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In September 2014, the US FDA published its first edition of the so-called ‘Purple Book,’ with the rather lengthy title – ‘Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.’ This new publication, like its well-established ‘Orange Book’ counterpart, will list approved biologic drug products and also their biosimilar and interchangeable generic equivalents. However, the Purple Book is still in its infancy. As of this writing, the published information is far from complete. Furthermore, the FDA has been slow in publishing the necessary guidance documents. Will the new Purple Book rise to the challenge of providing the necessary bridge between the patent and regulatory systems governing biologics? Will the requirements for demonstrating biosimilarity and interchangeability for biosimilar drug products turn out to be too onerous? This commentary explores the regulatory challenges for the role of the Purple Book as the first biosimilars begin receiving FDA approval this year.

Both 2013 and 2014 had been roller coaster years for proposed patent reform legislation to curb abusive activities by non-practicing entities – so-called “patent trolls”. The roller coaster is again gaining momentum as House Judiciary Committee Chairman Bob Goodlatte (R-VA) reintroduced the “Innovation Act” (H.R. 9) on February 5th.

The revised Guidance is a step in the right direction by the PTO to simplify the somewhat cumbersome and confusing patent claim analysis set out in the previous guidance and memo documents. The Guidance is an attempt to consolidate the separate frameworks the PTO had previously created for analyzing the patent eligibility of claims relating to laws of nature, natural phenomena, and natural products, versus claims relating to abstract ideas. I agree with the PTO that it is important to have a guidance that “promotes examination efficiency and consistency across all technologies.”

Just last week the Federal Circuit affirmed the dismissal of a declaratory judgment in a patent case involving a biosimilar product. I found this case interesting for two reasons: (1) because the Court punted and failed to address the key question of whether a developer of a biosimilar must go through the complex patent infringement adjudication requirements of the Biologics Price Competition and Innovation Act (BPCIA) and (2) perhaps more interestingly, because the facts of the case suggest the FDA may be requiring full-blown Phase III human clinical trials for the approval of a biosimilar product. See Sandoz Inc. v. Amgen Inc., 2014-1693 (Fed. Cir. December 5, 2014).

Just a few weeks back the Federal Circuit decided an interesting patent infringement case in which the U.S. government waived its sovereign immunity from suit. In this case, the plaintiff, Iris Corporation, had originally brought suit against Japan Airlines Corporation for infringement of its patent on an electronic passport system. What is even more interesting about this case is that it involves 28 USC §1498(a). This is a little-known statute governing patent infringement activities by the United States government and the requirement to adjudicate such suits in the specially-created Court of Federal Claims. See Iris Corp. v. Japan Airlines Corp., 769 F.3d 1359, (Fed. Cir. October 21, 2014). […]

The Supreme Court is currently scheduled to take on only one patent case this upcoming term. On October 15th, the Court will hear oral arguments in Teva Pharm. USA, Inc. v. Sandoz, Inc., No. 13-854. This is an appeal dealing with important issues of patent claim construction. The central question before the Court is whether a district court’s factual findings on claim construction may be reviewed de novo by the Federal Circuit.

On March 4th the US Patent and Trademark Office issued guidelines to its examining corps for assessing patent eligible subject matter under 35 USC §101. The guidelines were issued in light of the Supreme Court’s decisions in Myriad, Prometheus, and related cases. See, “Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.” The Guidance is intended to help examiners determine whether the subject matter of a patent claim is significantly different from what exists in nature.

Some fashion trends may come and go, but in the not too distant future the majority of prescription drug sales will be purple.1 For those of you not yet familiar with this latest trend, allow me to explain.

Most drug products are small, synthetically produced substances. The common pain reliever ibuprofen, for example, contains only 33 atoms and has a molecular weight of 206. In contrast, there is a whole new class of complex drug products that are isolated or produced from biological sources such as living cells. These biologically produced drugs, more commonly called “biologics”, are orders of magnitude larger than their small molecule cousins and present special challenges in their preparation, isolation, and administration. Insulin is a common example of a biologic. It is a protein having a molecular weight of approximately 5800. Another example is the hormone erythropoietin (or “EPO”), which is used to treat anemia. EPO is a far larger biological drug with a molecular weight of nearly 35,000.

Naturally abundant, stable isotopes have already protected the identity and origin of $1.5 billion in pharmaceutical materials against intellectual property infringers. In an effort to find a simple, accurate way to unequivocally identify and secure the origins of drugs and other compounds, a Niantic, Connecticut-area scientist developed an alternative, finding a way to use the naturally occurring molecular fingerprint of drug products, active pharmaceutical ingredients and their synthetic pathways to help biotech and pharmaceutical companies enforce their hard-won patent rights against counterfeiters and other bad actors looking to profit by stealing intellectual property.

Last week I reported The Supreme Court unanimously decided that computer implemented business methods are not patent eligible subject matter. See Alice Corp Ruling Spells Trouble but There May Be a “Diamond” in the Rough for Business Method, Software, and Biotech Patents. Now, less than a week later the US Patent and Trademark Office (USPTO) has issued an instruction memorandum to its Patent Examining Corps for analyzing patent claims involving abstract ideas. See USPTO Preliminary Examination Instructions.