BIOTECHNOLOGY

September 07, 2007

Fertility Monitoring Device on a Cell Phone? Really!!!?

Cell phones continue to offer more and more features. Not only can you check your email and surf the internet, but someday you may even be able to determine your significant others optimal baby making temperature! Check out this patent application filed by Samsung which states that:

“[t]he present invention relates to a portable device for measuring a user's basal body temperature (BBT) and a BBT measurement method utilizing the portable device. More particularly, the present invention relates to a portable BBT measurement device and method which can detect a location of a user's eardrum via a predetermined distance sensor, measure the user's eardrum temperature, convert the eardrum temperature into the user's BBT and record the converted BBT into a memory, to generate the user's menstruation information from the BBT recorded for a certain period, e.g. a month, and provide the user with the generated menstruation information.”

Maybe I’m a little old fashioned but a fertility monitoring device on a cell phone just sounds creepy.

Posted by Ward Hobson at 09:59 AM.
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BIOTECHNOLOGY

October 29, 2006

Slow patent process continuing to hurt nanotech enterprises.

Via the Chicago Tribune, a quick update on the progress of efforts at the USPTO to increase the speed of processing patents on nanotechnology.  The conclusion in a nutshell: not much has happened.

Alan Gotcher, president and chief executive of Altair Nanotechnologies Inc. based in Reno, Nev., whose firm is working with nanomaterials to improve battery performance, said he's been filing for nanotech patents since the late 1980s and the lag in processing them has become a problem recently.

'The impact is one of perception,' Gotcher said. 'When you don't get a response from a patent application filing, you don't know what else is going on.'

Posted by Douglas Sorocco at 08:55 PM.
Permalink: Slow patent process continuing to hurt nanotech enterprises.
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BIOTECHNOLOGY

November 26, 2005

stanford chemistry offers forward thinking pregnancy policy for graduate students

I am somewhat behind in my journal reading, so while this may be somewhat older news it was something that I wanted to share with the blog-o-sphere.

According to C&EN News (Chemical and Engineering News – November 7, 2005 issue), Standford University’s chemistry department recently implemented a very forward thinking pregnancy policy (PDF of policy) for graduate students. 

The pregnancy policy provides that graduate students receive 12 weeks of paid leave “to accomodate late-stage pregnancy, childbirth, and the care of a newborn.”  The pregnancy policy also allows graduate students to maintain full-time student status (important for school loans and financial aid) and provides for the facilitation of return to classwork, research and teaching duties.

Jackie Tyson, executive director of the National Association of Graduate-Professional Students, said she was very pleased about the move at Stanford because most universities do not have formal policies. "Many women have felt penalized by having to ask, and the reality is that a lot of men still leave everything to women or most everything to women, so this has a real impact," Tyson said.

This is an incredibly powerful step Stanford has taken – as the spouse of a former graduate student, I know how stressful and trying it can be to juggle a pregnancy, graduate work and research.  Stanford’s policy will hopefully spur similar policies at every university and academic research institution. 

It always comes back down to the simple things – treat people fairly and with compassion and you will reap the rewards ten-fold.

For additional information, follow the links:

• Inside Higher Ed
• The Stanford Daily

Posted by Douglas Sorocco at 07:26 AM.
Permalink: stanford chemistry offers forward thinking pregnancy policy for graduate students

BIOTECHNOLOGY

February 15, 2005

cambia pushes for "open source" biotechnology innovation

from Bio-IT World:

CAMBIA, an independent, nonprofit institute based in Canberra, Australia, has set up BIOS (Biological Innovation for Open Society), which aims to extend the concepts of open source to biotechnology and other forms of innovation in biology. Last week CAMBIA introduced under an open source license biotechnology tool kits that it developed. The technologies include TransBacter, a new method for transferring genes to plants, developed as an alternative to Agrobacterium-mediated transformation, and GUSPlus, a new reporter gene for use in molecular biology.

The problem I see is that biotechnology and biotech products are not like open source software code that can be duplicated, manipulated and changed at whim by anyone with some training and a computer.  Biotechnology research requires a laboratory, research tools (microscopes, pippettes etc.) and significant regulation and compliance resources.  None of these items are free or even within the range of being “affordable” for most start ups or small biotechnology companies that are not funded or capitalized. 

As biotechnology is an inherently unpredictable field or “art” — start up biotech companies are able to attract funding and/or capital, in some cases, only because they are able to hedge such unpredictability by using patents to wall off a protected commercial market for the product IF and WHEN it is ever approved.  Rather than increasing the number of companies in this area, such an open source biotechnology strategy would appear to stifle investment and put a company at a significant disadvantage.

Any thoughts?

Posted by Douglas Sorocco at 05:54 PM.
Permalink: cambia pushes for "open source" biotechnology innovation
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BIOTECHNOLOGY

February 14, 2005

Chimera Claim Rejected

According to a Washington Post article, a human-animal hybrid is not patentable. Apparently a human hybrid is too close to a human. However, since the famous case of Diamond v. Chakrabarty, patents have been awarded to bacteria, yeast, and even animals. Chakrabarty's most famous quote on patenting allows "anything under the sun that is made by man."

Of course, the controversy will certainly continue. See the legal column written by the inventor of the Chimera, The Human Chimera Patent Initiative (starting on page 4 and continuing on page 7). For more information, you may be interested in the Mother Jones article, Gods and Monsters.

UPDATE 2-23-05: Patently-O: Patent Law Blog has a great post that gives more information.

Posted by Douglas Sorocco at 09:47 AM.
Permalink: Chimera Claim Rejected

BIOTECHNOLOGY

February 02, 2005

Merck Defeated in Federal Circuit

According to the Report on Law.com, Federal Court Invalidates Patent on Merck's No. 2 Drug:

The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated the patent for the once-a-week version of Merck's Fosamax, which dominates the market for osteoporosis drugs. Under the ruling, generic competition could begin as soon as early 2008, instead of 2018.

Merck shares were down considerably after the ruling.

