In March, Chembio Diagnostics Inc. (Medford, NY) announced that it had been awarded U.S. Patent 7,189,522 for its dual path immunoassay device and would begin seeking collaborators that would license the technology as the basis for developing their own tests.

"I am very pleased with the issuance of this new patent," said Chembio president and CEO Lawrence Siebert. "The dual path immunoassay system, which we will brand as the DPP test, gives us a great opportunity to enhance shareholder value and bring a new generation of lateral-flow rapid tests to a wide variety of markets."

As distinguished from other approaches used in developing lateral-flow rapid diagnostic tests, the Chembio patent describes a device and method for detection that includes a separate, second flow-path for application of the sample material to be tested. According to Chembio studies, the separate, second flow-path enables the development of diagnostic tests that can increase sensitivity; extend the spectrum of useful sample types beyond blood, serum, and plasma; improve results when testing for multiple conditions or different parameters of one condition; and reduce the amount of reagents required.

Chembio's patent was prosecuted by David P. Gordon, a principal in the boutique intellectual property law firm of Gordon & Jacobson PC (Stamford, CT).

As Chembio's core competency is in the development and manufacture of serological tests for infectious diseases, studies demonstrating the performance of the DPP test have so far focused in this area. The company's pipeline already includes an oral fluid HIV test, an HIV confirmatory test, a screen-and-confirm rapid test for syphilis, and new tests for human tuberculosis, Chagas disease, and a number of other neglected diseases. The company is also conducting studies to confirm the expected performance of the DPP technology in nonclinical applications such as the detection of antigens in biological samples, food, and the environment.

Chembio believes that products developed within the scope of its newly issued dual path immunoassay system patent will be outside the scope of all existing patents for single-path lateral-flow technologies, a field that is unusually crowded with many overlapping patents issued over the past 20 years. With freedom to operate in this new area, the company claims that licensees will have lower overall licensing costs than they would incur for licensing multiple single-path lateral-flow patents.

"I am most appreciative of the commitment of Chembio vice president of research and development Javan Esfandiari, as well as the entire Chembio R&D team, for designing this proprietary platform, which has several advantages over well-established conventional single-path lateral-flow rapid test systems," said Siebert.

Additional patent protection is also pending both in the United States and worldwide. A video animation of Chembio's oral fluid HIV test employing DPP test technology can be viewed at www.chembio.com/newtechnologies.html .

Diomed Gets $12.4 Million in Patent Infringement Win

At the end of March, a jury in the Federal District Court for the District of Massachusetts awarded $12.46 million in patent-infringement damages to Diomed Holdings Inc. (Andover, MA) in litigation involving two defendants, AngioDynamics Inc. (Queensbury, NY) and Vascular Solutions Inc. (Minneapolis).

Diomed develops and commercializes minimally invasive and microinvasive medical procedures that use proprietary laser technologies and disposable products. The company's EndoVenous laser treatment is a vein ablation procedure used in varicose vein treatments.

Diomed commenced legal action against AngioDynamics in January 2004, seeking injunctive relief and damages for infringement of Diomed's U.S. Patent 6,398,777, which covers the endovascular laser treatment of varicose veins. Diomed acquired exclusive rights to the patent from the five inventors of the procedure in September 2003.

The company initiated similar infringement actions against Vascular Solutions, CoolTouch (Roseville, CA), and Total Vein Solutions (Houston) later in 2004. The latter two actions are still pending under the jurisdiction of the same court and are expected to move to trial later this year.

The jury trial followed a summary judgment ruling last summer that Diomed's patent is valid and enforceable. In its verdict, the jury found each defendant liable for both inducing infringement and contributory infringement of Diomed's patent. However, the jury found the infringement was not willful.

"We are obviously extremely pleased with the outcome of this critical case. We are thrilled that the jury has recognized the value of Diomed's pioneering patent," said Diomed president and CEO James A. Wylie Jr. "We plan to immediately file for a permanent injunction against AngioDynamics and Vascular Solutions that, if granted, will require both companies to cease marketing their infringing products. We are hopeful for an early ruling from the court, which will allow us to focus our efforts on growing this exciting market."

Across the aisle, meanwhile, AngioDynamics announced that it would act to have the jury verdict set aside and, if necessary, would appeal the verdict to the U.S. Court of Appeals for the Federal Circuit (Washington, DC). "AngioDynamics strongly disagrees with the verdict reached by the jury today," said company CEO Eamonn P. Hobbs. "We firmly believe our VenaCure procedure falls outside the scope of the Diomed patent, and are confident this will be established through the court's review of the verdict or the appeal process."

AngioDynamics noted that, regardless of the final outcome of the lawsuit, the company expects to be fully indemnified pursuant to the terms of its supply and distribution agreement with its laser system subsupplier.

