Raymond Van Dyke: Merchant & Gould partner in DC

Raymond Van Dyke is a partner at Merchant & Gould’s Washington, D.C. office and focuses his practice in technology and intellectual property counseling, procurement, licensing, and litigation.

Ray has nearly 20 years experience representing technology companies in the intellectual property area, including strategic counseling, patent and trademark litigation, expert witnessing, and IP licensing portfolio management. He represents domestic and international companies in addition to universities in the biotechnology, pharmaceutical, medical, chemical, software, financial services, telecommunications, Internet, voice over IP (VoIP), and digital industries.

Ray’s extensive technical background in both information-based and life sciences-focused technologies enables him to effectively counsel clients in emerging and converging disciplines, such as bioinformatics, cheminformatics, genomics, pharmacogenomics and personalized medicine, nanotechnology, proteomics, and computational analysis.

He represents clients in federal, state, and international intellectual property litigation, mediation, and dispute resolution in patent, trademark, unfair competition, copyright, antitrust, and trade secret cases. He also enforces and litigates intellectual property rights before the U.S. International Trade Commission and U.S. Customs, prepares clients for hearings before the Federal Trade Commission, and advocates intellectual property and regulatory positions before Senators and Representatives, domestic and foreign trade associations, and ambassadors.

Ray counsels clients in a variety of matters, including infringement, validity, freedom to operate, right to use, reissue, reexamination, appeals, artists’ rights counseling, and other patent and trademark opinion work.

His non-legal work in the software industry and during his graduate studies focused on a variety of cross-disciplinary software applications and techniques, including protein and molecular visualization, animation and modeling, computational optimization, graphics, stimulators, and virtual reality for pharmacological, biophysical, and biochemical research with real-time haptic interface with a robotic force-feedback arm (a nanomanipulator); modeling and analysis of steric forces in protein deformations; designing relational databases for complex proteins from X-ray crystallography data; designing enhancements to UNIX C-Shell; signal and image processing and pattern recognition; 3-D texturing; and SPICE modeling semiconductor chip architecture and performance.

Education

University of North Carolina

• J.D., 1990
• President, American Indian Law Student Association
• M.S., Computer Science, 1989
• B.S., Mathematics, summa cum laude, honors
• Minor in Classical Greek, 1985

Wilbur Wright College, Chicago, IL

• AA, with honors

Bar Admissions

District of Columbia
New York
New Jersey
Texas
Virginia (pending)
U.S. Patent and Trademark Office
U.S. Supreme Court
USCA – Federal Circuit
USCA – 2d Circuit
USCA – 3rd Circuit
USCA – 4th Circuit
USCA – 5th Circuit
Southern District of New York
Eastern District of New York
District of New Jersey
Northern District of Texas
Eastern District of Texas
District of Columbia
U.S. Court of International Trade
U.S. Court of Federal Claims

Professional Affiliations

Ray is active in a variety of legal and technical organizations, and also teaches at two universities. Chair, Greater Washington, D.C. Chapter of the Licensing Executive Society Chair, Emerging Technology Committee, American Intellectual Property Law Association

Speeches and Publications

Ray is a regular speaker to legal, university, and professional audiences on various technology, intellectual property protection, and litigation issues, both nationally and internationally. His recent presentations analyze Supreme Court cases affecting intellectual property rights, proposed changes and reforms to the U.S. patent system, nanotechnology, software patenting, ethics, International Trade Commission litigation and procedures.

Medtronic wins $57M amid a sea of payouts

In the first phase of a patent infringement lawsuit Minneapolis medical device giant Medtronic filed against its fellow Twin Cities firm AGA Medical Corp, a San Francisco jury sided with Medtronic in federal district court — although the $57 million is only half the amount Medtronic asked for in the suit.

Medtronic accused AGA of infringing a pair of patents with AGA’s Amplatzer Occluder and vascular plug product lines. The decision also calls for AGA to pay 11% royalties to Medtronic on future U.S. sales of the devices through 2018.

AGA had a different outlook on the ruling. In a press release, AGA stated it looks forward to the second, non-jury phase “dealing with other issues of invalidity and unenforceability of the Medtronic patents”. Further litigation is slated to resume later this year and could affect the final outcome. The Medtronic patents in question cover self‐expanding medical devices using a metal alloy such as Nitinol, a shape memory alloy containing nickel and titanium that expands to its original shape after deployment.

