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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”.

The rapidly changing landscape of intellectual property law makes it challenging for experts to stay current. Imagine how much more difficult it is for scientists, engineers, and business leaders, who experience IP issues indirectly and less frequently, to appreciate the law’s contours. If you’re already an IP expert, Top Ten Patent Myths will underscore or help you better understand what your in-house business and R&D colleagues or your client groups may not adequately understand about IP matters. If you’re not an IP attorney, you’ll gain a better understanding of patent law and practice, and you’ll quickly recognize when a colleague has fallen victim to one of these “top ten” common misconceptions. Dr. Jonathan Schuchardt, Partner at Dilworth IP will be presenting a free webinar entitled Top Ten Patent Myths on Wednesday, June 25th from 1pm – 2pm EDT. Click through to register for this event.

When I was your age, and Pluto was a planet, “obvious to try” was not the standard for evaluating patentability under 35 USC § 103. In KSR v. Teleflex, the US Supreme Court qualified this by rejecting the Federal Circuit’s “TSM” test in favor of a more flexible standard. Thereafter, a skilled person might respond to a “design need” or “market pressure” to solve a problem having only a “finite number of predictable solutions.” Such an application of “common sense” would be unpatentable and “obvious to try.” Perhaps your patience has also worn thin in considering the possibilities?

Recent Federal Circuit decisions continue to shape the law of obviousness and the meaning of “obvious to try.” Here are three examples:

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.

Dr. Anthony Sabatelli, Partner at Dilworth IP, has been invited by the United States Patent and Trademark Office to present his perspectives on the USPTO’s recently issued guidance memorandum for determining subject matter eligibility of claims reciting or involving laws of nature, natural phenomena, and natural products. The presentation will take place during a public forum this Friday, May 9th beginning at 1pm EDT. A webcast of the event will be broadcasted. Interested parties can view it by going to https://new.livestream.com/uspto/myriadforum.

Dr. Anthony Sabatelli, Partner at Dilworth IP will be presenting a free webinar entitled What is Patentable? Insight Into the New USPTO Guidance on Wednesday, May 21st from 1pm – 2pm EDT. Interested parties should note that Dr. Sabatelli has been invited by the USPTO to present his comments in person on this Guidance on May 9th and he will relate his impressions on that forum to webinar participants. Further details about the presentation can be found below.