Commercial necessity often dictates that even though an innovation in the manufacturing process for a product occurs in the United States, the product may actually be made overseas and then sent to the United States for sale.  Product developers know all too well that innovation in manufacturing can lead to substantial reductions in fabrication cost even though the product, once made, may be indistinguishable from competing products that are made using older and more expensive processes.  The implication here is that if protection for your manufacturing innovation is limited to actions inside the United States, your attempt to stop those foreign made products from entering the United States may be frustrated.  

Protection for the United States Manufacturing Process Patent Holder

One often overlooked tool to help address this frustration can be found in Section 271(g) of the United States patent law, which can provide a way to sue an importer of a product that is made using your patented process. 

Section 271(g) reads in part:

Whoever without authority imports into the United States or sells or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer…

Section 271(g) can therefore give you, as a United States patent holder, a means to stop a foreign-made product from entering the United States if the product is made by a process covered by your patent.  In other words, Section 271(g) does not require a United States patent directed to the product itself; rather it protects how that product was made. 

If, for example, you invent a new process for making an existing product, you may obtain a United States patent for that new process even though the resulting product would not qualify for patent protection.  If another party uses your new process to make a product in another country and then imports that product into the United States, Section 271(g) would allow you to sue the other party for patent infringement even though the product was made outside the United States.

Limitations on the Protection

There are, however, some limitations on the use of Section 271(g).  For example, the imported product must be "made" using your patented process for 271(g) to apply.  In Momenta Pharm., Inc. v. Teva Pharm. USA Inc., the United States Court of Appeals for the Federal Circuit, which has exclusive appellate jurisdiction over patent claims, interpreted the term "made" as used in Section 271(g) to mean "manufacture," which can extend to the creation or transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties. 

Accordingly, the Federal Circuit's holding in Momenta can be used to limit what processes are within the scope and protection of Section 271(g) by allowing a trial court to find that an accused product wasn't made by the process claimed in the patent.  For example, the court held that the term "made" did not extend to a test used to determine whether an already made product was manufactured correctly because the test was not used in the "actual" making of the product.  In other words, the court thought testing was too far removed from the actual making of the product to be within the reach of Section 271(g).

It is important to note that under Section 271(g), a court will first decide the boundaries of "making" the target product and this determination will be done without reference to a claim to the patented process.  For example, if your claim is for a method of testing a device, and the testing operations included in your process claim fall within the court-determined boundaries of "making" the product, then the court will likely conclude that Section 271(g) can be the basis of your infringement claim.  If those test operations, however, do not fall within the court-determined boundaries, then Section 271(g) may not apply. 

Stated differently, the boundaries set by the court will not depend on your claim, they will depend on the court's understanding of how the allegedly infringing device is "made."  Furthermore, the court-determined boundaries of the "making" process will not decide whether the imported device actually infringes your claim, but rather will only determine whether your claim of infringement under Section 271(g) may proceed.

It would also not matter whether your claim included additional fabrication steps if the court determined that the test operations in your claim fall outside of the boundaries of "making" the product.  Furthermore, if the test does fall within those court-determined boundaries, it may not be wise to recite those additional steps because doing so may narrow your claim unnecessarily. 

Accordingly, one of the most important steps in the proper use of Section 271(g) is in choosing the correct target for litigation.  For example, if an imported product is fabricated by a process of testing components of the product which are then selected for inclusion in the product based on the test, a better target for Section 271(g) may be the product, not the components.

Unresolved Issues Regarding the Protection of Section 271(g)

While the Momenta case dealt directly with the issue of whether testing operations may be involved in the actual making of a product, many other questions remain unresolved.  For example:

• The Federal Circuit did not directly address the definition of "transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties"; and,  
• Would a test that modified the components described above based on the results of the test be considered a "transformation" of the product?

Conclusion

No cases have interpreted Momenta as of the date of this article, so it is not clear how other courts might react to a claim of the type described above.  Accordingly, although there does not appear to have been a ruling that changes the analysis or result in Momenta, there also does not appear to be any case law yet that could clarify the above points.  In view of this, it would be advisable to not only consider the application of Section 271(g) during prosecution, but also pursue alternative approaches to protection under it.