Source: http://www.patentdocs.org/2008/02/index.html
Timestamp: 2014-07-11 18:15:37
Document Index: 523598909

Matched Legal Cases: ['§ 311', '§ 103', '§ 103', '§ 103', '§ 102', '§ 103', '§ 102', '§ 103', '§ 103', '§ 102', '§ 103', '§ 1', '§ 302', 'Application No. 10', 'Application No. 10', 'Application No. 60', '§ 112', '§ 112', '§ 112', '§ 154', '§ 1', '§ 1', '§ 122', '§ 1']

Patent Docs: February 2008
Drug prices being the key motivator for governments in the developing world to grant such compulsory licenses, it would seem prudent for companies to lower their own prices and thus blunt if not forestall the generic companies' justifications for government action. While this has happened sporadically in the past, there has been no coordinated effort by Western drug companies to develop a strategy around drug pricing in the developing world to address the compulsory licensing issue. Actions such as the ones contemplated in India and elsewhere make it apparent that such a coordinated strategy is necessary if innovator drug companies are not to be left with none of the advantages that the TRIPS agreement was intended to have for their industry.For information regarding this and other related topics, please see:
• "Novartis to Supply Cancer Drug to Thai Patients," February 5, 2008• "Neocolonialism in the Current Global Drug Pricing Regime?" August 19, 2007• "More on the Global Drug Patenting Crisis," August 14, 2007• "EU Trade Commissioner Sends Warning Letter to Thailand," August 13, 2007• "Trying to Find a Solution to the Global Drug Pricing Crisis," July 16, 2007• "Pharma Sanity Lacks Global Reach," July 13, 2007• "Brasil Prevails in Dispute with Abbott over AIDS Drug Pricing," July 9, 2007• "Africa (Still) Depending on the Kindness of Strangers in Anti-AIDS Drug Pricing," May 29, 2007• "U.S. Trade Policy Becoming Less Pharma-Friendly," May 18, 2007• "The "Unfairness" of World Intellectual Property Protection According to The New Yorker," May 17, 2007• "Worldwide Drug Pricing Regime in Chaos," May 9, 2007• "Not Getting It about Patented Drug Prices at The Wall Street Journal," May 6, 2007• "A Modest Proposal Regarding Drug Pricing in Developing Countries," May 2, 2007• "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries," May 1, 2007• "Abbott Agrees to Offer AIDS Drug at Reduced Price," April 12, 2007• "No New Abbott Medicines for Thailand," March 14, 2007• "More Compulsory Licensing in Thailand," February 1, 2007
IPO Conference on Recent IP Decisions The Intellectual Property Owners Association (IPO) will be holding a conference entitled "Recent Decisions: How They Affect Your Corporate IP Practice" on March 17, 2008 in Washington, DC. Topics to be addressed at the conference include:
• Changes in Patent Jurisprudence: The Aftermath of KSR -- litigation and prosecution panels• Willfulness and Opinions of Counsel as Affected by In re Seagate• Licensing and Cease & Desist Letters in Light of Medimmune• Global Litigation Strategies and Extraterritorial Patent Enforcement• Fraud before the U.S. Patent & Trademark Office• Trends in Federal Circuit Damages Decisions
The conference's luncheon speaker will be Judge Kimberly A. Moore of the U.S. Court of Appeals for the Federal Circuit.
A complete brochure for this conference, including the conference program, a list of speakers, and registration form can be downloaded here.
The registration fee ranges from $750 (for IPO members) to $1,100 (for non-members). Those interested in registering for the conference can do so here.
23rd Annual ABA Intellectual Property Law Conference
The American Bar Association (ABA) section of Intellectual Property Law will be holding the 23rd Annual Intellectual Property Law Conference on April 10-12, 2008 in Arlington, Virginia. Among the topics that will be covered at the conference are:
• Are the Supreme Court and Federal Circuit on the Same Page For Patent Law?• What Patent Law Reform Really Means For You• Latest Developments in the U.S. Patent Office• Litigation Skills - Representing Unpopular Defendants in IP Litigation• Patent Trolls: Are They Down for the Count?• Death and Texas: How to Survive and Thrive in Patent Litigation in the Eastern District• Ethics Issues Part I: latest Developments in IP Litigation Ethics• Breaking News - Hot Topics in Copyright, Trademark and Patent Law
On the first day of the conference, the luncheon speaker will be Chief Judge Paul R. Michel of the U.S. Court of Appeals for the Federal Circuit, who will discuss patent law reform. In addition, an evening reception will be held at the U.S. Court of Appeals for the Federal Circuit.
The registration fee ranges from $245 for students to $795 for non-ABA members. Those registering before March 26 will receive a $50 discount. Detailed registration information can be found here.
PharmaBiotech IP Summit
The 2008 PharmaBiotech IP Summit, organized by Worldwide Business Research, will occur in Philadelphia at the Ritz-Carlton, May 28-30. The conference, "Protect Critical Patents and Drive Sustainable Growth Through IP-Driven Business Strategies," consists of two main conference days and a master class. The Patent Protection and Enforcement Masterclass occurs on May 28, and covers topics such as the upcoming regulations, lifecycle extension relative to assessing best time to file applications, the new IDS rules, changes to Markush practice, avoiding inequitable conduct in prosecution, and the Examiners' guidelines on obviousness.
