On March 20, 2012, in a unanimous decision, the Supreme Court held that a method for optimizing therapeutic efficacy merely recites a law of nature and, thus, is not patentable. In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (U.S., Case No. 10-1150, slip op.), a case of particular interest to the medical diagnostics community, the Court upheld the long-standing principle that laws of nature are not patent-eligible subject matter. Typically, processes that apply a law of nature or natural phenomenon may only overcome this prohibition by claiming other additional inventive features that are patent eligible. In this case, the Court held that the additional features in the claims of the patents at issue (U.S. Patent Nos. 6,355,623 and 6,680,302) were well-known, conventional steps that were not patentable, either alone or in combination, and therefore did not transform the claimed process into a patentable application of a law of nature (i.e., the correlation between drug metabolite levels and drug efficacy/harmful effects).
Claim 1 of U.S. Patent No. 6,355,623 is representative of the claims at issue and recites:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The Court’s analysis began with identifying the law of nature, i.e., the relationship between the levels of drug metabolite in a patient’s blood and drug efficacy. Read More
$4,683,653.03. That’s the total amount of the bill that the Federal Circuit stamped “due and payable” by MarcTec, a medical device maker, in MarcTec, LLC v. Johnson & Johnson and Cordis Corporation, 664 F.3d 907, in a decision handed down on January 3, 2012. $3,873,865.01 of this amount was for attorneys fees awarded under the “exceptional case” provision of 35 U.S.C. § 285, and $809,788.02 was for expert fees and expenses, awarded under the court’s inherent sanctioning authority.
While many practitioners include in their pleadings a claim for attorney fees under Section 285, few cases proceed to a favorable determination on the merits of such a claim. However, when these cases do, like MarcTec, the amounts can be staggering.
The Initial Lawsuit
The January 3, 2012 decision was the second time this case was before the Federal Circuit. In the first appeal, MarcTec appealed a summary judgment of non-infringement in favor of Cordis. At issue were two patents, with identical specifications, directed to a surgical implant in which a heat-bondable material is bonded to the surgical device or implant. The district court, in its claim construction ruling, concluded that “heat bonding” was the only form of bonding taught by the patents and that the inventor had so limited the form of bonding during prosecution of the patents, as well as disclaiming “stents”, in order to gain allowance of the patents over prior art – even though MarcTec had argued at the Markman hearing that the court should focus on the term “bondable” in the claim language and, in effect, ignored both the specifications and statements made during prosecution.
Following claim construction, Cordis moved for summary judgment of non-infringement, which the district court granted, on the ground that the undisputed evidence showed that the coating on Cordis’ accused stent was applied and bonded at room temperature, and therefore there could be no infringement. Read More
Factual Background
Claimant had sustained occupationally-related cervical and lumbar spine injuries on June 6, 1997 and on March 31, 1998, and had incurred another work-related cervical injury on September 3, 1998. After the 1998 injury, claimant never returned to work. At that point, he was fifty-one years old and had been a twenty-year employee of the employer. He thereafter received workers’ compensation indemnity benefits, as appropriate.
On June 5, 2003, claimant underwent an Independent Medical Examination conducted by Dr. Levenberg, who concluded that, despite residuals from his injuries, claimant was nevertheless appropriate for full time sedentary work. A Notice of Ability to Return to Work, Workers’ Compensation Bureau form LIBC-757, was issued to claimant on June 26, 2003. On June 22, 2004, a Modification Petition was filed on employer’s behalf based upon a Labor Market Survey conducted by a vocational rehabilitationist, premised upon Dr. Levenberg’s medical allowances for claimant to work. On June 24, 2004, a Suspension Petition was filed on employer’s behalf, alleging that claimant had voluntarily withdrawn himself from the labor market because he had retired, that any wage loss he was experiencing was due to this fact, and that he was therefore no longer entitled to workers’ compensation indemnity benefits.
