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With so many new microbreweries popping up in Sacramento, the Bay Area,transparent and the Greater San Diego area, I felt compelled to write the present piece for the benefit of the aspiring, as well as the established, microbrew entrepreneur. These individuals undoubtedly pour (excuse the pun) their hearts, souls, and hard-earned money into the development of their breweries and their attempts to formulate the perfect brew. However, from my own research and analysis it seems clear that these entrepreneurs are regularly overlooking one thing in particular—their intellectual property rights.

The thought first occurred to me when I was sitting in San Diego having an IPA with a couple of my friends. As I stared at the bottle on the table it occurred to me that despite my everyday involvement with intellectual property, I had never looked into whether some of these companies were properly safeguarding their intellectual property rights. I immediately went to the United States Patent and Trademark Office (“USPTO”) website on my cellphone and began searching for some of my favorite breweries and their assorted brews on the database. I quickly learned that some of the companies were prudently protecting their intellectual property in their company’s name, certain brews, and certain designs/graphics. However, I also learned that some of my favorite breweries were not doing anything to protect their intellectual property. I discussed the matter with my friends and express how I could not understand why these companies would not try to protect their intellectual property. Then, it occurred to me that some of them probably never thought about it, or were simply unaware what types of protection exist under the intellectual property laws. After all, prior to my involvement in the intellectual property world, I never thought about trademarks, trade dress, copyrights, or patents. Accordingly, I decide to draft this brief, non-exhaustive discussion of trademark law’s application to the microbrewery industry and suggest that breweries consider protecting their rights as they grow as businesses.Continue Reading Brewing Up Some IP

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

On February 5, 2015, Congressman Bob Goodlatte reintroduced the “Innovation Act”; a bill designed to implement several changes to the legal framework governing United States patent law. The law is designed to make it more difficult for non-practicing entities (also known as “patent trolls”) to maintain patent infringement lawsuits. The law appears to have significant support among both houses of Congress, and may soon become law.

If passed, the Innovation Act purportedly will create several disincentives aimed at increasing the risk faced by non-practicing entities when bringing patent infringement lawsuits. First, the Innovation Act would require non-practicing entities to meet a heightened pleading requirement. Non-practicing entities would be required to plead “with detailed specificity” how the accused products allegedly infringed their patents. Additionally, the Innovation Act contains a fee-shifting provision which would allow the court to award attorneys’ fees to the prevailing party. This provision was included in the Act to address the fact that most lawsuits brought by non-practicing entities are settled by the accused party because the defense costs and legal fees associated with defending patent infringement cases often run into the millions of dollars.
Continue Reading Congress is Reconsidering “Anti Troll” Legislation

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