Biotechnology

Today is the deadline for filing amicus briefs for the Federal Circuit to consider when it decides the Myriad gene patent litigation, i.e. The Association for Molecular Pathology v. US Patent and Trademark Office , on remand. The first time the Federal Circuit heard the case, I joined with Robert Cook-Deegan in filing a brief arguing that the isolated DNA claims should not be declared patent ineligible, but rather that their validity should be assessed under the more conventional requirements of patentability, i.e., novelty, nonobviousness and enablement. This time I went it alone, and filed a brief on my own behalf, available here (I believe that Bob will also likely be filing his own brief). In my latest brief, I focus largely on the nature of genomic DNA and cDNA, and the processes by which they are "isolated," and argue that the challenged isolated DNA claims (when properly interpreted) are limited to synthetic molecules that did not originate in the human body, and which...

Before becoming an independent consultant, Lori Pressman was Assistant Director of the MIT Technology Licensing Office. She recently published an article in the Bloomberg BNA Life Sciences Law & Industry Report that provides interesting empirical insight into the role of "DNA patents" in the development of diagnostic tests, and a comparison of the licensing practices of the NIH and independent academic institutions with respect to these patents and technologies. Ms. Pressman conclused that the results of her study suggest that "broad patent eligibility combined with field specific license exclusivity and diligence best serve innovation in diagnostics and personalized medicine." Her article is described in a recent press release issued by the Association of University Technology Managers (AUTM), which includes a link to the article. An abstract of the article is provided below. Abstract: To investigate the effect of exclusivity in license agreements, licens...

Most traditional pharmaceutical drugs are relatively simple molecules that have been found primarily through trial and error to treat the symptoms of a disease or illness. Biopharmaceuticals are large biological molecules known as proteins and these usually target the underlying mechanisms and pathways of a malady (but not always, as is the case with using insulin to treat type 1 diabetes mellitus, as that treatment merely addresses the symptoms of the disease, not the underlying cause which is autoimmunity); it is a relatively young industry. They can deal with targets in humans that may not be accessible with traditional medicines. A patient typically is dosed with a small molecule via a tablet while a large molecule is typically injected. Small molecules are manufactured by chemistry but larger molecules are created by living cells such as those found in the human body: for example, bacteria cells, yeast cells, animal or plant cells. Modern biotechnology is often associated with the...

Tue May 5, 2009 2:45am EDT By Maggie Fox , Health and Science Editor - Analysis WASHINGTON (Reuters) - With Mexico saying the worst may be over and the new H1N1 virus starting to look more like a seasonal flu strain in the United States and elsewhere, critics are going to start asking if public health officials overreacted to the outbreak. Since the new swine flu virus was first identified two weeks ago in two children in Texas and California, the World Health Organization pushed its pandemic alert level from a three to a five, meaning a pandemic is imminent. Mexico closed schools, stopped public events and took a big hit to tourism. The U.S. government mobilized 25 percent of its stockpile of antiviral drugs and started work on a vaccine against the new strain. But the death toll is being rolled back as Mexican officials realize it will be impossible to know if long-buried or cremated victims died of H1N1 swine flu . And while the infection is spreading rapidly across the Unit...

Gene therapy may be used for treating, or even curing, genetic and acquired diseases like cancer and AIDS by using normal genes to supplement or replace defective genes or to bolster a normal function such as immunity. It can be used to target somatic (i.e., body) or gametes (i.e., egg and sperm) cells. In somatic gene therapy, the genome of the recipient is changed, but this change is not passed along to the next generation. In contrast, in germline gene therapy, the egg and sperm cells of the parents are changed for the purpose of passing on the changes to their offspring. There are basically two ways of implementing a gene therapy treatment: 1. Ex vivo, which means “outside the body” â€" Cells from the patient’s blood or bone marrow are removed and grown in the laboratory. They are then exposed to a virus carrying the desired gene. The virus enters the cells, and the desired gene becomes part of the DNA of the cells. The cells are allowed to grow in the laboratory befo...

Genetic testing involves the direct examination of the DNA molecule itself. A scientist scans a patient’s DNA sample for mutated sequences. There are two major types of gene tests. In the first type, a researcher may design short pieces of DNA (“probes”) whose sequences are complementary to the mutated sequences. These probes will seek their complement among the base pairs of an individual’s genome. If the mutated sequence is present in the patient’s genome, the probe will bind to it and flag the mutation. In the second type, a researcher may conduct the gene test by comparing the sequence of DNA bases in a patient’s gene to disease in healthy individuals or their progeny. Genetic testing is now used for: * Carrier screening, or the identification of unaffected individuals who carry one copy of a gene for a disease that requires two copies for the disease to manifest; * Confirmational diagnosis of symptomatic individuals; * Determining sex; * Forensic/identi...