"It's a big deal," said Barbara Ryan, a managing director at Deutsche Bank Securities. "Merck obviously has a lot of issues facing it, including the withdrawal of Vioxx from the market and the loss of the Zocor patents in the middle of 2006."

For more on patent issues and prescription drugs, you can see an article by me in OKJOLT, "Are Patents Really Limited to 20 Years? - A Closer Look at Pharmaceuticals" (html) (word) (pdf). The article was published about a year and a half ago, so it's a little dated, but it's interesting nonetheless (in my humble opinion).

Posted by Douglas Sorocco at 09:10 AM.
Permalink: Merck Defeated in Federal Circuit
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BIOTECHNOLOGY

December 14, 2004

Save Money on Patents - File Electronically

Russ over at Anything Under the Sun Made By Man recently posted Silver Lining to Fee Increases.

With the new legislation on fees for patents, comes some structural change. Now you can save 50% on filing fees by using electronic filing. While it requires learning the software, it may actually save time as well as money. For more information, go to the USPTO site. If you have technical problems, here is a good place for help.

You may also want to review a previous PHOSITA post, File A PCT Patent Application In Your Pajamas.

Posted by at 09:24 AM.
Permalink: Save Money on Patents - File Electronically

BIOTECHNOLOGY

December 13, 2004

Inventor Tax Update

As many of you already know, the fee increase for the USPTO is official. As of last Wednesday, fees have increased again. That's two fee increases in a little over 2 months. President Bush signed the Consolidated Appropriations Act for 2005 on December 8, 2004, effective immediately.

Unfortunately for inventors, these fees will continue to fund non USPTO programs.

In a current lawsuit, one inventor claims this is unconstitutional. The U.S. Constitution states "The Congress shall have Power . . . To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." This inventor reasons that fee diversion is actually a tax on inventors, which fails to promote progress. Since the fees paid by inventors currently provide funding the general welfare, this is an interesting position.

For more information on the lawsuit (which was filed in 2001), click here.

For prior PHOSITA postings on the legislation and related issues, click on the appropriate link below:

• Inventor's Tax - November 18, 2004
• Another USPTO Fee Increase? - November 11, 2004
• Tech Lobbyists Spending Millions - May 20, 2004
• Patent Office Revised Fee Chart - May 3, 2004
• Senate Judiciary Committee Passes PTO Anti-Fee Diversion Bill - April 29, 2004
• Patent Office User Fee Diversion - March 8, 2004
• Higher Patent Office Fees? Interesting - February 23, 2004
• President Bush's Budget Patent Friendly - February 3, 2004

Posted by at 09:48 AM.
Permalink: Inventor Tax Update

BIOTECHNOLOGY

December 09, 2004

All Business Have Intellectual Property

Oklahoma Inventors Congress has a link to an article discussing the various aspects of intellectual property associated with ordinary businesses.

The article is on mondaq.com (free registration required). It is directed to U.K. readers, so don't take every detail as absolute truth. It is certainly wise to consult a professional who deals with that area of law before making any crucial decisions.

Part 1 answers the following questions:

• What is Copyright?
• Who owns Copyright?
• Who owns the Copyright in websites?
• How do you protect Copyright?
• What are designs?
• Who owns a design?
• How do you protect designs?

Part 2 answers the following questions:

• What is a Trade Mark?
• Who owns a Trade Mark?
• How can you protect a Trade Mark?
• What is a Domain Name?
• Who owns a Domain Name?
• How can you protect a Domain Name?

Part 3 answers the following questions:

• What is a Patent?
• Who owns a Patent?How do you protect an Invention?
• What is Know-how?
• Who owns Know-how?
• How do you protect Know-how?

This article is a very useful overview of intellectual property for small business owners. Just be sure to check with a professional before acting on the statements (for instance, Business Methods are patentable in the U.S.).

Posted by at 05:03 PM.
Permalink: All Business Have Intellectual Property

BIOTECHNOLOGY

December 02, 2004

pto nanotechnology classification to improve nanotechnology patents

As PHOSITA previously reported, the USPTO has instituted a new classification for nanotechnology, Class 977–nanotechnology, to provides for disclosures:

• related to research and technology development at the atomic, molecular or macromolecular levels, in the length of scale of approximately 1-100 nanometer range in at least one dimension, and
• that provide a fundamental understanding of phenomena and materials at the nanoscale and to create and use structures, devices and systems that have novel properties and functions because of their small and/or intermediate size.

The Small Times has a quite detailed discussion of the new classification and its impact on nanotechnology patents. 

Experts say the action will lead to stronger, more defensible patents and encourage innovation by increasing confidence in the patent system. They added that the action was necessary because of the difficulty in classifying nanotechnology inventions.

The article goes on to cite several ways that it will help patentees and the patenting process by:

• Making it easier to search for prior art patents and patent applications.
• Making it easier to spot or identify interfering patent applications — i.e. applications claiming the same invention or substantially the same invention.
• Providing examiners a group mentality — a group having historical knowledge and depth of knowledge in the scientific area.

Posted by Douglas Sorocco at 05:34 PM.
Permalink: pto nanotechnology classification to improve nanotechnology patents

BIOTECHNOLOGY

November 20, 2004

outsourcing and trade secret issues

Outsourcing is a highly contentious and potentially cost-saving measure that is constantly in the news these days.  Sending work off-shore (or, more specifically, outside the U.S.) provides a company the benefits of oftentimes highly educated labor forces that can complete specific tasks at substantially reduced costs.

Outsourcing is rife with potential IP conflicts and pitfalls.  Computerworld has posted an in-depth look at one such pitfall: outsourcing and its effect on trade secrets.

Taking work offshore may cut costs, but it still comes with a not-so-hidden price. Asian countries, including the No. 1 outsourcing destination, India, have weak or untested intellectual property laws, inefficient courts, and financial and public records mechanisms that make it difficult to conduct employee background checks.

