Tag Archives: Federal Courts

Supreme Court to Consider Patentability of Natural Phenomena—Grants Cert in Mayo Collaborative Services v. Prometheus Laboratories

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Yesterday, the Supreme Court granted cert in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (No. 10-1150) to address whether a patentee can monopolize basic, natural biological relationships. This case could have far-reaching effects for those patenting medical procedures and biological processes. In particular, the Court appears to be confronting the issue of what are the bounds of patentable subject matter with natural phenomena and processes. The specific question presented is:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

The Court previously began to consider this issue in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006), but dismissed the case for technical reasons. Three dissenting Justices (Breyer, Stevens, and Souter) and would have decided the case and held that such claims are not patentable subject matter because they cover a law of nature and a basic scientific relationship. The full Court will now consider this issue.

The Patent at Issue

At issue in Mayo Collaborative is Prometheus’s patent claim involving the treatment of autoimmune disorders by administering a drug and determining whether the dosage was appropriate based on an observed metabolite level in the patient. Once administered, the body automatically converts the drug into a metabolite, the amount of which determines whether the dosage was appropriate. Specifically, the claim reads:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Case Below

Defendant (Mayo) argued that this claim was invalid because it was not patentable subject matter–all it amounts to is administering a drug and observing a reaction. Prometheus did not try to patent the reaction, which is a naturally-occurring one. Mayo also argued that the claim was unpatentable as a matter of public policy because of its broad scope and the effect it would have on public health and research. In particular, Mayo argued that any doctor that administered a drug and saw the results may infringe the patent, even if the doctor never took any action based on the results.

The patent was held invalid in the District Court, but the Federal Circuit reversed, finding that the claims satisfied the “machine-or-transformation” test under 35 U.S.C. § 101. On its first appeal, the Supreme Court remanded so that the Federal Circuit could consider the then-recent decision in Bilski v. Kappos, 130 S. Ct. 343 (2010). On remand, the Federal Circuit again reversed the District Court, finding that the patent claims were not invalid. Mayo again petitioned the Supreme Court for cert, which was granted yesterday.

What This Case Means

This case should clarify the scope of patents, especially as they relate to biological and natural processes. In Bilski, the Court rejected the Federal Circuit’s prior “machine-or-transformation” test as being too rigid. It will be interesting to see if and how they revise or clarify that standard. In addition, the Court will likely have to address whether an idea that is not abstract can nonetheless be so broad as to be unpatentable on that basis (as opposed to being anticipated or obvious).

If the LabCorp decision is any guide, the Court (or at least Justice Breyer) will be particularly hostile to claims that appear to cover laws of nature, natural phenomena, and abstract ideas. In that case, which also involved a patent claim for correlating test results with a physical condition, Justice Breyer found the claim invalid because it simply patented a natural phenomenon, albeit in the cloak of the abstract patent language of a process. In addition, Justice Breyer was concerned about the chilling effect of patents like these on doctors and their patients.

Regardless of what the Court determines, this case should be particularly important for those in the biological and pharmaceutical markets and could have a large impact on what kinds of inventions and processes can be patented.

Court Threatens to Sanction Copyright Troll Righthaven LLC

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Yesterday, Chief Judge Roger Hunt of the United States District Court for the District of Nevada issued a stern ruling threatening sanctions against Righthaven LLC in one of the numerous copyright infringement lawsuits brought by Righthaven in Nevada (Righthaven LLC v. Democratic Underground, LLC, No. 2:10-cv-01356-RLH-GWF). In dismissing the case, the Court found that Righthaven misrepresented its rights in the underlying copyrighted works and did not have standing to sue for infringement. The Court further ordered Righthaven to show cause why it should not be sanctioned for failing to disclose another party’s (Stephens Media LLC) pecuniary interest in this and hundreds of other cases filed in Nevada.

Who Is Righthaven LLC?