On March 30 the United States District Court for the District of Columbia dismissed a lawsuit between Plaintiff SmartGene, Inc., a North Carolina corporation and Defendant Advanced Biological Laboratories, SA, a company with its principal place of business in Luxembourg, after declaring the patents in dispute (U.S. Patent No. 6,081,786 (the “786 patent”) and U.S. Patent No. 6,188,988 B1 (the “988 patent”)) patent ineligible under 35 USC 101. (Click here for decision) The plaintiff SmartGene brought the suit as a declaratory judgment action, after ABL filed a lawsuit alleging that “Smartgene’s IDNS™ HIV program incorporates at least one technology which infringes at least claim 1 of each [of] the ‘786 and ‘988 Patents.” The court's analysis focused on Claim 1 of the ‘786 patent as exemplary of the subject matter covered by the patent dispute: 1. A method for guiding the selection of a therapeutic treatment regimen for a patient with a known disease or medical ...

On March 16, the popular National Public Radio (NPR) program This American Life (TAL) was forced to retract statements made during an episode that aired in January alleging abuse of workers at Chinese factories manufacturing products for Apple. The explanation provided by “monologist” Mike Daisy, source of the "significant fabrications" reported on the TAL program, provide some insight I think into the mentality behind the flood of misinformation that has been promulgated with respect to gene patents and agricultural biotechnology, and which unfortunately has found its way into the courts and Congress. TAL admits to having excerpted the fabricated story from "The Agony and The Ecstasy of Steve Jobs," a one-man show that Mike Daisey had been performing across the country, and which is currently in production at the Public Theater in New York. In a press release, TAL says it first learned Daisey had fabricated parts of his story when another public radio program...

In a complaint filed September 7 in the Western District of Wisconsin, Brandeis University joins its exclusive licensee (GFA Brands) in suing a number of cookie companies, including Keebler, Famous Amos, Nestlé's and Pillsbury for infringing its patents directed towards methods of "Increasing the HDL Level in the HDL/LDL Ratio in Human Serum by Balancing Saturated and Polyunsaturated Dietary Fatty Acids." As an example, one of the asserted claims is claim 7 of US patent 5,843,497, which recites: 7. A prepared food product, comprising a cholesterol-free fat composition suitable for human or animal ingestion for increasing the HDL concentration and the HDL/LDL concentration ratio in the blood serum, comprising one part by weight polyunsaturated fat and at least one part by weight cholesterol-free saturated fat, where said fat composition comprises linoleic acid and at least one saturated fatty acid selected from the group including lauric acid, myristic acid, and palmitic ...

Based on assessment of all available information and following several expert consultations, Dr Margaret Chan, WHO's Director-General raised the current level of influenza pandemic alert from phase 4 to 5. She stated that all countries should immediately activate their pandemic preparedness plans. At this stage, effective and essential measures include heightened surveillance, early detection and treatment of cases, and infection control in all health facilities. Statement by WHO Director-General, Dr Margaret Chan 29 April 2009 Swine influenza Ladies and gentlemen, Based on assessment of all available information, and following several expert consultations, I have decided to raise the current level of influenza pandemic alert from phase 4 to phase 5. Influenza pandemics must be taken seriously precisely because of their capacity to spread rapidly to every country in the world. On the positive side, the world is better prepared for an influenza pandemic than at any time in history...

O ne of the major concerns in today's world is the pollution and contamination of soil. The use of chemical fertilizers and pesticides has caused tremendous harm to the environment. An answer to this is the biofertilizer, an environmentally friendly fertilizer now used in most countries. Biofertilizers are organisms that enrich the nutrient quality of soil. The main sources of biofertilizers are bacteria, fungi, and cynobacteria (blue-green algae). The most striking relationship that these have with plants is symbiosis, in which the partners derive benefits from each other. P lants have a number of relationships with fungi, bacteria, and algae, the most common of which are with mycorrhiza, rhizobium, and cyanophyceae. These are known to deliver a number of benefits including plant nutrition, disease resistance, and tolerance to adverse soil and climatic conditions. These techniques have proved to be ...

