Archive for June, 2009

COURT “CUSSES OUT” SANOFI – HOLDS OXALIPLATIN PATENT NOT INFRINGED

Monday, June 22nd, 2009

For some years, Tom Irving of Finnegan Farabow, et al. has been giving a very amusing, but increasingly serious, talk about the dangers of what he calls “Patent Profanity.” The version I heard in May was, “Patently Profane at You and Your Client’s Peril.” He warns that the specification and prosecution history will be used by the courts to construe the claims, and that appellate review of claim construction is de novo. By “patent profanity,” he means statements in the specification or arguments made in the prosecution history that will lead the court to ignore the once well-established maxim that “[a]s a general proposition, a limitation that does not exist in a claim should not be read into that claim.” McCarty v. Lehigh Valley R. Co., 150 U.S. 110 (1895) The district courts, following the lead of the Federal Circuit, have increasingly side-stepped this principle by casting the issue as one of claim interpretation, not of claim limitation:

“We recognize that there is sometimes a fine line between reading a claim in light of the specification, and reading a limitation into a claim from the specification. …In locating this ‘fine line’ it is useful to remember that we look to the specification to ascertain the meaning of the claim term as it is used by the inventor in the context of the entirety of his invention, and not merely to limit a claim term.” Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323 (Fed. Cir. 2001).

That is a fine line indeed. The point of Tom’s talk is to warn the prep/pros community about the need to avoid terms (often adjectives) that will lead a court to cross that “fine line,” even when they recognize it in the first place. He indentifies assertions like “special” (as in form), “peculiar” (as in effect achieved), “necessary,” “critical,” “key”(as in a feature), “necessarily” (as in the type of product), “requires,” “important,” “essential,” “unique,” and on and on. Even using “is” can lead to an unexpectedly narrow claim construction, e.g., “Feature X is the basic structure of element X of all embodiments herein disclosed and contemplated.”

On June 18, 2009, Judge Pisano (D.N.J.) held that U.S. Pat. No. 5,338,874 was not infringed by a group of generic drug companies, thus clearing the way for generic versions of oxaliplatin, an important drug in therapy for colorectal cancer. This opinion, document 378 in Sanofi-Aventis v. Sandoz, Inc., Lead Civil Action No. 07-2762 (JAP), is a prime example of how easy it is for defendants to convince a court to limit claims to (even) a compound to the disclosed method of making it.

The ‘874 patent contains only one independent claim: “Optically pure [oxaliplatin] having the general formula of Formula I:….” This isomer of oxaliplatin is referred to in the opinion as “l-OHP,” e.g., the “L” enantiomer. So this is a compound claim and, as the court noted more than once: “product claims generally are not limited by how the product is produced.” In fact, the specification contains a fair helping of the language of qualification that we all use when disclosing how the compounds we want to claim are prepared – that the compound “may be prepared in accordance with” the “illustrative method” thereafter described, and that “a representative process of preparing” the compound is described in the examples. However, the only process disclosed in the specification to isolate l-OHP was preparative HPLC. The defendants used other processes and argued that the claim should be interpreted as a product-by-process claim. They moved for S.J. of non-infringement.

It is worth noting that the ‘874 patent is an add-on patent; the primary patent on oxaliplatin had expired. These days, betting against infringement or validity of an “add-on patent” in Hatch-Waxman litigation is a pretty safe bet (but, again, this is a “compound patent” not a treatment regimen or formulation patent). Also, it originated from a Japanese company, and the U.S. translation is awkward. Still, it was clearly “patent profanity,” particularly during the prosecution, and to some extent, taken from deposition testimony, that caused the court to hold that “the claims of the ‘874 patent are properly construed as product-by-process claims.” Motion granted.

It is a bit of a job to separate the court’s discussion of patent profanity from the patent profanity actually used during prosecution, but applicants attorneys had argued that “[o]nly after HPLC resolution, in accordance with the teaching of the present specification, was optical purity obtained, and that the inventors “developed a specific HPLC method and show[sic] that they were able to manufacture [the optical isomer of high purity].” The court relied heavily on the former argument, stating: “Thus, the Applicant did not attempt to rebut the examiner’s rejection by simply pointing to the lesser purity of the prior art compound, it was unequivocal that ‘[o]nly after HPLC resolution’ was the claimed purity achieved.” The court noted that the Examiner relied on these representations.