That doesn't mean that intellectual property sent to reputable offshore developers is more likely to be stolen and sold than it is here. Sophisticated U.S. and Canadian companies have lost valuable intellectual property in their home countries because of dishonest employees and hackers. Employees in India and elsewhere aren't any more dishonest than workers here. But because overseas court systems and laws aren't as strong as in those the U.S. and evaluating potential employees is more difficult overseas, the odds of intellectual property theft could be higher.

U.S. businesses are also sending valuable code to regions of the world with high piracy rates. In China, for instance, 92% of the software installed on computers is pirated, according to a recent study by IDC and the Business Software Alliance. In India, the piracy rate is 73%, and in the U.S., it's 22%, the lowest rate in the global study.

Those jumping on the outsourcing band wagon may want to consider some of the issues outlined in this article.  

Posted by Douglas Sorocco at 09:06 AM.
Permalink: outsourcing and trade secret issues

BIOTECHNOLOGY

October 26, 2004

Nanotechnology Gets a Category in the USPTO

According to IP News Blog:

Last Monday, the United States Patent and Trademark Office announced a new registration category specifically for nanotechnology inventions.

The patent office's criteria for this category is that at least one dimension of an invention be less than 100 nanometers and the nanoscale property of this invention must be essential to the novelty of it.

The decision to set up this new category is an indicator that many nanotechnology inventions are headed into the patent office. As a result, the patent office is currently training its examiners in nanotechnology and has set up outside experts to give advice.

Posted by at 12:50 PM.
Permalink: Nanotechnology Gets a Category in the USPTO

BIOTECHNOLOGY

October 13, 2004

Jury Orders Medtronic To Pay $400M Punitive Damages In Patent Suit

According to IP Law Bulletin, "A jury in Tennessee has ordered a subsidiary of medical device maker Medtronic to pay $400 million in punitive damages to the doctor who invented some of its spinal fusion technologies, bringing the total value of the verdict in the patent infringement lawsuit to more than $1 billion by some estimates."

Before punitive damages were considered, compensatory damages were already $110M.  Medtronic was also ordered to pay a 10% royalty on gross revenue from infringement.

The doctor/inventor was seeking $1.7 billion in compensatory damages alone.  While $110M in compensatory damages doesn't quite reach this figure, the royalties could be $470M.  Add that to the compensatory damages, and the punitives, and the total award comes to almost $1 billion.

Of course, this isn't money in the bank.  The company stated "MSD intends to pursue all appropriate post-trial remedies, including exercising its right to appeal, and believes its position will ultimately be vindicated."

Update: 10-14-2004  IP law bulletin reports Medtronic was hit again this week.  This time with an injunction.  A federal judge ordered Medtronic to stop selling screws used with some spinal implants because they infringe another patent.

Posted by at 08:54 AM.
Permalink: Jury Orders Medtronic To Pay $400M Punitive Damages In Patent Suit

BIOTECHNOLOGY

October 08, 2004

congratulations to Receptor Logic ltd.

Congratulations to Receptor Logic Ltd. of Amarillo, Texas for winning a multi-million dollar Advanced Technology Program (ATP) grant from the National Institute of Standards and Technology.

Receptor Logic's proposal, entitled "TCR Mimics: A New Class of Antibodies Against HLA-peptide Complexes for Diagnosis and Therapy of Breast Cancer" was one of 4 ATP grants awarded to companies in the state of Texas, the first ATP grant awarded to a west Texas company, and one of only 32 awards made nationwide.

Another win for a DCR client!

Posted by Douglas Sorocco at 03:41 PM.
Permalink: congratulations to Receptor Logic ltd.

BIOTECHNOLOGY

October 06, 2004

Onco-Mouse Article Published

Congratulations to our very own Kati McClatchey on the publication of her article entitled THE EFFECT OF THE “ONCO-MOUSE” DECISIONS ON THE EXCEPTION TO PATENTABILITY FOR “ANIMAL VARIETIES” UNDER THE EUROPEAN PATENT CONVENTION.

This article gives great a great review of the European patent system, and of the patentability of animals.  Check it out at www.okjolt.com.

Posted by at 03:04 PM.
Permalink: Onco-Mouse Article Published

BIOTECHNOLOGY

October 05, 2004

monsanto wins 12 year interference case against max planck institute

Monsanto Company has won a key patent office battle regarding biotech-gene technology for the transformation of plants such as cotton. The decision by the U.S. Patent and Trademark Office that Monsanto's scientists were the first to invent this important discovery ends a 12-year patent interference dispute with the Max Planck Institute and other parties.

The decision, issued Monday by U.S. Patent and Trademark Office, recounts the basis for finding that Monsanto was the first company to invent the agrobacterium transformation process which is used to introduce genes into plants.

"We are delighted that this scientific dispute has been resolved in Monsanto's favor," said Hugh Grant, chief executive officer for Monsanto. "We're pleased for our Chief Technology Officer Robb Fraley, and the team of devoted researchers at Monsanto who drove the groundbreaking science that pioneered the tools of agricultural biotechnology."

Simply put: An interference is a priority fight (i.e. who invented first) in the patent office.  In the U.S. we grant patents to the first person to invent and at times there are debates as to who the first inventor of a particular technology.  An interference proceeding is a procedural nightmare and a very specialized area of patent law.  A key indicator of this nightmare is the time it took to finalize this proceeding: 12 years of uncertainty relating to the ownership of a particular technology.

Posted by Douglas Sorocco at 09:39 PM.
Permalink: monsanto wins 12 year interference case against max planck institute

BIOTECHNOLOGY

September 17, 2004

US H-1B Visa Cap for 2004-05 fiscal year almost reached

The H-1B U.S. visa is one of the cornerstones of the US scientific and research community.  The H-1B visa is a nonimmigrant classification used by an alien (i.e. non U.S. citizen) who will be employed temporarily in a specialty occupation or as a fashion model of distinguished merit and ability.  Congress has tightened up the number of H-1B visas that are to be issued in the coming years and it appears that the opportunity for the 2004-05 fiscal year may be drawing to a close.

