Royalty Report: Medical, Device, Drugs – Collection: 375422

License Grant

The Settling Parties agreed to terminate the patent infringement lawsuit the Plaintiff had filed against the defendant on April 14, 2018 in the U.S. District Court for the Central District of California, Southern Division (the Lawsuit).

License Property

In the Lawsuit, the Plaintiff alleged that the Defendants Hydrus® Microstent device infringes the Company’s U.S. Patent Nos. 6,626,858 and 9,827,143.
6,626,858 – Shunt device and method for treating glaucoma
9,827,143 – Shunt device and method for treating ocular disorders

Field of Use

The medical device is for the treatment of eye disorders such as glaucoma and ocular.

License Grant

The Licensee, a specialty manufacturer and marketer of prescription, over-the-counter and nutritional products, entered into an Agreement with the Licensor, the plaintiff in a lawsuit against the Licensee.  Plaintiff has asserted claims for false advertising, unfair competition and common law misappropriation against defendant, based on the defendant's marketing and sale of Salicylic Acid 6% Cream and Salicylic Acid 6% Lotion. Plaintiff has filed a motion to substitute the Licensor for the original plaintiff, Coria Laboratories, and the Court has granted that motion. The Agreement provides for a stay to all pending matters and motions in this lawsuit for a certain period as stipulated. On July 16, 2009, the Licensee entered into an agreement with the Licensor in the lawsuit against the Licensee, whereby in exchange for a payment, upon signing the term sheet of the settlement, the Licensee has obtained the right to purchase five ANDAs (Abbreviated New Drug Application) and/or a manufacturing facility from the Licensor for consideration agreed to in the agreement.

Additionally, if the lawsuit is dismissed the Licensee will enter into another Agreement whereby they will have the right to continue to manufacture and market the product subject to the lawsuit.

License Grant

The U.S. Licensor hereby grants to Swiss Licensee an exclusive license under the Patent Rights, Know How and Trademarks, to make, have made, use, and sell Products in the Territory.

License Property

'PRODUCTS' shall mean ophthalmic medical devices used in the treatment of presbyopia, hyperopia, ocular hypertension and glaucoma, the manufacture, use or sale of which, would, but for this Agreement, constitute or would result in an infringement of the Patent Rights in any country including, but not limited to, the products set forth in the attached SCHEDULE B and any enhancements or improvements thereto.

Licensor's primary products are the patented PresVIEW device and the related PresVIEW Incision System, the automated surgical instrument for the surgical treatment of Presbyopia, Ocular Hypertension and Primary Open Angle Glaucoma, or POA Glaucoma, in the human eye.

The PresVIEW device consists of four separate tiny plastic segments, each about the size of a grain of rice, made from polymethylacrylate, or PMMA. PMMA has been implanted in the eye for other types of surgical procedures (intraocular lenses, hard contact lenses) for over fifty years. The surgeon uses the PresVIEW Incision System to make four superficial incisions in the quadrants of the sclera (white of the eye). The PresVIEW device is inserted into the superficial tunnels, causing a lift in the sclera that in turn reduces the crowding of the underlying muscles.

The full royalty rate schedule has not been made public, the only publicly available rate is a know-how royalty rate for countries where a relevant patent has expired.

Field of Use

The rights granted apply to the human eye.

License Grant

Trial in the Company's U.S. case based on the Kastenhofer patent in Federal District Court in California concluded in October 2007 with a jury finding that the patent was invalid. The licensee was found to infringed a patent covering features of the chemically treated and multi-layered guide wire tubes that enable catheters to slide into place. The jury also found for patent owner on its counterclaim that sale by the Company of its balloon catheters and stent delivery systems infringe owner's Fontirroche patent. The Court has denied the Company's post trial motions.

License Property

Fontirroche patents pertain to designs for balloon catheters and stent delivery systems.

License Grant

In May 2004, the Licensor filed a complaint alleging that we infringement upon their patent related to antivirus software.  In November 2008, the Licensee filed a complaint against the Licensor in the United States District Court for the Northern District of California alleging, among other claims, that the patents are invalid.

License Grant

We commenced a lawsuit in the U.S. District Court for the District of Massachusetts against the licensee for infringement of U.S. Patent No. 6,206,873 – methods for liquefying and removing subcutaneous fat cells through the use of laser energy.  

