Cases Update
2013; Future Science Ltd; Volume: 2; Issue: 4 Linguagem: Catalão
10.4155/ppa.13.39
ISSN2046-8962
AutoresAlexandra Sklan, Takeshi S Komatani,
ResumoPharmaceutical Patent AnalystVol. 2, No. 4 Cases UpdateFree AccessCases UpdateAlexandra Sklan & Takeshi S KomataniAlexandra Sklan* Author for correspondenceFuture Science Group, Unitec House, 2 Albert Place, London, N3 1QB, UK. & Takeshi S KomataniShusaku Yamamoto Patent Attorneys, Crystal Tower, 1-2-27 Shiromi, Chuo-ku, Osaka, 540-6015 JapanPublished Online:15 Jul 2013https://doi.org/10.4155/ppa.13.39AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail AbstractKey recently filed cases and noteworthy rulings of relevance of the pharmaceutical and biotechnology industriesUS Court of Appeals for the Federal Circuit, March 25In this ruling, the Federal Circuit upheld a USPTO decision awarding priority of invention to Dawson and Bowman, where the patents in question claimed methods for treating and preventing eye infections. While working for the University of California, San Francisco (UCSF; CA, USA) in 1997, Dawson disclosed the possibility of developing a topical antibiotic treatment. After leaving UCSF, Dawson collaborated with Bowman to find a suitable topical carrier. Dawson and Bowman filed their first patent application in 1999, signed a declaration of joint inventorship, and assigned their rights to their employer, InSite. In 2007, UCSF filed a patent application listing Dawson as the sole inventor. The USPTO found that UCSF failed to prove sole conception by Dawson because the latter did not fully appreciate how to implement his idea into actual practice without his subsequent collaboration with Bowman. The Federal Circuit agreed. A disclosure by Dawson on the possibility of developing a topical antibiotic treatment fell short of the "definite and permanent idea of the complete and operative invention" required for conception.Source: www.cafc.uscourts.gov/images/stories/opinions-orders/12–1214.pdfSupreme Court of India, April 1The Supreme Court of India finally rejected Novartis' patent on Glivec (Gleevec in the US; generic nomenclature: imatinib mesylate; hereafter collectively called as 'Glivec'). In 2009, the Supreme Court of India issued a decision denying the Glivec β-crystal form patent on two grounds, based on Sections 3(d) and 3(b) of the Indian patent law. After the decision, the Swiss company filed a 'special leave petition' with the Indian Supreme Court in order to challenge the previous 2009 decision, in pursuit of clarifying these unique aspects of the patent law, in addition to seeking a patent for Glivec. The Court denied the Novartis appeal, challenging the rejection of a patent for Glivec, a tyrosine-kinase inhibitor used in the treatment of multiple cancers including chronic myelogenous leukemia and gastrointestinal stromal tumors. According to Novartis, they patented in nearly 40 countries including China, Russia and Taiwan, but not in India. Novartis filed a special leave petition with the Indian Supreme Court in 2009 challenging the denial of the Glivec β-crystal form patent on two grounds, based on Sections 3(d) and 3(b) of the Indian patent law. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects of the patent law. Specifically, in the lawsuit, "What is the true import of section 3(d) of the Patents Act, 1970? How does it interplay with clauses (j) and (ja) of section 2(1)? Does the product for which the appellant claims patent qualify as a 'new product' which comes by through an invention that has a feature that involves technical advance over the existing knowledge and that makes the invention 'not obvious' to a person skilled in the art? In case the appellant's product satisfies the tests and thus qualifies as 'invention' within the meaning of clauses (j) and (ja) of section 2(1), can its patentability still be questioned and denied on the ground that section 3(d) puts it out of the category of 'invention'?" The court discussed the history of Indian patent law, in view of the TRIPS agreement coupled with the Doha Declaration. Thereafter, the Court alleged that "we have seen in some detail the 'why' and the 'how' of the law. Let us now examine what the law is in light of its 'why' and 'how.'" [paragraph 87]. The Court summarized, "On a combined reading of causes (j), (ac) and (ja) of section 2(1), in order to qualify as 'invention', a product must, therefore, satisfy the following tests: (i) it must be 'new'; (ii) it must be 'capable of being made or used in an industry'; (iii) it must come into being as a result of an invention which has a feature that: (a) entails technical advance over existing knowledge; or (b) has an economic significance