30Apr 2018

Silvia Salvadori - Schizophrenia Drug Patent Case Divides Federal CircuitIn a recent case, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided Federal Circuit held valid a patent directed to a schizophrenia drug, finding that the claims met the “Mayo standard”.

The patent at issue directs physicians to treat patients who have low CYP2D6 activity (an enzyme) with a lower amount of iloperidone, a drug to treat schizophrenia.

Iloperidone is metabolized by CYP2D6, thus, a patient who is characterized with lower CYP2D6 activity is more prone to iloperidone cardiac side effects.

The Court held that the patent specifically tells physicians how to connect the relationship between dosage and a patient’s genotype to find the correct treatment, and that the claims do not describe any natural factor.

According to the Court, the claims were directed to “a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” These claims differ from the claims cited in the “Mayo standard” because they recite more than a natural phenomenon since they link the activity of the enzyme CYP2D6 and a cardiac rhythm parameter.

Thus, the Court held that the claims were eligible under step 2 of the “Mayo test” (they were directed to significantly more than just a law of nature or a natural phenomenon) because the discovered results are not routine and conventional.

Judge Prost, dissented saying, “the patent was just an optimization of an existing treatment of schizophrenia, just as the claims in Mayo.”

Ultimately, the Federal Circuit held that the patent was valid.

Please contact me at silvia@salvadorilaw.com with questions or comments.

Silvia Salvadori, PhD

Silvia Salvadori, PhD



28Mar 2018

Silvia Salvadori - Patent Law - Claims Drawn to Antibodies: Written Description Guidance by the USPTORecently, the United States Patent and Trademark Office (USPTO) issued a memorandum over the written description for claims drawn to antibodies. The first part of the memorandum is based on the Federal Circuit case Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). In Amgen, the Federal Circuit explained that when an antibody is claimed, 35 U.S.C. § 112(a) it requires adequate written description of the antibody itself. (Amgen, 872 F.3d at 1378-79.) Continue reading

28Feb 2018

Silvia Salvadori - USPTO Relies on Prosecution History of Claim LanguageIn a recent case decided by the Federal Circuit, Aptalis Pharmatech, Inc. v. Apotex Inc., the Appeal Court held that the prosecution history can explain the claim meaning, even without clear and unmistakable disclaimer of the claim scope.

The patents at issue are listed in the Orange Book for Aptalis’s AMRIX® product. A representative claim is as follows: Continue reading

27Dec 2017

profits-1953616_1280Effective January 16, 2018 the USPTO will raise some of its fees, and it will also add new fees. Below, I have included a few tables which display some of the new or increased fees.

If you would like a copy of the USPTO’s final rulingclick here to download the 38-page PDF document.

If you would like to view the Table of Patent Fees – Current, Final Rule and Unit Cost, click here to download the 6-page PDF document.

Contact me with questions or comments at silvia@salvadorilaw.com.

Silvia Salvadori, PhD

Silvia Salvadori, PhD



(212) 897-1938 Continue reading

28Nov 2017

Silvia Salvadori - Patent Examiner Withdraws Rejection Due to Impermissible Hindsight {4:18 minutes to read} In a recent decision, Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling based on impermissible hindsight.

Unfortunately, this decision is non-precedential.

The Patent at Issue

The patent at issue was Merck’s U.S. Patent No. 5,989,581, which is listed in the Orange Book for its NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) contraceptive product. Dependent claims 4 and 11 were at issue. Dependent claim 4 is representative.

Dependent claim 4 states: A drug delivery system wherein the amount of progestogenic compound dissolved in the thermoplastic core material is 2 to 5 times the amount necessary for obtaining saturation concentration.

The claims of the patent were directed as “a drug delivery system comprising of at least one compartment which comprises….”

Warner Chilcott Co. asserted invalidity of the claims in view of a reference which disclosed a two-compartment vaginal ring and that criticizes one-compartment vaginal rings.

Nevertheless, the district court found the Merck claims to be obvious.

The Federal Court reversed citing KSR:

A patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).

Even if all elements of the claim were known, we still must resolve whether a person of ordinary skill in the art would have found it obvious to combine these elements or modify them in a way that meets the claim.

In making this inquiry, we have cautioned that “the inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight.” Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012).

Thus, it is improper to combine references “like separate pieces of a simple jigsaw puzzle” without “explain[ing] what reason or motivation one of ordinary skill in the art at the time of the invention would have had to place these pieces together.”InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1349 (Fed. Cir. 2014).

The court concluded that starting from the teachings of the references—but without the impermissible hindsight—one skilled in the art would have had to use the issued patent as a roadmap.

Moreover, the Federal Circuit also raised the issue of the reasonable expectation of success in going from a two-compartment ring to a one-compartment ring, considering that the reference was teaching away from using a single compartment.

This opinion is very reassuring, since rarely the Examiner withdraws from rejections based on impermissible hindsight. It is important to remember that, even if references can be combined or modified, ”the resultant combination is not obvious unless the results would have been predictable to one of ordinary skill in the art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 538, 417, 82 USPQ2d 1385, 1396 (2007).

It must also be remembered that rejections on obviousness cannot be sustained by mere conclusory statements; instead, the examiner must articulate a reasoning with some rational underpinning to support the legal conclusion of obviousness explaining why a person of ordinary skill in the art would have made the stated modification.

Contact me with questions or comments at silvia@salvadorilaw.com.

Silvia Salvadori, PhD Silvia Salvadori, PhD



(212) 897-1938