The decision is a rare win for device giant Medtronic as recent weeks have brought a string of tough decisions to the company dockets. These include a nearly $180 million judgment against it in a pedicle screw patent dispute with DePuy Spine Inc., the recall of nearly 60,000 insulin infusion sets, its inclusion in a “qui tam” whistleblower lawsuit along with six other firms that stand accused of promoting the off-label use of microwave cardiac ablation products and bilking the Medicare system.

Also in the news, Medtronic made a $400 million settlement payment to Abbott Laboratories, preventing the companies from suing each other over heart stents or delivery systems for at least 10 years. The new agreement follows earlier deals this year resolving heart stent patent disputes with Boston Scientific and Johnson & Johnson, two other stent rivals. Medtronic now believes it has resolved or settled “substantially all” intellectual property litigation surrounding stent design and delivery.

Covidien ranked top innovator

MedicalDevices.com reports that Covidien, a leading provider of healthcare products, was ranked top innovator in the medical devices and services industry.

The Patent Board™, the official patent ratings partner of The Wall Street Journal,  ranked 122 companies in the industry by patent portfolio strength. The Scorecard is a tool to recognize that patent portfolios are measurable financial assets that can be market-value drivers.

Read more

Patent Issues around Swine Flu Threat

The drug Tamiflu so far is the most effective treatment for combating the threat of

Demand for antiviral increased in 2004 with the threat of the virulent bird flu, and so all 50 states and many other nations now have large enough  stockpiles of the drug for 220 million people. Roche has stated it could ramp up production to 400 million courses a year.

The Obama administration said it would seek $1.5 billion from Congress to combat the threat of a swine flu pandemic and is in talks with Roche about increasing production. Those with high fevers and consistent symptoms within 48 hours of illness are appropriate patients to receive the drug. Other vulnerable populations such as the elderly and home bound are also being considered candidates for the antiviral.

The flu sweeping Mexico and now appearing in several other countries is a strain never seen before by experts; it is a mix of genetic material from humans, birds and pigs. CDC officials told a Senate hearing Tuesday the agency was considering whether to develop a vaccine for just this strain of flu or a combination of flu viruses.

Gilead Sciences, Inc., Foster City, CA, is the patent holder, (Patent #5763483 for oseltamivir) having been assigned it by the five named researchers who invented this particular compound. Gilead Sciences’ patent on oseltamivir will not expire until December 26, 2016. Originally discovered by Gilead, Tamiflu was licensed to Roche for late-phase development and marketing. Roche produces and markets the anti-viral medication oseltamivir (as “Tamiflu®”)

Roche has made 5 million courses of Tamiflu available to the World Health Organization and has licensed other manufacturers to make the drug. Earlier this month, Gilead was denied patent protection for Tamiflu (formally known as oseltamivir) by India’s Patent Protection Office, and so the Indian pharmaceutical maker Cipla Ltd. has since moved its own version of the drug into production.

Similar issues arose with the 2005 avian flu threat, when Taiwan amidst a rising threat and frustrating negotiations with Roche, eventually moved forward with production of a generic version of Tamiflu. As a show of good faith, Taiwan’s National Health Research Institutes did not market the drug and  limited it to public use.  Arguments were that the NHRI could produce the drug more quickly and at lower cost, and being that negotiations fell apart they moved forward with their generic in the interest of their people. These past and present issues raise concern over the handling of these situations by the pharmaceutical Roche, still trying to strongly enforce patent rights abroad when threats are imminent. Only time will tell but let us hope that all parties involved handle the delicate situation and more delicate threat appropriately.

New Peptide Enhances Bone Growth

Brookhaven and BioSET develop synthetic bone-growth-enhancing peptide that moves from the lab to the clinic

Brookhaven Lab’s operating company, Brookhaven Science Associates, received a patent for a new peptide that promises to speed up bone growth. By embedding the peptide into a special ceramic bone substitute, the lab’s scientists have developed a new implant for fusion surgeries that is currently undergoing early clinical trials.