and (c) makes the invention not obvious to a person skilled in the art." Then the Court continued to discuss the meaning of 'invention' and 'patentability'. In summary, the Court held in paragraphs 103 and 104 that, "We are clearly of the view that the importance of the amendment made in section 3(d), that is, the addition of the opening words in the substantive provision and the insertion of explanation to the substantive provision, cannot be under-estimated. It is seen above that, in course of the Parliamentary debates, the amendment in section 3(d) was the only provision cited by the Government to allay the fears of the Opposition members concerning the abuses to which a product patent in medicines may be vulnerable. We have, therefore, no doubt that the amendment/addition made in section 3(d) is meant especially to deal with chemical substances, and more particularly pharmaceutical products. The amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds." [paragraph 104] "We have so far seen section 3(d) as representing 'patentability', a concept distinct and separate from 'invention'. But if clause (d) is isolated from the rest of section 3, and the legislative history behind the incorporation of Chapter II in the Patents act, 1970, is disregarded, then it is possible to see section 3(d) as an extension of the definition of 'invention' and to link section 3(d) with clauses (j) and (ja) of section 2(1). In that case, on reading clauses (j) and (ja) of section 2(1) with section 3(d) it would appear that the Act sets different standards for qualifying as 'inventions' things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold further higher, by virtue of the amendments made in section 3(d) in the year 2005." The Court found that, "[The] first invention lies in selecting example 21 out of the 37 examples given in the Zimmermann patent and then choosing methanesulfonic acid to produce the 14-(4-methylpiperazin-1–ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl] benzamide. methanesulfonic acid addition salt of the free base imatinib, called imatinib mesylate. In the second invention, the appellant arrived at the beta crystal form of methanesulfonic acid addition salt of imatinib." Then, the Court proceeded to examine in paragraph 162; that, "how far the β-crystalline form of imatinib mesylate stands up to the test of section 3(d) of the Act. It is noted, in the earlier part of judgment, that the patent application submitted by the appellant contains a clear and unambiguous averment that all the therapeutic qualities of β-crystalline form of imatinib mesylate are also possessed by imatinib in free base." Thereafter, the court concluded in paragraph 191 that, "We have held that the subject product, the β-crystalline form of imatinib mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgment to mean that section 3(d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Parent Act. That is not said in this judgment." And, "In view of the findings that the patent product, the β-crystalline form of imatinib mesylate, fails in both the tests of invention and patentability as provided under clauses (j), (ja) of section 2(1) and section 3(d) respectively, the appeals filed by Novartis AG fail and are dismissed with cost" [paragraph 195].Sources: http://supremecourtofindia.nic.in/outtoday/patent.pdf; http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212; www.novartis.com/newsroom/product-related-info-center/glivec.shtmlUS Court of Appeals for the Federal Circuit, April 4In this ruling, the Federal Circuit overturned a district court's infringement finding against Johnson & Johnson. Saffran had been awarded US$600 million. Saffran's patent claimed devices for treating and stabilizing serious bone fractures. At issue was the proper construction of the claim elements 'device' and 'release means'. The Federal Circuit decided Saffran made statements during prosecution that clearly limited 'device' to a continuous sheet and that the specification supported this conclusion. The court also decided that "release means for release of … treating material" invoked by the Patent Act section 112 paragraph 6 and was limited to the structure disclosed in the specification for releasing treating material, hydrolyzable bonds. Johnson & Johnson's accused drug eluting stents did not infringe as a matter of law, because they did not contain a continuous sheet or hydrolysable bonds. Judge O'Malley concurred, but disagreed on the construction of the term 'device'. Judge Moore concurred, but disagreed on the construction of 'release means'.Source: www.cafc.uscourts.gov/images/stories/opinions-orders/12–1043.Opinion.4–1–2013.1.pdfUS Court of Appeals for the