Cytori Patent Allows Inclusion of Stem Cells

The United States Patent and Trademark Office has granted Cytori Therapeutics a Notice of Allowance, which expands the company’s protection of their Celution System.  In a press release, the company states that the patents contain over 40 claims, the most notable being the following: alternative Celution system configurations beyond those already covered in patents; expanded protection for cosmetic and reconstructive surgery applications; and technology within the device that optimizes intravascular delivery of adipose-derived stem and regenerative cells.

Cytori has already achieved significant breakthroughs in the field of regenerative medicine.  Their Celution 800 system is currently being introduced to Europe for reconstructive surgery, while the Celution 900 system is being commercialized globally for cryopreserving a patient’s own stem and regenerative cells.  Yet, the claims in the new patent also expand the array of Celution output compositions, so that combinations of cells, matrices, and other specific needs would also be protected.  Furthermore, the claims related to intravascular delivery could potentially broaden the Celution System output, to help those with cardiovascular disease, liver disease, and renal failure.

Cytori’s intellectual property portfolio contains nine U.S. and international patents, and over 120 applications pending worldwide.  These patents are related to the devices, methods, and uses of adipose-derived stem and regenerative cells.

King to Cut 760 Jobs After Losing Patent Battle

King Pharmaceuticals, Inc. has announced that they will restructure their workforce to decrease their company’s operating expenses.  The announcement comes on the heels of a federal court decision that invalidated key patents on King’s muscle relaxant, Skelaxin.

Brian A. Markison, President and Chief Executive Officer, stated the following on their website:

Following the recent court decision relating to our SKELAXIN® (metaxalone) patents and the uncertainty that it creates with respect to the continued exclusivity of the product, we thoroughly assessed our cost structure.  We concluded the restructuring measures announced today will better position us to support the near-term priorities of our strategic plan.

King expects to cut roughly 760 jobs, including 240 corporate positions associated with the Alpharma acquisition, which King acquired in November for $1.6 billion.  Another 380 positions to be cut will be field sales positions, and approximately 140 more are also corporate positions.

Due to the restructuring and layoffs, King estimates that it will incur special charges between $50 and $55 million.  Yet, the company still plans to appeal the court’s decision that invalidated the patents.

FTC Challenges Deal on Testosterone Gel

The Federal Trade Commission has filed suit against four drug companies, which have agreed to delay generic competition to Solvay’s AndroGel, a form of testosterone replacement.  As reported on The Wall Street Journal’s Health Blog, Watson Pharmaceuticals and Par Pharmaceutical Companies would have received payments from Solvay Pharmaceuticals, who created the testosterone gel.  In exchange for the payments, the two companies agreed to drop their challenges to the validity of the drug’s patent and wait until 2015 to bring generic versions to the market.

All sides contend that the deal is perfectly legal, and that a federal court approved the settlement that the FTC is challenging.  Watson’s CEO said, “the agreement fully complies with both the spirit and letter of the antitrust and consumer protection laws, as interpreted by numerous appellate courts throughout the U.S.”  In a statement, Solvay said:

These settlements were completely lawful, facilitated both wider distribution of AndroGel and earlier generic competition for AndroGel than if the company had enforced its patent rights fully, and brought an end to expensive and burdensome patent litigation.

Recently, the FTC has become move involved in antitrust and other litigation.  For instance, last year the FTC filed a similar suit against Cephalon over delays for generic Provigil.

QIAGEN & Applied Biosystems settle “DNA Copier” patent suit

QIAGEN has now fully licensed the real-time thermal cycler technology for all molecular research and diagnostic applications. As Globe Newswire reports, Corbett, QIAGEN, ltf Labortechnik, and Applied Biosystems, LLC, (ABI) part of Life Technologies Corporation have reached agreements which fully resolve all pending disputes between Corbett, QIAGEN, ltf Labortechnik, and Applied Biosystems.

