The Palm Beach Post reported that the Scripps Research Institute has started issuing home loans — I guess they heard about the sub-prime bonanza and decided to jump on the bandwagon. Despite sounding like they’ve branched into some wildly diversified operations, the loans come as a bribe an incentive to get top scientists to move to the Institute. One top recruit snagged a $1 million mortgage for an oceanfront condo that cost $850,000.  A good deal if you can get it.

Scripps won’t say why the mortgage exceeds the condo’s purchase price, or whether the loan was derived from a $310 million state grant used to attract the biomedical research powerhouse here in 2003. In the past year, five Scripps recruits were provided with mortgages totalling $1.4 million. The terms of the loans are being kept under wraps and Scripps will only say that the state’s agreement gives the institute “broad authority” to use grant money for employee compensation and benefits.

The million-dollar mortgage recently was filed in the public record. After The Palm Beach Post asked about it, Scripps notified the Scripps Florida Funding Corp., which oversees Scripps’ grant.

Scripps claims that the intense competition for scientists and the added housing troubles have led it to up the ante with housing loans. Scripps indicated that the main reason for the incentive packages is to recruit scientists who bring in big grants and intellectual property. This is an interesting case of using grant money to lure scientist into moving and bringing along more grant money.

This begs the question:  Are such incentives a good idea?

more at twiigs.com…

See also:  Are Tax Breaks for Biotech Worth the Price?

Posted May 15th, 2008 by Stephen Albainy-Jenei in Biotech News
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The U.S. Patent and Trademark Office (USPTO) came down on the side of Wisconsin Alumni Research Foundation (WARF) in upholding one of its patents on human embryonic stem cells. 

WARF’s licensee, Geron Corp., holds an exclusive license to these patents to develop and commercialize therapies based on three types of cells derived from human embryonic stem cells: neural cells, cardiomyocytes and pancreatic islet cells.

Earlier, the USPTO announced it would re-examine patents covering embryonic stem cell discoveries made by University of Wisconsin researchers. The patents, US Pat. Nos. 5,843,780, 6,200,806, and 7,029,913, cover all embryonic stem cell research in the U.S.  The USPTO granted each of the requests in September 2006 and rejected all claims of each of the patents on March 30, 2007.

In the Office Actions rejecting the claims, the examiners said the Wisconsin cells appeared to be either the same or obvious variations of cells described in previous patents issued to others or in scientific papers.

In the latest action on the reexamination of ‘913 Patent (95/000,154), the Patent Office has confirmed that the amended claims 1-3 are allowable and has closed prosecution on the merits.  The original patent covered all embryonic stem cells no matter how they are derived.  However, in the course of the re-exam, the applicants have now narrowed the claim only to stems cells derived from pre-implantation embryos.

The amended claim 1 is to:

1. (amended) A replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo, wherein the stem cells [comprising cells which] (i) [are capable of proliferation] will proliferate in an in vitro culture for over one year in an undifferentiated state 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

The reexamination requesters, the Foundation Taxpayer and Consumer Rights (FTCR) and the Public Patent Foundation (PUBPAT), , tried to get the claims rejected as unpatentable under 35 U.S.C. §103(a) as being obvious in view of the Declaration by Dr. Jeanne F. Loring. They indicated that the Loring Declaration was submitted in order to explain “what the prior art disclosed to, and what motivations or suggestions it provided to those of ordinary skill in the art.”

However, the USPTO came back and indicated that only patents or printed publications can be used in the reexamination proceeding to raise a substantial new question of patentability. The USPTO said that the Loring declaration cannot by itself provide the necessary motivation to combine references even though the declaration had been given full consideration as evidence supporting obviousness in each rejection under 35 USC §103(a) in the non-Office action. Accordingly, the proposed rejections were not adopted.

The question now is whether or not a newer stem cell technology, Induced Pluripotent Stem Cells (IPS cells) , which are derived without destroying embryos, would be covered by the more narrowly-defined patent scope.

Still, a lot of money is at stake. WARF has made free licenses and cells available to more than 300 academic research groups but charges companies $75,000 to $400,000, depending on their size and the terms of the license. WARF also claims royalties from products produced using the patents.  WARF has said the patents apply to all human embryonic stem cells, no matter how derived, but had not slowed research.

If the action is made final, look for the nonprofit groups to appeal the patent claims to the patent office’s Board of Patent Appeals and Interferences. They also could appeal any board decision to federal district court. The parallel reexamination proceedings involving U.S. Patent Numbers 5,843,780 and 6,200,806 which claim preparations of, respectively, primate and human embryonic stem cells and methods for their isolation, are still pending.

