Replies to post #113336 on Biotech Values

[tinkershaw]

Bolar Exception: An exception to patent rights allowing a third party to undertake, without the authorisation of the patentee, acts in respect of a patented product necessary for the purpose of obtaining regulatory approval for a product.

And the summary of the case:

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Roche Products v. Bolar Pharmaceutical, 733 F.2d 858 (Fed. Cir. 1984), was a court case in the United States related to the manufacturing of generic pharmaceuticals. See Research exemption.

Bolar was a generic drug manufacturer. Roche was a brand-name pharmaceutical company which made and sold Valium, the active ingredient of which was protected by patent.

Before patent expiration, Bolar used the patented chemical in experiments to determine if its generic product was bioequivalent to Valium in order to obtain FDA approval for its generic version of Valium. Bolar argued that its use of the patented product was not infringement under the experimental use exception to the patent law.

The Court of Appeals for the Federal Circuit rejected Bolar’s contention holding that the experimental use exception did not apply because Bolar intended to sell its generic product in competition with Roche’s Valium after patent expiration and, therefore, Bolar’s experiments had a business purpose.

Bolar also argued that public policy in favor of availability of generic drugs immediately following patent expiration justified the experimental use of the patented chemical because denying such use would extend Roche’s monopoly beyond the date of patent expiration. The court rejected this argument, stating that such policy decisions should be made by Congress. Likewise, the court decided that apparent policy conflicts between statutes such as the Food and Drug Act and the Patent Act should be decided by Congress and not the courts.

Shortly after Roche v Bolar was decided, Congress did pass a law permitting use of patented products in experiments for the purpose of obtaining FDA approval (section 271-e-1 of the Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], which established the modern system for FDA approval of generic drugs

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If Hatch-Waxman simply legislated the holding in Bolar, then I think the application to a patent other than that on the underlying innovator drug is likely to not be covered by the Bolar exception. It would require an extension to this holding. That extention would vitiate third-party patents such as MNTA holds.

If you look at it, Bolar really does nothing to vitiate the innovator's patents, as the generic drug cannot be marketed, anyways, until the patent expires. What it does is enable creation of generic drugs, utilizing an otherwise patented chemical, so that said drug can be launched when the patent in question expires. So the patent right is only minimally impacted.

This is utterly different from applying the same exception to a third-party's patent that is totally unrelated to the innovator drug. If you apply it to MNTA's patents, you destroy MNTA's patents, and don't just provide a small exception that otherwise protects the innovator's patent rights. That would be a much farther reaching decision than Bolar. I'm not going to take the time to research it further (maybe someone else can) but going through the issue, if you want to toss a third-party's patent into the mix, that is a patent not related to the innovator drug, then that would be an enormous expansion to the Bolar exception. I cannot see a court going this far. Although it certainly is an appellate issue that can be raised (and perhaps wrongly decided by the trial court - which is a good reason for Teva to pursue the argument).

Tinker

[genisi]

Bolar exception

A partial list of acts in which this has been extended to:

Manufacturing a device or drug; selling to institutions/hospitals to obtain PMA; testing or selling the device to international distributors for clinical trials; demonstrating the device at a trade show. (in Intermedics). Exporting the reference standards for commercial development overseas; conducting purity and safety testing; producing scaled up amounts of the drug in the U.S.; characterizing the drug (in Amgen). Using a patented process; submitting data for foreign regulatory approval after it was first submitted to the FDA (in NeoRx). Conducting product research & development activity “upstream” in product development (in Bristol-Myers Squibb).