Thanks to the law firm of LeClair Ryan Flippin Densmore for the following informational bulletin relating to H-1B Visas:

The U.S. Citizenship and Immigration Services (“USCIS”) recently announced that as of mid-August it has received 45,900 H-1B visa petitions that will count against the annual cap for the next fiscal year, i.e., October 1, 2004 through September 30, 2005 (“FY 2005”).  As you will recall, Congress mandates that the USCIS approve only 65,000 petitions for new H-1B employment in FY 2005.  Thus, in the next few weeks (if not sooner), we expect the USCIS to announce that it will not accept any new H-1B petitions for first-time employment which are subject to FY 2005 cap. 

Reaching the H-1B visa cap less than one month into the fiscal year is unprecedented.  Unfortunately, it does not appear that there will be a legislative fix (if any) until after the November election. 

Based on this information, we strongly advise employers and employees to file new H-1B petitions as soon as possible and to consider using the Premium Processing program.  In particular, if you have any employees who are currently working in optional practical training as F-1 students, you should file an H-1B petition for them now, even if their employment authorization cards do not expire until next year. 

Please note that the following are not subject to the cap and the USCIS will continue to accept H-1B petitions filed to:

• Extend the amount of time a current H-1B worker may remain in the United States;
• Change the terms of employment for current H-1B workers;
• Allow current H-1B workers to change employers; and
• Allow current H-1B workers to work concurrently in a second H-1B position.

The USCIS will also continue to accept petitions for new H-1B employment where the petitioner/employer is not subject to the annual cap.  To qualify as a “cap exempt” petitioner, the employer must be: (i) an institution of higher education or a related or affiliated nonprofit entity; (ii) a nonprofit research organization; or (iii) a governmental research organization.

For those companies and institutions who rely on H-1B workers -- time is slipping by for such an "unprecedented" occurrence.

Posted by Douglas Sorocco at 05:02 PM.
Permalink: US H-1B Visa Cap for 2004-05 fiscal year almost reached

BIOTECHNOLOGY

September 09, 2004

Who Invented Your Genes?

Regardless of your beliefs, it was probably not any medical researcher or scientist. Recently, however, PXE International received the patent for a gene associated with pseudoxanthoma elasticum (PXE). PXE is a rare inherited disease which affects connective tissue, resulting in changes in the skin, eyes, cardiovascular system, and gastrointestinal system.

Sharon Terry, the executive director of PXE International, was quoted on Betterhumans.com stating, "we are stewards of this gene, we are responsible for using it to develop diagnostics and therapeutics that are accessible and affordable." The ultimate goal of PXE International is to develop an FDA approved diagnostic kit for PXE.

So, does this make Sharon Terry one of the gene's "inventors"? Can genes, which are naturally occurring sequences, be considered inventions at all?

The purpose of patenting genes, of course, is so that companies may charge for the use of their patented genes in the development and use of diagnostic tests, treatments, and therapies.

Is this ethical? If it is ethical, is it a very good idea?

On one hand, it presents companies with an incentive to discover genes related to certain diseases, as well as an incentive to develop diagnostic tests and the like. Many consider patent rights to be the greatest reward for innovation and discovery.

On the other hand, gene patenting greatly reduces the accessibility of genetic tests, treatments, and therapeutics. It also limits concurrent research on the same disease. Further, non-profit agencies and other companies without adequate funding may not be able to pay for the license to use the genes in their research, on top of all of the other costs associated with medical research.

The Australian Law Reform Commission has come up with 2 possible solutions to this dilemma. First, it advises governments and health departments to "challenge dubious patents or questionable licensing practices." This may require the courts to be involved from time to time. Perhaps a higher showing of usefulness of the genetic "invention" would reduce overbroad claims and dubious patents.

Second, the Commission suggested that scientists and researchers should be immune from prosecution for infringement. This would greatly reduce the problem of inhibition of medical research, but what, then, would be the point of patenting the gene at all? Would the companies and organizations who fund the researchers also be immune?

Clearly, this is an ethical and legal dilemma which will only grow more complex. What do you think should be done to protect medical researchers and "inventors" of genetic material at the same time? Is this even possible?

Kelsey L. Buntyn

Posted by at 01:36 PM.
Permalink: Who Invented Your Genes?

BIOTECHNOLOGY

August 26, 2004

hoax or horror

As a cat lover (and biotech patent attorney), I am not sure what to make of Allerca -- a company genetically engineering an allergen free cat. 

We are a biotechnology company that is working to produce the world's first allergen-free cats. These cats will allow some of the millions of Americans allergic to cats enjoy the love and companionship of a household pet without suffering from allergy symptoms.

The first ALLERCA allergen-free kittens will be sold for $3,000.We expect the price for allergen-free cats to come down to $1,750 - $2,000 each. We are happy to contact interested buyers when these cats become available for sale in early 2006.

Is this a hoax?  Further probing turns up that Allerca is a division of Geneticas Life Sciences:

Geneticas Life Sciences is a group of diverse, world leading companies directly involved in the development and production of cloned and transgenic animals. Please click on Division from the menu to read more about our products and services.

A quick primer on "transgenic animals": the term transgenic refers to an animal or other organism whose genome (genetic material or profile) has been altered by the transfer of a gene or genes from another species or breed.  For example, I wrote a patent application entitled "Fucosyltransferases, polynucleotides encoding fucosyltransferases, and transgenic mammal incorporating same" (U.S. Patent No. 6,461,835, which was licensed by and thereafter prosecuted by Cheryl Becker of Abbott Labs.) wherein a transgenic non-human eukaryotic mammal whose germ cells and somatic cells incorporate nucleic acid sequence(s) encoding one or more of the novel .alpha.-1,2 and .alpha.-1,3 fucosyltransferases from C. elegans was described.  The production of recombinant proteins from fucosyltransferases or products requiring action by fucosyltransferases were described as being produced in a non-human mammal's milk (i.e. a cow's milk).  Thus, transgenic mammals can be engineered to have certain properties or produce certain products by the introduction of a gene from another species or breed.  Doing so can turn the transgenic mammal into a biological factory. 