On January 14, 2010, the licensee agreed to a Consent Judgment that it has infringed on the 6,206,873 patent and that the patent is valid and enforceable.

License Property

This groundbreaking system was designed as an alternative to traditional liposuction in patients with small areas of localized fat.

Field of Use

The Licensee also has granted to us a royalty free license to any patents or patent applications owned or controlled by the Licensee related to the treatment of fat and cellulite.  

The rights granted apply to the healthcare industry.

License Grant

A Judgement by the U.S. District Court of Massachusetts in Boston has issued an initial decision in the case of  U.S. Patent No. 6,410,516 , is valid and infringed by licensee's sale of Evista(R) and Xigris(R).  

This case was tried before a jury in the U.S. District Court from April 10, 2006 through April 28, 2006. After deliberations, on May 4, 2006, the jury rendered a verdict in favor of the Plaintiffs by finding that the NF-kB ‘516 Claims asserted in the lawsuit are valid and infringed by Lilly through sales of Evista and Xigris in the United States.  One defense regarding validity was not submitted to the jury and was instead the subject of a bench trial, as addressed below. The jury awarded damages to the Plaintiffs in the amount of approximately $65.2 million, based on the jury’s determination of a reasonable royalty rate of 2.3% to be paid by Lilly to the Plaintiffs based on U.S. sales of Evista and Xigris from the date of the filing of the lawsuit on June 25, 2002 through February 28, 2006. The jury awarded further damages on an ongoing basis, in amounts to be determined, equal to 2.3% of U.S. sales of Evista and Xigris through the year 2019, when the patent expires. If the verdict is upheld, damages paid by Lilly will be applied first to reimburse us for any unreimbursed legal fees and expenses relating to the litigation. We will receive 91% of the remainder, and the co-plaintiffs will receive 9%.

The dispute involved licensor's U.S. patent covering methods of treating disease by regulating NF-kappa B cell-signaling activity, and jurors awarded damages to licensor and its co-plaintiffs.  Licensee plans first to ask the judge to set aside the jury's verdict regarding Evista and Xigris and then to appeal, if necessary.

Field of Use

Evista is used to treat or prevent osteoporosis in postmenopausal women. It is also used to reduce the risk of invasive breast cancer in postmenopausal women who have osteoporosis or who are at risk of invasive breast cancer.

License Grant

The Company announced today that it received a ruling from the U.S. District Court in regards to ongoing royalty rates for Phase I of its patent litigation with Plaintiff. As previously announced, Phase 2 surrounding the cervical plates involved in the dispute was settled.

License Property

On August 17, 2012, Plaintiff filed additional patent claims in the U.S. District Court for the Northern District of Indiana alleging that the Company various spinal implants (including its CoRoent® XL family of spinal implants) infringe U.S. Patent No. 8,021,430, and that the Company's Osteocel® Plus bone graft product infringes U.S. Patent No. 5,676,146 C2. On August 28, 2012, Plaintiff amended its complaint in the Northern District of Indiana alleging that NuVasive's XLIF® procedure and use of MaXcess IV retractor during the XLIF procedure infringe methodology claims of U.S. Patent No. 8,251,997.

Field of Use

The CoRoent XL is a family of spinal implants used to replace weakened or damaged intervertebral discs. These discs act as the spine’s shock absorber allowing forces to be distributed evenly during the body’s movements.

And MaXcess instruments provide access to the spine in a manner that affords direct visualization and our nerve monitoring systems assist surgeons in avoiding critical nerves.  Our MaXcess system consists of instrumentation and specialized implants that provide maximum access to the spine with minimal soft tissue disruption. MaXcess has a split blade design consisting of three blades that can be positioned to build the surgical exposure in the shape and size specific to the surgical requirements rather than the fixed tube design of other minimally invasive surgical systems. MaXcess’ split blade design also provides expanded access to the spine, which allows surgeons to perform surgical procedures using instruments that are similar to those used in open procedures but with a significantly smaller incision. The ability to use familiar instruments reduces the learning curve and facilitates the adoption of our products. Our system’s illumination of the operative corridor aids in providing surgeons with direct visualization of the patient’s anatomy, without the need for additional technology or other special equipment.