According to the conference website, the Summit will enable its attendees to:
• Effectively navigate recent and potential regulatory changes to ensure long term protection and enforcement of your patents.• Enhance strategic management of your portfolio to get the best out of it.• Implement innovative ways to extend the useful life cycle of your most commercially valuable assets.• Meld IP and business strategies to become a true partner of the business and drive future growth.
CLE credit is available. For more information, including the agenda and registration information, visit the PharmaBiotech Summit IP website.
(Finally) It May Be Time to Stop the Hypocrisy over Stem Cell Patents By Kevin E. Noonan --
The U.S. Patent and Trademark Office rendered its final decision on Monday in one of the re-examinations of the Thomson stem cell patents provoked by two groups: the Public Patent Foundation (PUBPAT), headed by Dan Ravicher, and The Foundation for Taxpayer and Consumer Rights (FTCR), a California taxpayer group. The Patent Office decision comes in the inter partes (35 U.S.C. § 311-318) re-examination of U.S. Patent No. 7,029,913.
The inter partes requesters had asserted four grounds of unpatentability against the claims of the '913 patent:
• That the claims are unpatentable under 35 U.S.C. § 103(a) for being obvious in light of the Robertson '83 reference (Cold Spring Harbor 10: 647-63) in view of the Loring Declaration (see "It's Time to Stop the Hypocrisy over Stem Cell Patents - Part I").• That the claims are unpatentable under 35 U.S.C. § 103(a) for being obvious in light of the Piedrahita 1990 reference (Theriogenology 34: 879-901) in view of the Loring Declaration.• That the claims are unpatentable under 35 U.S.C. § 103(a) for being obvious in light of the Robertson '83 reference, the Robertson '87 reference (Teratocarcinomas and Embryonic Stem Cells: A Practical Approach, IRL Press) and the Piedrahita 1990 reference in view of the Loring Declaration.As set forth in the decision, the Examiner refused to adopt any of these grounds of unpatentability, since they improperly relied on the Loring declaration (which does not properly form a basis for re-examination). The Examiner instead raised the following grounds of unpatentability:
• That the claims were unpatentable under 35 U.S.C. § 102(b) for being anticipated by U.S. Patent No. 5,166,065 to Williams, either alone or based on evidence of inherency.• That the claims were unpatentable under 35 U.S.C. § 103(a) for being obvious in light of the '065 patent, either alone or based on evidence of inherency.• That the claims were unpatentable under 35 U.S.C. § 102(b) for being anticipated by U.S. Patent No. 5,690,926 to Hogan, either alone or based on evidence of inherency.• That the claims were unpatentable under 35 U.S.C. § 103(a) for being obvious in light of the '926 patent, either alone or based on evidence of inherency.• That the claims were unpatentable under 35 U.S.C. § 103(a) for being obvious in light of Robertson '83 reference, the Robertson '87 reference, the '065 patent, and the '926 patent.
However, in Monday's decision, the Examiner withdrew all these grounds of rejection, finding that the claims were patentable over the combinations of the cited references and under 35 U.S.C. §§ 102 and 103. The Examiner did not merely withdraw these rejections, however, but rather set forth the basis for these determinations for all of the art and all of the arguments raised by the requestor. Specifically, the Examiner made these determinations:
U.S. Patent No. 5,166,056 to Williams does not anticipate the '913 patent claims; the Williams patent disclosed only mouse ES cells and did not inherently enable the human ES cells claimed in the '913 patent. Moreover, any implied teaching with regard to human ES cells was contradicted by a later paper (Cherny, 1994, Reprod. Fert. Develop. 6: 569-75; Williams co-authored), stating that isolation of human pluripotent ES cells had "remained elusive." Moreover, the Examiner considered the "precise impetus" for Cherny, 1994 was to find alternative methods for producing ES cells from non-mouse species, because the methods used for mouse ES cells had not been "applicable to other domestic animals." Indeed, the Examiner agreed with WARF's position that Cherny, 1994 contradicted any interpretation that the Williams patent enabled human ES cell preparation. Finally, the Examiner believed that undue experimentation would be required to practice the methods of the Williams patent to produce human ES cells, since there could be no reasonable expectation of success in view of all of the evidence of record.
This belief was supported by evidence from the art, specifically the Gardener and Brook reference (1997, Proc. Natl. Acad. Sci. U.S.A. 94: 5709-12) and the Brook et al. reference (2003, Diabetes 52: 205-08), of the failure of others to produce human ES cells using prior art methods such as those set forth in the Williams patent. The Examiner's undue experimentation determination was also supported by the Iannacone et al. (1994, Develop. Biol. 163: 288-92) and Ouhibi et al. (1995, Molec. Reprod. Devel. 40: 311-24) references, showing the unpredictability of producing rat ES cells. On the other hand, Doetschman (1988, Develop. Biol. 127: 224-27) isolated hamster ES cells, but Piedrahita (1990, Theriogenology 34: 879-901) failed to isolate ES cells from pigs or sheep, and while unable to determine whether Talbot (1995, Molec. Reprod. & Develop. 42: 35-52) isolated bovine ES cells, the evidence supported the Examiner's position that the art evidence showed that ES cells were sufficiently unpredictable to amount to undue experimentation absent evidence that ES cells from a particular species had in fact been made.
