Invalidation of Patents through Indefiniteness 

The latest case of Horizon Pharma vs. Dr. Reddy touches upon an important aspect of drafting the specification and indefiniteness in the US Patent Law. 35 U.S.C. § 112(b), which says that the specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

An important part arises which specifies the reasonable certainty in the claim language which is expected from the patent application thereby, not making it under the zone of uncertainty.

Point of Dispute

Horizon Pharma's U.S. Patent Nos. 9,220,698 and 9,393,208 were primarily in question. The patent primarily dealt with combination therapy of a non-steroidal anti-inflammatory (NSAID) medication and a proton-pump inhibitor (PPI) that minimized the gastrointestinal complications of NSAID administration.

The issue was raised concerning claim 1 of 698 patents. The claim substantiated itself with the word 'Target' that was primarily used to explain the efficacy of the drug. The defendant contended this particular patent being invalid for indefiniteness thereby, creating a zone of uncertainty.

The United States District Court affirmed the defendant's contention that these patents were invalid for indefiniteness. And the basis of the decision was the term 'target'. The patentee's claim of alternative construction to replace the word "Target" with "Produce" was also rejected. The Court held that even though the goal was visible but the 'act of targeting the goal was not', since the pills could not be said to set the goals.

The District Court found that the differing views of plaintiff's and defendant's experts as to the meaning of the term did not raise issues of material facts because the dispute involved opinion and not fact.

The decision was appealed to the Federal Circuit who reiterated the District Court's reasoning of taking the meaning of the word target not more than its ordinary meaning i.e. set as a goal. The court affirmed- "the claim term 'target' is a commonly understood word, and nothing Appellants point to in the specification or the prosecution history suggests that it should be given anything other than its ordinary meaning".

The court also reiterated the decision of Supreme Court in Nautilus, Inc. v. Biosig Instruments, Inc., (572 U.S. 898, 910 (2014)), and construed that "one circumstance in which claims are indefinite is where the claims, as properly construed, are nonsensical". The word target in claim 1 renders the patent as indefiniteness.

The Appellate Court agreed with the District Court that a dispute between experts does not raise a genuine issue of material fact that would preclude summary judgment. The panel therefore affirmed the construction and the District Court's decision that the claims were indefinite and consequently invalid.