Expanding the Reach of Pharmaceutical Patents: Generic Manufacturer Held Liable For Inducing Infringement By Physicians and Patients

By W. John Keyes, Ph.D.. A member of our Patent Practice Group

Pioneer pharmaceutical firms are sure to welcome the boost to their patent portfolios resulting from a recent opinion by the Court of Appeals for the Federal Circuit.  In the wake of Eli Lilly v. Teva, infringement may now be found even where the defendant follows none of the steps in a patented method of treatment and no single actor performs all the steps of that method of treatment. Depending on the wording of the patent claims and the content of the prescribing information provided with their products, generic pharmaceutical manufacturers might not escape liability even if some steps of the method are performed by physicians and others by patients.

The claims of Eli Lilly’s patent are directed to methods of administering the chemotherapy drug pemetrexed after pretreating a patient with two common vitamins –folic acid and vitamin B12.  The pretreatment is designed to reduce the toxicity of pemetrexed.  Eli Lilly markets pemetrexed under the brand name ALIMTA®, and the drug is used to treat certain types of lung cancer and mesothelioma.

The patent owner sued a number of generic pharmaceutical manufacturers, including Teva, to prevent their launch of a generic version of ALIMTA® with accompanying product literature that would allegedly infringe methods of treatment claimed by the patent.  The district court found that no single actor performed all the steps of the asserted claims because the actions of both physicians and patients were required.  Nonetheless, by applying the theory of divided infringement, the court attributed direct infringement to physicians and held the generic manufacturers liable for inducing that infringement.

As for the pretreatment of patients with folic acid and vitamin B12, physicians administered the vitamin B12 (and the pemetrexed), while patients self-administered folic acid with guidance from physicians.  The judicial analysis therefore weighed liability under a theory of divided infringement, an area of law which has recently undergone important developments.

Specifically, the Akamai V decision (2015) has broadened the circumstances in which others’ acts may be attributed to a single actor to support direct-infringement liability.  The Federal Circuit held that one person can be deemed accountable for directing or controlling another person’s performance if the first person (1) conditions participation in an activity or receipt of a benefit upon the performance of one or more steps of a patented method, and (2) establishes the manner or timing of that performance.  The question in Eli Lilly v. Teva thus became: Did physicians direct or control patients to self-administer folic acid within the meaning of this two-part test? More...

A State University’s Patents May be Immune From PTAB Review

By Nancy Wilker, Ph.D and W. John Keyes, Ph.D.

Members of our Patent Practice Group

Since its introduction in 2012, inter partes review (IPR) has provided a relatively efficient means of challenging an issued patent on the basis of lack of novelty or obviousness.  Instead of challenging the patent in a court of law, a party can now petition the Patent Trial and Appeal Board (PTAB) to initiate an IPR.

IPR proceedings are heard by a panel of administrative law judges from the PTAB who decide whether to institute a review.  If one is instituted, they eventually issue a final decision on patentability of the challenged patent.

This powerful tool has become so popular that it is almost universally employed by parties defending against patent-based lawsuits. Consumer electronics giants have enthusiastically embraced IPRs as a means for challenging patents. Apple alone has filed more than 200 IPR petitions.  The automotive and pharmaceutical industries also have leveraged this tool extensively.

It appears now there are limits.  In its January decision in Covidien LP v. University of Florida Research Foundation Inc., the PTAB ruled that patents held by certain state-affiliated institutions are immune from challenges in IPR proceedings because of the protection afforded by the Eleventh Amendment of the US Constitution.

That amendment provides that the “Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.”

The Eleventh Amendment has been interpreted broadly.  For example, in Federal Maritime Commission v. South Carolina State Ports Authority, the Supreme Court determined that it precludes certain adjudicative administrative agencies organized under Article I of the Constitution, such as the Federal Maritime Commission (“FMC”), from adjudicating complaints filed by a private party against a non-consenting state. More...

Non-Infringing Parties May Be Able to Challenge a Patent in an IPR, but Not Appeal the Result

By Brandon Scruggs. A member of our Litigation Practice Group

A recent court decision leaves some patent challengers using the inter-partes review (IPR) process facing a conundrum: They may be allowed to challenge a patent’s validity in an IPR, but not to appeal an adverse result.

The IPR is a procedure for challenging the validity of a U.S. patent on the basis of it being either anticipated or obvious in light of prior art.  A challenge can be made by any third party who requests the Patent Trial and Appeal Board (PTAB) to initiate an IPR.  The PTAB will initiate the IPR if it believes that there is a reasonable likelihood that the challenger will prevail with respect to at least one challenged claim.

Phigenix, Inc. sought an IPR of a U.S. patent owned by ImmunoGen, Inc. covering methods for treating certain cancers. Phigenix alleged that certain claims were unpatentable as obvious over various prior art references.

The PTAB instituted an IPR and eventually issued a final decision that the claims are valid and non-obvious. When Phigenix appealed, the Federal Circuit dismissed the appeal for lack of standing.

One of the elements of standing, a constitutional requirement for federal court, is “injury in fact.” This means that a party appearing in federal court must point to an injury that exists or is imminent and is particularized (i.e., that it affects that party in an individual way).  By contrast, to appear before an administrative agency like the PTAB, constitutional standing is not necessarily a requirement.

In Phigenix, Inc. v. ImmunoGen, Inc., the Federal Circuit addressed the legal standard for demonstrating standing in an appeal from a final agency action, something the court had not done in the 35 years of its existence.

First, the court decided that where a party seeks review of a final agency action and its standing comes into doubt, the party must supply good evidence of specific facts to support its standing.  Second, a party who appeals an IPR must demonstrate standing at the earliest opportunity, generally in response to a motion to dismiss the appeal or in its opening brief.

A party’s standing can be “self-evident” in some cases, said the court, like when the patent owner has accused the party of infringement. Otherwise the party pursuing an appeal must demonstrate its standing.  To do so, it may proffer arguments, affidavits or other evidence, whether already in the record in the IPR or supplied during the appeal itself.

Did Phigenix have standing to appeal?  Phigenix admitted it did not manufacture any products, so it could not claim that it faced any risk of infringing ImmunoGen’s patent.  Indeed, Phigenix could point to no business plans that would involve the patent. (More...)