Righthaven is a Nevada company that acquired limited rights from a variety of copyright holders, including Stevens Media LLC and News Media Group, to file hundreds of lawsuits against individuals and entities that allegedly infringe copyrights by posting excerpts of articles from newspapers such as the Las Vegas Review-Journal and the Denver Post. Righthaven has filed suit in a variety of jurisdictions throughout the United States, including Nevada, Colorado, and South Carolina.

Righthaven does not create or publish the works it is suing on. Instead, it acts as an enforcement arm of the original copyright holders that it has a relationship with. It scours the web looking for individuals, typically bloggers, that have reposted all or portions of articles appearing in newspapers such as the Las Vegas Review-Journal or Denver Post. It then files suit, threatening substantial sanctions, including damages up to $150,000 and forfeiture of web site domain names. Righthaven has sued everyone from political candidates to charities, individuals, bloggers, and companies—even those that a newspaper featured in the very article that was copied.

Because Righthaven does not create or publish the content that it is suing on, Righthaven is often referred to as a “copyright troll,” in an apparent tip to how many people refer certain types of non-practicing entities in the patent infringement arena.

Righthaven Lacks Standing to Sue

With respect to copyrights from Stevens Media, Righthaven entered into a Strategic Alliance Agreement (“SAA”) in 2010 that was made public for the first time this year as a result of discovery in one of the lawsuits. The agreement purported to assign all rights to the copyrighted materials to Righthaven. In fact left all of the rights with Stephens Media except for the bare right to sue. For example, Stephens Media expressly retained the rights to license, receive royalties, and exploit the copyrighted works. In addition, Stephens Media receives 50% of any of the litigation proceeds (minus costs) that Righthaven receives for lawsuits involving Stephens Media’s copyrights.

The Copyright Act only allows the legal or beneficial owner of an exclusive right to the copyrighted work to sue for infringement, and a copyright holder cannot (under Ninth Circuit law) assign the bare right to sue to another. In the Court’s decision yesterday, it found that the SAA gave Righthaven only a bare right to sue, so it was ineffective and Righthaven lacked standing—“ The plain and simple effect of this section was to prevent Righthaven from obtaining, having, or otherwise exercising any right other than the mere right to sue as Stephens Media retained all other rights.”

Righthaven Faces Sanctions

The Court was very troubled by Righthaven’s actions during this and other lawsuits brought in federal court in Nevada. In particular, the Court called some of Righthaven’s arguments and statements “disingenuous,” “inaccurate,” and “dishonest.” Most troubling to the Court was Righthaven’s failure to disclose that Stephens Media had a pecuniary interest in the litigation, despite Local Rule 7.1-1’s explicit requirement that all parties disclose anyone that has a direct, pecuniary interest in the outcome of the case. The Court believed that Righthaven also failed to disclose this information in approximately 200 other cases it filed in Nevada. Therefore, the Court ordered Righthaven to show cause within two weeks “why it should not be sanctioned for this flagrant misrepresentation to the Court.”

Is Righthaven Finished?

The Court’s decision yesterday is a stinging rebuke to Righthaven and its tactics. It will be interesting to see if it can survive this ruling and the likely challenges by defendants in the hundreds of other cases around the country. What may have appeared to be an easy way to make money off of these copyrights could end up costing Righthaven significant amounts of money in sanctions and attorneys’ fees.

Additional Blog Resources for more information

Update: What You Need to Know About PDF/A ECF Filings in Federal Court

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

As discussed in an earlier post on this blog, the federal courts will be requiring all electronic filers to move to the PDF/A standard for ECF filings. The Western District of Pennsylvania announced that it is beginning its transition to this format now, and all filings starting on January 1, 2012 must be in the PDF/A standard (link to Court’s PDF announcement).