QIAGEN inherited the dispute when it acquired Sydney, Australia-based Corbett Life Science last year. Corbett makes the Rotor-Gene Real-Time PCR-Cyclers, which were the focus of an infringement suit filed by ABI in Germany. Corbett later filed a declaratory judgment lawsuit in California and then Corbett and ltf Labortechnik filed an intervention in opposition proceedings before the European Patent Office.

Thermal cyclers are essential instruments in performing PCR, or polymerase chain reactions, an extremely common procedure in life science and molecular diagnostics, is a process where a portion of DNA or RNA is copied many times over so that the nucleic acid can be more readily analyzed. The powerful technique of Real-Time PCR (RT-PCR) allows the amplified DNA to be detected during, rather than after, the PCR process, enabling greater accuracy in important applications, including pathogen detection, gene expression quantization and genotyping.

QIAGEN, acquired the Australian instrumentation manufacturing company Corbett in July 2008. QIAGEN N.V., is a Netherlands-based company and leading provider of sample and assay technologies, which are used to isolate and process DNA, RNA, and proteins from biological samples (i.e. blood or tissue) and to make such isolated bio-molecules visible. Life Technologies Corporation, created by the combination of Invitrogen Corporation and Applied Biosystems Inc., is a California-based global biotechnology company with a wide-ranging scope in biological medicine, molecular diagnostics and beyond.

In connection with the settlement, Corbett entered into an agreement with ABI to take a license to certain technology relating to Corbett’s RT-PCR Instrumentation and its use. The license covers all fields including research-related fields, applied fields and the fields of human and animal in vitro diagnostics. Financial terms of the settlement and the related license agreement were not disclosed.

“This Real-Time Thermal Cycler license agreement for all fields including human in vitro diagnostics expands our existing PCR intellectual property estate which is truly unique in the industry,” said QIAGEN CEO Peer Schatz. “The Rotor-Gene™ Q Real-time Thermal Cycler technology adds high performance, proprietary PCR detection technology to QIAGEN. This addition extends our molecular testing solution portfolio and puts QIAGEN in a position to offer sample and assay technology solutions spanning from sample to result. This settlement agreement allows us to place our full focus on delivering the most advanced technology solutions to our customers in molecular diagnostics, applied testing, pharma and academic research.”

New Germ to Stem Cell Patent Application

Stem Cell Innovations, Inc., a cell biology company in Houston, TX, has filed a new patent application for the production of pluripotent stem cells with many potential outcomes from primordial germ cells. As PR Newswire reports, “We have been working for several years to develop a more effective method for producing stem cells from germ cells,” said CEO James H. Kelly, PhD. “This filing was submitted to secure our intellectual property prior to publication in the scientific literature.”

Stem Cell Innovations has been developing PluriCells™ for use in drug discovery. These PluriCells™ the company’s proprietary, human pluripotent stem cells, have the potential to aid in drug discovery, cell therapy, and beyond. The company feels their PluriCells™ have the capacity to aid in the development of treatments for degenerative diseases such as Mutiple Sclerosis, Huntington’s Disease, Parkinson’s and even hearing loss. Kelly explained, “the method in this application provides for a substantial improvement in both the yield and quality of stem cells produced. It builds on our already strong IP position in germ cell-derived stem cells and will allow us to expand in new directions”.

SkinMedica sues Histogen over Fountain of Youth patent

Skinmedica®, Inc., a dermatologics company based in Carlsbad, CA, announced that it has initiated a patent and trade secret action against Histogen, Inc., Histogen Aesthetics, LLC and Dr. Gail Naughton, founder, President and Chief Executive Officer of Histogen and Histogen Aesthetics. Histogen, based in San Diego, CA and founded in 2007, is a regenerative medicine company which expanded Histogen Aesthetics as its dermatologics unit in 2008.

Dr. Naughton, a respected scientist with expertise in tissue engineering, was co-founder of Advanced Tissue Sciences (ATS), which initiated bankruptcy proceedings in 2002. SkinMedica then acquired several assets from ATS, including intellectual property encompassing its NouriCel® technology. BusinessWire reports that the complaint seeks damages and an injunction against the defendants for the development and manufacture of aesthetic and therapeutic products using SkinMedica’s patented conditioned cell culture medium technology. According to the patent verbiage, this dynamic technology involves production of media conditioned using developing eukaryotic cells, which can be delivered internally via a food item, topically as a form of ointment, or even incorporated into surgical glue to accelerate the healing of sutures and the like.

