“Celltrion is arguing that even if approval is years away, the case is still ripe and Johnson & Johnson can’t keep them out of court, and that if it does, it could add another ten to 12 months to legal proceedings, time in which the Remicade biosimilar could be on the market. Celltrion says that it should be able to litigate this now and get this taken care of,” Jean explains. Te somewhat fuzzy definition (there doesn’t appear to be an agreed one worldwide) of biosimilars might also provide some options for the drugs’ makers, an issue which Jean says will play out away from the district courts. “Biosimilars makers may push for legislation in Congress, or start filing citizens’ petitions with the FDA, asking for more clarification on what a biosimilar is,” she explains.
Tat biological products are, compared with small molecule pharmaceuticals, so difficult to make and so complex in structure, is what makes settling on a regulatory pathway for biosimilars (compared with generic drugs) so challenging.
However, the FDA has lent a hand in the establishment of the Purple Book, a list of licensed biological products and proprietary names. At the moment it’s a work in progress, missing data on the patent expiry dates of reference products. But when the first biosimilars begin to be approved, it will feature information on those products’ interchangeability with the reference product. It’s the differences between the Orange Book and the Purple Book that will make the approval processes for generic drugs and biosimilars so different, Jean says.
Te Purple Book will be useful for those considering making biosimilar products, but they will have to do their own research and
gather their own intelligence to identify the patent landscape, Brinckerhoff says.
Biosimilars are making their US debut in a turbulent time for naturally-derived products. Since the Supreme Court’s decisions in Myriad and Mayo, which narrowed the scope of patentability for products made from natural materials, it’s been unclear which biologic products may or may not be patent-protected. Jean says that because of the matter concerned in biosimilars, including proteins, vaccines and antibodies, a lot more challenges to reference biologic products under section 101 are likely. Tis, she says, is very different from what has occurred with small molecules. She predicts that biosimilar companies may start filing inter partes reviews at the US Patent and Trademark Office’s Patent Trial and Appeal Board, where many companies have successfully revoked patents under section 102 and 103, which also state conditions for patentability.
Te new BPCIA framework will make way for new patent litigation strategies, Brinckerhoff says. “It will be interesting if all patents are litigated at once, whether parties try to drag out the litigation, or if they try to resolve the big issues first and then save lesser important patents for a second round,” she says. It’s a “bidding process”, Brinckerhoff continues. “As the patent owner lists its patents and the biosimilar company can decide how many to be litigated, there can be strategies involved where patents are concerned in the first instance, how many patents the biosimilar decides to litigate are in the second, and then which patents the patent owner decides to enforce.
“It’s a very odd poker game,” she adds. If a company loses at the patent game, there are other options available.
“We might see a surge in trademark actions,” says Jean. She believes that brand companies will bring actions at US district courts or at the International Trade Commission to keep biosimilars off the market due to a likelihood of consumer confusion based on the brand’s trademark or trade dress.
“Many people get tied to the name of a certain drug and there may be a real push for the generics to gain access to those names. If a brand company somehow has its patent invalidated, the only thing it’s going to have to lay its hat on is its trademark or trade dress.” Among all the uncertainty biosimilars bring, one thing is for sure: it will be a compelling year in terms of district court litigation for those drug makers, which will be furiously revising their legal strategies to secure FDA approval. Even more compelling will be what may follow: a steady decrease in the cost of healthcare for all.
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