Copies of the challenges filed by FTCR and PUBPAT.

If you are interested in more details of the ongoing dispute between California and Wisconsin, check out the coverage on the California Stem Cell Report.

Also see:

WARF Stem Cell Patents Knocked Down in Round One 

WARF Backhanded by PUBPAT

Posted March 3rd, 2008 by Stephen Albainy-Jenei in Biotech, USPTO, Biotech News
| | 2 Comments »

Robert Shapiro, chairman of Sonecon, LLC, and former advisor to U.S. President Bill Clinton and British Prime Minister Tony Blair, has published a study on the potential savings when generic biologic treatments (biogenerics) find a pathway in the U.S.   I say when and not if since the government is the largest consumer of medical care via medicare and medicaid and given the fact that sales of biotech drugs were $40.3 billion last year.

With such enormous amounts of money involved, Congress is seriously interested in creating a new regulatory pathway for the approval and marketing of generic or follow-on versions of biological treatments that no longer have patent protection. This is purely an economic (and political) issue, not one of health and safety.  Today, more than 150 biopharmaceuticals are available in the United States, including therapeutic serums, antitoxins, vaccines and biological therapeutics that induce immunity in infectious diseases, and the number of new biologics is growing at twice the rate of new small molecule pharmaceuticals.

Under the Hatch-Waxman Act, a pharmaceutical producer can secure FDA approval to market a generic version of an original drug no longer under patent protection without having to conduct lengthy and expensive safety and effectiveness studies and clinical trials, by demonstrating that the generic is the bioequivalent of the original drug. The process involves the approval of an Abbreviated New Drug Application (ANDA), which rests on a certification that the original patent has expired or is invalid, and that the dosage and active ingredients of a generic are identical to those in the original treatment.

However, the law covers only traditional, small-molecule pharmaceuticals. There is no mechanism for generic-drug makers to gain approval for generic biotech drugs or so-called follow-on biologics, sometimes called biosimilars or biogenerics.  The FDA evaluates and approves biologics mainly under the Public Health Safety Act, although a small number have been approved under the Food, Drugs and Cosmetic Act. The Center for Biologics Evaluation and Research (CBER) regulates biological products for safety. For the FDA to approve follow-on biologics, many difficult issues have to first be addressed such as safety, effectiveness and intellectual property rights have to be resolved.

The reason for the lack of a regulatory pathway for approval of biogenerics lies in the complexity of the biological products themselves. Biologics are large, complex, heterogeneous molecules for which the manufacturing process can be a determinant of the end product. Demonstrating that a generic version of the product is as safe and effective as the brand name product would be a difficult at best since, for example, establishing that immunogenicity had not been altered and that any undetected differences in the product would not impact safety and efficacy would be problematic without conducting extensive clinical trials.

Currently, the cost of conducting clinical studies from scratch keeps competitors out of the market. Biogeneric companies need an abbreviated approval pathway to avoid undertaking the same large scale clinical development process as the originator companies, and thus allow them to market their product at a discount to the brand while maintaining a profit margin.

It is likely that any follow-on biologic applicant would be required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product. An applicant would need to provide evidence that its product has profound similarity — it is impractical to show identical biological products — and that these will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products.

During a conference call this morning, Shapiro noted that the conventional wisdom held that the high cost of building the manufacturing infrastructure would be so high as to result in very little savings even if biogenerics are allowed. He argues that this is not the case given that there are plenty of other options in the marketplace. Shapiro pointed out the facilities currently available in Europe and Asia and the potential for partnerships.

According to the present study, the potential savings likely to follow from the introduction of these follow-on biologics over the next 10 and 20 years would be quite large. The study found that generic versions of the top 12 categories of biologic treatments with patent protections that have expired or are due to expire in the near future could save Americans, in net present value, $67 billion to $108 billion over the first 10 years and $236 billion to $378 billion over 20 years. Moreover, these estimates almost certainly understate the savings, because they could not take full account of a number of factors likely to reduce the price of biogenerics and further expand their use in the United States.

Currently, biogenerics are used in the European Union and the major countries of Asia. The study concludes that the United States has led the world in developing biologics, and when the U.S. Congress approves a regulatory pathway for biogenerics, the United States very likely will quickly become the world’s largest market for follow-on biologics.

See the entire report here.

See also:  Why are biogenerics so hard to regulate?

More from the Orange Book Blog and the BioJobBlog.

Posted February 19th, 2008 by Stephen Albainy-Jenei in Biogenerics, FDA, Biotech News
| | 3 Comments »

Drug developers often search for new leads in the biodiversity often found in developing countries. Often, a new theraputic or genetically engineered product is developed and patented.

