Last Week in the Federal Circuit (September 28 – October 2): Product-by-Process Methods of Treatment

The Supreme Court is abuzz, kicking off a new term this morning and announcing several cert grants last week.  Things have been calmer across town at the Federal Circuit—which, unlike the Supreme Court, has been working all summer.  The Federal Circuit issued only three precedential opinions last week and accounted for none of the recent cert grants.  Below we provide our usual weekly statistics and our case of the week—our highly subjective selection based on whatever case piqued our interest.

Precedential opinions: 6

Non-precedential opinions: 3

Rule 36: 0

Longest pending opinion from argument: Biogen MA Inc. v. EMD Serono, Inc., No. 19-1133 (206 days)

Shortest pending opinion from argument: Mote v. Wilkie, No. 19-2367 (55 days)

Case of the week:  Biogen MA Inc. v. EMD Serono, Inc., No. 19-1133 (Sep. 28, 2020)

Panel:  Judges Newman, Linn, and Hughes, with Judge Linn writing the opinion.

You should read this case if:  you have a novelty challenge to a “product by process” claim.

The Federal Circuit has a rule for “product by process” claims: An old product is not patentable even if it is made by a new process.  For example, a manmade version of a naturally occurring protein is not a patentable composition.  But what if the manmade protein is used in a method of treatment?  Is a method of treatment novel if it uses an old product made by a new process?  In our case of the week, the district court said “yes” but the Federal Circuit says “no.”

Biogen owns a patent for a method of treating conditions like multiple sclerosis with a recombinant (lab-produced) version of a protein called interferon-beta.  This method, Biogen says, has advantages over using naturally occurring interferon-beta (for one, the natural version is scarce).  Biogen accused EMD Serono and Pfizer of infringing the patent with the sale of Rebif, a recombinant interferon-beta drug used to treat multiple sclerosis. 

The jury found the claims anticipated because using naturally occurring interferon-beta to treat viral diseases was known in the prior art.  The district court, however, disagreed and granted judgment as a matter of law.  The prior art, the district court reasoned, did not address the use of lab-made interferon-beta.  And the product-by-process doctrine, in the district court’s view, governs only claims to a product, not claims to a method of treatment.

The Federal Circuit reversed.  The only difference between the claimed invention and the prior art was the use of interferon-beta produced in a lab rather than in the human body.  And under the product-by-process doctrine, patentability turns on the product, not the process.  So in the Federal Circuit’s view, the “key” to the anticipation inquiry is that the “recombinant product is identical to the prior art product.”

Although composition and method-of-treatment claims are often analyzed differently, the Federal Circuit saw no reason to do so here.  The court saw this method-of-treatment claim as containing a “nested” product-by-process limitation.  Burying a product-by-process limitation within a claim “does not change the proper construction of the product-by-process limitation itself.”  The upshot: An “old method of administration of an old product made by a new process is not novel and cannot be patented.”

The court went on to reject Biogen’s arguments that even under a product-by-process analysis, the products were not identical.  In Biogen’s view, recombinant and native interferon-beta are identical only if they have matching three-dimensional shapes—which the jury had insufficient evidence to find.  The court, however, saw no basis in the claims, specification, or jury instructions to focus on three-dimensional structure.  That case-specific resolution leaves open to future patentees to argue that recombinant proteins are not identical to their native counterparts if their three-dimensional shapes differ.

Michael F. Qian is the author of this blog post. He is an associate in our Appellate + Supreme Court practice.