Source: https://patentlyo.com/patent/pharma
Timestamp: 2017-03-24 13:58:27
Document Index: 121359786

Matched Legal Cases: ['UKSC ', 'UKSC ', '§ 101', '§ 156', '§156', '§ 156']

Pharma | Patently-O
November 2, 2011Patent, Patent Cases 2011, PharmaDennis Crouch	Human Genome Sciences v. Eli Lilly (UK Supreme Court, 2 Nov 2011) [Decision] Case No. [2011] UKSC 51. The Supreme Court of the United Kingdom (UKSC) began hearing cases in 2009 — taking on the role of court-of-last-resort formerly played by the House of Lords. The UKSC normally sits in five-member panels — here the panel consisted of Lords Hope, Walker, Neuberger, Clarke, and Collins. This decision focuses on EPC and UK version of the utility doctrine — the requirement that a patentable invention be “susceptible of industrial application“. In a unanimous decision, the court determined that US utility doctrine creates an unduly high bar of patentability. Thus, rather than requiring proof of specific, credible, and substantial utility at the time of filing, the UK court agreed that HGS’s genetic sequence coding for Neutrokine-α was patentable even though there was no known use of the protein at the time the patent application was filing. The patent did not reveal how the protein “could be used to solve any particular problem” nor did it identify “any disease or condition which it could be used to diagnose or treat.” Yet, the UK court held that the industrial application requirement was met because the protein a member of a “TNF ligand superfamily” and all members of that family have been associated with important biologic activity. “[A]ll known members of the TNF ligand family were expressed on T-cells and were able to co-stimulate T-cell proliferation, and therefore Neutrokine-α would be expected to have a similar function.” The UK Court of Appeals (Sir Robin Jacob) had previously held the patent invalid. In his opinion, Lord Neuberger explicitly rejected the US cases of Brenner v Manson, 383 U.S. 519 (1966) and in re Fisher, 421 F 3d 1365 (2005) — finding that “there are obvious risks in relying on US jurisprudence when considering the precise nature of the requirements of Article 57 in relation to a claim for a patent for biological material under the EPC.” There have been moves over the past fifty years (and more) to harmonise patent law across jurisdictions (the EPC and TRIPS – the Trade-Related Aspects of Intellectual Property Protection – being two important examples), and it is a laudable aim to seek to ensure that all aspects of the law of patents are identical throughout the world. However, the achievement of such an aim is plainly not currently practicable, and, although they have a great deal in common, there are significant and fairly fundamental differences (over and above the different words used in Articles 52 and 57 of the EPC and section 101 of 35 USC) between US patent law and the EPC (two notorious examples being the first to file rule in Europe, and file wrapper estoppel in the US). Accordingly, particularly when it comes to a nice question such as the precise delineation of boundaries between patentability and unpatentability on the ground of industrial application, it would be unsurprising if the law was not identical under the two jurisdictions. Instead of following US law, the panel instead latched onto the jurisprudence of the EPO — the body that also interprets the European Patent Convention (EPC). Notes: The UK court of first instance (Kitchin J) found the patent invalid while the EPO Board had held the patent valid. The patent in question is European Patent 0,939,804 IPKAT Of course, it is interesting that both HGS and Lilly are US-based companies.
January 21, 2011Articles and Publications, Patent, Pharma, SettlementDennis Crouch	FTC v. Cephalon (E.D. Pa. 2010)
January 6, 2011CAFC, Obviousness, Patent, Pharma, Rantanen, ReexaminationJason Rantanen	By Jason Rantanen
Update: PharmaPatents Blog provides a detailed discussion of the CAFC's reversal of the Board's prima facie case of obviusness, asking whether there was anything else the applicant could have done to avoid a rejection by the examiner and Board. Prometheus Laboratories v. Mayo: The Broad Scope of Statutory Subject Matter
December 22, 2010CAFC, Patent, Patent Cases 2010, Patentable Subject Matter, Pharma, RantanenJason Rantanen	By Jason Rantanen
Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)Panel: Rader, Lourie (author), Bryson
Last Friday, the Federal Circuit released its second noteworthy post-Bilski decision (the first being Research Corp v. Microsoft). The opinion, Prometheus v. Mayo, issued following a grant-vacate-remand order from the Supreme Court instructing the CAFC to revisit its original decision in light of Bilski. Despite this procedural posture, however, the new opinion is quite similar to the old, arriving at the same conclusion through essentially the same reasoning. Prometheus initially came to the Federal Circuit following a district court grant of summary judgment of invalidity under § 101 (lack of patentable subject matter). After the CAFC reversed the ruling of invalidity using its "machine-or-transformation" test, Mayo sought review by the Supreme Court. The Court granted certiorari, vacated the CAFC decision, and remanded for consideration in light of its Bilski opinion. Earlier Patently-O commentary includes a summary of the original Federal Circuit opinion and a discussion of the remand.