The PDF/A format should be a longer lasting file format that will allow attorneys and the public to access these records well into the future. The PDF/A standard requires that the files be self-contained and not refer to use any information outside of the file itself. So, all the fonts and other information will be embedded inside the file. There are two types of PDF/A formats—the PDF/A-1a and PDF/A-1b formats. The “a” format requires strict tagging of information, while the “b” format is less stringent. As a practical matter, one will likely need the original source file (for example, the original Microsoft Word file) to create a PDF/A-1a file. This will make it more difficult to convert standard PDF files into PDF/A-1a files. On the other hand, because the PDF/A-1b format is more forgiving, and it should be possible to convert standard PDF files into this format. It appears that the federal courts will accept either PDF/A format.

There are a variety of websites offering advice and tutorials to help ease the transition to the PDF/A format. The Adobe Acrobat for Legal Professionals website recently posted a tutorial on using the save as feature in Acrobat 9 and X to create or convert files into the PDF/A format. It also hosted a webcast on the topic that can be viewed here.

For additional information:

  • Federal Court FAQ regarding PDF/A change
  • past Adobe Acrobat for Legal Professionals blog posts on this topic 1, 2, 3, 4
  • ISO 19005-1:2005 FAQ describing the standard (downloads FAQ)
  • PDF/A compliance organization FAQ

Federal Courts to Move to PDF/A for CM/ECF Filings

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Federal court practitioner are now well-familiar with the CM/ECF, which allows parties to file documents in a PDF format on-line rather than hand-filing them with the Clerk of Court. In an effort to improve its archiving and preservation of its records and to address concerns over new features that have been incorporated into the PDF format, federal courts will require filers to submit documents in the PDF/A format. The courts have not all set a timeline for implementing these changes, but the Western District of Pennsylvania will require all uploads to be in this format after January 1, 2012.

PDF/A is an International Standards Organization (ISO) approved version of the popular Adobe PDF format designed for archival purposes. It is a self-contained file, which means that it does not rely on external media players or hyperlinks outside of the documents. In addition, it embeds all of the fonts used in the document inside the file, so the recipient need not have any of the fonts installed on his or her computer. It also prevents security measures of any kind (such as passwords).  It appears that the federal courts will be using the minimal PDF/A-1b “flavor” of PDF/A, rather than the full PDF/A-1a “flavor,” which is more exacting.

As the PDF format has evolved, it has incorporated some new features that raised concerns, such as the ability to monitor when a document is read and the ability to incorporate active software inside the file. In theory, by moving to the PDF/A format, electronically-filed documents will be more accessible in the future and less dependent on technologies or features that may become unsupported.

Federal courts currently will accept PDF/A files, but do not yet require them. As practitioners are preparing for the transition to only PDF/A files, they should be aware of a number of changes that will result from this shift:

  1. Because all of the fonts will be embedded into the file, file sizes will be larger. In addition, some specialized fonts will not allow programs to embed them in the PDF/A file or require an additional license to do so. Use of these fonts will be problematic and may have to be avoided.
  2. Hyperlinking to webpages, judicial decisions, and other hypermedia is not possible because the file must be self-contained. Content rich briefs and exhibits will be more difficult to create, and, in particular, one will have to be careful in creating exhibits that contain these items (such as copies of webpages or electronically-downloaded caselaw). While some courts may allow exceptions to this limitation, one should not count on regularly being able to obtain these.
  3. Passwords and other security features are not permitted. The purpose of switching to PDF/A is to make the files as accessible as possible for as long as possible. Passwords and other security measures interfere with that goal.
  4. PDF/A requires the presence of certain meta-data to verify conformance with the standard. For firms with systems that automatically strip meta-data, care will have to be taken so as not to render PDF/A files non-conforming in the process.

For further information, you can see:

  • Federal Court announcement of the change
  • Adobe Acrobat for Legal Professionals blog posts on this topic 1, 2, 3, 4
  • ISO 19005-1:2005 FAQ describing the standard (downloads FAQ)
  • PDF/A compliance organization FAQ

Update: See this later post for additional information on the PDF/A transition.