The most directly applicable reference to the human ES cells of the '913 patent was the Bongso reference (1994, Human Reprod. 9: 2010-17) (see "WARF Responds to the Patent Office on Its Re-examined Stem Cell Patents"). However, although the Examiner believed that Bongso may have in fact isolated human ES cells, he was unable to maintain them in culture as recited in the claims.
With regard to obviousness under 35 U.S.C. § 103(a), the Examiner determined that the Williams patent did not support a prima facie obviousness determination, expressly considering the matter under the Supreme Court's recent KSR Int'l Co. v Teleflex Inc. decision. Specifically, the Examiner determined that the art failed to provide a reasonable expectation of success in achieving the claimed invention, in view of the previously-determined unpredictability in producing ES cells from a variety of mammalian species (including human). The Examiner also determined that evidence of "public acclaim" submitted by WARF would be properly considered as one of the "secondary indicia" of non-obviousness if WARF had established the source of the acclaim as being from those of at least ordinary skill in the art. Since the Examiner concluded that the evidence did not support a prima facie obviousness determination, he did not need to consider the secondary indicia in this case.
Importantly, the Examiner also determined that the declaration evidence submitted by the third party requestor to the effect that Dr. Thomson succeeded in isolating human ES cells where others failed merely due to access to resources (human embryos) and funding others did not have, was merely hindsight reasoning and thus impermissible for consideration in an obviousness determination. The Examiner also noted for the record that at least two of the declarants were not disinterested parties.
Turning to the Hogan patent, the Examiner determined that the EG cells disclosed by Hogan are distinct from the ES cells claimed in the '913 patent, and thus that the Hogan patent neither anticipates nor renders obvious the claims of the '913 patent. The Examiner's conclusions were based on comparisons between characteristic properties of the two cell types, including the presence or absence of certain cell surface markers (such as SSEA-1).
Finally, the Examiner considered whether the combination of the '065 patent and the '926 patent, in view of the Robertson '83 reference or the Robertson '87 reference rendered obvious the invention claimed in the '913 patent. He found that while the two Robertson references disclosing mouse ES cells provided strong motivation in the art to produce human ES cells, the unpredictability in the art noted above made the claimed invention non-obvious. The Examiner came to the same conclusion with regard to the combination of the '065 patent and the '926 patent with the Piedrahita 1990 reference discussed above. The Examiner came to the same conclusions when considering the obviousness question in view of the teachings of all these references combined.
The Patent Office decision issued Monday was not a Notice of Allowance or other final determination. Rather, it was a (non-final) Action Closing Prosecution. According to the paper itself, no appeal could be taken from this Action; the patentee has one month to file a "submission," and if one is filed the Third Party Requester has the right to file responsive comments within 30 days. Thereafter, the Office will issue a Right of Appeal Notice pursuant to 37 C.F.R. § 1.953(a), giving the parties one month to file an appeal to the Board of Patent Appeals and Interferences.
One final note: the patentee submitted amendments to the claims that the Examiner states are not necessary for patentability but that "provide further clarity to the claims." Presumably, a re-examination certificate will include the amendments to the claims, which are as follows:
1. A replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo, the culture comprising cells which (i) [[are capable of proliferation]] will proliferate in an undifferentiated state in in vitro culture for over one year without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.
2. The in vitro cell culture [[preparation]] of claim 1, wherein the stem cells will spontaneously differentiate to trophoblast and produce chorionic gonadotropin when cultured to high density.
3. The in vitro cell culture [[preparation]] of claim 1 wherein the cells are negative for the SSEA-1 marker, positive for the SSEA-4 marker, and express alkaline phosphatase.
