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Personalized Medicine Gets a Booster Shot From Patent Court

When new drugs come on the market, the warnings about side effects can seriously dampen the advertised benefits.

Personalized medicine through genetic testing holds the promise of changing all that. Designed to reduce adverse side effects on an individual basis, it seeks customized solutions for all kinds of ailments.

In Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, a federal appeals court affirmed the validity of a patent for treating schizophrenia based on such genetic testing. Industry watchers say it could help solve problems before they begin.

Patent Claim Invalidated, SteadyMed Drug Treatment Moves Forward

An appeals court breathed more life into Trevyent, a treatment for pulmonary arterial hypertension.

In United Therapeutics Corp. v. SteadyMed Ltd., the U.S. Court of Appeals for the Federal Circuit knocked out a competing patent claim. In a one-word decision, the court "affirmed" a ruling in favor of SteadyMed, a Northern California pharmaceutical company.

It was one step forward for the drug treatment on a path marked by legal steps forward and back again.

Attorneys' Fees Denied for Last-Minute Filing

When it comes to attorneys' fees, some good deeds go unpaid.

Counsel for Henry Simmons, who suffered from Guillain-Barre Syndrome, learned that lesson the hard way. After the attorney filed a last-minute claim under a federal statute, the client disappeared and the case was dismissed.

The lawyer filed a petition for attorneys' fees, which were allowed under the law. But a federal appeals court said the claim was not reasonable -- even though the attorney had to file the case if only to preserve the statute of limitations.

Court Cuts Back at PTO on Scalpel Invention

A federal appeals court has breathed life into a doctor's patent claim for a scalpel that helps surgeons repair torn knee ligaments and other injuries.

The U.S. Federal Circuit Court of Appeals said the Patent and Trademark Office wrongfully denied the doctor's patent by shifting the burden on him to continue his claim. The trademark examiner and board said that a prior invention could perform the same function, but the appeals court said the doctor had done enough to show his scalpel design worked differently.

"For that reason, the examiner failed to make the necessary prima facie showing to shift the burden of going forward to applicant," the court said.

A Vaccine Injury Case Succeeds at the Federal Circuit

Vaccines are overwhelmingly safe, but in a few very rare instances, they can have unintended side effects. The National Vaccine Injury Act of 1986 provides a federal cause of action for parents whose children have been injured by vaccines.

The Paluck family sued the Secretary of Health and Human Services for compensation over a claim that an MMR vaccine caused infant K.P. to lapse into a "severe neurological disability." After the case bounced around the court system for a bit, the Court of Federal Claims vacated a special master's determination that K.P.'s deterioration wasn't caused by the vaccination. The Federal Circuit affirmed.

Many parents are concerned about the supposed risks between vaccination and autism, but the CDC has stated that the studies have not supported a link between vaccinations and incidence of autism. Because of the rise of litigation in the '70s and '80s with big damage awards, even in the absence of scientific evidence, Congress enacted the National Childhood Vaccine Injury Act ("Vaccine Act") to limit liability and address public health concerns.

Parents Say Vaccine Caused Epilepsy in Child, Court Says No

Do vaccines cause illness in children? If a parent believes that his or her child has been injured by a vaccine, is there a legal remedy?

In recent consolidated cases before the Federal Circuit Court of Appeals, parents sued the Secretary for Health and Human Services for illnesses they claim were caused by the administration of vaccines to their respective daughters.

The parents sought compensation under the National Vaccine Injury Compensation Program, alleging that DTaP (Diptheria-Tetanus-acellular Pertussis) caused their daughters’ seizure-related illnesses.

Myriad's Medical Patent Case Sent Back After Prometheus Decision

The Mayo v. Prometheus case from last week is already generating the effect that many legal analysts predicted it would. On March 20, the U.S. Supreme Court overturned a decision from the Federal Circuit Court of Appeals, citing in its decision that companies cannot patent their observations on a natural phenomenon.

In light of that ruling, the U.S. Supreme Court is sending another case back to the Federal Circuit Court of Appeals. The high court is asking the Federal Circuit to review a case that challenged two patents held by Myriad Genetics Inc.

Arctic Slope Native Ass'n, Ltd. v. Sebelius, 10-1013

Indian tribe's suit against the Secretary of Health and Human Services for contract support costs

Arctic Slope Native Ass'n, Ltd. v. Sebelius, 10-1013, concerned an Indian tribe's suit against the Secretary of Health and Human Services for breach of contract, claiming that the government failed to pay plaintiff's so-called contract support costs shortfall for fiscal years 1999 and 2000.


Wanless v. Shinseki, 10-7007, involved an incarcerated veteran's request for full reinstatement of his disability benefits following his transfer from a state-operated prison to a privately owned prison.  In affirming the Board of Veterans' Appeals' and the Veterans Court's denial of the request, the court held that the Veterans Court properly construed section 5313 to include penal institutions that are privately operated, yet state-contracted.