Wed May 6, 2009 4:16pm EDT WHO expert says flu viruses can survive freezing Blood of H1N1 infected pigs may also contain virus Meat from sick pigs or pigs found dead must not be eaten Existing food safety, trade checks offer ample protection (Recasts with more comments on food safety standards) By Tan Ee Lyn HONG KONG, May 6 (Reuters) Meat from pigs infected with H1N1 flu should not be eaten by humans, a WHO official said on Wednesday, while stressing that existing checks were sufficient to safeguard the food supply from the new virus strain.Jorgen Schlundt, director of the World Health Organisation's Department of Food Safety, Zoonoses and Foodborne Diseases, said care must be taken to ensure that pigs and their meat were checked for all diseases, including the H1N1 virus that may be present in the blood of infected animals."Meat from sick pigs or pigs found dead should not be processed or used for human consumption under any circumstances," he told Reuters. It is possib...

Yesterday Pioneer Hi-Bred (a subsidiary of DuPont) sued Monsanto, its rival in the agricultural biotechnology sector, for allegedly infringing its patents directed towards a method of increasing "seed vigor" in maize that entails defoliating maize plants during a specific period after pollination. The lawsuit was filed in the Southern District of Iowa, Pioneer's home territory. The two companies have been involved in a high-profile patent litigation ever since Pioneer announced its plans to release genetically modified maize comprising Pioneers Optimum GAT trait stacked with Monsanto's Roundup Ready trait. Both traits confer resistance to glyphosate (i.e. Roundup), albeit by different mechanisms - Roundup Ready essentially works by rendering the plant resistant to glyphosate, while Optimum GAT causes the plant to express a protein that breaks down the glyphosate molecule. Pioneer responded by suing Monsanto for antitrust violations, based on the company’s licensing ...

Today the Supreme Court granted certiorari in Association for Molecular Pathology v. Myriad Genetics , and sent the case back to the Federal Circuit to reconsider in light of Mayo v. Prometheus . The case has important implications not only for the patent eligibility of isolated DNA, but more generally for purified natural products and other inventions based on naturally occurring biological materials. When the Federal Circuit originally decided Myriad, it held the method of genetic diagnostic claims to be patent ineligible, but the claims directed towards isolated DNA molecules patent eligible. The Supreme Court's decision in Mayo clearly would not change the outcome regarding the former - Myriad's diagnostic method claims lie further down the spectrum of patent ineligibility than the Prometheus claims, since they do not recite a step of physically analyzing a DNA molecule, but could potentially be infringed by merely comparing DNA sequence information (at least according to t...

27 April 2009 -- The Emergency Committee, established in compliance with the International Health Regulations (2005), held its second meeting on 27 April 2009. The Committee considered available data on confirmed outbreaks of A/H1N1 swine influenza in the United States of America, Mexico, and Canada. The Committee also considered reports of possible spread to additional countries. On the advice of the Committee, the WHO Director-General has raised the level of influenza pandemic alert from the current phase 3 to phase 4. In the 2009 revision of the phase descriptions, WHO has retained the use of a six-phased approach for easy incorporation of new recommendations and approaches into existing national preparedness and response plans. The grouping and description of pandemic phases have been revised to make them easier to understand, more precise, and based upon observable phenomena. Phases 1â€"3 correlate with preparedness, including capacity development and response planning acti...

In a recent post , I pointed out similarities between "fabrications" regarding conditions at factories in China manufacturing Apple products, and the misinformation being promulgated regarding gene patents and agricultural biotechnology. Some prime examples of this sort of misleading information are evident, I think, in the lawsuit filed last year by the Public Patent Foundation against Monsanto. In a post on the case, I pointed out that the plaintiffs in the case seemed to lack standing, and that there seemed to be no basis for PubPat’s allegation that Monsanto had sued involuntary/inadvertent infringers, or that there was any reasonable likelihood that the plaintiffs (organic farmers and the like) would be sued for infringing Monsanto patents on recombinant crops. Fortunately, the district court saw through the exaggerated allegations raised by the Public Patent Foundation in the lawsuit against Monsanto, and dismissed the case last February. The court's decision spe...

In this post, I explain why my recent analysis of 533 patents identified by Jensen and Murray as "gene patents" (described in a previous post ) suggests the Federal Circuit’s recent decision in AMP v. PTO implicates the validity of very few gene patent method claims. Background As I pointed out in a blog post last December, the patent eligibility of Myriad's claims to methods of detecting mutations in the BRCA gene by "analyzing" or "comparing" DNA sequences hinged entirely on the court's interpretation of the word "sequence" as it appears in the claims. In the field of molecular biology, the term "sequence" is routinely used not only to refer to the description of the chemical structure of a DNA molecule, but also to the actual DNA molecule as well. For example, a scientist might say that "I determined the sequence of the BRCA gene." In this context, she is using the word sequence in reference to the abstract descri...