Biosimilar Litigation and how its works

We have seen companies coming up with questions such as what is Biosimilar Litigation and how to make sure that our drug is patented and safe. To start off let’s understand what Biosimilar drugs are and how you can protect your drug from infringement.

It has been almost 10 years since the US Biosimilar Pathway (the Biologics Price Competition and Innovation Act) was introduced. The very first biosimilar product in U.S. history was approved and launched back in 2015. Later ten more biosimilars were approved in 2019. The Food and Drug Administration (FDA) till now has approved 26 biosimilars in total, including biosimilars of nine of the world’s most important biologic medicines

Biosimilar drug is nothing but a biological drug that is very much like another biological drug (called the reference drug) that has already been approved by the U.S. Food and Drug Administration (FDA). Biosimilar drugs and reference drugs are produced from living organisms but they may or may not be made in different ways and of slightly different substances too.

For being called a biosimilar drug, a biological drug it must be shown as safe and work in the same way as its reference drug from where it is being taken. It is to be used in the same way, as the reference drug. It is mandatory that Biosimilar drugs must be approved by FDA, and may even cost lesser than the reference drugs.

Looking for — Biosimilars Litigation Attorneys

Let’s now understand how you can create a safe harbour for your company. In the world of biosimilar drugs, safe harbor is a legal arrangement that allows use of an original/originator product to help develop biosimilar drugs without danger of patent copyright.

However, case law shows that correctly implementing a safe harbor has been challenging for some. Biosimilar developers are extremely cautiously keeping the 2019 ruling in mind, that penalized Hospira with a $70 million penalty for legally unprotected use of Amgen’s epoetin alfa (Epogen).

That kind of liability for premarket, preauthorization manufacturing was definitely something that everybody watched eye fully. So as a consequence of that ruling, everyone is scrutinizing whether any of the companies pre approval activities could be held to be commercial instead of purely in support of the FDA regulatory process.

Antitrust is an unforeseeable concern in the biosimilars domain because various barriers, such as excessive patenting, product rebates, and wrong information, are said to hamper the smooth and rapid production of low-cost biosimilars in markets dominated by originator brand manufacturers.

Now let’s understand the patent litigations between biosimilar competitors of the same biologic medicine component.

Biosimilar makers are filing and obtaining manufacturing patents of their own as they do not have to use the manufacturing processes of other producers to obtain approval for their products. In 2019 we saw the first lawsuit between two biosimilar makers — both with biosimilars of AbbVie’s adalimumab (Humira). In 2019, Coherus BioSciences, a manufacturer filed a complaint alleging that Amgen’s biosimilar of adalimumab (Amgevita) infringed patents for its own biosimilar version. As per the complaint, Amgen launched Amgevita in Europe but manufactured Amgevita in the United States. On the other hand Coherus claimed that production of Amgevita in the United States infringed its formulation patents. The parties settled the suit in November 2019.

Manufacturing Process Disclosure

The Biologics Price Competition and Innovation Act contains a path for getting biosimilar approval that forecasted the growing dominance of biologics in medicine and the need for low-cost variants of these products. Companies appear to be getting used to the process of figuring out patent disputes prior to the FDA approval of biosimilar. However, some issues still need attention, such as the extent of manufacturing processes that must be disclosed to the originator manufacturer by the biosimilar developer.

Another area which has its own shade is the conditions under which a biosimilar manufacturer must reissue a 180-day notice of intent to begin marketing (Notice of Commercial Marketing). Changes to the biologics application and other developments appear to have the potential to trigger such an event and also may require a new patent designs, “but where exactly that line is has not been resolved. It’s going to take the right case with the right approach in order for the Federal Circuit to resolve this issue.

Another complexity which is observed in biosimilars litigation that is equivalent with the complexity of manufacturing these agents. Biosimilars are covered by many more patents, such as patents for composition of matter, methods of usage, dosage strength, dosage time, devices that are being used such as syringes and vials. And impurities and protein charge variation. This means that lots of experts and often-sustained litigation timetables. Also we’ve seen that the extremely complicated mandates that often look like miniature trials.

The value of not having a brand-authorized biosimilar will be lower to biosimilar companies than to generic companies because there is no 180-day exclusivity for non-interchangeable biosimilars. This 180-day period is when generic companies obtain the vast majority of their profits and is a reason why no-brand-authorized generic clauses have raised antitrust concerns in reverse payment cases involving generic drugs. Such considerations will be different in reverse payment cases involving biologics.

It is also important, is the fact that settlements often include early entry provisions that let the generic drug launch before the patent expires without liability. These provisions may be net procompetitive, as has been noted in defense of Hatch-Waxman reverse payment settlements.36 Such provisions are likely expected as well under BPCIA because a biosimilar would not have an incentive to enter into a settlement without such early entry provisions. Moreover, like in Hatch-Waxman, early entry provisions can lead to more biosimilar competition, and not less, and thus be procompetitive.

A lot needs to be considered in this complex and important field, and we have a long way to go — especially in relation to the legal framework. There is a need for specific legislation governing biosimilars, with strict regulatory guidelines and effective cooperation between originators and biosimilar manufacturers, to help improve healthcare standards. Moreover, there has been few hurdles in the field so far and the relevant issues are yet to be tested in court.