On June 7, 2018 the United States Patent and Trademark Office (USPTO) issued a new Memorandum that clarifies its view of Subject Matter Eligibility, under 35 U.S.C. § 101, regarding the patentability of Personalized Medicine discoveries.

The Memorandum was prompted by the Federal Circuit’s recent Vanda decision, where the Court provided its own insights as to the Subject Matter Eligibility of Personalized Medicine patent claims. [1] The claims in Vanda recited a method of treating a patient suffering from schizophrenia with the drug, iloperidone, and included specific steps, such as administering iloperidone to the patient in an amount guided by the genotype of the patient, which can predict the rate of drug metabolism. The Court summarized Vanda by stating: “The inventors recognized the relationships between iloperidone, CYP2D6 metabolism, and QTc prolongation, but that is not what they claimed. They claimed an application of that relationship.”
Continue Reading Patent Office Guidance Improves Personalized Medicine’s Long-Term Prognosis

For those of you who may have lost hope regarding the patentability of personalized medicine discoveries, here’s some encouragement.  Recently the Federal Circuit affirmed the validity of a patent directed to a method of treating schizophrenia, which is based on genetic testing of the patient. Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., Nos. 2016-2707, 2016-2708, 2018 WL 1770273, —F.3d — (Fed. Cir. Apr. 13, 2018).  The Court found that the claims of U.S. Patent No. 8,586,610 were patent eligible and not drawn to a law of nature under 35 U.S.C. § 101.  Claim 1 is representative and is shown below:
Continue Reading Personalized Medicine Patents: Federal Circuit Gives Personalized Medicine Patents a Shot In The Arm

The patentability of genes is under scrutiny all over the world.

Several weeks ago, the High Court of Australia shed light upon the patentability of nucleic acids (D’Arcy v. Myriad Genetics Inc.). Similar to the situation in the U.S. for 35 U.S.C. §101, the High Court found that an isolated nucleic acid coding for a mutant BRCA1 protein was not patentable subject matter.
Continue Reading Courts review gene patents

Case law regarding written description is in a state of flux so it is beneficial for the patent practitioner to understand some key Federal Circuit decisions involving the written description requirement.

One might ask why a separate written description of the invention is needed in the specification when the claims are there to define the subject matter of the invention. The reason is historical.
Continue Reading The Written Description Requirement

Recently, the Federal Circuit provided some insight about the “error” upon which a reissue patent application can be based under 35 U.S.C. § 251. See In re Dinsmore, No. 2013-1637, 2004 WL 2337372 (Fed. Cir. June 10, 2014).

The current section 251 states:

Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more of less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. 35 U.S.C. § 251 (2012).  (The previous version of this statute, which was in effect at the relevant time for the case, included the phrase: “without any deceptive intention.”  This change was made Sept. 16, 2012.)
Continue Reading Errors in reissue patent applications

A deluge of patent applications were filed at the United Stated Patent and Trademark Office on the day before central provisions of the new America Invents Act (AIA) went into effect on March 16, 2013.  This rush to file indicates many inventors wish to preserve their patent status under the pre-AIA provisions.

The first-to-file provisions apply to any patent application that contains OR CONTAINED AT ANY TIME a claim having an effective filing date on or after March 16, 2013, and also apply to any patent application claiming priority of another application/patent that contains OR CONTAINED AT ANY TIME such a claim. America Invents Act § 3(n)(1) (emphasis added).
Continue Reading Patent law: Bridging the gap between ‘first-to-invent’ and ‘first-to-file’ — Preserve your status!

If you are forming a new venture or starting a new research project, consider these important IP issues before taking the plunge…

1)  Evaluate the “Patent Landscape” before you invest significant resources. A patent attorney can help you with a “Freedom to Operate” opinion. This FTO opinion will contain a “prior art” search, which provides information regarding comparable patents, their inventors/assignees, whether the patents are in good standing, and the remaining patent term. This information will give you a greater understanding of the patentability of your new idea, will help you avoid infringing someone else’s patents, and will help you identify potential licensing issues. The FTO opinion can also help to avoid “willful” infringement should you later be sued.
Continue Reading Intellectual property matters: New business or project? Look before you leap!

New guidelines from the United States Patent and Trademark Office were issued to address recent changes in the law regarding subject matter eligibility. The guidance applies to all claims “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” There is no change to claims reciting abstract ideas.

This step-by-step analysis of patent