The Capitol View

//The Capitol View

Micro-biome Receives Macro-funding from White House Initiative

Over the past year our firm has been reporting on major intellectual property developments and the R&D and commercialization efforts in the microbiome. The importance of this scientific area for bringing new drug therapies to the marketplace has now been given a big shot in the arm by the US government. On Friday, May 13, the White House launched a public-private coalition “to foster the integrated study of microbiomes across different ecosystems.” This expansive R&D effort comes with $121 million of funding from the federal government, with another $100+ million of investments from academia and the private sector. The National [...]

By |May 17th, 2016|Blog, The Capitol View|0 Comments

JULY 2015 UPDATE: US Patent Office Subject Matter Guidance

Last December, the US Patent and Trademark Office issued the “2014 Interim Guidance on Patent Subject Matter Eligibility” as further guidance to its examining corps for assessing patent eligible subject matter of claims reciting or involving laws of nature, natural phenomena, and natural products under 35 USC §101. The guidelines were issued in light of the high-profile Supreme Court decisions in Alice Corp., Myriad, and Mayo. On July 30, the USPTO published an update to the Interim Guidance titled “July 2015 Update: Subject Matter Eligibility.” This update was produced in response to the public comment on the 2014 Interim Patent [...]

By |August 4th, 2015|Blog, The Capitol View|0 Comments

Controversial Patent Reform (“Patent Troll”) Legislation Reintroduced In Congress Last Week

Both 2013 and 2014 had been roller coaster years for proposed patent reform legislation to curb abusive activities by non-practicing entities – so-called “patent trolls”. The roller coaster is again gaining momentum as House Judiciary Committee Chairman Bob Goodlatte (R-VA) reintroduced the “Innovation Act” (H.R. 9) on February 5th. As a brief history, the House at the close of 2013 had passed by nearly a 4 to 1 margin an earlier version of this Innovation Act (H.R. 3309). In response, the Senate introduced its “compromise” Transparency and Improvements Act (S. 1720) to trim the broader, more controversial House Bill. Despite [...]

By |February 9th, 2015|Blog, The Capitol View|0 Comments

Dr. Anthony Sabatelli Returns to USPTO to Present Views on Revised Patentability Guidance

Dr. Anthony Sabatelli, leader of Dilworth IP’s biotech and pharmaceutical patent practice group, has once again been invited by the USPTO to share his thoughts and insights on the Office’s recently issued 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), a supplement to the patent eligibility Guidance issued earlier in 2014.  Dr. Sabatelli’s presentation will take place this Wednesday, January 21st, between 1pm and 5pm EST at the public eligibility forum held at the USPTO’s Madison Building.  A live internet feed of the forum will be made available by the USPTO.  Further information about the Guidance and [...]

By |January 20th, 2015|Blog, The Capitol View|0 Comments

41 New Drugs Approved in ‘14- A random spike or a growing trend of drug innovation?

If innovation drives progress, then 2014 was the year of progress! During the past year the U.S. Food and Drug Administration approved 41 new drugs. That is 14 more than 2013 and the highest number in 18 years! What spurred this increase? And what challenges do these new drugs face in the 2015 market? The FDA publishes the drug approval data based on New Molecular Entities (NMEs)[1]. These drugs can be both the traditional small molecule drugs in addition to newer high-molecular weight biologics. For information on NMEs and how they are classified, see “The Scorecard- Fewer New Drug Approvals [...]

By |January 14th, 2015|Blog, The Capitol View|0 Comments

PTO Issues New Revised Guidance for Patent Eligibility

The United States Patent and Trademark Office published a new, revised Guidance today on patent subject-matter eligibility.  This new memorandum is in direct response to criticism received by the PTO from its publication of a previous guidance which had sought to address patent eligibility issues raised by the Myriad and Mayo decisions.  The latest revision not only seeks to address the criticisms of the previous Guidance, which dealt primarily with patents in the life sciences, but also includes guidelines on patent eligibility for software and business method patents as set forth in the Supreme Court’s recent Alice Corp. decision.  The [...]

By |December 16th, 2014|Blog, The Capitol View|0 Comments

Supreme Court to Hear the Only Patent Case of the 2014/15 Term This Week

The Supreme Court is currently scheduled to take on only one patent case this upcoming term. On October 15th, the Court will hear oral arguments in Teva Pharm. USA, Inc. v. Sandoz, Inc., No. 13-854. This is an appeal dealing with important issues of patent claim construction. The central question before the Court is whether a district court’s factual findings on claim construction may be reviewed de novo by the Federal Circuit. This rather light Supreme Court patent docket is in sharp contrast to the six patent cases the Court heard during the 2013-14 term, and even compared to the [...]

By |October 15th, 2014|Blog, Government Advocacy, The Capitol View|0 Comments

Pacific Pact Could Hurt Drug Innovation, Drug Makers

This month, negotiations over the Trans-Pacific Partnership resume in Australia. Officials from the United States and 11 other major economies are meeting to settle the final details of the trade pact, with the hope of passing the final deal by year's end. The particulars of the agreement could have a massive impact on the Connecticut economy. One contentious issue is the intellectual property rights afforded pharmaceutical firms. These businesses play an essential role in our state economy. Without sufficiently strong intellectual property protection, the drug industry would be unable to continue its innovative work to develop new drug products. Local workers [...]

By |October 9th, 2014|Blog, Government Advocacy, The Capitol View|0 Comments

Alice Corp Ruling Spells Trouble but There May Be a “Diamond” in the Rough for Biotech Patents

The Supreme Court unanimously decided on June 19th that computer implemented business methods are not patent eligible subject matter.  See Alice Corporation Pty. Ltd. v. CLS Bank International et al.  The case centered on a group of patents owned by Alice Corporation that cover a method for reducing the risk that the parties to a financial transaction will not pay their obligations. CLS Bank, who operates a global network that facilitates currency transactions, filed suit against Alice Corporation, arguing that the patents are invalid, unenforceable, and not infringed.  The District Court ruled against Alice Corporation, holding that the claims were ineligible for [...]

By |June 24th, 2014|The Capitol View, Uncategorized|0 Comments

FDA Issues List of Qualifying Pathogens Under GAIN

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 [...]

By |June 6th, 2014|The Capitol View|0 Comments