalent to launching "at risk," which can have serious financial consequences if the litigation does not go as planned for the biosimilar applicant.
Access of confidential information by the BLA holder was a major point of concern at the session. Under the statute, within 20 days after the FDA has accepted its application, a biosimilar applicant must provide the BLA holder a copy of the full application, including a description of the process for manufacturing the biosimilar product. The BLA holder must keep the application and information confidential, and the use of such information is restricted. From the side of the biosimilar applicant, it is extremely unsettling to have to provide the entire application to the BLA holder. Essentially, the biosimilar applicant must hand over all of the most important information pertaining to the biosimilar to its fiercest competitor, including manufacturing processes which may apply to future pipeline biologic products. The panelists noted that this disclosure seems excessive, particularly when the applicant has no intention to challenge the patents covering the BLA reference product.
One of the hallmarks of the new biosimilar scheme is the complex exchange of patent lists and detailed statements of infringement/validity/enforceability between the BLA holder and the biosimilar applicant. The question was raised — how does one decide which patents to list? The panel was nearly unanimous in their assessment that every patent that can plausibly be asserted should be listed at least on the original exchange list. There is simply much more risk in not listing a patent, for the BLA holder is forever barred from bringing an infringement action relating to that patent, even in the later pre-commercial marketing stage where litigation can arise. These patent lists are likely to be extensive, for the BLA holder will likely have in patents not only on the composition itself, but it will also have patents on the platform technology used to make the biologic. All of these patents conceivably can be asserted under the biologics scheme, which is in contrast to the Orange Book, which has restrictions on which patents can be listed.
The listing of newly acquired patents during an active litigation may present serious logistical problems. Under the statute, the BLA holder has 30 days to supplement its patent listing with newly granted or newly licensed patents. The biosimilar applicant then has 30 days to put forth its detailed statement. However, depending on the stage of litigation and proximity to trial, it may be practically impossible to add the new patent to the litigation. It is unclear how a judge would handle such a case — it is possible that the new patent would have to be litigated separately at a future date. One panelist suggested that, if possible, a BLA holder should expedite the prosecution or licensing of any applications or patents that could potentially be listed in the litigation immediately upon the filing of a biosimilar application against their biologic product.
Finally, of particular interest to the session audience, half of which were IP counsel, the new biologics pathway will have a major impact on the roles of outside counsel. With small molecules, most pharma companies are classified generally as "brand" or "generic," and these companies retain their outside counsel allegiance on their respective sides of the Hatch-Waxman scheme. However, under the new biosimilar pathway, many companies will step out of their traditional roles, where "brand" companies may be filing biosimilar applications, essentially becoming a "generic" and reversing roles. For biosimilars, the line is not as clear as "brand" and "generic," which has the potential to cause major conflict problems for outside counsel. The panelists recommend planning far ahead to line up counsel with specific roles. In-house counsel will not have time to shop firms and clear conflicts since the timeframes for the patent exchanges and the detailed statements are extremely short.
It is unclear exactly how, or if, the new biosimilar framework will work in practice. Even if it does work, will anyone even bother to file a biosimilar application over a traditional BLA? The panelists at today's session were of the opinion that we will see a biosimilar application sometime in the near future. The first biosimilar application filed under the new framework is certain to generate major interest within the biotech sector, and will undoubtedly be the subject of several future BIO sessions.
If any Patent Docs readers who may be attending BIO this week are interested in discussing today's session further, you are encouraged to stop by the MBHB booth #4723 – Hall C, or send me an e-mail. I will be at the booth from 3:00 – 5:00 pm on Wednesday, June 29, and from 11:30 am – 1:00 pm on Thursday, June 30. Enjoy the rest of the BIO conference.
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