Major Patent issues that European biosimilar Manufacturers should consider before entering the US market

As new patents requests are coming up, originator biologic medicines are beginning to expire. But there are growing opportunities for biosimilars to enter the US market at lower prices. In this document we will discuss key aspects of US patent law that European developers should consider before entering the American market.

BIOPHARMACEUTICAL companies around the world and many in Europe, are targeting to develop biosimilar products to sell on the US soil. The FDA defines a biosimilar as a biological product only if that is approved based on that it is similar to an FDA-approved originator biological product, known as a reference product. And therefore has no clinically meaningful differences in terms of safety and effectiveness from the reference product.” Generic small molecule drugs, in contrast, must be “bioequivalent” to the branded reference drug. With the help of bio similar litigation attorney’s, we would be better able to understand the bio pharmaceutical manufacturing process. 

8iA landmark decision for the US biosimilar system is the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA passed a gateway for regulatory pathway for biosimilar approvals and a very distinct litigation framework for resolving patent disputes between the biologic drug innovator reference product sponsor or RPS and biosimilar applicant.

The BPCIA is a complicated law that can be difficult to implement without any significant experience in the US patent litigation domain. Entering in the US market without prior experience will create some issue for you. Therefore, it is advisable that the regulatory experience required for manufacturing the bio similar litigation attorneys is much needed. To give you another example of the previously established Hatch-Waxman Act for generic drugs is the BPCIA submitting a regulatory application for a biosimilar to the FDA act of infringement.  

Typically, the company making the application spends hours of time-consuming and expensive patent paper work which involves preparing a detailed statement of its patent infringement defences. From the large number of patents often are disclosed by the RPS during the hearings. And the chances for statements to be used in a wrong manner when shown during the legal proceedings. Where applicants are asked to engaged with the sophisticated US counsel to understand the patent framework to develop a thorough defence strategies before the FDA-submission.

Manufacturing a bio similar product outside the country cannot be an infringing act under US law, but bringing that product into the US and marketing it can be said as infringement

In this article, we provide you with five relatively unique giveaway of US patent law that often come across in BPCIA litigation:

1. The doctrine of equivalents” infringement theory
2. Infringement of manufacturing process patents under 35 U.S.C. § 271(g)
3. Safe harbour from infringement;
4. Non-infringement via label carve-out; and 
5. Preliminary injunctions. 

These issues have in the picture for years now and with respect to the use of generic drug litigation. But these are comparatively less developed lesser with the recent biosimilar litigation attorneys.  Even though these issues are expected to arise. Thus, European biosimilar manufacturers should always consider these important principles when preparing their litigation strategies before entering the new market as suggested by the bio similar litigation attorneys.

1. Doctrine of equivalents- To understand more about the patent infringement, a bio similar requester has to show either that the manufacturers product has every patent copyright for being called as an infringement and to verify whether the product is equivalent to the reference product. This infringement theory is known as the doctrine of equivalents which can be shown by showing that the accused contains a component that is interchangeable or is different from the original product.

The doctrine of equivalents is unavailable in Janssen’s court case against Celltrion. The case which was related to the product Celltrion’s infliximab manufacturing biosimilar. There, the court found that the company Janssen’s given scope would have improperly caught in the prior art.

The failure of the doctrine of equivalents in some cases states that this infringement theory is still relevant and has been successful in numerous other drug patent cases. similarly, biosimilar manufacturing applicants should consider how the RPS might invoke this doctrine to expand the patents at issue in BPCIA litigation.

2. Process patents- Patent infringement in the US typically requires infringement cases registered need to occur within the US. 

To give you an example the accused product manufacturer must be used, sold or offered for sale which may be imported in or to the US during the patent’s term. Another important exception that applies to manufacturing of the biosimilar products as per the biosimilar litigation attorneys, which has played a considerably a large role in BPCIA litigation.

The section 17 35 U.S.C. § 271(g) of the US federal government constitutes infringement rights of a product that which is produced outside US using a process registered in the US which later is then sold in the US. Therefore, making a product outside the United States can be included in the infringing act of the US law.

 Although there are some exceptions to secton 271(g) which mentions that not all process patents fall within the jurisdiction of the law, any biosimilar product manufacturer that produces its products outside the US but in future has plans to sell in the country’s markets should have the potential liability under § 271(g).

3. Section 271(e)(1) safe harbour- Developing or manufacturing a biosimilar product for FDA approval will surely involves instances that could be included in on an RPS’s patents request. To put moment to the R&D and to facilitate approval of cheaper substitute drugs, the US government has created a safe harbour law that is section 35 U.S.C. and section 271(e)(1) that protects infringing activities which are related to the development and submission of information to the FDA in connection with regulatory approval.

4. Label carve-outs- According to bio similar litigation attorneys a commonly tried and tested strategy for avoiding infringement of US treatment method patents is to create certain indications from a generic or biosimilar product label that potentially doesn’t have the patents’ claims.

Removing such composition might avoid infringement and liability for patents covering the obvious and evident indication, as the applicant’s product label will not describe the patients or providers the use of the product in an infringing manner. It is important for biosimilar manufacturers that they minutely check the reference products which has multiple signs that are covered by different patents, at that time it is advisable for biosimilar applicants to consider the possibility of a carve-out. 

5. Preliminary injunctions

Lastly at least 180 days before the manufacturers launch the biosimilar in the US market. The BPCIA requires an application to notify the RPS body of such marketing plans. But as per the BPCIA the sponsor may respond by seeking an opening order to prevent biosimilar sales during the litigation trial period. 

Opening rule passed act as a relief that federal courts can grant to maintain the status quo during litigation, for example, by blocking sales of an accused product.

Although opening orders as passed by the govt. bodies can be sought in other different way of patent litigation, they were alternatively seen as a means for solving patent disputes among different producers of a biosimilar product which are market-ready. But in the end to get the approval, the RPS must pass the four-factor test used on all patent litigation. 

In order to conclude the given, provisions involved in launching the biosimilars as per the biosimilar litigation attorneys for the US market. The applicants should be involved in a very crucial US committee that understands the complexity between the regulatory and litigation rights of the BPCIA. As early as put together an advantageous, moudable legal strategy takes significant time and expertise, the importance of which should not be overlooked or downplayed.