Federal Circuit, April 16Bayer filed an application directed to a low-dose, extended-regimen combined oral contraceptive in 1993, which eventually led to the RE37,564 patent. Bayer received final approval to market YAZ in the US in 2006. Defendants filed abbreviated new drug applications with the US FDA, seeking approval to market generic versions of YAZ, with certifications asserting that the RE37,564 patent is invalid. Bayer responded with patent infringement actions. The district court entered summary judgment that the patent's claims are not invalid for obviousness in view of numerous cited prior art references. The Federal Circuit reversed, finding that Bayer did not present evidence that overcomes the plain disclosures and express motivation to combine those disclosures in the prior art.Source: www.cafc.uscourts.gov/images/stories/opinions-orders/12-1397.Opinion.4-12-2013.1.pdfUS Court of Appeals for the Federal Circuit, April 16In this ruling, the US Court of Appeals for the Federal Circuit affirmed the district court's judgment that GlaxoSmithKline did not infringe its '612 patent, which relates to an anti-CD20 antibody such as Biogen's Rituxan® (rituximab) for treating chronic lymphocytic leukemia. Biogen obtained the '612 patent covering a method for treating patients with chronic lymphocytic leukemia involving administering a therapeutically effective amount of the anti-CD20 antibody, entitled 'Treatment of hematologic malignancies associated with circulating tumor cells using chimeric anti-CD20 antibody'. However, the patent was not limited to any particular type of anti-CD20 antibody. In 2002, GlaxoSmithKline and Genmab developed a breakthrough anti-CD20 antibody, Arzerra®, which is distinctly different from Rituxan. In 2010, Biogen sued GlaxoSmithKline for infringement. The district court applied a construction of 'anti-CD20 antibody' that narrowed the term based on prosecution history disclaimer. Under that construction, Biogen stipulated that it could not prove infringement and appealed the claim construction. The Federal Circuit affirmed.Source: www.cafc.uscourts.gov/images/stories/opinions-orders/12-1120.Opinion.3-27-2013.1.pdfEngland & Wales High Court (Chancery Division) Decisions, April 17Following an appeal by the International Stem Cell Corporation against a decision that the two of its patent applications relating to human stem cells were excluded from patentability, the UK High Court of England and Wales has made a reference to the Court of Justice of the EU requesting that the term 'human embryos' be clarified under the Biotechnology Directive. In particular, the matter in question is whether this definition includes unfertilized human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings. The case follows the Brüstle v. Greenpeace decision, in which the court ruled inter alia that any nonfertilized human ovum whose division and further development have been stimulated by parthenogenesis constitutes a 'human embryo' within the meaning of Article 6(2)(c), due to it being capable of commencing the process of development of a human being, just as an embryo created by fertilization of an ovum can do. The High Court has asked the European Court of Justice for guidance on how Article 6(2)(c), and the precedent set by Brüstle, would be applied where the process would not "commence the … development of a human being."Source: www.bailii.org/ew/cases/EWHC/Ch/2013/807.htmlIP High Court of Japan, April 18The IP High Court of Japan held that Mitsubishi Chemical Corporation (hereinafter referred to simply as 'Mitsubishi') pay considerable amount of employee's contribution to an inventor, in an appeal lawsuit dealing with employee's right challenged by an inventor who invented a product, or the compound sarpogrelate hydrochloride sold under the name of 'Anplag', which is an inhibitor for platelet aggregation and vascular contraction, substantially accepting the original Tokyo District Court's decision. In the subject case, the inventor Y filed a lawsuit in the Tokyo District Court in pursuit of the inventor's right contributing the potential blockbuster for cardiovascular diseases. The Plaintiff Y is an inventor of a patent directed to the compounds encompassing sarpogrelate hydrochloride (JP1466481), in which antidepressant use is acknowledged, and a patent directed to the use of the compound as an inhibitor of platelet aggregation and vascular contraction, especially the first drug having selectivity against 5-HT2 receptor of platelets and vascular smooth muscle cells (JP1835237). The district court held that the contribution ratio between the compound patent and the use patent to be 60:40, since the compound patent covers