Brookhaven Lab reports, B2A enhances the effects of a tissue growth factor known as bone morphogenetic protein 2, or BMP-2. BMPs are a family of proteins in the human body responsible for the proliferation, repair and differentiation of cells in many tissues, including bone.
Brookhaven Lab scientist Louis Peña developed B2A with BioSET, performing the initial studies at Brookhaven. Peña became interested in bone growth factors through the phenomena of weightlessness and cell-damaging cosmic radiation as introduced by NASA’s radiation research facility at Brookhaven.

BioSET has taken this development to the next level. “About 250,000 Americans undergo lumbar spine fusion surgeries each year to treat lower back pain,” said Tom Rouche, BioSET President and CEO. “We have developed a novel combination medical device, called AMPLEX, that incorporates B2A osteo-inductive growth factor with an ultra-high grade ceramic bone substitute for use in this type of surgery. Preclinical studies have found that it is a safe and highly effective.” Recent preclinical studies have involved rabbit and sheep to evaluate AMPLEX spine fusion. In rabbits, they found it enhanced spinal bone fusion, compared to a conventional surgical method using the rabbit’s own pelvic bone to form the bone graft. A BioSET group announced promising results in the sheep model as well, exciting because sheep have more similar spinal properties to humans.

BioSET has received approval from the FDA to initiate a pilot study to evaluate the safety and preliminary efficacy of AMPLEX in approximately 22 patients here in the U.S. In addition, the company has approval from Health Canada for a similar study with 24 patients. Both studies aim to compare AMPLEX to an autograft from the patient’s own hip bone in lumbar fusion procedures to treat degenerative disc disease.

The first patient surgery in the Canadian study was performed by a neurosurgeon at Foothills Medical Centre in Calgary, Canada. The surgeon reported that AMPLEX handled as well as other ceramic graft alternatives and the patient was recovering well after surgery. Data from all patients in the clinical studies will be evaluated at six-month intervals.

MedX Granted Patent for Bone Healing

Announced earlier today, MedX Health Corp. has received a Notice of Allowance by the USPTO for its MedX Laser and Light Probe.  This device can be used for bone healing, bone growth stimulation and bone cartilage regeneration.  MedX claims their probe can be used to help those that currently suffer from carpal tunnel syndrome, tendonitis, rheumatoid arthritis, and wound healing.

The Laser and Light Probe will promote healing by triggering biological changes within the body, as well as stimulating and accelerating cellular metabolic processes.  MedX claims that utilizing their probe will increase the circulation by forming new capillaries, and stimulating collagen protein production.  Thus, healing would be accelerated by damaged bone and tissue cells being replaced more rapidly.

“This notice of allowance from the U.S. Patent & Trademark Office broadens our device portfolio,” states Steve Guillen, president and CEO of MedX Health. “It is another important step toward our entry into the wound healing market, which we expect will take place this year,” adds Guillen.

Pfizer Looking To Biotechnology

In a recent interview with the Chicago Tribune, Pfizer Chairman and Chief Executive Jeffrey Kindler stated that Pfizer is in the midst of changing its business model.  The company will no longer rely on blockbuster medications such as Viagra and Lipitor.  Instead, Pfizer will be targeting unmet medical needs through biotechnology.

Lipitor is the world’s best-selling cholesterol drug, but Pfizer will begin losing more than $6 billion when the pill’s U.S. patent expires near the end of 2011.  Many speculated that losing the Lipitor patents were a key reason why the deal with Wyeth was signed.  Yet, Kindler leads one to believe that the deal was also struck in order to diversify Pfizer’s portfolio.  He said, “The dependence on a couple of large blockbuster products is not a good model.  If Pfizer of the past was best known for a few very large blockbuster drugs, then the new Pfizer is vastly more diversified.”

Kindler believes that the acquisition of Wyeth will do wonders for future products, as he believes that Wyeth’s technology is as good, if not better, than current market leaders.  Pfizer will be gaining Wyeth’s platform to treat Alzheimer’s in different ways.  Pfizer currently sells Alzheimer’s pill known as Aricept, but “it doesn’t cure the disease; it modifies symptoms over time.”

Hopefully the joining of these two companies will produce future breakthroughs in medications.