Diomed was represented by Wolf, Greenfield & Sacks PC (Boston), an intellectual property law firm. "We're delighted for our client and proud of our litigation team who worked long and hard on this case," said Michael Albert, who heads Wolf Greenfield's litigation practice.

"The process of protecting our intellectual property rights has been lengthy and expensive," said Wylie. "We will now be able to focus our resources on accelerating the development of the laser market for treatment of varicose veins, particularly in reaching out and educating patients about the advantages of endovenous laser treatment over alternative procedures."

"This decision radically alters the competitive landscape in the treatment of venous disease and is expected to have a significant impact on our financial performance going forward," added Diomed CFO David B. Swank. "At existing growth rates, AngioDynamics and Vascular Solutions sales represent approximately $20 million to $25 million in annual customer demand, and we have already initiated plans to maximize our share of that business. We also expect the ability to recover royalty payments and the elimination of the legal burden associated with the '777 litigation to assist in improving our financial performance."

Sofamor Danek Seeks Extended Patent for Infuse Device

At the end of March, FDA published a Federal Register notice of its formal determination of the regulatory review period for the Infuse bone graft and LT-Cage lumbar tapered fusion device by Medtronic Sofamor Danek (MSD; Memphis).

FDA's notice was issued after Medtronic subsidiary SDGI Holdings Inc. applied to the U.S. Patent and Trademark Office (PTO) for an extension of two patents related to the device. Under the Drug Price Competition and Patent Term Restoration Act of 1984 (P. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (P. L. 100-670), manufacturers of FDA-regulated products may receive patent extensions of up to five years, so long as the patented item was subject to FDA premarket review. The product's regulatory review period forms the basis for determining the length of the patent extension an applicant may receive.

FDA approved the Infuse and LT-Cage device in 2002 for spinal fusion procedures in skeletally mature patients with degenerative disc disease at one level from L4--S1. In its applications for patent term restoration, MSD requested 463 days of patent term extension for U.S. Patent 5,984,967 or 347 days of patent term extension for U.S. Patent 5,782,919.

FDA's determination of the length of a regulatory review period for a medical device includes both the clinical testing phase and approval phase. However, only a portion of a product's regulatory review period counts toward the patent extension period. PTO is required to subtract half of the time designated as belonging to the product's testing phase as well as any time that elapsed before the patent was issued. In its Federal Register notice, FDA described the chronology of regulatory milestones related to the MSD device.

Based on these dates, FDA determined that the applicable regulatory review period for the Infuse and LT-Cage device is 2052 days. Of this time, 1515 days occurred during the testing phase of the regulatory review period, while 537 days occurred during the approval phase.

The full text of the FDA determination can be found in the Federal Register, 72FR 14582-14583 (March 28, 2007).

Arbios In-Licenses Blood Filtration Portfolio

At the end of March, Arbios Systems Inc. (Waltham, MA) announced the exclusive in-licensing of a portfolio of issued and pending U.S. patents, foreign applications, and other intellectual properties focused on the treatment of organ failure through selective blood filtration. The source of the in-licensed properties was not disclosed.

Arbios is developing proprietary medical devices and cell-based therapies for the treatment of liver failure, multiorgan failure, multiorgan dysfunction syndrome, sepsis, septic shock, systemic inflammatory response syndrome, and related inflammatory disorders.

"The in-license of this important patent portfolio represents a significant development for Arbios and our products," said Walter C. Ogier, president and CEO. "We now have the protection of issued and pending patents for our lead Sepet liver-assist device development program. This intellectual property provides further protection for our planned extension of our Sepet technology into other areas of critical care medicine, including major opportunities for the treatment of multiorgan failure, sepsis, and related indications in critical care medicine."

The company's exclusive license includes five issued U.S. patents relating to the use of blood filtration devices that remove a broad spectrum of inflammatory and other disease mediators ranging from small molecules to intermediate-size blood proteins with molecular weights up to the size of beneficial immunoglobulins. The patents also relate to the combined use of replacement fluids, including human serum albumin, or combined uses of secondary selective plasma adsorption devices or certain classes of antiinflammatory therapeutic drugs.

Arbios is currently investigating the safety and biological effectiveness of its Sepet liver-assist device in a clinical trial authorized under an FDA investigational device exemption. A total of 15 patients have been enrolled in the trial. Arbios is currently analyzing patient data from the trial and plans to release further information regarding the results of the study shortly.

J&J Wins a Round in Delaware

At the beginning of April, Johnson & Johnson got a win in another installment of the ongoing patent litigation between Boston Scientific Corp. (Natick, MA) and Cordis Corp. (Miami Lakes, FL), a Johnson & Johnson company. But almost no one imagines this could be the end of the process.

In the ruling, Judge Sue L. Robinson of the U.S. District Court for the District of Delaware granted a Cordis motion for summary judgment, indicating that the company's Cypher drug-eluting stent does not infringe on patents belonging to Boston Scientific. "Based on the evidence of record," Robinson said, "no reasonable juror could find for Boston Scientific on the issue of infringement."