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said im-mune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
As before, the Federal Circuit disagreed, noting that Bilski provides a broad – although not unlimited – scope for patent protection, and “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Slip. Op. at 12, quoting Bilski, 130 S.Ct. at 3230. Furthermore, the court stated, neither the Supreme Court's order to vacate and remand the original Prometheus decision nor Bilski dictates a wholly different analysis or different result. The crux of the CAFC's determination that the asserted claims recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity as opposed to the natural correlation itself rests on the specific treatment steps recited by the claims: the "administering" step and the "determining" step. "The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment." Slip. Op. at 15-16.
In reaching this conclusion, however, the court was forced to distinguish its earlier decision In re Grams, 888 F.2d 835 (Fed. Cir. 1989), which similarly claimed a process that involved "(1) performing a clinical test on individuals and (2) based on the data from that test, determining if an abnormality existed and determining possible causes of any abnormality by using an algorithm." Id. at 20. Unlike the claims in Grams – which the CAFC found unpatentable "because the tests were just to 'obtain data'" (Slip Op. at 20) – the claims of the Prometheus patents "require the performing of clinical tests on individuals that were transformative." Mental StepsIn addition to its overarching analysis of the subject matter issue, the opinion also includes an interesting discussion of the use of mental steps in patent claims. Although the CAFC agreed that the final "wherein" clauses are mental steps, "A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole." Slip Op. at 21. Because no claim in the Prometheus patents claims only mental steps, "contrary to Mayo’s assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps." Id.
October 6, 2010Declaratory Judgment, Patent, Patent Cases 2010, Pharma, StandingJason Rantanen	By Jason Rantanen
With respect to the discretionary component of the Declaratory Judgment Act, the Federal Circuit concluded that the district court had abused its discretion in declining jurisdiction, both because it had relied on its determination that it lacked subject matter jurisdiction as well as being unsupported by the facts. Sun Pharmaceuticals v. Eli Lilly: obviousness-type double patenting in the pharmaceutical context
In addition to the issues discussed above, the scope of the injunction in Ortho-McNeil is worth noting. Although the extension authorized by 35 U.S.C. § 156 covers the "selling" or "using" of the product covered by the patent, the district court enjoined Lupin from engaging in any of the traditional forms of direct infringement, including "making" or "importing." Despite the literal language of §156, the Federal Circuit affirmed the scope of this injunction because there are no non-pharmaceutical "uses" of the drug product, a point that Lupin apparently conceded. Although as a practical matter this distinction may be of little value, as pharmaceutical companies often have production facilities located outside the United States, it is something to consider when seeking or opposing litigation under § 156. Federal Circuit Orders Another Case Transferred Out of Texas
December 2, 2009Patent, Patent Cases 2009, PharmaDennis Crouch	In re Hoffamann-La Roche (Fed. Cir. 2009)(on writ of mandamus) Novartis sued Roche and its partners in the Eastern District of Texas for infringement of its HIV treatment patent. After being denied by District Court Judge Folsom, Roche petitioned the Federal Circuit for a writ of Mandamus — asking the appellate court to order the case to be transferred to the Eastern District of North Carolina. Following its own TS Tech precedent as well as the 5th Circuit’s Volkswagen case, the Federal Circuit complied and has ordered the case transferred.
January 5, 2009Bits and Bytes, Patent, PharmaDennis Crouch	BPAI Plummeting Reversal Rate. [LINK] Accessing Patently-O: I have set up several ways to access Patently-O depending upon your preferences: Via the Website; Via daily Email Digest; Via Full Content RSS Feed; Via RSS Squib. Obama‘s original selection for Secretary of Commerce – Bill Richardson – will not pan out. Richardson has decided to withdraw his nomination. Although we rarely see the Secretary of Commerce directly shaping USPTO policy, the Office is still part of the Department of Commerce and the USPTO Director reports directly to the Secretary of Commerce. The greatest impact of the Secretary of Commerce may be on the selection of high-level PTO officials (including the Director). The Patent Troll Tracker debacle made the ABA Journal’s list of the top ten legal stories of 2008. (The only IP related issue to make the list). [Link] Patently-O Jobs: Microsoft (Redmond, WA) needs a patent portfolio manager (at least 5 years exp.) [LINK] Google (Mountain View, CA) needs an IP litigation counsel (at least 3 years exp.) [LINK] Amin Hallihan (Chicago) focuses on IP & FDA issues. The firm is looking one or more experienced patent attorneys to join their ranks. [LINK] Phama Law: Pozen’s migraine drug (Treximet) is special because it combines two types of migraine treatments into one pill: naproxen sodium (Aleve) and sumatriptan (Imitrex). Alphapharm (Mylan) filed an abbreviated new drug application (ANDA) to begin marketing a generic version of the drug – arguing that the patent is invalid. On January 2, Pozen sued Alphapharm for infringement in the Eastern District of Texas. Claim 1 of the asserted patent reads as follows: 1. In a method for treating a migraine patient by administering a 5-HT agonist [Imitrex], the improvement which comprises: concomitantly administering to said patient a long-acting, non-steroidal, anti-inflammatory drug (LA-NSAID) [Aleve] in an amount that, together with said 5-HT agonist, is effective to reduce migraine relapse or produce longer lasting efficacy compared to the administration of said 5-HT agonist in the absence of said LA-NSAID.
