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Major Patent issues that European biosimilar Manufacturers

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

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.

  1. 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).

  1. 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.

  1. 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. 

  1. 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. 

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.