broader subject matter than the use patent, although the use patent is important for the pharmaceutical product. In the compound patent, Y, as the main inventor in the organic synthesis part, was granted 50% contribution, whereas in the use invention, as having little experience in the cardiovascular field, Y was granted only 10% contribution. Furthermore, the Tokyo District Court calculated contribution ratio between Mitsubishi and the inventors including Y, and held 95:5 considering the circumstances of pharmaceutical industry. Furthermore, in considering the contribution ratio between the two patents, the district court held that the re-examination system under the Pharmaceutical Affairs Act, which is said to be substantially equivalent to the data protection/exclusivity right in the US or Europe, cannot be considered since the re-examination system in Japan does not render the absolute exclusivity, as it does not prohibit other party to request for approval based on their own clinical trial data.Sources: www.courts.go.jp/hanrei/pdf/20130430093251.pdf (decision); www.courts.go.jp/hanrei/pdf/20120313150131.pdf (original decision)US Court of Appeals for the Federal Circuit, May 1There is an appeal lawsuit between Allergan and a group of generic pharmaceutical makers, including Sandoz Inc., dealing with patentability of different dosage regimen of an eye-drop formulation for treating glaucoma, sold by Allergan under the trademark Combigan®. In the decision, although the composition per se has been found to be obvious, the court held that the dosage regimen per se is not inherently obvious even in the case where the composition per se would have been obvious, therefore the generic makers would infringe the method claim directed to the dosage regimen. This patent infringement case involves a combination ophthalmic drug treatment. The issues on appeal are invalidity and claim construction. Sandoz et al. have challenged the district court's finding that the claims of US patents US7642258, US7320976, US7323463 and US7030149 are not invalid under 35 USC § 103 (obviousness). Allergan challenges the court's construction of certain claims. The claim in issue directed to the dosage regimen reads "[A] method of reducing the number of daily topical ophthalmic doses of brimondine administered topically to an eye of a person in need thereof for the treatment of glaucoma or ocular hypertension from three- to two-times a day without loss of efficacy, wherein the concentration of brimonidine is 0.2% by weight, said method comprising administering said 0.2% brimonidine by weight and 0.5% timolol by weight in a single composition." As such, the subject method claim has a number of relevant limitations, including the combination of brimonidine and timolol, and the use of this combination twice a day with the same efficacy as brimonidine administration three-times a day. The problem with administering brimonidine only twice a day was that efficacy would drop 8–9 h after administration, in a phenomenon referred to as 'afternoon trough'. The majority found that the defendants did not establish by clear and convincing evidence that the claimed method would have been obvious. Therefore, the US Court of Appeals for the Federal Circuit reversed in part, where the district court erred in finding the claims of the '463 patent (formulation claim) not invalid as obvious; affirmed in part, where defendants failed to prove by clear and convincing evidence that claim four of the '149 patent (dosage regimen claim) would have been obvious; and affirmed in part, where there was no error in the district court's claim construction.Source: www.cafc.uscourts.gov/images/stories/opinions-orders/11-1619.Opinion.4-25-2013.1.pdfUS Supreme Court, June 13The Supreme Court held the 'paradigm-shifting' decision on 13 June 2013 – in the so-called the Myriad case [1,2] – that inventions directed to naturally occurring DNAs are NOT patent eligible even if they are 'isolated', wherea inventions directed to cDNA derived therefrom are patent eligible, under §101 of the 35 USC (the US patent law), which states "[w]hoever invents or discovers any new and useful … composition of matter." The subject case is directed several patents owned by Myriad Genetics et al., which cover particular isolated human genes directed to so-called BRCA1 and BRCA2, which encodes early-onset breast cancer, cDNA therefor, methods for obtaining the DNA, and methods for using the DNA to test for disease. It is said that the finding of these genes has enabled saving many lives. The Myriad case has been challenged over several years, and after the Prometheus case [3] where the Supreme Court of the USA has held mere application