Patent Law Practice Center

Tentative FDA Approval for Oral Pediatric HIV Treatment

Mylan Inc. recently announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR), which is a U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world, means the formulations meet all of the agency’s quality, safety and efficacy standards. Mylan’s products are expected to be eligible for purchase in early 2015.

The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource-limited countries including all low-middle  income, least-developed countries and sub-Saharan Africa.

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Big Tech Turns to Biometric Innovation

Over on IPWatchdog.com, I publish what we call Companies that We Follow. The goal is to look for interesting new technologies by exploring what some of the most innovative companies in the world are working on. After a while, you see a lot of different technologies and sometimes you start to notice patterns. Analysis of biometric data has been a major area of new research among electronics manufacturers in recent years, and over the last several months we have seen quite a few biometric innovations from a variety of very large tech corporations.

One recent innovation that we saw came from Microsoft, and it related to something that you might not ordinarily associate with the giant from Redmond, Washington…namely, a mood detection device. Stress is something that everyone experiences throughout their daily life, and biometric systems for determining mood and stress levels are not new. However, reducing stress and the associated negative impacts, like chronic health conditions and poor work performance, is an important goal that could easily result in a meaningful increase in productivity in the workplace. To tackle this problem, Microsoft came up with a device that uses a microcontroller capable of processing biometric data about a person’s stress levels. The patent application filed, U.S. Patent Application No. 20140085181, claims priority to a provisional patent application filed in September 2012, which is incorporated by reference. The device described in this patent application includes a flexible material that morphs its shape to create a representation of the received biometric information. Stress information can also be output to a display that lets a person view stress and mood information and add their own personal input. This system could receive biometric data signals indicative of mood from a variety of sources, including a heart rate monitor, galvanic skin monitor, camera or microphone. For instance, a camera and image processing system could determine a change in mood based on an eyebrow shift or another facial expression. Along with changing shapes, the device can indicate a person’s mood through sounds or light display.

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Australia Court: Isolated DNA Patent Eligible

The Federal Court of Australia issued a ruling recently that is directly opposite to the ruling rendered by the United States Supreme Court relative to gene patents. In Yvonne D’Arcy v. Myriad Genetics, Inc., the Federal Court of Australia ruled that Myriad’s claims to isolated DNA are patentable under the laws of Australia. That is the ruling the U.S. Supreme Court should have reached in Association of Molecular Pathology v. Myriad Genetics. As the patent eligibility laws of the U.S. become increasingly inhospitable to high-tech innovative businesses, we can expect more job losses and worse news for the U.S. economy on the horizon.

Particularly interesting is that the Federal Court of Australia went out of their way to question the reasoning of the United States Supreme Court, and say that it is exceptionally difficult to reconcile Diamond v. Chakrabarty with AMP v. Myriad Genetics. I have previously written that AMP v. Myriad Genetics overrules the fundamental holding in Chakrabarty, with many disagreeing. I feel certain that my reading is correct, and the Federal Court of Australia agreed.

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Canine Genetic Testing Patent Dispute Settled

On December 13, 2013, Genetic Veterinary Sciences, Inc. (d/b/a Paw Print Genetics) filed a declaratory judgment action against VetGen, LLC, in the United States District Court for the Eastern District of Washington (Spokane). The lawsuit sought a declaration that Paw Print Genetics was not infringing various claims of patents owned by VetGen. The complaint specifically sought a declaration of non-infringement with respect to U.S. Patent Nos. 6,040,143, 6,074,832, 6,767,707, 6,780,583, and 6,410,237. Each of these patents are titled DNA encoding canine von Willebrand factor and methods of use. In the alternative, Paw Print Genetics also sought a declaration that the claims of the patents are invalid. Both Paw Print Genetics and VetGen offer inherited disease testing to identify carriers and affected dogs for a variety of different canine genetic conditions.

In both dogs and humans, von Willebrand’s disease is a bleeding disorder of variable severity that results from a quantitative or qualitative defect in von Willebrand factor. This clotting factor has two known functions, stabilization of Factor VIII (hemophilic factor A) in the blood, and aiding the adhesion of platelets to the subendothelium, which allows them to provide hemostasis more effectively. If the factor is missing or defective, the patient, whether human or dog, may bleed severely. The disease is the most common hereditary bleeding disorder in both species, and is genetically and clinically heterogenous.

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FTC Says Thermo Fischer Must Sell Assets to GE Healthcare

On January 31, 2014, the Federal Trade Commission announced that Thermo Fisher Scientific Inc., a global manufacturer and distributor of scientific products, laboratory equipment and consumables headquartered in Waltham, Massachusetts, agreed to sell assets to GE Healthcare. This asset sale settles FTC charges that Thermos’ proposed $13.6 billion acquisition of Life Technologies Corporation (Life), headquartered in Carlsbad, California, would likely substantially lessen competition.

The FTC complaint challenging the transaction alleges that the deal as originally proposed would have eliminated competition between Life and Thermo Fisher, which supplies siRNA reagents under its Dharmacon brand, and cell culture media and sera under its HyClone brand. The FTC specifically charged the acquisition would substantially increase concentration in the markets for short/small interfering ribonucleic acid (siRNA) reagents, cell culture media, and cell culture sera, enabling the combined firm to raise prices and reduce quality for consumers.

The proposed order settling the FTC’s charges requires Thermo Fisher to divest its gene modulation business, Dharmacon, which contains the siRNA reagents business, as well as its cell culture media and sera business including the HyClone brand to GE Healthcare, along with all intellectual property and know-how necessary to operate each of the divested businesses.

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