Back to the cats -- another one of Geneticas Life Sciences is Genetiate.  Genetiate's primary project is the "NightSave Deer":

With over 500,000 deer/auto collisions every year, the cost in lives and money is staggering. While insurers pay over a billion dollars in claims annually, over 200 people are killed. Countless other drivers and passengers suffer injuries and other serious medical complications. By implanting the gene of a special jellyfish into deer, the transgenic NIGHTSAVE deer produced by GENETIATE (patent pending) have fluorescing hair and skin when illuminated by car headlights. The implanted gene has no other effect on the deer, who appear normal in daylight. The NIGHTSAVE project aims to reduce the number of night time deer/auto collisions,  saving the lives of both deer and people.

And, best of all:

TO VIEW A SIMULATED COMPARISON BETWEEN NORMAL AND NIGHTSAVE DEER, CLICK HERE

The world is going to become a much stranger place.

Posted by Douglas Sorocco at 07:50 PM.
Permalink: hoax or horror

BIOTECHNOLOGY

August 23, 2004

US stem cell patent issued

StemCells, Inc. has announced that the Company has been issued U.S. patent 6,777,233 for work done at the Company covering composition of matter claims for the human neural stem cell.  According to their press release:

"This patent further strengthens StemCells' leading position in the human neural stem cell field," said Martin McGlynn, President & CEO of StemCells Inc. "The patent covers human neural stem cell cultures derived from any source, including embryonic as well as fetal, neonatal and adult tissue. Next year, we intend to begin the process of testing the potential of our neural stem cells in the clinic to treat a wide range of diseases of, or injuries to, the central nervous system. As we have previously announced, we intend to file our first IND by the first quarter of 2005 for a clinical trial in Batten Disease, a rare, fatal neurodegenerative lysosomal storage disorder affecting the central nervous system," McGlynn added.

 Independent claim 1 is fairly broad and recites:

1. A cell culture comprising:

(a) a culture medium containing one or more predetermined growth factors effective for inducing multipotent central nervous system (CNS) neural stem cell proliferation; and

(b) suspended in the culture medium, human multipotent CNS neural stem cells wherein

(i) the cells are grown in culture medium containing one or more predetermined growth factors effective for inducing multipotent CNS neural stem cell proliferation;

(ii) the population comprises cells which stain positive for nestin;

(iii) in the presence of differentiation-inducing conditions, the cells produce progeny cells that differentiate into neurons, astrocytes, or oligodendrocytes; and

(iv) the cells have a doubling rate faster than 30 days.

Stem Cells Inc. touts in its offering prospectus that they are outside the stem cell controversy because their line of stem cells is not directly derived from embryos.  Stem Cells Inc.'s process reproducibly grows large numbers of stem cells so that they can be "banked" and used for therapeutic treatments at a later date. 

An important distinction to keep in mind, the stem cells claimed by Stem Cells Inc. are downstream stem cells -- i.e. the cells are destined or committed to become a certain type of cell -- i.e. they are "multipotent". 

Multipotent or bipotent stem cells are cells that have continued down the path of specialization and are committed to becoming cells of a certain type. For example, hematopoietic (blood) stem cells are committed to becoming cells that circulate in the blood but may become one of many different types of blood cells. Multipotent or bipotent stem cells can be found in children and adults.

Thus, the patent appears to only cover a cell culture capable of enhancing the growth or reproduction of multipotent stem cells and not stem cells in general.

Posted by Douglas Sorocco at 12:44 PM.
Permalink: US stem cell patent issued

BIOTECHNOLOGY

August 14, 2004

TELL THAT TO THE SHEEP....

In the "science isn't infallible" category:

AUSTIN - Texas officials on Friday were trying to determine what caused a discrepancy between the results of rabies tests conducted by state and federal labs.

Two tests conducted by the Texas Department of Health on a sheep from the Fossil Rim Wildlife Center in Glen Rose were positive for rabies, department spokesman Doug McBride said.

But the Centers for Disease Control and Prevention informed the department on Wednesday that its test showed the Barbados sheep did not have rabies.

Posted by Douglas Sorocco at 02:18 PM.
Permalink: TELL THAT TO THE SHEEP....

BIOTECHNOLOGY

August 12, 2004

INCREDIBLE EDIBLE EGGS: THEY'RE NOT JUST FOR BREAKFAST?

OK - I smashed together a couple of slogans in that title, work with me on this...

File this in the interesting chicken egg technology in an IP/patent lawsuit category -- which is a really small category.

From LocalTechWire.com, Embrex, Inc. (the "In Ovo Company(R)" ) filed suit against New Jersey firm AviTech in the United States District Court for the Middle District of North Carolina (04-CV-00693), alleging AviTech “infringed” on its in-ovo (in egg) injection system claimed in U.S. Patent No. 5,136,979. 

The '979 patent claims:

1. An injection apparatus that is particularly suitable for accurate and precise injection of eggs to the same depth and location when the eggs are of varying sizes and may be presented to the injection apparatus in somewhat different orientations, said injection apparatus comprising:

a generally horizontally oriented tooling plate with an opening therethrough;

an injector resting generally vertically in said opening in said tooling plate with a lower portion of said injector depending downwardly below said tooling plate and an upper portion of said injector resting at or above said tooling plate; and

means for raising and lowering said tooling plate and said injector therewith so that when said plate is lowered and said lower portion of said resting injector contacts an object such as an egg to be injected, said resting injector stops while said tooling plate proceeds downwardly until said injector disengages from said tooling plate and is free to move in a translational direction independent of said tooling plate, and so that when said tooling plate is raised it reengages said injector and carries it upwardly and away from the object being injected.

According Embrex's press release:

"Invention is a critical component of our business strategy, and we are proud of the success we've had in patenting what we have discovered, designed and commercialized," said Randall Marcuson, president and chief executive officer of Embrex, in a statement. "As The In Ovo Company(R), we will not allow others to infringe upon our patents. As we've done in the past, we will defend our intellectual property portfolio against any infringement so that we may protect our investment and that of our shareholders."

According to the USPTO website, Embrex has 38 issued patents in the area which is an impressive technology/IP portfolio. 