Merck to buy Insmed Biosimilars for $130 Million

Merck has just announced that they will buy Insmed’s portfolio of follow-on biologic therapeutic candidates, as well as a manufacturing facility, for $130 million.  As reported on Forbes.com, Insmed agreed to sell its pipeline of “biosimilars” which are drugs that are attempted copies of biotech drugs made from living cells.

The new drugs will be managed by Merck’s new BioVentures business.  Also, the deal is expected to speed up Merck’s entry into making follow-on biologic products.  Examples of follow-on biologic products are Insmed’s INS-19 and INS-20, which are intended to prevent infections in patients recovering from chemotherapy.  Merck gains control of both products, which are currently in early-stage testing.

The manufacturing plant included in the deal is a 50,000 square-foot facility in Boulder, Colorado.  The plant is used to make and analyze biologic drugs.

Merck will pay Insmed $10 million upfront, and will make the rest of the payment when the deal is closed.  Merck will not owe any additional milestone or royalty payments.

Ultraviolet Patents for Clean Air and Drinking Water

Remote Light has appointed System Change, a management consulting provider, to license its portfolio of ultraviolet light, optics, and fiber-optic patents.  Remote Light, an optics technology company, has developed a global portfolio of over 120 U.S. and international patents for UV lighting technologies.

As posted on Laser Focus World, Remote Light’s UV technologies can be used for drinking water, wastewater, other fluids, air, medical, consumer appliance, and surface applications.  The company believes that System change will help establish Remote Light as not only a technology company, but as a licensing company as well.  System Change will accomplish this task by facilitating transactions with companies who can create products using the core solutions developed by Remote Light.

Isaac Horton, Remote Light’s chairman and CEO, stated, “Remote Light has developed proprietary solutions that support innovative applications of UV light, optics and fiber optics, particularly for addressing the world-wide challenges of clean drinking water and safe air.  Remote Light’s UV fluid and air treatment solutions are many times faster, more effective, and more energy efficient than conventional systems at the same initial costs.”

As Horton stated, since these patents are energy efficient, they could be particularly important to areas of the world where clean water is not readily available.  However, if electricity is still needed for the UV light, then use of this technology may still be somewhat limited.

Antarctic Patents Strain Shared Science Treaty

In 1959, the Antarctic Treaty was signed to make all scientific findings on the continent freely shared.  The treaty intended to set the continent aside for peace and science, and defuse any bigger territorial claims during the Cold War.  Half a century into the agreement, however, more and more companies are trying to file patents on Antarctic organisms or molecules, putting significant strain on the treaty.

As reported by Reuters, the treaty states that “Scientific observations and results from Antarctica shall be exchanged and made freely available.”  It also says that all plans for scientific programs should be exchanged in advance to ensure efficiency and economy.

Yet, some argue that the treaty lacks clear rules for prospecting for animals and plants on the continent. “Biology is going through a revolution…it’s a tricky situation,” said Jose Retamales, head of the Chilean Antarctic Institute.  He added, “The world has changed.  Now we are talking about different things – things you do not even see.”

The attraction of the continent is that it separated from South America more than 30 million years ago, and life has evolved with very few outside influences.  Therefore, more and more companies are looking to Antarctica, as the continent’s organisms have evolved interesting characteristics, such as conserving energy and surviving in a deep freeze.  Much of the research involves studying cells, but companies are also very interested in Antarctica since advances in genetic technologies are making “bioprospecting” easier.

Two of the companies that are currently utilizing bioprospecting on the continent are Unilever, and French cosmetics group, Clarins.  Unilever currently has a patent based on an anti-freeze protein found in a bacteria that may help keep ice cream smooth.  Meanwhile, Clarins uses algae from Antarctica in a face cream.

Many are concerned that corporate involvement in Antarctica might delay publications of key scientific findings until the patent applications are filed.  Yet, one idea to help innovation and research on the continent would be to impose a tax on the profits that are made from Antarctica-based products.  The money would then be put  towards poorer countries that are conducting research on the continent.  However, one wonders if corporate-heavy countries such as the U.S. and Japan would be as gung ho on any regulations that could restrict corporate access. 

The parties of the treaty plan to debate the issues at an annual meeting commemorating “50 years of peace and science” in Baltimore from April 6-17.

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