Two ex parte re-examinations (35 U.S.C. § 302-307) remain: Control No. 90/008102 for U.S. Patent No. 5,843,780 (claiming primate embryonic stem (pES) cells) and Control No. 90/008139 for U.S. Patent No. 6,200,806 (claiming human embryonic stem cell (hES) cells). Since the progress of these re-examinations have paralleled the inter partes re-examination, and in view of the "special dispatch" provisions of the re-examination rules, we should expect a decision in these re-examinations shortly.For information regarding this and other related topics, please see:
• "WARF Licenses Stem Cell Patent Portfolio to BioTime," January 23, 2008• "It's Time to Stop the Hypocrisy over Stem Cell Patents - Part III," July 4, 2007
Posted at 11:39 PM in Biotech/Pharma News, Patent Prosecution | Permalink
The decision raises questions of how the FDA will address approval standards for late-stage cancer treatments. According to Dr. Kay Dickerson of the Center for Clinical Trials at Johns Hopkins University, "[i]f FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint." The decision also suggests an acceptance at the FDA of principles advocated by academic critics (and supporters) of the FDA, such as Professor Richard Epstein at the University of Chicago Law School (see "Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation"), that the FDA should permit patients to make the judgment of whether to use drugs like Avastin® for terminal diseases. However, those espousing such "free market" solutions neglect to consider whether decisions like the FDA's approval of Avastin® represents an abdication of the agency's responsibility to make scientifically-reasoned, dispassionate assessments of drug efficacy for individuals in the throes of deadly diseases, whose capacity for dispassion may be compromised. While certainly the case that the drug can give patients hope (a sentiment expressed by Margaret C. Kirk, Executive Director of the Y-ME National Breast Cancer Organization), whether this is enough to determine approval as a consistent policy is an important question the FDA has yet to adequately address.For additional information regarding this and other related topics, please see:
• "Compromise Resolves Avastin® Dispute," December 26, 2007• "Genentech Beset with Avastin® Woes," December 6, 2007• "Age-related Macular Degeneration Patients Get a (Limited) Reprieve," November 7, 2007• "Genentech Acts to Halt Off-label Use of Avastin® for Age-related Macular Degeneration," October 21, 2007• "Genentech CEO Defends Differential Cost for Avastin®/Lucentis® Treatment of Macular Degeneration," June 6, 2007• "Retinal Specialist on the Avastin®/Lucentis® Controversy," February 23, 2007• "Lower Doses of Genentech's Avastin® Effective in Treating Lung Cancer," February 23, 2007
Sigma-Aldrich Licenses Apoptosis Marker
Sigma-Aldrich Co. has announced a licensing deal with NeuroSurvival Technologies Ltd. by which Sigma-Aldrich will be allowed to market and manufacture a marker that can detect apoptosis in vitro and in vivo. The marker, commercially known as Apo-TRACE, is one of a number of small molecules, referred to collectively as ApoSense™, that NeuroSurvival has developed to detect apoptotic cells in vivo. An overview of NeuroSurvival's ApoSense™ technology is available here. The markers can be used for molecular imaging in the areas of disease staging/diagnosis, treatment monitoring, and drug development.
ApoSense™ Positron Emission Tomography (PET) scans can be viewed here.
Jason Derry, Ph.D., who graduated with honors from DePaul University
Posted at 10:58 PM in Licensing | Permalink
As It Turns Out, It Doesn't Have to Be a Rose to Smell as Sweet
Insidious (adj.): operating or proceeding in an inconspicuous or seemingly harmless way but actually with grave effect.
On Saturday, The New York Times published an article analogizing two industries most readers would not have thought to be similar: the perfume industry and innovator pharmaceutical companies (see "Ahh, the Seductive Fragrance of Molecules under Patent"). But the similarities are manifold, and upon reflection are not that surprising.
Like the pharmaceutical industry, perfumeries are constantly in need of new molecules, not to treat diseases of course but to provide the source material for new fragrances. For example, the article cites Kate Greene, vice president for marketing at Swiss scent maker Givaudan, as saying the company makes more than 2,000 new scent molecules every year, but develops only 3 or 4 of them as commercial products. Development costs are high: although Givaudan has annual profits of 2.9 billion Swiss francs, it also invests almost 400 million francs in research each year and employs more than 50 scientists in these efforts. Similar efforts are reported in the article for Japanese scent company Takasago International Corporation; Symrise of Holzminden, Germany; and International Flavors and Fragrances of New York, who collectively spend "billions" in research.
The return on investment is high, with individual scents (used as components for popular perfumes and other fragrances) so dear, their producers decline to specify their cost (other than saying they were "not cheap). These new scent molecules provide the raw material for the up to 600 new fragrances introduced each year. They also have advantages over naturally-occurring scents, such as lacking allergenicity present in natural products such as rose ketones, the amount of which is restricted due to their propensity to provoke allergic reactions. Other advantages include the capacity to cling to fabrics, to be used in scented laundry products and soaps, while at the same time being more potent so that less scent must be used (and less water used to wash the scent away).
Importantly, there are also ecological advantages: for example, the article cites the price of natural sandalwood as reaching $1,700 per kilogram, due to severe over-foresting of Indian sandalwood that forced the Indian government to ban further harvesting. Additionally, using synthetic rather than naturally-occurring scents avoids the ancillary economic and ecological costs of fertilizers, soil erosion, and diverting cropland to non-agricultural uses.
Some of the most expensive of the scents, described as "captives" in the industry, are those that are under patent, the most potent analogy made by the article to the pharmaceutical industry. In addition to the analogies noted above to the high development costs and low probability of success, the article also notes the importance of toxicology and the effects of the scope of available patent protection in different countries (while getting the current extent of U.S. patent term wrong, citing a figure not used for the past thirteen years).
