The commercialization of biosimilars was enabled by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 which was signed into law on March 22, 2010 as part of the Patient Protection and Affordable Care Act.

Biologics are produced using living organisms, and thus, are usually much more complex than most small molecule drugs. Biosimilars (also called Follow-on Biologics) are drugs that have:

• An amino acid sequence identical or nearly identical to an originator (FDA-approved) biologic drug
• A secondary/tertiary structure sufficiently similar to the originator biologic drug
• No clinically meaningful differences relative to the originator in terms of safety, purity, and potency.

Importantly, regulatory agencies across the globe have specified that the generic drug approval process is not suitable for biologics.

The FDA has provided guidance describing quality attributes that need to be assessed in the biosimilar and reference products, including the bioanalytical, preclinical, and clinical studies that are required. FDA categorizes biosimilars as either not similar, similar, highly similar, or highly similar with fingerprint-like similarity relative to the reference product.

Only products determined to be highly similar are considered for approval. If a product is judged to be similar, further studies may be required to ultimately establish high similarity.

The Biosimilar Patent Dance

The complexities of patent litigation are best addressed by attorneys that practice patent law, but very broadly, if an existing biologic is patent protected, submitting a biosimilar application triggers a series of events that may lead to what is best described as a “patent dance.”

According to the BPCIA, a biosimilar application can only be submitted four years after the existing biologic was licensed, and the application cannot be approved until 12 years after initial licensure. From biosimilar application to approval, there are eight years for potential patent disputes, including claims of infringement (by the existing product sponsor) and claims of patent invalidity and unenforceability (by the applicant).

This graphic from the Biosimilars Resource Center illustrates the complex sequence and strict timing of the “patent dance”, in which the product sponsor and biosimilar applicant exchange information regarding patents that may become the subject of litigation.

A Fox Can Help Maximize Potential Success of Your Biosimilar Patent Case

Seasoned litigators understand the value that the right experts can bring to legal cases. As with patent disputes in traditional drug cases, an ideal expert lineup can be the difference between winning and losing a case involving a biosimilar patent dispute.

We have previously written about Isaiah Berlin’s two types of thinkers: hedgehogs and foxes. In short, hedgehogs know one big thing, while foxes dart from idea to idea. This metaphor extends nicely to illustrate how clever biosimilar patent litigators can maximize the potential success of their cases by relying upon both consulting (foxes) and testifying (hedgehogs) experts.

It is certainly not unusual for attorneys working on a patent case to seek strategic guidance from their testifying experts or inventors. After all, these individuals are the subject matter experts. However, many clever defense attorneys also recognize the need for skilled consulting experts to work closely with their team (see our previous post on this topic where we outlined five reasons why litigators might need foxes and hedgehogs to support their case).

Overall, the secret to the optimal expert team – and we have seen this first-hand many times – lies in recruiting both foxes (consulting experts) and hedgehogs (skilled in subject matter, testifying experts).

As foxes we have helped litigation teams in several recent (high-profile) biosimilar patent cases identify and vet testifying experts (hedgehogs) across an array of disciplines to address specific issues including (among others):

• Biosimilar Manufacturing – What quantity of biologic drug is typically manufactured for specific phases of drug development?

• Clinical Pharmacology – How are dosing regimens and doses for biologics arrived at when entering the clinic?

• Physicians (multiple disciplines) – Are certain dosing schedules obvious? What are the medical uses of a specific biologic?

• Marketing/Advertising – What are the components of a dossier used to promote a drug, including the types of data that go into the dossier?

In addition, patent cases may also benefit from fresh scientific literature searches regarding prior art and other relevant literature. The right consulting experts often bring new perspectives to these types of important searches which can supplement what the subject matter experts have already identified.