These matters were litigated, and the Workers’ Compensation Judge (WCJ) ultimately credited Dr. Levenberg’s medical findings, assessing claimant as capable of performing sedentary work, over claimant’s doctor’s testimony that claimant could not work. However, the Judge did not grant the Modification Petition. In regard to the Suspension Petition, claimant was receiving a retirement pension through the employer, as well as Social Security Administration (SSA) disability benefits. Claimant testified that he believed he could not work. The WCJ concluded that claimant had not voluntarily withdrawn himself from the workforce, and that claimant’s choice to take his retirement pension was an economic decision. Read More
According to the U.S. Census Bureau, between 1980 and 2007, the number of Americans who speak languages other than English at home grew by 140 percent. Correspondingly, there has also been an increase in non-English speaking workers in the U.S. labor force. Linguistic diversity can present both opportunities and challenges for employers. Over 30 states have enacted legislation making English their official language for purposes of state and even local government functions. Pennsylvania may join those states, as two bills introduced in 2011, House Bill Nos. 361 and 888, would require the use of the English language for official state government, and possibly county, municipal and school system, functions. Similarly, private employers have also decided to implement “English-only” rules in the workplace. Although some court decisions and potential changes to the applicable guidelines regarding English-only rules may provide some support to employers who implement such rules, employers should remain cautious and be sure that their rules follow the guidelines, so as to avoid potential national origin discrimination claims under Title VII of the Civil Rights Act of 1964 and similar state discrimination statutes, including the Pennsylvania Human Relations Act.
Under the current state of the law, guidelines established by the Equal Employment Opportunity Commission (“EEOC”) in its regulations and its Compliance Manual permit employers to adopt English-only policies only in certain circumstances. The EEOC distinguishes English-only rules that apply “at all times” from those that apply “only at certain times” in the workplace. According to the EEOC’s guidelines, blanket English-only rules that apply at all times are presumed to constitute national origin discrimination in violation of Title VII and are, thus, “closely scrutinized.” As a result, employers should avoid policies that require employees to speak English at all times and in all situations.
Business Necessity Exceptions
The EEOC guidelines, however, do not prevent an employer from implementing an English-only rule that applies only at certain times, as long as the rule is justified by “business necessity,” or necessary for an employer to operate safely or efficiently. Read More
After two trials resulted in acquittals for three defendants, hung juries as to seven others and no convictions, the United States has given up on what it had originally touted as “the largest single investigation and prosecution against individuals in the history of DOJ’s enforcement of the Foreign Corrupt Practices Act (FCPA).” On February 21, 2012, the government filed a motion to dismiss, with prejudice, the indictments of all remaining defendants (including those not yet brought to trial and those who had been granted a mistrial) in United States v. Goncalves, et al. , D.D.C., Criminal No. 09-335. Judge Richard J. Leon granted the government’s motion.
In its three paragraph motion, the government indicated that its request to dismiss all remaining charges was based on three primary factors: (1) the unfavorable outcomes of the first two trials; (2) the impact of the court’s ruling on certain evidentiary matters in the first two trials, including rulings relating to Rule 404(b) and other “knowledge and intent” evidence; and (3) the substantial resources that would be expended to proceed with four or more additional trials.
Although Judge Leon granted the government’s motion from the bench, he did not do so without comment. According to the Washington Post, Judge Leon was critical of the government, indicating that, in his opinion, the case was a “long and sad chapter in the annals of white collar criminal enforcement.” The Post further reported that the Judge specifically criticized how prosecutors handled evidence, managed their key informant and pushed an “aggressive” interpretation of conspiracy charges.
The original indictment charged twenty two executives and employees of companies in the military and law enforcement products industry for an alleged scheme to bribe foreign government officials to obtain and retain business. Specifically, the defendants were charged with engaging in a scheme to pay bribes to the Minister of Defense for the African nation of Gabon. Read More
On February 17, 2012, a panel of the United States Court of Appeals for the Second Circuit affirmed the conviction and 24-year sentence of former prominent Democratic fundraiser, Norman Hsu. United States v. Hsu, No. 09-4152-CR slip op (2d Circuit 2/17/12). Hsu raised funds for former Sen. Hillary Clinton and other marquee Democrats, and became what is known as a “bundler” on behalf of political candidates.
According to the Court, Hsu ran a 10-year Ponzi scheme through which he stole more than $50 million from investors. After obtaining funds from investors by promising high returns, Hsu would provide investors with post-dated checks in the amount of the investor’s principal, plus a “guaranteed” return on that investment, usually, on an annualized basis, of 60%. While on certain occasions, investors would immediately cash the checks when they became due, more often they would “roll over” their investment, thereby investing the original principal plus accumulated gains in anticipation of further returns that would accrue during the next cycle. Instead of investing the money he collected, Hsu spent it on himself or made charitable contributions to burnish his public image.
