Source: https://www.orangebookblog.com/obviousness/page/2/
Timestamp: 2019-06-18 01:28:58
Document Index: 534146127

Matched Legal Cases: ['§ 156', '§ 291', '§ 156', '§ 291', '§ 291', '§ 253', '§ 135', '§ 291']

Orange Book Blog: Validity--Obviousness
Posted by Aaron Barkoff in Inequitable Conduct, Paragraph IV Cases, Validity--Obviousness | Permalink | Comments (0)
Federal Circuit Affirms Dismissal of Factor VIII Priority Case for Lack of Interfering Subject Matter
Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc., No. 2010-1264 (Fed. Cir. 2011)
by Scott P. McBride
In 2000, Genetics Institute obtained a patent term extension under 35 U.S.C. § 156 on U.S. Patent No. 4,868,112, based on the time consumed by testing and regulatory review of its commercial recombinant Factor VIII product, ReFacto®, which is indicated for the treatment of hemophilia A. The PTO extended the term of the '112 patent approximately 3.5 years, to February 28, 2010.
In May 2008, during the extended term of the '112 patent, Genetics Institute sued Novartis Vaccines and Diagnostics, Inc. under 35 U.S.C. § 291 to determine priority of invention between claims 1, 5, 9 and 10 of the '112 patent and certain claims of Novartis's U.S. Patent Nos. 6,228,620 and 6,060,447. Genetics Institute asserted that the claims at issue were all directed to the same subject matter, namely truncated Factor VIII proteins lacking all or part of the B domain while retaining procoagulant activity.
Novartis moved to dismiss the suit on two grounds: (1) lack of subject matter jurisdiction because the extension of the '112 patent under 35 U.S.C. § 156 applied only to certain claims, and not to the entire patent; and (2) lack of interference in fact.
Last year, the U.S. District Court for the District of Delaware granted Novartis's motion to dismiss, concluding that there was no interference in fact as to any of the allegedly interfering claims. In an opinion last week, the Federal Circuit affirmed the dismissal on the same grounds.
Claim 1 of the '112 patent recites:
A recombinant DNA which upon expression results in a truncated Factor VIII protein which is an active procoagulant wherein the recombinant DNA encodes for a protein having the amino acid sequence of a human Factor VIII:C except for having a deletion corresponding to at least 581 amino acids within the region between Arg-759 and Ser-1709, wherein the amino acid numbering is with reference to Met-1 of the human Factor VIII:C leader sequence.
In the appeal, Novartis first argued that the Federal Circuit lacked appellate jurisdiction because the '112 patent's extended term expired in 2010. Novartis argued that an interference between patents under 35 U.S.C. § 291 requires that the allegedly interfering patents be unexpired. Novartis relied on case law interpreting 35 U.S.C. § 291, specifically Albert v. Kevex Corp., 729 F.2d 757 (Fed. Cir. 1984). In Albert, the defendant statutorily disclaimed the allegedly interfering claims under 35 U.S.C. § 253, which divested the district court of subject matter jurisdiction.
The Federal Circuit rejected Novartis's argument that the expiration of the patent term extension had the same effect as a disclaimer, because statutory disclaimers are retroactively considered part of the original patent such that the disclaimed claims are treated as though they "never existed." In contrast, an expired patent may form the basis of an action for past damages, subject to a defense raising the six-year time limitation on damages. Moreover, unlike 35 U.S.C. § 135, which relates to interferences between applications or a pending application and an "unexpired patent," Section 291 for interferences between patents is not limited to "unexpired" patents.
Novartis next argued that the district court lacked subject matter jurisdiction because the extended term allegedly applied to less than all claims of the '112 patent. Specifically, Genetics Institute’s application to extend the patent term identified only claims 9 and 10 of the '112 patent as relating to its commercial product ReFacto® and claim 10 was allegedly construed by the district court such that it could not cover ReFacto®.
The Federal Circuit rejected Novartis's arguments based on its conclusions that (1) the language of Section 156 makes clear that the extension applies to the entire patent, not merely on a claim-by-claim basis; (2) the legislative history states that "all provisions of the patent law apply to the patent during the period of extension"; (3) the "rights derived" provision of Section 156(b) was intended to limit the effect of an extension, not to restrict the extension to particular claims (for patents that claim a product, rights in the extended term are "limited to any use approved for the product"); (4) because claim 9 depended from claims 1 and 5, and Novartis conceded that claim 9 covered ReFacto®, Novartis thus conceded that claims 1 and 5 also covered ReFacto®; and (5) the district court did not make any findings of fact that claim 10 did not encompass ReFacto®, but merely stated that claim 10 "may not" encompass ReFacto®.
