Los Angeles – The United States Court of Appeals for the Federal Circuit recently held in Classen Immunotherapies v. Biogen IDEC that certain methods of scientific research pertaining to a particular field of study may be patentable. Classen Immunotherapies was issued a patent for testing an immunization schedule against a control group. Researchers would then use the results of the tests to adjust the immunization schedule in both timing and dosage.

The patent states that the schedule of infant immunization can have significant effects in the advancement of chronic disorders such as diabetes. The patent is a method of determining which immunization schedule minimizes the risk of development of chronic disorders. Once the optimal immunization schedules were determined, Classen planned to implement that schedule to prevent risk of development of chronic disorders in infants and children.

The action arose when defendant Biogen IDEC, allegedly began using the Classen testing method and discovered the optimal immunization schedule for diabetes and other ailments. Classen brought an action against Biogen IDEC for patent infringement which was then appealed to the Federal Circuit. The Federal Circuit held that the immunization schedule research method contained patentable subject matter under 35 U.S.C. § 101.

Prior to the decision of the United States Supreme Court in Bilski v. Kappos, an invention had to qualify for patent protection under the machine-or-transformation test. The machine-or-transformation test pertains to process patents and requires that, for a process to be patentable, it must be either implemented with a machine or transform an article into another. In Bikski, the Supreme Court held that the machine-or-transformation test was not the only appropriate test for patentability, but instead should be regarded as a useful tool or guiding principle.

In this case, the Federal Circuit noted that one of the steps in the research process, “reviewing the relevant literature,” was not fatal to the patent’s validity. Though this was a “mental step” in contrast to a physical step, the patent contained physical steps such as immunizing on a fixed schedule. Because the methods were directed toward a specific useful goal and included physical steps such as immunizing on a certain schedule, the processes were eligible for patentability.

The Federal Circuit ultimately held that two of the three Classen patents contained patentable subject matter under 35 U.S.C. § 101. However, a third Classen patent that did not pertain to an immunization schedule was found to be invalid.

Los Angeles – Apple announced that the USPTO has recently published its patent application for an advanced gesture based toolbar. The patent would involve technology designed to allow iPad users to control their iPads from across the room using body movements such as hand sweeps and other gestures. These body movements would manipulate the iPad display through the gesture based toolbar.

Invented by Peter Langenfeld and Michael Hailey, the toolbar would have preset controls associated with predetermined gestures but would allow advanced users to customize their own movements to correspond to certain tasks. The gestures would be captured by the “front-facing” camera found on newer iPads and iPhones. The front facing camera would capture the 3D gestures and the Apple device would respond in kind.
The patent application, originally filed in mid-2010, notes that the toolbar system will have facial recognition capabilities. In addition, the device will have predetermined gestures for certain functions such as selecting and pointing. The system will feature an associating gesture, used to associate items with one another.

The toolbar will also allow for on-video annotation. The device will allow transfers from images captured using the front facing camera of the iPhone to the iPad to allow users to take advantage of the greater video editing capabilities of the iPad.

The patent application suggests that older Apple devices such as older models of the iPhone and iPad would not have the processing power to utilize the gesture capturing feature. However, the iPad 2, launched in March of 2011 and the recently released iPhone 4S will be capable of running the toolbar system and allow the device to manipulated remotely by the user’s 3D gestures.

os Angeles – Some of the most widely-used and expensive brand-name drugs are soon to come off of their patents and go generic.

With almost $11 billion in sales last year, Lipitor, the largest drug to fall off what analysts call the “patent cliff”, will come off patent in November with multiple generic versions expected to be available by next June. Lipitor, which is prescribed to manage high cholesterol, is just one of many popular, pricey drugs whose prices are expected to plummet when their generic alternatives arrive on the market. Other major pharmaceuticals to come off patent in the near future include Plavix (for heart disease), Seroquel (for depression), and Nexium (used to treat digestive issues.)

Although the “patent cliff” is bad news for major pharmaceutical manufacturers such as AstraZeneca, Pfizer, and Bristol-Myers Squibb/Sanofi Pharmaceuticals, many patients will finally be able afford the prescriptions they need to manage their conditions. Without generic competition, the brand-names are often too expensive for patients, even if they have insurance coverage. Some patients have resorted to purchasing drugs online, which often have turned out to be ineffective counterfeit knock-offs manufactured in China.

Howard Weintraub, a cardiologist at New York University, says that many patients on those drugs go to their doctors and beg for free samples. Others patients don’t bother to fill the expensive prescription, or if they do, they cut the dosage in half in order to stretch it out longer.

“People come in with their blood pressure not as well controlled, or they come in and their cholesterol’s all of a sudden mysteriously higher. And you realize, OK, the medicine hasn’t stopped working, but you also realize the medicine doesn’t work when it’s still in the bottle,” Weintraub commented.

Generic medicines already represent 70-80 percent of pharmaceutical sales, which is expected to grow larger in the future. Some marketing analysts believe that patent expirations over the last five years are one of the main reasons why Medicare spent $50 billion less than federal officials projected five years earlier.