The complaint, filed in the United States District Court for the Southern District of California, seeks relief against the defendants for infringing SkinMedica’s U.S. Patents No. 6,372,494 and/or 7,118,746. The patents, which were filed in 1999 and 2000, respectively, relate to methods and uses of SkinMedica’s proprietary conditioned cell media technology. The complaint also seeks relief for the misappropriation of SkinMedica trade secrets and confidential information by Histogen, Inc., Histogen Aesthetics, LLC and Dr. Naughton.

Oncolytics Biotech receives “Tumor Killer” patent

Oncolytics Biotech Inc., a Calgary –based company announced that it has been granted its 31st U.S. Patent, No. 7,476,382, entitled “Reovirus for the Treatment of Neoplasia.” The patent includes claims to pharmaceutical compositions containing reovirus.

Reoviruses (respiratory enteric orphan viruses), initially deemed ‘orphan’for their apparent lack of association with any disease, have an unclear role in disease and treatment, but their propensity to affect the gastrointestinal and respiratory tracts seems to have allowed for an avenue for treatment of neoplasia (the abnormal proliferation of cells usually resulting in a tumor) in these regions and even further, to clinical trials combating brain tumors.

Oncolytics, a biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, runs a clinical program including a variety of Phase I/II and Phase II human trials using REOLYSIN®, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy.

Oncolytics’ VP of Intellectual Property. Mary Ann Dillahunty, please with the news, noted that, “this U.S. patent expands and strengthens our proprietary position for REOLYSIN®. The pharmaceutical composition claims cover the formulation being used in our ongoing clinical trials.”

Radiation-Blocking, Anti-Chemical Fabric Receives Patent

Radiation Shield Technologies recently announced that their company has received a U.S. nanotechnology patent.  Entitled “Radiation Detectable and Protective Articles,” the patent secures the nanotechnology in RST’s proprietary Demron, the first and only protective material for all types of chemical, biological, radiological and nuclear incidents.

According to Nanowerk, traditional suits only provide limited radioactive protection.  This new patent, however, describes the use of nonpolymeric compounds that enable the newest version of Demron to provide enhanced chemical, biological, radiation and flame protection.  Demron is a lead-free, toxin-free and PVC-free material that allows heat dissipation and resists chemical penetration and cracks.  Demron nuclear protection fabrics are made of liquid metal, and are lightweight, flexible and foldable.

“As the manufacturer and marketer of advanced nuclear suits and personal-protection technologies that are in high demand worldwide, Radiation Shield Technologies developed an intellectual property strategy that gives us freedom to meet our customers’ radiation protection needs while safeguarding our company’s commercial advantages,” said Ronald DeMeo, the president and CEO of RST.  “We will continue to introduce new Demron products, apply for additional patents worldwide and help promote awareness, education and scientific research to advance the field.”

Boston Scientific and Medtronic Settle Lawsuits

Boston Scientific Corp. and Medtronic Inc. have agreed to settle two patent infringement lawsuits, and put three other lawsuits on hold.  According to Boston.com, the suits were over heart stents which are tiny mesh tubes used to prop open heart arteries after they are cleared of fat.

The settlement includes a recent case, where Boston Scientific was ordered to pay Medtronic $250 million over balloons that inflate heart arteries.  A federal judge had cut the award to $19 million and threw out two of the three questioned patents before the settlement.  However, an order signed on January 23 increased the amount to $24.6 million with interest.

Hank Kucheman, a senior vice president for Boston Scientific, said in a statement, “[The agreements] will allow us to focus our efforts and resources on developing new products and therapies that improve patients’ lives.”

The other four cases at issue hadn’t yet gone to trial.  But, Medtronic will continue to pursue patent-infringement claims against another heart device maker, Abbott Laboratories.

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