Posted by Douglas Sorocco at 02:32 PM.
Permalink: INCREDIBLE EDIBLE EGGS: THEY'RE NOT JUST FOR BREAKFAST?

BIOTECHNOLOGY

Britain grants license for human cloning

The BBC reports that Britain granted a license for human cloning yesterday, making it the second country to allow licensing of human cloning.

University researchers hoping to create insulin-producing cells for diabetics now have a license for their work in Britain.

Because embryos must be destroyed to harvest stem cells, embryonic stem cell cloning has been a hot political topic, both in Britain and elsewhere.  The ProLife Party of Britain is considering the prospect of suing.  In the United States, federal funding for stem cell research and cloning is prohibited, and several states also prohibit any embryo cloning.  Opponents include the Vatican, and Life Site.

The BBC article does a good job of explaining how cloning works, as does howstuffworks.com.  Other sites of interest include The Human Cloning Foundation, Advanced Cell Technology, a BBC article "Cloning humans: Can it really be done?," and newscientist.com.

This promises to be a highly debated topic for quite a while, so we should all be aware of the argument each side is making.

Posted by at 08:52 AM.
Permalink: Britain grants license for human cloning
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BIOTECHNOLOGY

August 10, 2004

WATCH OUT BUGS: THE VACCINE IS ON THE WAY!

A little known fact is that hospitals can kill you. Truly -- they can.  People can and do get sick from infections caused by the bacteria (namely, Staphylococcus aureus, Staphylococcus epidermidis and Enterococcus gram-positive bacteria) lingering around the hospital.  Combine this with the fact that bacteria are becoming ever more resistant to antibiotics -- and you whip up a nasty brew of hospital funk.

Nabi Biopharmaceuticals is coming to the rescue.  According to a press release on the Pharmacy Times:

Nabi Biopharmaceuticals announced today that it has been granted U.S. Patent No. 6,756,361 entitled "Enterococcus Antigens and Vaccines" by the U.S. Patent and Trademark Office.  The [patented] polysaccharides cover more than 85% of all enterococcal infection isolates from hospitals across the United States. The patent also covers the use of these antigens as vaccines, and methods for obtaining and detecting the antigens.

"Enterococcus faecalis and Enterococcus faecium are responsible for almost all enterococcal infections in hospitalized patients. The identification and isolation of these antigens is a significant contribution in our efforts to expand our approaches to preventing and treating deadly Gram-positive bacterial infections. For the first time, these antigens will allow us to induce protective immunity against these multiple drug resistant pathogens," stated Thomas H. McLain, chairman, chief executive officer and president of Nabi Biopharmaceuticals. Mr. McLain continued, "The issuance of this patent has further strengthened the intellectual property position around our Gram- positive pipeline portfolio. We now have significant patent positions that cover the most significant bacteria causing hospital acquired Gram-positive infections namely Staphylococcus aureus, Staphylococcus epidermidis and Enterococcus."

The patent didn't have any pretty pictures (a la Patently Obvious) so to the right is a electron microscope image of Enterococcus faecium (thanks to Dennis Kunkel who has one of the most extensive and complete libraries of scientific images available on the web) -- which, according to Dr Gary Kaiser, "The enterococci have become the second most common bacterium isolated from nosocomial urinary and wound infections, and the third most common cause of nosocomial bacteremia. Each year in the U.S., in fact, enterococci account for approximately 110,000 urinary tract infections, 40,000 wound infections, 25,000 cases of nosocomial bacteremia, and 1100 cases of endocarditis. Furthermore, the enterococci are among the most antibiotic resistant of all bacteria, with some isolates resistant to all known antibiotics."

Doesn't it just make you want to go in for that face-lift you have been wanting. A little nip here, a little tuck there and some Enterococcus faecium for good measure.

Posted by Douglas Sorocco at 06:32 PM.
Permalink: WATCH OUT BUGS: THE VACCINE IS ON THE WAY!

BIOTECHNOLOGY

August 09, 2004

RUSSIAN BIO ENTREPRENEUR: STRONGER IP REQUIRED

Interesting article at nature.com about the state of biotechnology commercialization in Russia.  The main perceived problem: a lack of strong intellectual property protection coupled with an unfamiliarity with "western" style commercialization activities such as licensing, patenting and business plans.

"One of the saddest things I ever saw was in the early 1990s when a ministerial delegation [from Russia] came to the UK with a thick book listing all their biotech prospects and inventions," says Ian Harvey, CEO of the London-based British Technology Group (BTG) and chair of the UK Intellectual Property Institute. By publishing these ideas in a brochure, the group had put them in the public domain, destroying their patentability, he says. "It's like if you're [trying to] help your parents but it turns out you've actually killed them instead."

Education is key in the circumstances:  the scenario discussed above could easily be forestalled with a small amount of planning and education.  Unfortunately, such a lack of understanding is not uncommon in the U.S. or Europe and many innovators or entrepreneurs have found themselves on the wrong end of a "who invented/patented first" dispute.  Universities and academic institutions have the decked stacked against them -- the academic culture of "publish or perish" and collaboration ensures that all too often the university tech transfer department is the last department to know of a ground-breaking innovation.

What is the solution?  Ask 10,000 technology specialists and you would get 10,001 different answers.  My take: The simple and sometimes non-obvious starting point -- education.  We as individuals interested in IP must do a better job educating folks outside our profession: instead of a lawyer focused CLE, speak to a business group or technology trade group. Your clients (and their peers) will appreciate your efforts.

As an aside, if anyone would like a speaker for the Bahamas in January, 2005 .... email me.

Posted by Douglas Sorocco at 10:15 PM.
Permalink: RUSSIAN BIO ENTREPRENEUR: STRONGER IP REQUIRED

BIOTECHNOLOGY

August 05, 2004

Biotechnology Overtaking Information Technology as Engine of SE Asia Economy

from emedia.com:

Ernst & Young’s report entitled On the Threshold – The Asia-Pacific Perspective says the number of public and private biotechnology companies in the region increased by 11 per cent, with total revenues of 120 publicly-traded companies increasing by nine per cent while research and development (R&D) spending increased 10 per cent. Globally, the report states the biotechnology industry public revenues increased by 17 per cent to US$46.6 billion (RM177.08 billion) in 2003.

