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“Biologics” are some of today’s most promising medications. Unlike “small molecule drugs” (such as acetaminophen), biologics are made from living organisms, which may come from humans, animals, or even microorganisms like yeast or bacteria. They offer great promise in treating chronic diseases like rheumatoid arthritis and certain types of cancer.
Since biologic manufacturers use their own proprietary starter material, reproducing biologics is a more complex process than that of creating traditional generic drugs. The maker of a biosimilar drug, the biologic counterpart to generic small molecule drugs, does not make an identical product to the original, because they start from different living materials. For example, they may use a different human cell line than the original maker used. Therefore, patent issues are far more complex with biosimilars than with ordinary small molecule drugs.
Provisions of the Affordable Care Act introduced pathways for quicker FDA approval for biosimilars to already-approved biologic reference products. Biosimilars must be shown to be highly similar to the reference product, demonstrating similar biological activity and quality and producing no meaningful differences in safety or effectiveness compared to the original biologic product.
The so-called patent dance is a method for resolving potential patent disputes between biosimilars and the original biologics once a biosimilar has submitted its approval application to the FDA, but before it enters the market. It is a prescribed exchange of information that is essentially designed so biosimilar manufacturers can demonstrate that they would win injunctive relief should the original product manufacturer decide to bring patent litigation to court.
A Supreme Court ruling in June on whether the patent dance was enforceable under federal or state law stated that it is up to the states. In other words, the biosimilar producers may be able to sit out the patent dance altogether. However, the Supreme Court also left open the possibility that they may interpret the terms of the patent dance differently in the future.
Biosimilar manufacturers generally liked this ruling because it could allow biosimilars onto the market 180 days sooner than if they participated in the patent dance. Manufacturers of original biologics, however, were less pleased, because the patent dance in effect granted them longer exclusivity than they would have had otherwise.
The patent dance could inadvertently prolong exclusivity for original manufacturers
Ultimately, biosimilars would pursue the status of “interchangeability” with original compounds. Interchangeability would allow a biosimilar to be substituted for the original product without the intervention of the prescribing doctor. While interchangeability would be a boon for biosimilars, the FDA is still figuring out how to prove interchangeability, and has suggested that possibly five years of post-approval data on safety would be enough to allow the FDA to approve interchangeability. It will probably be several years, therefore, before biosimilars start seeking interchangeability since they are so new on the market.
As for patent litigation outcomes for biosimilars, expect prediction to be even more complicated than predicting outcomes for small molecule drugs. With small molecule drugs, you can look at factors like whether a patent lawsuit was filed by a practicing or non-practicing entity, how many backward and forward citations a litigated patent had, and where the case was filed to gain insights into likelier outcomes.
While those considerations may be a starting place for biosimilars, bear in mind that non-practicing entities probably will not be part of the equation any time soon, if ever. Biosimilar manufacturers want to sell their products and profit from them. Also bear in mind that patent litigation concerning biosimilars is new enough that there are not many cases from which you can draw conclusions.
The wisest course of action may end up being close monitoring of whether or not a biosimilar manufacturer chooses to engage in the patent dance or not, and whether more biosimilars start pursuing interchangeability after having been on the market for several years. It is possible that pursuit of interchangeability will expose biosimilars to more patent litigation since the goal is to be substitutable without the approval of a doctor, but there is not enough data on interchangeability to know whether or not this is likely.
As for approval of biosimilars in the first place, original manufacturers may have a more challenging time bringing patent litigation to court since by definition biosimilars are similar, rather than having identical active ingredients, as generic small molecule drugs do. Monitoring future Supreme Court rulings, particularly on whether the patent dance is mandatory or optional, is also a smart move.