But the analogies to patenting and its importance to the industry are where an otherwise informative article goes a little wrong. Maybe it's because the Times published it, or maybe it's the title ("Ahh, the Seductive Fragrance of Molecules under Patent") (something that could be the product of a copy editor well aware of the Times patent animus). Whatever the reason, rather than being enlightening, the patent angle seems gratuitous. The antiparallels to pharmaceuticals are never mentioned: the much higher regulatory costs and barriers for drugs, the factors other than toxicity that can make even fewer potential drug leads suitable for commercialization, and of course the unstated difference between "luxury" items like perfumes and life-saving drugs. And the overall effect is insidious: another Times article where patents are not described as helping companies protect hard-earned investment but rather just make things cost too much. The unspoken assumptions have substantive consequences: in discussing Takasago's patent strategy for it synthetic must product, l-muscone (the company patented the synthetic methods rather than the scent itself), the effect, that these methods will be dedicated to the public when Takasago's patents expire goes unmentioned. It seems a shame that such important considerations are left to innuendo or discussed obliquely, even by the Times. You might even say it stinks.
Posted at 08:37 PM in Media Commentary | Permalink
Galderma Laboratories, LP et al. v. Actavis Mid-Atlantic, L.L.C.4:08-cv-00115; filed February 21, 2008 in the Northern District of Texas
Infringement of U.S. Patent No. 7,316,810 ("Foaming Composition for Washing and Treating Hair and/or Scalp Based on an Active Principle," issued January 8, 2000) following a paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Galderma's Clobex® Shampoo (clobetasol propionate shampoo, used to treat psoriasis). View the complaint here.
Sepracor Inc. et al. v. Geopharma, Inc. et al.3:08-cv-00945; filed February 20, 2008 in the District Court of New Jersey
Novartis Vaccines and Diagnostics, Inc. v. Wyeth et al.2:08-cv-00067; filed February 15, 2008 in the Eastern District of Texas
Infringement of U.S. Patent Nos. 6,060,447 ("Protein Complexes Having Factor VIII:C Activity and Production Thereof," issued May 9, 2000) and 6,228,620 (same title, issued May 8, 2001) based on Wyeth's manufacture and sale of its ReFacto® (recombinant antihemophilic Factor VIII, used to treat hemophilia). View the complaint here.
Novartis Vaccines and Diagnostics, Inc. et al. v. Bayer Healthcare, LLC et al.2:08-cv-00068; filed February 15, 2008 in the Eastern District of Texas
Infringement of U.S. Patent No. 7,138,505 ("Factor VIII:C Nucleic Acid Molecules," issued November 21, 2006) based on defendants' manufacture and sale of their Kogenate® (Bayer) and Helixate® (CSL Behring) (recombinant antihemophilic Factor VIII, used to treat hemophilia). View the complaint here.
OREXIGEN Therapeutics Secures Allowance for Application Covering Zonisamide
Last Thursday, OREXIGEN Therapeutics, Inc. announced that the U.S. Patent and Trademark Office mailed a Notice of Allowance for a patent application directed to the treatment of obesity using zonisamide, either alone or in combination with other drugs. According to OREXIGEN, the allowed application will complement U.S. Patent No. 7,109,198. Both the recently allowed application (believed to be U.S. Application No. 10/830,071) and the '198 patent, the latter of which OREXIGEN has exclusively licensed from Duke University, will expire in 2023.
OREXIGEN President and CEO, Dr. Gary Tollefson, stated that "[t]his notice from the USPTO is an important milestone toward issuance of the patent and would give us an additional layer of protection for our use of zonisamide in treating obesity." Dr. Tollefson believes that the allowed application will discourage competitors from copying OREXIGEN's approach for treating obesity with zonisamide-based compounds.
Zonisamide is one of the active constituents of EMPATIC, a novel formulation of zonisamide and bupropion. Bupropion is a dopamine and norepinephrine re-uptake inhibitor while zonisamide is an approved anticonvulsant medication. The rationale behind EMPATIC is that the combination of zonisamide and bupropion affects two groups of hypothalamic neurons, the POMC and NPY/AgRP neurons, to reduce the feeling of hunger. The POMC neurons release the hormone alpha-MSH while the NPY/AgRP neurons release AgRP. Both alpha-MSH and AgRP competitively bind to the melanocortin MC4 receptors; alpha-MSH binding increases energy expenditure and reduces hunger, while AgRP binding reduces energy expenditure and increases hunger. In addition, monoamines, such as dopamine, norepinephrine, and serotonin, stimulate the neurons increasing alpha-MSH secretion and reducing AgRP secretion. The novel combination of zonisamide and bupropion exploits the opposing effects of alpha-MSH and AgRP on MC4. Zonisamide increases monoamine secretion which increases alpha-MSH secretion and reduces AgRP secretion, while bupropion increases alpha-MSH secretion by stimulating POMC. The net effect is that alpha-MSH is overproduced and AgRP is reduced, leading to increased energy expenditure and reduced hunger.
Results of clinical studies support OREXIGEN's rationale for weight loss. Studies with EMPATIC have shown that meaningful weight loss is sustainable over long periods. Patients with body mass indices between 30 and 40 lost in excess of 9% of their baseline body weight by week 24. In addition, weight loss continued for another 24 weeks with patients averaging a weight loss of 12% from baseline. The weight loss was dose dependent with the highest dose achieving the greatest weight loss.