Depending upon your view, this is either the free market at play in creating new and better products (so-called bioprospecting) or exploitation of developing nations (so-called biopiracy).

However, a lot of tension has arisen from such patents, such as the Enola patent derived from Mexican traditional crop mayocoba bean and the patent on Ayahuasca, a sacred plant. These disputes show that some genetic engineering exploitation and patents based on certain species may be offensive to certain indigenous people’s spiritual, religious, or cultural traditions.

Our Associates at Dannemann Siemsen, a law firm with offices in Rio de Janeiro, São Paulo and Brasília, have alerted us to a new proposed legislative bill that has recently published by the Brazilian Government. Currently, access to genetic resources and associated traditional knowledge, as well as benefit sharing in Brazil are regulated by Provisional Measure 2.186-16 of August 23, 2001.

The new bill, which is open to public consultation until February 28, 2008, is available in Portuguese at the website here. Although the proposed bill is somewhat long, some of its highlights are set forth below:

Genetic Resources And By-Products

The proposed bill makes it clear that access and benefit sharing rules will also cover activities involving the by-products of genetic resources and not only involving information of genetic origin, as provided for in the current Provisional Measure.

Records and Databases

The proposed bill provides for a number of databases and most of the activities involving access to genetic resources and traditional knowledge must be recorded.

No Need of Access Authorizations in Some Cases, in Special Research Without Commercial Purpose

Access to genetic resource for scientific and/or technological research without commercial purposes in some cases will not need previous authorization.

Benefit Sharing Agreement

According to article 86 of the proposed bill, a benefit sharing agreement may be executed after the access, provided that certain conditions are met.

Federal Sales/Royalty Tax

The proposed bill creates a sales/royalty tax (CIDE) directed to governmental funds aimed at financing R&D, supporting traditional communities, conserving biodiversity and benefit sharing.

Agricultural Biodiversity

A new category of biodiversity is created and the corresponding access and benefit sharing are regulated under more flexible rules.

Prison and Administrative Penalties

A number of penalties, such as fines and product seizure, are provided for in case of irregular access to genetic resources and traditional knowledge. Prison terms are defined, e.g., in case of the illegal remittance abroad of biological material.

Patent Disclosure

The corresponding access license must be attached to patent applications covering subject-matter obtained via access to genetic resources and to its by-products and associated traditional knowledge.

Please feel free to contact Dannemann Siemsen should you require further details on the current rules and on the provisional bill concerning biodiversity access and benefit sharing.

See also:

India Fights Back Against Biopiracy

Bioprospecting Discussed at the UN

Article on the Convention on Biological Diversity (“CBD”), the first international agreement aiming at the protection of biodiversity, sustainable use of biological resources and the sharing of benefits of its exploitation.

Posted February 15th, 2008 by Stephen Albainy-Jenei in BioAg, Biotech News
| | 2 Comments »

A new website popped up recently that is an attempt to serve as a global resource for dialogue on intellectual property rights and its role in advancing research and innovation.

The site, called Essential Innovation, is an online forum that will feature commentary and analysis on the importance of continued innovation, and the potential consequences a decline in intellectual property rights will have on global public health. This forum demonstrates cooperation to protect innovation from groups spread around the world, joining academic thought leaders, as well as scientists, researchers, doctors and inventors who create important advances in products and services.

The group believes that there has been an increase in attacks on intellectual property (IP) by nongovernmental organizations (NGOs) and governments. In a number of countries, notably Thailand and Brazil, recognized IP protections for life-saving medicines are being disregarded under the guise of promoting greater access. In addition, the World Health Organization (WHO) in November will also consider policy guidelines that significantly weaken IP protections on pharmaceuticals.

According to the group:

Patients around the world are in desperate need of new therapies to treat a variety of conditions. We need strong IP protection to encourage Brazil’s creative class, and the creative classes in countries around the world, to go for it and develop the next line of life-saving medicine.

This is an all-volunteer effort to provide a resource for anyone –media, NGOs, government officials, academics –looking for information from the scientists, researchers and inventors who are actually developing new medicine around the world. The Internet is littered with biased opinions about innovation from a small group of activists who have never done anything to advance science to save lives. This is most apparent in the claims from MSF, Oxfam and others that the patent system does not produce innovation. Nothing could be more patently absurd.

These issues are never as black and white as they seem — especially not as simple as the poll on the site puts it when it asks “Should one steal a medicine to extend a life?” and provides only a yes or no answer. This issue, like all of life, is complicated and often can only be answered with an “It depends.”

Read more here.

Posted November 7th, 2007 by Stephen Albainy-Jenei in Biotech News, Current Affairs
| | 2 Comments »