“Biotechnology provides more tangible benefits,” says Carol Wong, executive director, Ernst & Young. The survey shows the United States still dominating the market, with Europe experiencing a resurgence of interest in recent years.

Posted by Douglas Sorocco at 02:58 PM.
Permalink: Biotechnology Overtaking Information Technology as Engine of SE Asia Economy

BIOTECHNOLOGY

July 24, 2004

HEATED RHETORIC: ALTERNATE VIEWPOINT ON DRUG PATENTS IN DEVELOPING NATIONS

Although I am ardent supporter of the patent system in general and pharmaceutical/drug patents in particular, I don't want this Blawg to become truly one sided and blind to other arguments.

An online newspaper in India has an interesting article outlining some of the concerns of advocates in developing nations have about patent drugs. The rhetoric should continue to ratchet up in the next several months:

...as the transitional period of ten years, given to the developing nations to conform to the TRIPs agreement, ends on December 31, 2004, opening up the pharmaceutical sector to 'product patent' regime which gives exclusive rights to the inventor to use and sell his product, patented since 1995 for a period of 20 years. Contrary to this, India had been following a system of 'process patent', which gave right to the domestic pharmaceutical companies to manufacture a product patented elsewhere by employing slighter changes in the process of manufacture which do not amount to infringement. This permitted the local companies to research and develop cheaper 'generic' variants of the original drug suiting the country's economic and internal needs.

Interesting read for an alternative perspective.

Posted by Douglas Sorocco at 01:49 AM.
Permalink: HEATED RHETORIC: ALTERNATE VIEWPOINT ON DRUG PATENTS IN DEVELOPING NATIONS

BIOTECHNOLOGY

July 14, 2004

NEW ALZHERIMERS TREATMENT METHODS PATENTED

Elan Corporation and Wyeth Pharmaceuticals' joint venture, Neuralab Limited, has been issued three patents for its research on immunotherapeutic approaches to the treatment of Alzheimer's disease.

U.S. Patent Number 6,750,324, entitled "Humanized and chimeric N-terminal amyloid beta-antibodies," claims pharmaceutical compositions comprising an antibody that specifically binds to a region within the beta amyloid molecule.  According to the abstract of the invention:

The invention provides improved agents and methods for treatment of diseases associated with amyloid deposits [i.e. a protein aggregation] of A.beta. in the brain of a patient.  Such methods entail administering agents that induce a beneficial immunogenic response against the amyloid deposit.  The methods are useful for prophylactic and therapeutic treatment of Alzheimer's disease.  Preferred agents including N-terminal fragments of A.beta. and antibodies binding to the same.

U.S. Patent Numbers 6,743,427 and 6,761,888, entitled "Prevention and treatment of amyloidogenic disease" and "Passive immunization treatment of Alzheimer's disease" respectively, claim methods of prophylactically or therapeutically treating Alzheimer's disease, including the administration of a pharmaceutical composition comprising an antibody that specifically binds to a region within the beta amyloid molecule.

In layman's terms, a patient is injected with an antibody (from Wikipedia: "An antibody is a protein complex used by the immune system to identify and neutralize foreign objects like bacteria and viruses.") that binds to a specific region within the amyloid molecule within the brain.  Once the antibody binds the amyloid molecule, the patient's own immune system can attack and destroy the amyloid deposit and/or bind with precursor proteins and block the production of the amyloid deposits.

Posted by Douglas Sorocco at 11:22 PM.
Permalink: NEW ALZHERIMERS TREATMENT METHODS PATENTED

BIOTECHNOLOGY

July 12, 2004

GENERIC DRUG MAKER LIKES PATENTS AFTERALL

OPPS! -- HERALDED GENERIC DRUG MAKER PATENTS AIDS DRUG

Cipla, a heralded pioneer in supplying inexpensive generic AIDS drugs in Africa, has patented its own AIDS therapeutic -- a three-in-one combination tablet called Triomune which is comprised of three currently "on patent" drugs: GlaxoSmithKline?s lamivudine, Bristol-Myers Squibb?s stavudine and Boehringer Ingelheim?s nevirapine. 

Quote:

Cipla?s entry into the patent arena may offer it commercial protection from rivals looking to copy its know-how in combining the three original medicines. But it could prove politically embarrassing. 

Why politically embarassing?

Richard Feachem, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, called the study [proving Trimune effective] "extremely good news."  The fund buys generics approved by the World Health Organization, including Triomune, so "this gives strong scientific support for the procurement policies the Global Fund has been pursuing for 18 months," he said.

Posted by Douglas Sorocco at 11:51 PM.
Permalink: GENERIC DRUG MAKER LIKES PATENTS AFTERALL

BIOTECHNOLOGY

May 21, 2004

CANADIAN SUPREME COURT UPHOLDS MONSANTO INFRINGEMENT ACTION ON GENETICALLY MODIFIED CANOLA SEED

The Canadian Supreme Court awarded Monsanto a resounding victory May 21, 2004 in a ruling upholding Monsanto's Canadian patent on genes for genetically altered canola seed.

The gene at the centre of the litigation was introduced into canola to produce a canola plant, known as Roundup Ready, that is resistant to the common Monsanto produced weed-control herbicide known as Roundup. The altered canola plant's progeny or offspring are also resistant to Roundup.

The Canadian patent infringement action began in 1997, when Monsanto discovered genetically engineered canola plants growing on Percy Schmeiser's farm. Mr. Schmeiser contended that since a plant is a higher life form and cannot be patented, he had done nothing wrong.   Monsanto did not patent the genetically modified plant itself, but rather  the genes and the modified cells it contained.

According to the Canadian Supreme Court's decision (found here):

"The appellants actively cultivated Roundup Ready Canola as part of their business operations," a majority led by Chief Justice Beverley McLachlin and Mr. Justice Morris Fish concluded. "In light of all of the relevant considerations, the appellants used the patented genes and cells, and infringement is established.

