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So, what are the implications of this decision? What does it mean for business method patents, software, and even the biotech industry? If Justices Sotomayor, Ginsburg, and Breyer had their way, business method patents would essentially be dead and software patents would be very hard to come by. However, there is a ray of hope. […]

The Food and Drug Administration (FDA) has issued a regulation establishing a list of “qualifying pathogens” under the Generating Antibiotics Incentives Now (GAIN) act. Gain, which came into force back in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), provides strong incentives to encourage development of new antibacterial and antifungal drugs for treating serious or life-threatening infections. Under GAIN, new qualifying drugs would be awarded an additional five years of exclusivity, priority review, and eligibility for fast track designation. Based on analyses conducted both in the proposed rule and in response to comments, the FDA has now added additional “qualifying pathogens” to the list of pathogens proposed back in 2013. New drugs intended to treat serious or life-threatening infections caused by one of these listed pathogens may be eligible for the GAIN incentives. The new rule takes effect on July 7, 2014. Senator Richard Blumenthal, who has been a strong proponent of Connecticut’s biotechnology industry was originally responsible for introducing the legislation that resulted in the addition of GAIN to FDASIA.

In Nautilus, the Court deals with the complex question of patent claim construction and scope in view of the standard for definiteness (in layman’s terms, whether the patent claim is clearly written and defined in the patent disclosure). The governing statute here is the second paragraph of 35 USC § 112 (“definiteness”), which states that a patent “shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention”. If a patent fails to meet this requirement, the claims can be found invalid for being “indefinite”.

This past Monday was a busy day for the Supreme Court. It handed down two unanimous decisions, each overturning lower Federal Circuit Court rulings. In Nautilus, Inc. v. Biosig Instruments, Inc., the Court dealt with the esoteric question of patent claim construction and scope in view of the standard for definiteness (in layman’s terms, whether the patent claim is clearly written and defined in the patent disclosure). In Limelight Networks, Inc. v. Akamai Tech. Inc., the Court dealt with the more straightforward question of whether a party, who only carries out some of the steps of a method patent, is liable for infringement if it encourages others to carry out the remaining steps – even if there would otherwise be no direct infringement. I discuss the Limelight case in this article. The Nautilus case will be discussed in a future article.

On May 21st Senator Patrick Leahy (D-VT) announced he was yanking the Patent Transparency and Improvements Act (S. 1720) he had introduced last November. This Bill represented the Senate’s attempt to work towards compromise legislation to trim the broader – and certainly more controversial – House Bill (H.R. 3309) that was passed last December. Just the day after Senator Leahy’s announcement, the House held a hearing at which legislation focused on regulating abusive patent infringement demand letters was discussed. This demand letter legislation was proposed by Rep. Lee Terry (R-NE) in a draft Bill entitled “Bill to Enhance Federal and State Enforcement of Fraudulent Patent Demand”. Representative Terry remarked that the Senate, by pulling its Bill now “puts us in a position where we have to do something”.

It has now been a week since the US Patent and Trademark Office held its public forum on the March 4th Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance). I was invited to present at this Forum, where I provided comments before the USPTO on the necessity for the Guidance, how the Guidance can be improved, and also provided cautions to prevent its misapplication. I had previously written about the Guidance in an earlier article on this site (see, How to Patent Grapefruit Juice: the New USPTO Guidance for Patent Eligible Subject Matter is Both Sticky and Sour).

Remember Dolly the sheep? She was the first mammal to be cloned from an adult somatic cell (a cell other than a sperm or egg cell) – that was in 1996. Well, Dolly is back again in the news, even though she passed away prematurely in 2003.

Last Thursday (May 8, 2014) the Court of Appeals for the Federal Circuit affirmed a ruling by the US Patent and Trademark Office’s Appeal Board that cloned animals are ineligible for patent protection under 35 USC § 101. The Court determined that “Dolly herself is an exact genetic replica of another sheep and does not possess markedly different characteristics from any [farm animals] found in nature.” The Court went on to say, “Dolly’s genetic identify to her donor parent renders her unpatentable.” See In re Roslin Institute (Edinburgh), 2013-1407.

Back in February I reported that the Supreme Court had a heavy patent docket during this 2013-14 term. See, Busy Schedule for the Supremes – Court Takes on Six High Profile Patent Cases This Term. On Tuesday of this week, the Court issued unanimous decisions in two of these cases: Octane Fitness, LLC v. Icon Health and Fitness, Inc., U.S., No. 12-1184, 4/29/2014 and Highmark Inc. v. Allcare Health Management Sys., U.S., No. 12-1163, 4/29/2014. In deciding these cases, the Court held that the Federal Circuit’s current standard for finding a patent case “exceptional” for the purpose of awarding attorneys’ fees to the prevailing party to be “unduly rigid.”

On March 4th the US Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC §101. The guidelines were issued in light of the Supreme Court’s decisions in Myriad, Prometheus, and related cases. See, “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.” The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.

The story continues to unfold regarding the patentability of diagnostics. At issue in Sequenom is US Patent No. 6,268,540. This patent is exclusively licensed to Sequenom and claims non-invasive prenatal diagnosis methods using maternal blood samples. The method provides an alternative to techniques such as amniocentesis, which can pose a risk to both the mother and child. Last year, in reviewing the ‘540 patent, the District Court for the Northern District of California issued an Order holding that medical diagnostic method claims are not eligible for patent protection.