OREXIGEN is also pursuing another drug combination, CONTRAVE, which in patient studies has shown weight loss without a plateau after 36 weeks of treatment. CONTRAVE is a combination of bupropion and naltrexone designed to block the natural inhibition of alpha-MSH secretion by ß-endorphin.
Obesity has become a major health problem in the Unites States and around the World. The World Health Organization estimates that there are more than 1 billion overweight adults worldwide, and that at least 300 million of these individuals are clinically obese. In the United States, data from two National Health and Nutrition Examination Surveys show that among adults aged 20-74 years, the prevalence of obesity increased from 15.0% (in the 1976-1980 survey) to 32.9% (in the 2003-2004 survey). But obesity also increases the risk of many serious diseases, such as hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea, respiratory problems, and even cancer. So therapies such as EMPATIC and CONTRAVE represent important advances in the fight against obesity.
Among the allowed claims of the '071 application are independent claims 18, 35, 44, and 53:18. A method of reducing the weight of an overweight subject, said method comprising: identifying an overweight subject and administering to said overweight subject a pharmaceutical composition comprising zonisamide, or a pharmaceutically acceptable salt thereof, in an amount effective to reduce the weight of said subject.35. A method of reducing weight in an overweight subject, said method comprising: identifying an overweight subject and administering to said overweight subject a pharmaceutical composition comprising zonisamide, or a pharmaceutically acceptable salt thereof, in an amount effective to induce weight loss in said subject, wherein the weight lossis ≥ 5%, or wherein said weight loss continues during the period of administration of said composition comprising zonisamide or a pharmaceutically acceptable salt thereof.44. A method of treating obesity by reducing the weight of an obese subject, said method comprising: identifying an obese subject and administering to said obese subject an effective amount of a pharmaceutical composition comprising zonisamide, or a pharmaceutically acceptable salt thereof.53. A method of treating obesity by reducing the weight of an obese subject, said method comprising: identifying an obese subject and orally administering to said obese subject a capsule comprising a pharmaceutical composition comprising zonisamide or a pharmaceutically acceptable salt thereof, wherein said subject receives a daily dose of 100 to 600 mg of zonisamide.
Posted at 10:31 PM in Patent Profiles | Permalink
February 25-26, 2008 - Pharma/Biotech Patent Claim Drafting and Prosecution (American Conference Institute) - New York, NY***
February 25-26, 2008 - Strategic Intellectual Property Planning (American Conference Institute) - Scottsdale, AZ
March 12, 2008 - Biotechnology, Chemical & Pharmaceutical Art Group Customer Partnership Meeting (U.S. Patent and Trademark Office)
March 30-April 1, 2008 - Advanced Courses (Patent Resources Group) - Bonita Springs, FL
Mr. Frieder ends his piece by saying:US patent reform is a global issue, and Israelis - individuals, associations, and government alike - ignore the bill's implications at our peril. We should be doing all we can to make US lawmakers aware of our concerns.Mr. Frieder and his Israeli countrymen are limited to op-ed pieces, not having their own Senator to write to voice their concerns. None of us have this excuse.For additional information on this and other related topics, please see:
• "Judge Michel Doesn't Think Much of Senate Bill S. 1145, Either," February 20, 2008• "The (Un)Intended Consequences of the Law," February 18, 2008• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part I," February 14, 2008• "BIO Report Indicts "Patent Reform" Proponents," February 13, 2008• "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008• "Patent Reform and Infringement Damages: Some Economic Reasoning," February 5, 2008• "Department of Commerce Sends Letter on Patent Reform to Senator Leahy," February 4, 2008• "Biotech and Pharma Opposition to Senate Patent Reform Bill," February 3, 2008• "The Letters Keep Coming Over the Senate Transom," January 30, 2008• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill: An Update," January 23, 2008• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill," January 18, 2008• "Patent Reform Discussed on Senate Floor," December 21, 2007• "Enjoined New Rules and Patent Reform Finally Appearing on Biotech Industry's Radar," December 20, 2007• "Chinese IP Judge Discusses Implications of U.S. Patent Reform Bill and Two Congressmen Heed Warning," December 17, 2007• "IPO President Seeks Deletion of Patent Reform Provision," December 12, 2007• "Senate May Act on Patent 'Reform' Bill in the New Year," December 2, 2007• "The Wall Street Journal Gets It Half Right," November 5, 2007• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007• "Patent 'Reform' Bill Passes House of Representatives," September 9, 2007• "Reversal in Microsoft Case Weakens Patent Reform Argument," August 7, 2007• "San Francisco Chronicle Opines on Patent Reform," August 6, 2007• "Patent Reform Bill to Be Delayed?" June 12, 2007• "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007• "Could Creating a U.S. 'Utility Model' Patent Fulfill the 'Need' for Patent Law Reform?" May 21, 2007
Patent Profile: Geron Receives Patent for Producing Pancreatic Islets from Embryonic Stem Cells
Geron Corporation recently announced that it had been granted U.S. Patent No. 7,326,572, entitled "Endoderm cells from human embryonic stem cells." The '572 patent covers a method for producing endoderm cells from human embryonic stem cells (hESCs). The production of endoderm cells is a critical step in generating pancreatic islet cells from hESCs. Geron is developing ways to use this method in the treatment of diabetes.