"By cultivating a plant containing the patented gene and composed of the patented cells without licence, the appellants deprived the respondents of the full enjoyment of the monopoly," they said, writing on behalf of Mr. Justice Ian Binnie, Mr. Justice Jack Major and Madam Justice Marie Deschamps. "The appellants' involvement with the disputed canola was also clearly commercial in nature."

Mr. Schmeiser saved the seed and reused it "for production and advantage," the majority noted. "Whether or not patent protection for the gene and the cell extends to activities involving the plant is not relevant to the patent's validity." 

Posted by Douglas Sorocco at 07:44 PM.
Permalink: CANADIAN SUPREME COURT UPHOLDS MONSANTO INFRINGEMENT ACTION ON GENETICALLY MODIFIED CANOLA SEED

BIOTECHNOLOGY

May 20, 2004

MITOCHONDRIAL DNA TESTING UPHELD AS RELIABLE BY 6th CIRCUIT COURT OF APPEALS

From Daubert On the Web, the 6th Circuit Court of Appeals has upheld the reliability of mitochondrial DNA testing and provides a fairly in-depth discussion of the probabilities of a DNA match when mitochondrial DNA (DNA, which is found outside of the nucleus in the mitochondrion) is used for purposes of comparison. 

United States v. Beverly, No. 00-3617 (6th Cir. May 12, 2004).  According to the 6th Circuit's decision:

This technique, which generally looks at the differences between people?s mitochondrial DNA, has some advantages over nuclear DNA analysis in certain situations. For example, while any given cell contains only one nucleus, there are a vast number of mitochondria. As a result, there is a significantly greater amount of mtDNA in a cell from which a sample can be extracted by a lab technician, as compared to nuclear DNA.

Thus, this technique is very useful for minute samples or ancient and degraded samples. Ibid. In addition, mitochondrial DNA can be obtained from some sources that nuclear DNA cannot. For example, mtDNA can be found in shafts of hair, which do not have a nucleus, but do have plenty of mitochondria. Nuclear DNA can only be retrieved from the living root of the hair where the nucleus resides.

On the other hand, mtDNA is not as precise an identifier as nuclear DNA. In the case of nuclear DNA, half is inherited from the mother and half from the father, and each individual, with the exception of identical twins, almost certainly has a unique profile. MtDNA, by contrast, is inherited only from the mother and thus all maternal relatives will share the same mtDNA profile, unless a mutation has occurred.

Because it is not possible to achieve the extremely high level of certainty of identity provided by nuclear DNA, mtDNA typing has been said to be a test of exclusion, rather than one of identification.

. . . .

Even an article critical of mtDNA stated the most frequent pattern applies in no more than 3% of the population. Erica Beecher-Monas, The Heuristics of Intellectual Due Process: A Primer for Triers of Science, 75 N.Y.U.L. Rev. 1563, 1655 n.535 (2000).

Posted by Douglas Sorocco at 10:28 PM.
Permalink: MITOCHONDRIAL DNA TESTING UPHELD AS RELIABLE BY 6th CIRCUIT COURT OF APPEALS

BIOTECHNOLOGY

May 08, 2004

BABY GENDER SELECTION KIT PATENTED?

From CBS: A kit sold on the Internet by a company called GenSelect is reportedly making a difference in whether you paint the nursery pink or blue. GenSelect claims it can turn picking the sex of your baby from a crapshoot into a slam-dunk. "We've tallied up a 96 percent success rate," says Jill Sweazy, GenSelect's co-founder. 

Of course, GenSelect is being likened to PT Barnum: there is a sucker born every minute.  In response to such doubts, GenSelect's Sweazy points out that "Opinion's opinion. You can find someone contrary to antibiotics. We were just granted our United States patent, and they don't grant patents to wives' tales."  Well heck -- if it has a patent, it must work. Right? 

Not really -- it is a common misconception that patents are only issued to inventions that actually work.  If this was true, every ailment known to man would be cured (cancer, AIDS, hair loss).  In order to patentable, a disclosed invention only has to be novel (never done before), nonobvious, and useful.  If a patentee provides a use that is substantial and credible, the patent office must defer to the applicant.  Only in rare cases will patent applications be rejected by the Patent Office on the basis of failing to provide a substantial and credible utiltiy (perpetual motion machines, reincarnation, etc.)

So it isn't surprising that GenSeect may have received a patent on a gender selection kit.  Far more interesting, however, is what did GenSelect actually patent?  According to U.S. Patent No. 6,610,331 (the only patent listing the Sweazy's as inventors in this field) the Sweazy's claim:

1. A nutriceutical which improves the natural fertility process comprising:

(a) L-Arginine 50-500 mg;.
(b) L-Cysteine 10-100 mg;
(c) Selenium 10-400 mcg;
(d) Vitamin C 50-2000 mg;
(e) Vitamin E 100 iU-1000 iU;
(f) Zinc 10-100 mg;
(g) Astragalus;
(h) Pycnogenol 10-100 mg;
(i) Vitamin B-6 10-200 mg;
(j) Para-aminobenzoic acid (PABA) 50-300 mg;
(k) Vitamin A 1000-10,000 iU;
(l) Folic Acid 400-1000 mcg; and
(m) at least one phytoestrogen, wherein the at least one phytoestrogen is an isoflavone, coumestan, lignin, or any combination thereof.

So the '331 patent covers a "nutriceutical" (actually it is a neutraceutical) of several types of vitamins etc. The patented claims don't actually cover a gender selection kit -- more like a soup of various vitamins.  Is it scam?  Well, you have a 50/50 chance of the "gender kit" being right at any point in time.

Moral of the story: just because it says "patented" it isn't guaranteed to work and before assuming that the patent actually covers the product or "method" being sold, check out the actually claims first. Caveat emptor!

Posted by Douglas Sorocco at 01:20 PM.
Permalink: BABY GENDER SELECTION KIT PATENTED?
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