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Audrey A Millemann

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Audrey Millemann is a shareholder with Weintraub Tobin and practices in the Intellectual Property and Litigation sections. She is a litigator and a registered patent attorney.  Audrey advises clients on all issues of intellectual property law, including infringement, validity, and ownership of patents, trademarks, and copyrights.

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Enablement is the requirement that a patent teach a person Audrey-Millemann-03_webskilled in the art (the field of the invention) how to make and use the invention without undue experimentation. In other words, a patent must describe the invention clearly enough so that a skilled person in the field can replicate the invention without having to perform experiments to determine how to make and use the invention. The enablement requirement is set forth in 35 U.S.C. §112, first paragraph. If a patent is not enabled, it can be invalidated.

In the fields of biology and chemistry, referred to in the patent world as the “unpredictable” arts, enablement is particularly important. Thus, biotechnology patents must clearly satisfy the enablement requirement or they are at risk of being challenged and held invalid. That is what happened in Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2014) 773 F.3d 1338.

Promega sued Life Technologies for infringement of five patents. The patents covered methods and test kits for analyzing DNA samples and were used in forensic science. Promega alleged that Life Technologies manufactured and sold genetic test kits that infringed Promega’s patents.

Life Technologies moved for summary judgement of invalidity on four of the five Promega patents, arguing that the four patents were not enabled. The district court denied the motion. The court granted Promega’s motion for summary judgment, holding that the patents were infringed. The jury then awarded $52 million in damages to Promega, but the district court granted Life Technologies’ motion for judgment as a matter of law. The court then vacated its previous ruling of infringement.Continue Reading Enablement is Key – Especially in Biotech Patents

The Supreme Court recently decided a patent case involving a significant procedural issue.  In Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831 (1/20/15), the question before the Court was whether the Federal Circuit Court of Appeals should review a district court’s factfindings in its claim construction decision under a de novo or a “clearly erroneous” standard.   The Court held that the proper standard of review, under Federal Rule of Civil Procedure 52(a)(6), is “clearly erroneous.”  The case establishes a two-part standard of review of a district court’s claim construction decision: a clearly erroneous standard for subsidiary facts and a de novo standard for the question of law.

The case involved Teva Pharmaceuticals’ patent for a method of making a drug to treat multiple sclerosis.  Sandoz began to sell a generic version of the drug.  Teva Pharmaceuticals sued Sandoz for patent infringement.  The claim at issue referred to a polymer having a specific molecular weight.  Sandoz argued that Teva Pharmaceuticals’ patent was invalid because the term “molecular weight” was indefinite.  Sandoz contended that there were three possible meanings of “molecular weight,” and that the patent did not explain which one was to be used.

The district court held that the patent was valid, based on expert testimony, finding that the term “molecular weight” was definite to a person skilled in the art.
Continue Reading SUPREME COURT: PATENT CLAIM CONSTRUCTION – TWO STANDARDS OF REVIEW

The Federal Circuit Court of Appeals has applied the Supreme Court’s test for unpatentable abstract ideas to patents covering methods to determine a person’s likelihood of getting certain types of cancer.

In University of Utah Research Foundation v. Ambry Genetics Corp., 2014 U.S. App. LEXIS 23692, decided by the Federal Circuit on December 17, 2014, the court addressed the patentability of two types of claims:  compositions and methods.  The composition claims were directed to single strands of DNA called “primers” that correspond to the double-stranded DNA of a gene.  The method claims were directed to diagnostic methods used to determine whether a patient carries a particular gene mutation that carries an increased risk of breast and ovarian cancer.

The plaintiffs were Myriad Genetics, University of Utah, and others.  They discovered the BRCA1 and BRCA2 genes that, when mutated, cause breast and ovarian cancer.  Myriad developed diagnostic test kits to detect the presence of the mutations.  Myriad patented the natural gene sequences, synthetic primers, and medical test kits.

