Ortho-McNeil Pharmaceuticals v. Lupin Pharmaceuticals and Photocure ASA v. Kappos

Ortho-McNeil Pharma v. Lupin Pharma

and

Photocure ASA v. Kappos

Two recent cases decided before the U.S. Court of Appeals for the Federal Circuit (CAFC) on May 10, 2010 upheld two Patent Term Extensions (PTE) under 35 U.S.C. § 156.

In the first case, Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., Lupin challenged the USPTO’s granting an extension to US Patent No. 5,053,407 that claims Levofloxacin, an enantiomer of a racemic compound ofloxacin that had previously been approved by the Food and Drug Administration (FDA), but to no avail.

In the other case, Photocure ASA v. Kappos, Photocure challenged the USPTO’s denial of PTE to US Patent No. 6,034,267 that claims ethyl aminolevulinate (MAL) hydrochloride (methyl ester of the known drug aminolevulinic acid (ALA) hydrochloride), and won.

The Patent Term Extension statute was enacted in recognition of the lengthy procedures associated with regulatory review of a new drug product, for the patent term continues to run although the product cannot be sold or used until authorized by FDA. The statute was designed to restore a portion of the patent life lost during the period of regulatory review, in order to preserve the economic incentive for development of new therapeutic products. Under § 156, the term of a patent that claims a drug product, a method of using a drug product, or a method of manufacturing a drug product may be extended by up to five years if the drug product was subject to FDA regulatory review prior to its commercial marketing or use.

Only one patent term extension is allowed per drug product under the statute. The statute defines a drug product as the “active ingredient” of a new drug, antibiotic drug or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act)…..including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.

In both the cases decided by the Court of Appeals for the Federal Circuit (CAFC), the issue was whether the FDA approval sought for each drug was for the “first permitted commercial marketing or use” of the drug. Lupin argued that an enantiomer is half of its racemate, and thus is an “active ingredient” of the previously marketed ofloxacin and therefore is the same drug product as ofloxacin, and permission to market and use levofloxacin is not “the first permitted commercial marketing or use of the product” and is not eligible for the PTE under the statute. The District court agreed with Ortho that an enantiomer has consistently been recognized, by the FDA and the USPTO, as a different drug product from its racemate. The court observed that, in this case, levofloxacin was viewed by the FDA as a new product requiring full regulatory approval, and that levofloxacin was viewed by the USPTO as separately patentable subject matter. The Federal Court affirms the district court’s ruling that the ’407 patent on levofloxacin was properly granted the statutory term extension, for the enantiomer is a different drug product from the racemate ofloxacin, and was subject to regulatory approval before it could be commercially marketed and used.

In the other case, the Federal Circuit applied the similar reasoning: MAL hydrochloride was a new chemical compound, and was patented in 6,034,267 on the basis of its improved therapeutic properties as compared with the known compound ALA hydrochloride. ’267 patent discusses and exemplifies the biological and physiological advantages of the MAL product over the ALA product, although their chemical structure is similar. USPTO argued that pursuant to Pfizer v. Dr. Reddy’s, 359 F.3d 1361 (Fed. Cir. 2004) “active ingredient” does not mean the product that was approved by the FDA, but rather means the “active moiety” of that product. The USPTO held that MAL hydrochloride is the same product as ALA hydrochloride because the “underlying molecule” of MAL is ALA, and the USPTO stated that “ALA is simply formulated differently in the two different drugs” and therefore the FDA’s marketing approval of the MAL hydrochloride product is not the first commercial marketing or use of that product and is not eligible for the PTE under the statute.

The Federal Circuit, however, rejected the USPTO’s arguments and further distinguished the Pfizer case, stating: “Pfizer did not hold that an extension is not available when an existing product is substantively changed in a way that produces a new and separately patentable product having improved properties and requiring full FDA approval.”

While the question of the scope of protection conferred by extension was not directly addressed, these decisions provide insight as to how that question will be resolved in the future. These decisions will have important implications for the pharmaceutical industry because they clarify when PTE is available, and generally apply the active ingredient term of the statute broadly. The effect of these decisions could make PTEs from the USPTO easier for applicants to obtain. The rulings may give innovator companies broader patent protection in certain cases and might make it more difficult for generic companies to introduce their versions of drugs. The generic companies will get disappointed with the outcomes here.

Ortho-McNeil and Daiichi Sankyo v. Lupin, No. 2009-1362 (Fed. Cir. 2010)

Photocure v. Kappos, No. 2009-1393 (Fed. Cir. 2010)

About the Author: Ms. Meenakshi Khurana, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: [email protected].