Geron's senior vice president of business development and chief patent counsel, Dr. David J. Earp, believes that the '572 patent broadens the coverage for Geron's islet cell production protocol beyond the scope of U.S. Patent No. 7,033,831, which was issued to Geron in 2006. Earp states that "[a]dded to our already robust portfolio of IP covering the scalable production of pluripotent stem cells, these patents reinforce our proprietary position for diabetes cell therapy."
Geron's president and chief executive officer, Dr. Thomas B. Okarma, commented on the utility of the method covered by the patent stating that it "has been validated in a number of studies published in leading journals by scientists from both Geron and other organizations." Okarma also states that transplanted pancreatic islet cells of the method prolong the survival of severely diabetic animals as well as produce detectable human insulin in their bloodstream. Geron is continuing to develop plans "aimed at producing a cell therapy capable of restoring normal glucose regulation in patients suffering from diabetes."
Geron's portfolio of owned and in-licensed patents includes over 30 patents issued in the U.S., more than 65 issued in other countries, and over 130 applications pending worldwide that relate to pluripotent stem cells. Geron also holds the exclusive right to develop and commercialize hESC-derived pancreatic islet cells, cardiomyocytes, and neural cells for therapeutic applications under the fundamental hESC patents assigned to the Wisconsin Alumni Research Foundation (WARF).
The '572 patent is a divisional of U.S. Patent Application No. 10/313,739, filed Dec. 6, 2002, now U.S. Patent No. 7,033,831, which claims priority to U.S. Provisional Application No. 60/338,885, filed Dec. 7, 2001. Representative claims 1 and 3 of the '572 patent recite:1. A method for generating endoderm cells from human embryonic stem (hES) cells or human embryonic germ (hEG) cells, comprising culturing the hES cells or hEG cells in a medium comprising a sufficient amount of Activin A to cause differentiation of said cells into endoderm, thereby generating endoderm cells, wherein the endoderm cells express the markers Sox 17, HNF313 and HNF4a.
3. The method of claim 1, wherein the cells are human embryonic stem cells.For additional information regarding this or other related topics, please see:
• "stART Licensing Announces Issuance of Patents for Cloning Ungulates," January 3, 2008• "It's Time to Stop the Hypocrisy over Stem Cell Patents - Part III," July 4, 2007• "It's Time to Stop the Hypocrisy over Stem Cell Patents - Part II," April 26, 2007
USPTO News: Proposed Rule Change to Timing of Filing a Biological Deposit
In a Federal Register notice published on February 20, 2008, the U.S. Patent and Trademark Office announced proposed changes to the rules regarding submission of biological deposits in patent applications. In particular, the revised rules would require that any deposit of biological material be made before the application publishes, and that all restrictions on access to the deposited material imposed by the depositor be removed upon publication. The motivation behind this change, as articulated in the Notice, is to provide equal access to all information referred to in the published patent application, whether that information is contained in another patent document or in a biological deposit. The changes address the interplay of biological deposits, written description and enablement (35 U.S.C. § 112), and publication of U.S. patent applications under the AIPA.
A brief overview of biological deposits
Internationally, biological deposits are governed by the Budapest Treaty. In the U.S., a deposit of biological material can provide adequate written description for a biological invention (see, e.g., Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed. Cir. 2002)). For purposes of enablement, the Federal Circuit has held that even "the availability of a sample to the public after the patent has issued will meet the enablement requirement." In re Lundak, 773 F.2d 1216, 1223 (Fed. Cir. 1985). Since the AIPA went into effect, certain commentators have argued that because the publication of a U.S. application can create provisional rights for the applicant, the published application must be in compliance with the enablement and written description requirements of § 112. This means that, if needed for § 112 purposes, a deposit of biological material would need to be made prior to publication (i.e., that the AIPA supersedes the rule stated in Lundak). A more detailed and complete description of the rationale behind these proposed rule changes is provided in the Notice.
Certain notable rule changes include:
Section 1.804 would provide that if a biological material is necessary to preserve the availability of provisional rights under 35 U.S.C. § 154(d), the deposit of the biological material must be made prior to filing an application or during the pendency of an application, provided that the deposit is made before technical preparations for publication of the application as a patent application publication have begun (see § 1.215(a)).
Section 1.808(a)(2) would provide that all restrictions imposed by the depositor will be irrevocably removed upon the earlier of publication of the application under § 1.211 and 35 U.S.C. § 122(b) or grant of the patent, and to indicate that the rule applies regardless of whether the deposit was made to satisfy a statutory provision.
Section 1.808(b) would add "before the patent is granted or" before "term of the patent."
