Elaine Herrmann Blais, partner; Scott Lassman, partner; and Alexandra Valenti, associate at Goodwin, covered 3 areas of topics ranging from the Biologics Price Competition and Innovation Act litigation, updates on the Patent Trial and Appeal Board, and recent regulatory and FDA issues related to biosimilars.
Today, 3 attorneys from Goodwin hosted a webinar to provide an update on recent litigation and trends in the current biosimilars market.
Elaine Herrmann Blais, partner; Scott Lassman, partner; and Alexandra Valenti, associate, covered 3 areas of topics ranging from the Biologics Price Competition and Innovation Act (BPCIA) litigation, updates on the Patent Trial and Appeal Board (PTAB), and recent regulatory and FDA issues related to biosimilars.
The first issue up for discussion was “blind” infringement suits. Specifically, Blais explained that many biosimilar manufacturers are unsure how to comply with the BPCIA Patent Dance Statute 42 U.S.C. § 262(l)(2)(A)-(B). Whereas some biosimilar applicants have taken the approach that producing the abbreviated Biologics License Application (aBLA) complies with the statute, others have gone further and produced some manufacturing information in addition to the aBLA.
This practice leaves reference product developers to file allegedly “blind” infringement suits without information on manufacturing practices other than what is disclosed in the aBLA. To date, Blais noted, no court has definitively ruled on how to comply with the policy nor specified how much manufacturing information should be disclosed, if any, outside of the aBLA.
The attorneys went on to discuss a hot topic in the biosimilar sphere as of late: patent thickets. FDA Commissioner Scott Gottlieb, MD, has been on record as stating that patent thickets have delayed biosimilar market entry, and that the FDA will not be playing “regulatory whack-a-mole” with companies partaking in such practices.
Valenti explained that a specific biologic product may be covered by 10 or more than 100 patents, and patent-holders may assert infringement claims against biosimilar manufacturers based on any or all of these patents, depending upon the outcome of the patent dance.
For example, Valenti provided an overview of AbbVie v Boehringer Ingelheim (BI) where AbbVie asserted 74 patents over its reference adalimumab product, Humira. BI is arguing what Valenti referred to as an “unclean hands” defense, alleging that AbbVie engaged in a “pattern of pursuing numerous overlapping and non-inventive patents for the purpose of developing a ‘patent thicket,’ using the patenting process itself as a means to seek to delay competition.”
To support its defense, BI sought discovery of Research & Development (R&D) documents dated outside the default 6-year period. While the court rejected BI’s argument that the case was “unusual, given the number of patents and claims at issue,” the court did order AbbVie to produce R&D documents finding that the information is relevant to the litigation.
Next, Blais discussed the Safe Harbor Statute and the experience seen in the recent Amgen v Hospira case. Specifically, in September 2017, a Delaware federal jury found that Hospira had infringed on one of Amgen’s patents covering its epoetin alfa reference product, sold as Epogen, and awarded Amgen $70 million in damages (not including pre- and post judgement awards). However, a portion of each of the batches manufactured by Hospira were used for testing for purposes of submitting an aBLA to the FDA, which would be covered by Safe Harbor.
The case resulted in the jury agreeing with Amgen’s argument in finding that 21 of Hospira’s potential biosimilar epoetin alfa batches were produced not for testing, but instead to create a stockpile of commercial product which is not covered under Safe Harbor. Hospira has since filed an appeal.
Interestingly, Valenti noted that the extra batches of the proposed biosimilar epoetin alfa were never sold to consumers. She went on to say that “as a litigator, I found it interesting that this question went to a jury. [Given] the scope of Safe Harbor, [and] no sales [of the manufactured product] yet, I thought it was very very interesting. I haven’t spoken to counsel, but one could imagine a potentially different outcome if it had been tried to the court instead of the jury.”
Next, in a discussion around PTAB updates, Valenti explained that in March 2018, PTAB denied Allergan and St. Regis Mohawk Tribe’s motion to terminate inter partes review (IPRs) regarding cyclosporine (Restasis) patents based on sovereign immunity. In July, a panel of the Federal Circuit affirmed, holding that “tribal sovereign immunity cannot be asserted in IPRs.” Meanwhile, Sen. Tom Cotton (R-Arkansas) and a bipartisan group of cosponsors introduced the Preserving Access to Cost Effective Drugs Act (S. 2514), which would permit the Patent and Trademark Office along with the International Trade Commission to review patents regardless of any claim of tribal sovereign immunity made as a part of “sham transactions.”
Finally, Lassman spoke about regulatory updates from the FDA. Specifically, Lassman provided an overview around the current state of “transitional biologics,” which he defined as protein products that for historical reasons have been reviewed by regulators and approved as drug products, ie, insulin. Prior to the BPCIA revising this statutory definition, many proteins had been regulated and approved as drugs. Additionally, the BPCIA also required all biological products to be approved through BLAs, not New Drug Applications (NDAs), 505(b)(2) applications, or Abbreviated NDAs (ANDAs).
Given this change, Lassman explained that the BPCIA calls for NDAs, 505(b)(2) applications, and ANDAs are allowed to be permitted for most proteins until March 23, 2020. On March 23, 2020 and thereafter, approved NDAs, 505(b)(2) applications and ANDAs will be “deemed” to be BLAs. According to FDA Draft Guidance issued March 14, 2016, the FDA will not approve a pending NDA, 505(b)(2) application, or ANDA for a protein product after the March 23, 2020 deadline and will instead need to re-file as BLAs.
This decision, Lassman explained, creates a regulatory dead zone of several years due to what Lassman described as “reasonable applicants” deciding against submitting any one of the 3 applications for months or years before March 23, 2020 because of the risk that they may not be approved by then. Further, in Lassman’s opinion, the Draft Guidance is “arguably inconsistent” with the statute.
“Congress allows submission until March 23, 2020, so there is no statutory basis to deny approval, [but] the FDA is saying they won’t review the submission. I don’t believe that was the congressional intent.” Lassman concluded by stating that he views the issue as “ripe for litigation,” given that the United States is 18 months away from instituting the transition.