In two related rulings issued last year, Judge Robinson had previously found in favor of Boston Scientific. Those cases involved the companies' intellectual properties related to the design of their stent devices and to the polymer coatings that attach the drug to the stent.

Although competitors Abbott (Abbott Park, IL) and Medtronic (Minneapolis) are getting closer to U.S. launch of their own drug-eluting stents, the Cypher stent by Cordis and the Taxus stent by Boston Scientific are currently the only two drug-eluting coronary stents approved for marketing in the United States.

Alaris Spikes ICU Medical, Gets Favorable Fees Ruling

It has taken three years, but Cardinal Health subsidiary Alaris Medical Systems Inc. (Dublin, OH) may be close to ridding itself of the patent infringement suit filed against it by ICU Medical Inc. (San Clemente, CA).

ICU Medical originally filed suit against Alaris in June 2004, claiming that the company's SmartSite needle-free valves and systems had infringed ICU's patents. In June and July 2004, the U.S. District Court for the Central District of California denied ICU Medical's motions for a temporary restraining order and preliminary injunction on the only patent then in suit, but in December ICU added three more patents to its complaint.

It took two more years for Alaris to fend off ICU's claims. In a Markman hearing conducted in June 2006, the court construed the claims of the four patents in suit and granted partial summary judgment of noninfringement for two of the patents. Finally, in January 2007, the court granted Alaris's motion for summary judgment of invalidity for the two remaining patents in suit.

Having received favorable rulings on all asserted patents, in March Alaris renewed its motion for sanctions against ICU Medical, and moved for the recovery of its fees, costs, and expenses.

Earlier this month, Alaris got most of what it wanted. In a 27-page opinion, Judge Mariana R. Pfaelzer found the case exceptional under the terms of the Patent Act (35 USC 285), granted the company's motion for sanctions against ICU Medical (pursuant to Federal Rule of Civil Procedure 11), and granted part of Alaris's motion for attorney fees, costs, and expenses.

In the court order, Judge Pfaelzer repeatedly scolded both ICU Medical and its attorneys for their conduct of the litigation.

In finding the case exceptional, and thus qualified for sanctions, Pfaelzer wrote that ICU's request for a temporary restraining order and preliminary injunction, and its amended complaint asserting claims related to a 'spike' component within the valve, were "objectively baseless and brought in bad faith." The assertion of the 'spike' claims, in particular, "could not have been the product of a competent and reasonable inquiry."

ICU Medical was represented by attorneys from three law firms: S. Christian Platt, a patent litigation expert with the law firm of Paul, Hastings, Janofsky and Walker LLP (San Diego); James Pooley, an attorney from the law firm of Pooley & Oliver LLP (Palo Alto, CA) and president-elect of the American Intellectual Property Law Association; and Frank E. Scherkenbach, an attorney with the law firm of Fish & Richardson PC (Boston). Alaris was represented by Timothy J. Malloy, a patent litigation expert with the law firm of McAndrews, Held & Malloy Ltd. (Chicago), and his partners David D. Headrick, Scott P. McBride, and Wilhelm L. Rao.

Luminex Licenses Genetic Markers from Johns Hopkins University

In April, Luminex Corp. (Austin, TX) announced that it had acquired a nonexclusive license from Johns Hopkins University for use of the university's patented cystic fibrosis genetic markers. Rights to use the genetic markers will be included with the company's Tag-It cystic fibrosis products sold in the United States.

"These genetic markers from Johns Hopkins are an important element in advancing the diagnosis and monitoring of cystic fibrosis," said Jeremy Bridge-Cook, vice president of Luminex Molecular Diagnostics. "We are pleased to be able to provide our customers and distributors with the rights to these markers as part of our Tag-It cystic fibrosis kit."

Luminex Molecular Diagnostics is a new division of the company, created in March 2007 when Luminex acquired Tm Bioscience (Toronto). The new division specializes in DNA-based research and diagnostics and is focused specifically on the design, development, manufacture, and commercialization of nucleic acid-based products for genetic, personalized medicine, and infectious disease testing.

The Tag-It cystic fibrosis kit simultaneously screens for 23 cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations and four variants (polymorphisms), as recommended by the American College of Medical Genetics and the American College of Obstetricians and Gynecologists. It also screens for 16 additional CFTR mutations prevalent in North America or the world. The license from Johns Hopkins will provide kit users and distributors rights to four mutations (549N, 551D, 553X, 559T) tested for in the kit, and also covers two mutations (553X and 551D) included in the screening panel.

The Luminex cystic fibrosis kit is the first multiplexed human disease genotyping test to be cleared by FDA as an in vitro device for diagnostic use in the United States. It has also received CE mark certification and Health Canada clearance, allowing the test to be marketed for diagnostic purposes in the European Union and Canada.

© 2007 Canon Communications LLC

Return to MX: Issues Update.