of laws of nature are not patent eligible, by holding "'laws of nature, natural phenomena, and abstract ideas' … 'are basic tools of scientific and technological work' that lie beyond the domain of patent protection, … [The] rule against patents on naturally occurring things has limits, however. Patent protection strikes a delicate balance between creating 'incentives that lead to creation, invention, and discovery' and 'imped[ing]the flow of information that might permit, indeed spur, invention.'" It is said that under the US Patent Law, the mere information discovered is not patentable subject matter, since such information could be classified as a subject matter that lacks patent eligibility such as a natural phenomenon, or alternatively an abstract idea. However, in the Chakrabarty case [4] back in 1980s, the Supreme Court held that an isolated matter from the nature, such as a microbial entity may be a patent eligible subject matter, and thereafter an isolated DNA and cDNA have been granted patents, even if the sequence information per se, which is included therein, is mere abstract information and may not be patentable. The Supreme Court held that "[A] naturally occurring DNA segment is a product of nature andnot patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring," by stating that the standard for the judgment that "[This] standard is used to determine whether Myriad's patents claim a 'new and useful … composition of matter,' §101, orclaim naturally occurring phenomena." With respect to the DNA claims, the Supreme Court held "[Myriad's] DNA claim falls within the law of nature exception. Myriad's principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U.S. 303, is central to the patent-eligibility inquiry whether such action was new "with markedly different characteristics from any found in nature," id., at 310. Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry (see Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127). Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible "new … composition[s] of matter," §101. Myriad's patent descriptions highlight the problem with its claims; they detail the extensive process of discovery, but extensive effort alone is insufficient to satisfy §101's demands. Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together…" With respect to the cDNA claims, the Supreme Court held that "[cDNA] is not a 'product of nature,' so it is patent eligible under §101. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA." The Supreme Court also noted limitations of the subject decision by stating: "[This] case, it is important to note, does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered," and the case is "affirmed in part and reversed in part."Sources: www.supremecourt.gov/Search.aspx?FileName=/docketfiles/12-398.htm; www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdfDisclaimerThis Cases Update describes the opinions and observations of the authors and does not represent the viewpoints of the authors' employers or authors' firms. By its nature, the article provides the authors' general opinion, and necessarily limited, discussion of various topics; it does not purport to give specific legal advice or a substitute for legal counsel. As legal advice must be tailored to the specific circumstances of each case, nothing provided herein should be used as a substitute for advice of competent counsel. The authors and the authors' firms assume no liability for the use or interpretation of information contained herein.Financial & competing interests disclosureA Sklan is a freelance writer for Future Science Group. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript. References 1 Woessner WD, Chadwick RA. Diagnostic claims post-Mayo and Myriad: the pile-up begins. Pharm. Pat. Analyst2(2),165–167 (2013).Link, CAS, Google Scholar2 Sklan A, Komatani TS. Cases update. Pharm. Pat. Analyst2(2),181–186 (2013).Link, CAS, Google Scholar3 Perry LS, DiRamio JA. The Mayo v. Prometheus decision. Pharm. Pat.Analyst1(4),357–359 (2012).Link, CAS, Google Scholar4 Diamond v. Chakrabarty, 447US 303 (1980).Google ScholarFiguresReferencesRelatedDetailsCited ByInternational considerations: for effective global intellectual property strategy in the pharmaceutical industry2 February 2016Cases Update: International roundup of recently filed cases and noteworthy rulingsAlexandra Sklan & Takeshi S Komatani22 August 2013 | Pharmaceutical Patent Analyst, Vol. 2, No. 5 Vol. 2, No. 4 Follow us on social media for the latest updates Metrics History Published online 15 July 2013 Published in print July 2013 Information© Future Science LtdPDF download
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