Section 1.808(c) would provide that the Office will, on request, certify that an application referring to the deposit has been filed, that the subject matter of that application involves the deposited biological material or the use thereof, that the application has been published or patented or is otherwise open to public inspection, and that the requesting party has a right to a sample of the biological material. This is required by Rule 11.3 of the Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. WIPO provides a form, BP/12, for this purpose (see "Forms under the Budapest Treaty and Regulations").
Section 1.809(e) would delete "before or with the payment of the issue fee (see § 1.312)" and insert "(1) within a period of sixteen months after the date of filing of the application or, if the benefit of an earlier filing date is sought under 35 U.S.C. 119(e), 120, 121, or 365(c), within the later of four months of the actual filing date of the later-filed application and sixteen months from the filing date of the prior-filed application; and (2) before or with any request for early publication (Sec. 1.219)."
The Patent Office is accepting written comments to these rule changes, by e-mail, regular mail, or facsimile. To be ensured of consideration, any comments must be received on or before April 21, 2008. Comments are preferably sent by e-mail addressed to AB99.Comments@uspto.gov. Alternatively, comments can be submitted by regular mail addressed to: Mail Stop Comments--Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, or by facsimile to (571) 273-7754, marked to the attention of Kathleen Kahler Fonda. Comments may also be sent by e-mail via the Federal eRulemaking Portal, which can be accessed here.
• "Mr. Chairman, can you assure the House that the passage of this section four on damages will not seriously devalue the patent portfolios of every company in America?" • "Mr. Chairman, can you assure us that this bill won't result in more jobs and U.S. wealth going overseas?" • "Mr. Chairman, can you assure us that there have been some studies about the effects that will allow us to know, with reasonable confidence, what the actual consequences of these changes will be?"
What Judge Michel didn't say but others (like BIO CEO Bill Greenwood) have is that the Senate draft report, and S. 1145, was "hijacked" by certain special interests, and the impetus behind patent "reform" is not legal but political. Whether specifically targeted to protect specific groups (like the bankers whom had their champion, Senator Sessions of Alabama, insert provisions immunizing them from past and future patent infringement) or by certain sectors seeking to cripple the capacity of patent holders to protect their inventions from corporate depredation, the bill ready to be sent to the floor is about everything but patent "reform." Judge Michel reminded his listeners that he was not in a position to lobby or advise Congress on the wisdom (or its opposite) in considering this bill. Many others have, and the rest of us should join them.A transcript of the address given by Chief Judge Michel can be found here.For additional information on this and other related topics, please see:
• "The (Un)Intended Consequences of the Law," February 18, 2008• "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation - Part I," February 14, 2008• "BIO Report Indicts "Patent Reform" Proponents," February 13, 2008• "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008• "Patent Reform and Infringement Damages: Some Economic Reasoning," February 5, 2008• "Department of Commerce Sends Letter on Patent Reform to Senator Leahy," February 4, 2008• "Biotech and Pharma Opposition to Senate Patent Reform Bill," February 3, 2008• "The Letters Keep Coming Over the Senate Transom," January 30, 2008• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill: An Update," January 23, 2008• "U.S. Senate Mailbox Filling with Letters against Passage of Patent 'Reform' Bill," January 18, 2008• "Patent Reform Discussed on Senate Floor," December 21, 2007• "Enjoined New Rules and Patent Reform Finally Appearing on Biotech Industry's Radar," December 20, 2007• "Chinese IP Judge Discusses Implications of U.S. Patent Reform Bill and Two Congressmen Heed Warning," December 17, 2007• "IPO President Seeks Deletion of Patent Reform Provision," December 12, 2007• "Senate May Act on Patent 'Reform' Bill in the New Year," December 2, 2007• "The Wall Street Journal Gets It Half Right," November 5, 2007• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007• "Patent 'Reform' Bill Passes House of Representatives," September 9, 2007• "Reversal in Microsoft Case Weakens Patent Reform Argument," August 7, 2007• "San Francisco Chronicle Opines on Patent Reform," August 6, 2007• "Patent Reform Bill to Be Delayed?" June 12, 2007• "Senate Judiciary Committee Holds Hearing on Patent Reform," June 10, 2007• "Could Creating a U.S. 'Utility Model' Patent Fulfill the 'Need' for Patent Law Reform?" May 21, 2007
Pfizer Inc. has announced that it has an agreement in place to acquire Encysive Pharmaceuticals Inc. for about $195 million. Encysive is a biotechnology company that has a product currently marketed in the European Union, and several other foreign markets, for treating pulmonary arterial hypertension. The product, THELIN (sitaxsentan sodium), is an endothelin A receptor antagonist. THELIN has been approved in Australia and Canada, but is still awaiting approval in the U.S. Pfizer has indicated that it will conduct the necessary Phase III trial to move the drug toward approval. Encysive has several other drug candidates in its pipeline in various clinical stages of development. Pfizer has indicated that Encysive will eventually be merged with a Pfizer subsidiary.
Posted at 10:32 PM in Biotech/Pharma Business, Licensing | Permalink