As originally asked by James Zak.

A little known legal fact is that a company can use patented technology of another company or competitor for the purposes of complying with FDA regulations without being liable for patent infringement. It makes no difference if the regulation is a pre-approval or post-approval regulation. However, it does have to be for purposes of gathering required, rather than optional, information. Furthermore, the FDA has the discretion to determine what information you are required to track or submit.

So basically, if the FDA posts a regulation or sends your company a letter asking you to measure or track X for labeling / quality / safety purposes and your competitor has a great cheap way of measuring X then you can use it without worrying about patent infringement.

I am presenting a webinar on this topic May 7th for the Food Drug and Device Law Section of the MN State Bar Association. To help me prepare my presentation, I am curious to know how group members feel about FDA compliance giving free passes for patent infringement.

Additionally, will this influence decisions regarding compliance activities?

Lynn Tyler
Intellectual Property Litigator & FDA Practice Chair
James,

I had seen that the Solicitor argued that Momenta corrected (or perhaps limited) Classen and thought it was interesting because the Solicitor’s position appeared to conflict with the principle that “precedent may not be changed by a panel.” Kingsdown Med. Consultants, Ltd. v. Hollister, Inc., 863 F.2d 867, 876 n.16 (Fed. Cir. 1989) (en banc). In any event, as I’m sure you know Momenta has filed a petition for cert. so it will be interesting to see what the Supreme Court does with it. At the moment, I think the law is a little unclear.

James Zak
Patent Attorney
Mr. Wu,

The economics of compliance is a potential point of contention in future cases which may limit the holding of Momenta. This something I will be addressing in my upcoming CLE, so I am glad you noticed it.

In Momenta, the Fed. Cir. held “[Sec. 271(e)(1)’s] protection is not limited to the dire situation where the patented invention is the only way to develop and submit the information.” Momenta, 1359. Accordingly, the fact that there may have been other non-infringing means available, as the patent holder argued, was determined to be of no consequence.

However, the Supreme Court previously held the purpose behind Sec. 271(e)(1) was to eliminate the artificial extension of patent term created by the combined effect of the patent law and the premarket regulatory approval. Eli Lily & Co. v. Medtronic, Inc. 496 U.S. 661, 670 (1990).

As such, one should ask if the holding of Momenta is broader than necessary to accomplish the legislative intent.

Louis Wu
Intellectual Property (Patent, Trademark, Copyright) Attorney
I am not so sure about your contention that “you can use [your competitor’s cheap test] without worrying about patent infringement.”

Part of the legal analysis for section 271(e)(1) requires a “sole use” and an “reasonableness” inquiry. If your competitor is offering a “cheap” test, and you choose to use the test without paying your competitor, your failure to pay could be deemed more related to your watching out for your own economic concerns than to your efforts to complying with FDA requirements. In turn, your failure to pay your competitor could be deem unreasonable and unrelated to complying with FDA requirements.

There is a big conceptual difference between damages and injunctions. Similarly, there is a big difference between not being barred to use a particular technology and not having to pay for the use of the particular technology.

James Zak
Patent Attorney
Mr.Tyler,

You are correct that Classen is still in play. However, in Momenta the panel expressly limited the holding of Classen to optional (“routine”) compliance and held that sec. 271(e)(1) protects required acts of compliance.

Additionally, the Supreme Court of the United States denied cert. in Classen; presumably relying on the Solicitor General’s argument that Momenta corrected Classen.

Accordingly, the question becomes whether the alleged patent infringement was for the purposes of gathering information required to comply with a post-approval FDA regulation or for the purposes of gathering optional (i.e. routine) information not required for compliance. If it was to gather optional (routine) information than 271(e)(1) is inapplicable under Classen as “corrected” by Momenta. If, on the other hand, it was to gather required information than 271(e)(1) excuses the alleged infringement under Momenta.

Lynn Tyler
Intellectual Property Litigator & FDA Practice Chair
Yes, but in Classen Immunotherapies, Inc. v. Biogen IDEC, GlaxoSmithKline & Merck & Co., 659 F.3d 1057 (Fed. Cir. 2011), a different panel of the Federal Circuit held that section 271(e)(1) does not apply to post-approval activities, so I wouldn’t rely too heavily on Momenta just yet.

Derek White
Innovative Manager in Strategy, Operations, Purchasing, Project Management, International MBA, MSc in Innovation.
Interesting strategy in the Sanofi/Momenta partnership– patent the drug and when that IP is about to expire, patent the only way to test and prove equivalence/efficacy.

Eduardo Alvarez
Technical Sales Manager – Lighting Division at PLASKOLITE
Thanks, very relevant.

James Zak
Patent Attorney
The relevant statue is 35 U.S.C. §271(e)(1). The US Supreme Court In Eli Lily & Co. v. Medtronic, Inc. 496 U.S. 661 (1990) held §271(e)(1) applies when taking action in furtherance of or compliance with the FDCA.

Recently in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), the Court of Appeals for the Federal Circuit clarified §271(e)(1) applies to post-approval and pre-approval acts of compliance with the FDCA.

Eric Poole
Medical Device Software Development Consultant and Certified Scrum Master
Good afternoon, James. Can you cite a reference on this please? Thanks…