October 6, 2008Enablement, Patent, Patent Cases 2008, PharmaDennis Crouch	Impax Labs v. Aventis Pharmaceuticals (Fed. Cir. 2008) This appeal focuses on the question of when a prior art disclosure is sufficiently enabled. An Aventis patent covers the use of RILUTEK (riluzole) to treat ALS. Impax filed an ANDA with the FDA (seeking to market a generic version of the drug). In subsequent litigation, Impax also alleged, inter alia, that the listed patent should be held invalid. In particular, Impax argued that an earlier Aventis patent (the ‘940 patent) anticipates the asserted Aventis patent (the ‘814 patent) by suggesting a class of compounds may be used to treat ALS. The district court, however found that the ‘940 patent “does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ‘814 patent.” Burden particularly heavy: A defendant who hopes to use previously considered art to invalidate a patent has a “particularly heavy” burden. Thus, a party challenging patent validity has the burden to prove its case with clear and convincing evidence. When the examiner considered the asserted prior art and basis for the validity challenge during patent prosecution, that burden becomes particularly heavy. See Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1467 (Fed. Cir. 1990).
In this case, the ‘940 patent had been considered by the examiner during prosecution of the asserted patent. Enabled Prior Art: To anticipate, the prior art must be enabling – i.e., it must “enable one of ordinary skill in the art to make the invention without undue experimentation.” This enablement standard is different from the applicant’s 112 enablement requirement which requires enablement of both making and using the invention. That distinction becomes lost in cases like this, however, where the patent covers a method of treatment. Here, the Federal Circuit appears to require anticipatory prior art to enable practicing the claimed method. Enablement of prior art is a question of law, but is based on underlying factual findings. In close cases, the important factual finding is the amount of experimentation that would have been necessary. Applying Wands factors, the Federal Circuit agreed that the prior reference was not enabling. As shown by the trial court, the [prior art] ‘940 patent’s dosage guidelines are broad and general without sufficient direction or guidance to prescribe a treatment regimen. The alleged prior art also contains no working examples. Finally, nothing in the ‘940 patent would have led one of skill in the art to identify riluzole as a treatment for ALS. In sum, each component of the claimed invention—identifying riluzole as a treatment for ALS and devising dosage parameters—would require undue experimentation based on the teachings of the ‘940 patent.
Burden of Proving Enabled Prior Art: In judging anticipation, courts generally presume that prior art is enabled. That presumption may be overcome by a patentee by providing “persuasive evidence” of nonenablement. At that point, the ultimate burden of proof (with clear and convincing evidence) lies with the accused infringer. In this case, the district court did not explicitly follow this burden shifting framework. On appeal, the Federal Circuit held that articulation of the rule was not necessary. The burden was properly shifted because Aventis presented “sufficient evidence to overcome the presumption of enablement.” Holding: Affirmed. Validity challenge defeated because prior art was not enabled. Notes: The opinion did not focus on timing: As technology develops more and more prior art references become enabled. Thus, it is important to consider at what point in time the reference must be enabling. Disclosure: My former colleagues at MBHB represent Aventis in this case. The district court case was ongoing while I was there. Appellate Court Affirms that Generic Omeprazole does not Infringe Prilosec Patent
June 10, 2008Infringement, Patent, Patent Cases 2008, PharmaDennis Crouch	IN RE OMEPRAZOLE PATENT LITIGATION (Fed. Cir. 2008) (nonprecedential)
December 11, 2006CAFC, Chemical, Injunctions, Patent, Patent Cases 2006, PharmaDennis Crouch	Sanofi v. Apotex (Fed. Cir. 2006)