Mr. Hsu also used his political connections created by campaign fundraising to create an appearance of legitimacy useful in recruiting victims to his investment scam, and used the illusions of successful investments to recruit his investors as campaign “donors.”
On the eve of trial, Hsu pled guilty to the Ponzi scheme counts (mail fraud and wire fraud), and then had a jury trial with respect to the campaign finance charges. The jury returned a verdict of guilty on all four campaign finance fraud charges.
At sentencing, Mr. Hsu argued that the proper estimate of loss to be used in calculating his sentence was the amount of restitution that Hsu owed his victims. The government asserted that the losses associated with Mr. Read More
The United States Equal Employment Opportunity Commission recently announced that retaliation charges accounted for the highest overall percentage of private sector complaints in fiscal year 2011. Employers, therefore, must be on the lookout for those “magic words” spoken by an employee that may qualify as a protected activity triggering a subsequent claim of retaliation.
An employee states a claim for retaliation by demonstrating that she (1) engaged in protected activity, (2) suffered an adverse employment action either contemporaneously with or after the protected activity, and (3) there was a causal connection between the protected activity and the adverse employment action. The employer may defeat Plaintiff’s claim by showing a legitimate, non-retaliatory reason for the adverse action.
Unquestionably, protected conduct includes the filing of formal charges of discrimination and informal protests of discriminatory activities, including complaints to management. It also includes the expression of support by an employee for a co-worker who has filed a formal charge of discrimination. Protected conduct, however, does not include generalized complaints by an employee to a supervisor or other management team member about unfair treatment. The conduct – if it is to be protected – must convey a protest of discriminatory practices. Therefore, an employee’s complaint that a manager treated her unfairly, rudely or is too tough on her, likely will not constitute a protected activity. Similarly, an employee’s complaint that he is being treated differently than another employee – with nothing more – is insufficient to constitute a protected activity. The United States Court of Appeals for the Third Circuit recently found in favor of the employer in a retaliation claim because, while the employee complained to her supervisor that she was treating her differently than other employees, the employee failed to provide evidence that she specifically complained that the treatment was based on her race or gender. Read More
Factual Background of Case
In June 2007, the Oakmont Country Club, near Pittsburgh, hosted the annual U.S. Open Golf Tournament. Employer provided certain services at this U.S. Open, and hired Claimant to work there. Claimant’s assigned job duty was to watch an open tent with a Lexus vehicle on display inside. His shift was from 7 p.m. on June 9 to 7 a.m. on June 10.
Claimant filed a Workers’ Compensation Claim Petition for a June 10, 2007 injury, which was opposed by employer, based on the position that Claimant was outside the course of his employment when he was injured.
Claimant’s testimony differed significantly in comparison with that offered by various employer representatives.
Claimant testified that around 6 a.m. on June 10, he heard sounds and saw lights. Approximately forty minutes later, he said he decided to check the surrounding areas where he had previously seen the lights and heard the noises. He left the Lexus Tent. While away from the Lexus Tent, but still on the Oakmont Country Club grounds, and before his shift ended, Claimant incurred head and back injuries. He indicated that around 6:40 a.m., he walked to a grandstand with bleachers to get a better look around the area, when something let loose under him on the bleachers, causing him to fall. He said he had decided to investigate the area around the Lexus Tent because he had heard some noises earlier. He could not approximate the distance between the Lexus Tent and the grandstand. He described the bleachers as possibly being as little as twenty feet out of his way and less than one hundred yards from the Lexus Tent. He was unable to estimate the distance or direction he was walking when he came upon the bleachers, other than to say they were within the vicinity of the Lexus Tent. Read More
Gaetan J. Alfano, a partner in the law firm of Pietragallo Gordon Alfano Bosick & Raspanti, LLP, has been appointed as Chair of the Philadelphia Bar Association’s Commission on Judicial Selection and Retention.
The Philadelphia Bar Association’s Commission on Judicial Selection and Retention evaluates judicial candidates to help voters make decisions about candidates for judicial office. The Commission’s evaluations are based on criteria such as legal ability, experience, temperament, administrative ability, integrity and devotion to improvement of the quality of justice.
Mr. Alfano is Co-chair of the firm’s Commercial Litigation Practice Group. Read More
