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Author: Michael Dilworth

What is Patent Eligible? Initial Thoughts On The PTO’s Revised Guidance

The revised Guidance is a step in the right direction by the PTO to simplify the somewhat cumbersome and confusing patent claim analysis set out in the previous guidance and memo documents. The Guidance is an attempt to consolidate the separate frameworks the PTO had previously created for analyzing the patent eligibility of claims relating to laws of nature, natural phenomena, and natural products, versus claims relating to abstract ideas. I agree with the PTO that it is important to have a guidance that “promotes examination efficiency and consistency across all technologies.”

Biosimilar Controversy – Not Yet Ripe for the Picking

Just last week the Federal Circuit affirmed the dismissal of a declaratory judgment in a patent case involving a biosimilar product. I found this case interesting for two reasons: (1) because the Court punted and failed to address the key question of whether a developer of a biosimilar must go through the complex patent infringement adjudication requirements of the Biologics Price Competition and Innovation Act (BPCIA) and (2) perhaps more interestingly, because the facts of the case suggest the FDA may be requiring full-blown Phase III human clinical trials for the approval of a biosimilar product. See Sandoz Inc. v. Amgen Inc., 2014-1693 (Fed. Cir. December 5, 2014).

Friendly Skies Not So Friendly For Patent Holder Of E-Passports

Just a few weeks back the Federal Circuit decided an interesting patent infringement case in which the U.S. government waived its sovereign immunity from suit. In this case, the plaintiff, Iris Corporation, had originally brought suit against Japan Airlines Corporation for infringement of its patent on an electronic passport system. What is even more interesting about this case is that it involves 28 USC §1498(a). This is a little-known statute governing patent infringement activities by the United States government and the requirement to adjudicate such suits in the specially-created Court of Federal Claims. See Iris Corp. v. Japan Airlines Corp., 769 F.3d 1359, (Fed. Cir. October 21, 2014). […]

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.

Patent Office to Issue Revised Guidance on Patent Eligible Subject Matter

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.

Will Purple Become The New Orange? FDA Publishes Long-Awaited Lists Governing Biologics

Some fashion trends may come and go, but in the not too distant future the majority of prescription drug sales will be purple.1 For those of you not yet familiar with this latest trend, allow me to explain.

Most drug products are small, synthetically produced substances. The common pain reliever ibuprofen, for example, contains only 33 atoms and has a molecular weight of 206. In contrast, there is a whole new class of complex drug products that are isolated or produced from biological sources such as living cells. These biologically produced drugs, more commonly called “biologics”, are orders of magnitude larger than their small molecule cousins and present special challenges in their preparation, isolation, and administration. Insulin is a common example of a biologic. It is a protein having a molecular weight of approximately 5800. Another example is the hormone erythropoietin (or “EPO”), which is used to treat anemia. EPO is a far larger biological drug with a molecular weight of nearly 35,000.

Nature’s Indelible Marker

Naturally abundant, stable isotopes have already protected the identity and origin of $1.5 billion in pharmaceutical materials against intellectual property infringers. In an effort to find a simple, accurate way to unequivocally identify and secure the origins of drugs and other compounds, a Niantic, Connecticut-area scientist developed an alternative, finding a way to use the naturally occurring molecular fingerprint of drug products, active pharmaceutical ingredients and their synthetic pathways to help biotech and pharmaceutical companies enforce their hard-won patent rights against counterfeiters and other bad actors looking to profit by stealing intellectual property.

US Patent Office Issues Instructions to Examiners in Light of Recent Alice Corp Decision

Last week I reported The Supreme Court unanimously decided that computer implemented business methods are not patent eligible subject matter. See Alice Corp Ruling Spells Trouble but There May Be a “Diamond” in the Rough for Business Method, Software, and Biotech Patents. Now, less than a week later the US Patent and Trademark Office (USPTO) has issued an instruction memorandum to its Patent Examining Corps for analyzing patent claims involving abstract ideas. See USPTO Preliminary Examination Instructions.

Alice Corp Ruling Spells Trouble but There May Be a “Diamond” in the Rough for Business Method, Software, and Biotech Patents

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. […]

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 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.