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The Peril Of Claim Drafting in Pharma


Wednesday, January 20, 2021
As a non-precedential decision on claim construction, 
Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc., may not be relevant to any other case, but it caught my attention as an example of the perils of claim drafting. Claim language mirroring language in the specification that the examiner considered without difficulty during prosecution was held indefinite as being “nonsensical.”
The Claim Language At Issue
The claim language at issue is found in claim 1 of U.S. Patent No. 9,220,698, which is partially reproduced below with emphasis added:
1. A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis comprising orally administering to a patient in need thereof an AM unit dose form and … a PM unit dose form, wherein: ....

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Horizon Pharma, Inc. v. Dr. Reddy's Laboratories Inc. (Fed. Cir. 2021) | McDonnell Boehnen Hulbert & Berghoff LLP


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Indefiniteness under U.S. patent law is a failure to satisfy the statutory requirements of 35 U.S.C. § 112(b), which reads:  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 (emphasis added).  The meaning of the statute was most recently explicated by the Supreme Court in
Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014), which established the standard that the inherent imprecision of language cannot create ambiguity . . . so great that it creates a zone of uncertainty around the patent claims.   In practice, this led the Court to require reasonable certainty in claim language, a standard the patent claims at issue failed to satisfy in the Federal Circuit s recent decision in ....

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Federal Circuit Sides with District Court, Rules Pharma Patent Claims Indefinite


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January 8, 2021
On Wednesday, an opinion was issued in a Federal Circuit case brought by Horizon Pharma, Inc. against Dr. Reddy’s Laboratories, Inc. The case originated with two patent claims that were invalidated for indefiniteness after a summary judgment motion in the District of New Jersey. The claims both concerned the timed release of drugs used in the treatment of osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis.
The opinion explained that non-steroidal anti-inflamatory drugs (NSAIDS) are used in the treatment of a variety of conditions involving pain or inflammation. However, taking these drugs directly frequently causes gastro-intestinal complications as well as spikes in the amount of relief immediately after taking the medication, while causing ebbs toward the end of the dose period. Typical solutions for these issues have involved delivery methods that moderate the amount that is released into the patient over a lon ....

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