Rationalizing the Inequitable Conduct Doctrine

Posted on: March 3, 2009  |   Author: Ali
Filed Under: Drug & Device, Research Abstracts   |   Leave a Comment

Patent law seeks to balance promoting innovation with the right to a free and open market. Patent prosecution is conducted ex parte and the usual advantages of the adversarial system are unavailable. Therefore, courts have implemented the harsh doctrine of inequitable conduct. The Federal Circuit has established a two-part test for inequitable conduct. First, the misrepresentation or omission must satisfy threshold levels of materiality and deceptive intent. Second, the court must balance the materiality and intent to determine, as a matter of law, whether inequitable conduct occurred. If the court finds an instance of inequitable conduct as to any one claim the entire patent is invalidated.

At first glance, inequitable conduct appears to be a straightforward, easily applied doctrine. However, the application of this doctrine has been applied inconsistently since its conception in the mid-1940s. Additionally, inequitable conduct is asserted as a defense in almost every major patent infringement case. Ultimately, the inequitable conduct defense drains resources and injects uncertainty into patent litigation. The doctrine of inequitable conduct has had a great impact on the pharmaceutical industry.

The purpose of this paper is to illustrate the major issues an Intellectual Property attorney should be aware of when drafting patents in order to avoid invalidation due to inequitable conduct. Currently, it is best for inventors and patent attorneys to err on the side of caution and disclose everything. However, recent court decisions and the push for inequitable conduct reform could narrow or even eliminate the doctrine in the near future.

The Anti-Markup Provision: A Progressive Companion to the In-Office Ancillary Services Exception to Stark

Posted on: March 3, 2009  |   Author: Ken Briggs
Filed Under: Access to Care, Fraud & Abuse, Medicare, Research Abstracts   |   Comments Off

CMS recently finalized the 2009 Medicare Physician Fee Schedule which includes significant changes to the anti-markup provision. These changes seek to control the practice of improper referral by physicians to arrangements in which they have a financial interest. Physician organizations traditionally only had to worry about the In-office ancillary services exception when trying to decide whether their referrals are improper. Now, though, they must look also to the anti-markup provision. This paper asks who these changes benefit? The physicians or the patients? CMS has adhered to Congressional intent and has proposed an approach while admirably attacks improper utilization without unduly restricting the freedom of physician organizations to perform their business.

Hospital Billing Practices and the Uninsured

Posted on: February 10, 2009  |   Author: Uduak
Filed Under: Other, Research Abstracts   |   Comments Off

Mr. DiCalro was stuck with a huge hospital bill that would have been significantly less had he been insured. Unfortunately, his attempt to have the court apply a more reasonable price was unsuccessful. This comment re-examines the case of DiCarlo v. St. Mary’s Hospital under the contract theories of open price term and unconscionability. It explores different avenues of interpretation the court could have applied to his cause of action. In the end, this comment offers legislative recommendations on how to address the problem of hospitals overbilling the uninsured.

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