Finally, Novartis argued there was no interference in fact between the claims at issue. An interference in fact under § 291 requires that the two patents claim "the same or substantially the same subject matter," using a "two-way test." Under the two-way test, an interference exists between two claims if each claim anticipates or renders obvious the other. The majority opinion (authored by J. Lourie and joined by J. Plager) concluded that the first part of the two-way test (obviousness of Novartis's invention in view of Genetics Institute's invention) was not met. In reaching this conclusion, the majority held that evidence of unexpected results may be used to rebut a case of prima facie obviousness, even if that evidence was obtained after the patent's filing or issue date.
Judge Dyk dissented. Judge Dyk would have held that unexpected results must be disclosed in the junior party's specification or known by the junior party's inventor(s) prior to filing, for such results to be used in determining nonobviousness. For purposes of the first part of the two-way test, Judge Dyk would have held that unknown and unexpected results would not be usable to (1) show that there was there some reason why the junior inventor would have modified the senior party's invention to arrive at the junior party's invention, and (2) overcome a prima facie case of obviousness.
It remains to be seen whether and how the court's decision will impact future obviousness cases.
Posted by Aaron Barkoff in Patent Term Extension, Validity--Obviousness | Permalink | Comments (0)
Federal Circuit Affirms Summary Judgment of Nonobviousness of FORTICAL Formulation
Unigene Labs and Upsher-Smith v. Apotex, No. 2010-1006 (Fed. Cir. 2011)
In a decision yesterday, the Federal Circuit affirmed a district court opinion granting Unigene's motion for summary judgment that claim 19 of U.S. Patent No. RE40,812 is not invalid for obviousness. Claim 19 of the '812 patent covers the pharmaceutical formulation of FORTICAL (calcitonin nasal spray). The Federal Circuit also affirmed the district court's denial of Apotex's motion to breach the attorney-client privilege under the crime-fraud exception and the district court's determination that Apotex had waived certain counterclaims, but the validity decision is the most interesting.
Claim 19 of the '812 patent recites:
A liquid pharmaceutical composition for nasal administration comprising about 2,200 MRC units of salmon calcitonin, about 20 mM citric acid, about 0.2% phenylethyl alcohol, about 0.5% benzyl alcohol, and about 0.1% polyoxyethylene(2) sorbitan monooleate.
Unigene filed its NDA for FORTICAL under section 505(b)(2), naming Novartis's MIACALCIN as the reference listed drug. Whereas MIACALCIN contains benzalkonium chloride ("BZK"), an absorption enhancer, preservative and surfactant, FORTICAL contains citric acid (absorption enhancer), phenylethyl- and benzyl-alcohol (preservatives) and polysorbate 80 (surfactant). Unigene also filed a patent application on its formulation, which issued as the '812 patent.
Apotex filed an ANDA for a generic version of FORTICAL, alleging that claim 19 of the '812 patent is invalid for obviousness. Apotex argued that the formulation of claim 19 would have been obvious in light of MIACALCIN, a prior art patent (disclosing solid formulations of salmon calcitonin) and a prior art publication authored by Day. The district court granted summary judgment of nonobviousness, which is relatively rare in Hatch-Waxman cases.
On appeal, the Federal Circuit began its obviousness analysis with an extensive discussion of KSR, in which the Supreme Court held that the teaching-suggestion-motivation (TSM) test is not a required part of the obviousness analysis. The Federal Circuit acknowledges this, quoting from KSR: "The obviousness analysis cannot be confined by a formalistic conception of the words, teachings, suggestion, and motivation . . . ." But in the next paragraph, the Federal Circuit seems to rely on the TSM test, quoting from its 2006 decision in Eli Lilly v. Zenith Goldline:
to establish a prima facie case of obviousness based on a combination of elements in the prior art, the law requires a motivation to select the references and to combine them in the particular claimed manner to reach the claimed invention.