In 2013, the U.S. Supreme Court held that Myriad’s claims to the natural gene sequences were invalid.  Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013).  The Court found that the gene sequences were not patent-eligible subject matter, but were instead ineligible natural phenomena.
Continue Reading FEDERAL CIRCUIT CHIPS AWAY AT PATENTABLE SUBJECT MATTER

The last time I checked (which was a couple of years ago), I found 979 U.S. patents in the U.S. Patent and Trademark Office’s database that had the word “Christmas” in the title.  Every year at this time, I look at a few of the most interesting ones.

My favorite one this year is U.S. patent no. 5,523,741 entitled “Santa Claus Detector.”  This patent covers a Christmas stocking that contains a light bulb or LED, a battery to power the light, and a hidden switch that turns on the light.  The switch is connected to a pull cord.  When the stocking is hung on the fireplace, the pull cord is positioned across the opening of the fireplace, forming a barrier across the fireplace opening.  After the child has gone to sleep on Christmas Eve, Santa Claus comes down the chimney with his bag of toys and triggers the cord, which turns on the light.  The next morning, the child will see the light on and know that Santa was there! (Or, as the patent describes, the parent can secretly pull the cord and turn on the light.)  The purpose of this invention, according to the inventors, is to reassure children that their good behavior was rewarded by Santa.

Another fun Christmas patent is the “Santa Claus Visit Kit,” U.S. patent no. 7,258,592.  This kit is used by parents to prove to a child that Santa Claus has visited.  The kit includes a stencil to leave boot prints on the floor, a letter from Santa, and a snack item for Santa.  The kit is intended to alleviate a child’s fear that Santa Claus might not leave presents.

There are several patents for fire extinguishers incorporated into Christmas decorations.  One patent covers a fire extinguisher hidden inside the trunk of a synthetic Christmas tree that is activated by a heat sensor.  Another patent is for a Christmas tree ornament that contains a fire-retardant powder.  The ornament pops open when the temperature reaches a certain point, releasing the fire retardant powder and, hopefully, putting out the fire.
Continue Reading HO, HO, HO! AND FA-LA-LA-LA-LA! MORE CHRISTMAS PATENTS

One of the more important intellectual property cases decided in 2014 is the U.S. Supreme Court’s decision in Octane Fitness, LLC v. ICON Health & Fitness, Inc. (2014) 134 S.Ct. 1749.  In that case, the Supreme Court announced a new test for awarding attorneys’ fees in patent infringement cases, holding that the existing test used by the Federal Circuit Court of Appeals was “overly rigid.”

The plaintiff, Octane Fitness, and the defendant, ICON Health, both made elliptical exercise machines.  ICON owned a U.S. patent for its machine.  ICON sued Octane for patent infringement.  The district court granted summary judgment of noninfringement in favor of Octane.  Octane filed a motion to seeking its attorneys’ fees under 35 U.S.C. section 285.  The district court denied the motion.  On appeal, the Federal Circuit Court of Appeals affirmed.

The Supreme Court reversed, stating that “the framework established by the Federal Circuit in Brooks Furniture Mfg. v. Dutailier International (Fed. Cir. 2005) 393 F.3d 1378 is unduly rigid, and it impermissibly encumbers the statutory grant of discretion to district courts.”  Id. at 1755.  The Court held that the Federal Circuit’s test in Brooks Furniture was “overly rigid.”  Id. at 1756.  Under that test, a case was exceptional if there was either:  (1) litigation-related misconduct, or (2) subjective bad faith and objective baselessness.  According to the Federal Circuit, the first alternative, litigation misconduct, would be found it there was willful infringement, vexatious litigation, a Rule 11 violation, or fraud or inequitable conduct in obtaining the patent.  Under the second alternative, subjective bad faith was met only if the plaintiff actually knew that its suit was objectively baseless, and objective baselessness was met if no reasonable litigant could believe they would prevail.  In addition, the Brooks court held that a defendant had to prove an exceptional case by clear and convincing evidence.
Continue Reading Attorneys’ Fees for Patent Infringement – Easier to Obtain!