Bio/Pharma Patentee Challenges Ahead

As discussed last week, the USPTO’s Patent Trial & Appeal Board (PTAB) offers significant benefits to generic drug companies seeking to enter the market of a branded competitor. That is, the PTAB offers a short circuit to expensive district court litigation for challenging high value drug patents.

In addition to the proceedings discussed last week, three recent PTAB decisions involving DNA sequencing patents owned by the Trustees of Columbia University in the City of New York, the PTAB cancelled all challenged claims in the three patents, IPR2012-0006 and 00007 and IPR2013-00011. While not technically drug patents, their fate is indicative of what the drug industry faces in PTAB challenges. 

Unlike most patentees, drug companies have an advantage, the FDA statutory scheme governing generic drug applications. By statute, 21 USC 355(j)E(ii) a generic company cannot file an Abbreviated New Drug Application (ANDA) until four years after a New Drug Application (NDA) is approved if the FDA determines it involves a new chemical entity, the NCE exclusivity. While 35 USC 217(e)(1) provides a “safe harbor” allowing the generic companies the ability to develop their generic drug which by law must use the same active drug, § 271(e)(2) makes the filing of an ANDA a technical act of infringement. Thus, the patentee has a minimum of years in which to take action to protect its intellectual property rights, usually the FDA gives an indication that it will approve a new drug prior to the official approval date.

Most patentees prepare for the almost certain ANDA litigation by gathering and reviewing files and interviewing inventors to learn about any potential problems in their patents. Unfortunately it is rare that a patentee takes preventive action regarding the patent claims themselves. With the emergence of the fast-track PTAB challenges, this preventive care is now more critical than ever.

The FDA drug statute, 21 USC 355, provides drug patentees with a rare opportunity to take preventive measures. First, the FDA does not approve drugs per se; the FDA approves the use of a specific compound, the drug, to treat a particular disease, an indication in FDA language. The §355 requires that any ANDA applicant must use the same chemical compound, the drug, as in the approved NDA and must have label identical in all aspects relevant to this discussion, identical that of the approved ethical drug. The drug label specifies the indications for which the drug may be used as well as other information as to the drug’s formula, side effects, contra-indications, etc. Because of these requirements, the ANDA applicant has little chance to design around the approved, except for possibly the inactive excipients in the formulation.

These FDA requirements afford the patentee an opportunity to review their patent portfolio years before litigation to ensure the narrowest possible claims are procured to protect the drug and its indication. Because of the regulatory scheme, pin point claims are very powerful and difficult to design around. By the same token, pin point claims are formidable obstacles even for the challenger friendly confines of the PTAB.

In reviewing a valued portfolio it is now all the more important to cultivate pin point claims as to both the drug and the indication. If only broad claims are present, file a reissue patent application to secure the narrowest possible claims encompassing the drug and the indication (based on the written description and enablement provided in the patent specification). Keep in mind that patent reissue is exceedingly more appealing than attempting amendment before the PTAB.

Indication claims saved Allergan’s exclusivity for its ophthalmic drug Combigan®See Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed. Cir. 2013) re’hrg and re’hrg en banc denied. In Allergan, the Federal Circuit found Allergan’s claims to Combigan® formulation to be obvious but affirmed the district court’s decision that the narrowly drawn method of use (indication) claims were valid. This resulted in Sandoz being enjoined from launching its generic product until the Allergan patent expires since its label must recite the same indication and dosing as Allergan’s.

The advice for drug patentees and NDA holders, review your patent claims early, preferably no later than the NDA approval. If there are no narrowly drawn claims to the drug or its indication, file a reissue to add them if feasible. For those seeking patents on a new drug, remember you paid for 3 independent claims and 20 claims total, use them. Put in claims to the drug, pharmaceutical compositions containing the drug, and methods of using the drug. These will give you flexibility in the future should it be advisable to add narrower claims by reissue.