The Federal Circuit then explained how KSR should be applied in cases involving pharmaceutical formulation patents. The court compared the obviousness analysis in pharmaceutical compound cases to that in pharmaceutical formulation cases:
A prima facie case of obviousness in the chemical arts is often based on a known compound, called a "lead compound," which serves as a starting point for a person of ordinary skll developing the claimed invention. Where the patent at issue claims a chemical compound, a lead compound is often used to show structural similarities between the claimed compound and prior art. In the context of a composition or formulation patent where the patented formulation was made to mimic a previously FDA-approved formulation, the functional and pharmaceutical properties of the "lead compound" can be more relevant than the actual chemical structure (though not always mutually exclusive). Thus, the term "reference composition" is more appropriate than "lead compound" when considering obviousness for a chemical composition. . . .
Addressing Apotex's obviousness position specifically, the Federal Circuit stated: "To a person of ordinary skill in the art, citric acid would not be an obvious substitute for BZK's functions as an absorption enhancer and as a surfactant because citric acid has a vague role in even the closest prior art." The court further found that the prior art actually teaches away from using citrict acid "as an absorption enhancing agent or stabilizing agent in a liquid formulation with a salmon cacitonin active ingredient."
The court concluded: "There is no genuine dispute of material fact that a person of ordinary skill attempting to make a liquid composition to deliver salmon calcitonin into a human body through nasal administration, would not have considered using about 20 mM citric acid with the narrowly claimed amounts of benzyl alcohol, phenylethyl alcohol, and polysorbate 80, because the formulation would not be expected to perform properly to meet the specificity of a pharmaceutical use."
Federal Circuit Affirms Summary Judgment of Invalidity for Obviousness in Temazepam Case
Tyco Healthcare Group LP v. Mutual Pharm. Co., No. 2010-1513 (Fed. Cir. 2011)
RESTORIL (temazepam) is a hypnotic (sleep-inducing) drug marketed for the treatment of insomnia. In a decision last month, the Federal Circuit affirmed the invalidity of two claims of U.S. Patent No. 5,211,954 directed to temazepam formulations. Claim 1 recites:
Claim 2 "is identical except that it recites a composition containing 7.5 milligrams of crystalline temazepam."
In 2006, Mutual filed an ANDA for a generic version of 7.5 mg temazepam capsules, after which Tyco filed suit for infringement of the '954 patent. In 2009, after Mutual received tentative FDA approval of its ANDA, Tyco moved for a preliminary injunction, which was denied due to "uncontroverted evidence" of no literal infringement due to the "surface area" limitation.
In an opinion last year, District Judge Chesler (D.N.J.) concluded on summary judgment that the two asserted composition claims were invalid for obviousness. Judge Chesler noted that (1) RESTORIL capsules had been sold in the United States in 15 mg and 30 mg dosages more than a year before the 1986 priority date of the '954 patent, (2) a 1983 volume of the British National Formulary, a UK medical reference book, directed physicians to the use of temazepam at a dosage between 5 and 15 mg for the treatment of insomnia in the elderly, and (3) it was undisputed that "physicians always seek to prescribe the lowest effective dose of any medication, particularly hypnotics such as temazepam."
In affirming, the Federal Circuit noted that, when Tyco's predecessor filed a Supplemental NDA with the FDA for manufacture and sale of 7.5 mg temazepam capsules within the scope of both '954 claims, the application stated that:
[t]he formulation and manufacture of RESTORIL Capsules, 7.5 mg are similar to that used for the 15 and 30 milligram capsules . . . . The [7.5 mg] formulation differs only in the reduction of the dose. . . . The capsule manufacturing method is exactly the same as has been described for the currently marketed doses.
The Federal Circuit stated, "[g]iven that uncontested description, the only limitation of the two '954 claims that was not fully disclosed by the prior art RESTORIL capsules is the lower dosage of temazepam."
The district court and the Federal Circuit relied on, among other things, the 1983 British National Formulary book. The British National Formulary book stated that, for temazepam, the dose for "elderly patients [could be] 5-15 mg." According to the district court, "[t]his entry plainly tells one of skill in the art to treat insomnia in the elderly by administering a dose in the range of 5 to 15 mg." Moreover, the summary judgment record included evidence of a 1984 statement by an FDA representative to a group that included the named inventor of the 954 patent, that "the doses proposed in [certain] studies may be too high, [given] that in Great Britain, temazepam doses from 5-15 mg are recommended for geriatrics."
The Federal Circuit stated that where there is a range disclosed in the prior art, and the claimed invention falls within that range, the claim is presumed obvious. That presumption is rebuttable either by a showing that the prior art taught away from the invention or by a showing of new and unexpected results.
