Case Background

• MSN seeks to market a generic version of Entresto® (a valsartan-sacubitril complex).
• Novartis sued MSN and other generics for infringing U.S. Patent No. 8,101,659 (“the ’659 patent”).
• The ’659 patent claims a composition where valsartan and sacubitril are administered “in combination.” But it does not specifically claim or describe a “complex” of valsartan and sacubitril.
• The district court construed "in combination" broadly enough to cover complexes.
• MSN argued that the broad interpretation of the ’659 patent was invalid for lack of enablement and written description.

Question for the Supreme Court

• When a patent claim is interpreted broadly to capture technology that did not exist on the filing date, must that patent also enable and describe that later-developed (“after-arising”) technology?

Why This Issue Matters

• If the Supreme Court agrees with MSN, broad claims would be required to satisfy the enablement and written description requirements for an after-arising technology when those claims are asserted against that after-arising technology. This result would significantly diminish the value of broad claims. It is always a good idea to plan strategic follow-on, product-specific patent filings.

Key Lower Court Holdings:

• The district court construed “in combination” to cover complexes. Thus, third parties seeking to market generic Entresto® would infringe.
• The Federal Circuit affirmed that the patent did not need to enable the “complex” because it was unknown at the time the patent was filed. But it reversed district court’s decision on written description, holding that the patent was not required to show the inventor had possession of the “complex” at the time of filing because the complex was not what was claimed.