So what is the takeaway message, except to note that not even simple “compound claims” are safe from conversion into narrower product-by-process claims? The solution is not to add more potential synthetic routes, although this may be possible in some cases. It is to avoid “patent profanity” at all costs. Argue the novel inherent properties of the compounds, and not how clever your inventors were to have been able to make it in the first place. Don’t “attribute” the novel properties to any particular method-of-making. Sadly, in this case “only,” “specific” prep HPLC does not even seem to have been all that “critical,” “key,” “necessary,” “essential,” or “required” to obtain the claimed compound. Excuse my language!

USPTO Customer Partnership Meeting Materials

Tuesday, June 16th, 2009

The materials from the June 3, 2009 USPTO Customer Partnership Meeting are available online but I have downloaded them into a PDF format available here.
USPTO Meeting Materials.pdf

NATURE/BIOTECHNOLOGY SUMMARIZES ARIAD DECISION

Wednesday, June 10th, 2009

A recent article by Ken Garber in Nature/Biotechnology, 27, 494 (June 2009) summarizes the recent Federal Circuit decision invalidating the claims-in-suit in Ariad v. Lilly for failure to meet the WDR. (See my post of April 13, 2009 “Federal Circuit Throws Wrench Into ‘Mechanism of Action Claims’” for a summary of the decision.) Various patent law “experts,” including this author, are quoted. Mr. Garber did a good job of summarizing the court’s position, but I don’t recall saying that affirming the validity of Ariad’s claims would be like “accepting a claim on anti-gravity.”

Under the Patent Office’s utility requirement guidelines (which I feel are unsupported by case law), an asserted utility must be specific, substantial, and credible. A claim to anti-gravity would surely fail the credibility test, but credibility of the asserted utilities was not an issue presented to the Federal Circuit. The utility of the ‘516 claims is manifest, at least if they are construed to be limited to the treatment of deleterious effects of elevated NF-kB, and many of them recite very specific utilities. However, this big “if” leads to another issue with these claims – are they even patentable subject matter?

In fact, the District Court found that the claims-in-suit were not unpatentable as “natural phenomena.” As you know if you have been reading my previous posts, I am very unsympathetic to infringement defenses asserting that claims cover “products of nature” or pre-empt all uses of “natural phenomena.” Usually, the hand of man is involved in diagnostic, screening or monitoring processes (or methods), even if “natural phenomena” or “products of nature” are being isolated, detected, or measured. However, one of the claims of the ‘516 patent considered by the district court in Ariad, reads as follows:

7. A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-kB-mediated intracellular signaling, the method comprising altering NF-kB activity in the cells such that NF-kB-mediated effects of external influences are modified. [529 F.Supp.2d at 115.]

Lilly argued that this claim, which does not recite administration of any exogenous drug, covers a natural process which the court referred to as “the autoregulatory loop” (regulating NF-kB levels in cells). The court reviewed the testimony and found that Lilly had not established by clear and convincing evidence that this natural process occurred in cells, but only that it might occur in vitro.

Lilly did not appeal this finding, but sorting through the scientific testimony summarized by the District Court, it looks like Lilly had a pretty strong argument that at least claim 7 encompasses a natural phenomenon, in the way that a method claim could encompass both the process of photosynthesis, a natural phenomenon, and an industrial process for making sugars from carbon dioxide, water, and radiation. If such a claim were valid, the patentee could collect royalties from every farmer or horticulturist, as well as from the Acme Sugar Company.

Paragraph IV Patent Certifications

Monday, June 8th, 2009

For your reference here is a link to the FDA Paragraph IV Patent Certifications as well as a PDF of the certifications.

FDA Paragraph IV Patent Certifications

Paragraph IV Patent Certifications.pdf