The Federal Circuit did not accept Tyco's arguments that the prior art taught away from the claimed invention or that secondary considerations of new and unexpected results and commercial success permitted a conclusion of non-obviousness. The Federal Circuit also rejected, as "silly," one assertion made by Tyco's counsel at oral argument that the language "5-15 mg" did not actually disclose a range of doses (even though Tyco's expert had called it a "range").
Regarding that same range, the Federal Circuit also concluded that even if some of the references in the record taught away from the claimed dose generally, those teachings did not undermine the teachings in the British National Formulary book that related to the dosage in elderly patients.
Finally, the Federal Circuit acknowledged, as correct, Tyco's expert's statements that the British National Formulary book (1) "nowhere states that a temazepam dose of 5 mg, 6 to 8 mg, or 7.5 mg, is effective in treating insomnia," (2) nor does it "state that 7.5 mg was effective," and (3) the British National Formulary book provides "[n]o clinical or statistical evidence . . . demonstrating that a dose within a range of 5-15 mg would work" in treating insomnia. But the Federal Circuit also concluded that these observations do not undermine the district court's conclusions as to obviousness because the 954 patent's composition claims do not discuss the intended use of the capsules in a particular treatment regimen.
Federal Circuit Affirms Invalidity of Lilly's Gemzar Patent for Obviousness-Type Double Patenting
The principle behind the doctrine of double patenting is simple: a person may not obtain two patents on the same invention. The doctrine "is intended to prevent a patentee from obtaining a timewise extension of [a] patent for the same invention or an obvious modification thereof."
The two patents at issue in this case are U.S. Patent No. 4,808,614 and 5,464,826. Both are listed in the Orange Book with respect to Lilly's drug Gemzar (gemcitabine), a nucleoside analog used for the treatment of cancer. The '614 patent claims gemcitabine, as well as a method of using gemcitabine for treating viral infections. The '826 patent claims a method of using gemcitabine for treating cancer. The '614 patent issued on February 28, 1989 and expired on May 15, 2010 (Lilly chose the '614 patent for a patent term extension under 35 USC 156), while the '614 patent issued on November 7, 1995 and will expire on November 7, 2012 -- two-and-a-half years after the expiration of the '614 patent.
In August 2009, the U.S. District Court for the Eastern District of Michigan granted Sun's motion for partial summary judgment that the asserted claims of the later-expiring '826 patent are invalid for obviousness-type double patenting over the earlier-expiring '614 patent. The court found that given the '614 patent's disclosure of gemcitabine's anticancer use, claim 12 of the earlier '614 patent, which claims gemcitabine, and claims 2, 6 and 7 of the later '826 patent, which claim a method of using gemcitabine for cancer treatment, are not patentably distinct.
In an opinion released earlier today, the Federal Circuit affirmed the district court's decision of invalidity, and in doing so affirmed its prior holding of Pfizer v. Teva (Fed. Cir. 2008) and Geneva v. GlaxoSmithKline (Fed. Cir. 2003): "a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use." The Federal Circuit stated, "In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and the later patent claimed a method of using the compound for a use described in the specification of the earlier patent."
According to the Federal Circuit opinion, Lilly attempted to distinguish Pfizer and Geneva by contending "that in both cases, the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability." By contrast, here, "the specification of the earlier '614 patent disclosed gemcitabine's use in treating both viral infections and cancer, [but] the antiviral use provided the essential utility necessary to the patentability of the '614 patent's claim to gemcitabine." In other words, because the antiviral use was the key use in the earlier patent, the cancer use claimed in the later patent should be upheld.
The Federal Circuit, however, disagreed with Lilly's characterization of Pfizer, stating that in that case, "the earlier patent's specification unambiguously disclosed more than one utility for the claimed compound." In addition, the court explained that Lilly's proposed "single, essential utility test" would be "unworkable," because "where an earlier patent specification describes multiple uses for a compound, a court would be unable to identify the one use that was 'essential' or 'necessary' to patentability." According to the court, Lilly's counsel conceded this point at oral argument.
In a press release today, Lilly's general counsel stated that Lilly "strongly disagrees" with the Federal Circuit's ruling and "will consider all possible legal options," including a petition for rehearing.
Posted by Aaron Barkoff in Paragraph IV Cases, Validity--Obviousness | Permalink | Comments (1)