## Facts

- Human growth hormone (hGH) is a 191–amino acid polypeptide; earlier recombinant methods in bacteria often produced biologically inactive hGH due to an added “leader sequence.”
- Genentech owned two patents relating to recombinant DNA production of hGH: U.S. Patent No. 4,601,980 (methods to express hGH without a leader sequence, including use of an hGH cDNA fragment encoding codons 24–191) and U.S. Patent No. 4,342,832 (recombinant DNA constructs/cloning vehicles used to produce hGH).
- Bio-Technology General Corp. and its affiliate (BTG) manufactured recombinant hGH abroad and sought to import and market it in the United States as “Bio-Tropin,” after obtaining an FDA investigational new drug authorization.
- BTG filed a declaratory-judgment action seeking findings of invalidity, unenforceability, and noninfringement; Genentech counterclaimed for infringement and moved for a preliminary injunction.
- After an evidentiary hearing, the district court found Genentech likely to succeed because BTG’s plasmid construction and hGH production processes were within the literal claim scope of both patents and entered an injunction barring BTG’s U.S. importation and marketing pending trial.
- BTG appealed the preliminary injunction.

## Issues

1. Whether the district court clearly erred in finding a likelihood that BTG literally infringed the asserted claims of the ’980 and ’832 patents, supporting Genentech’s likelihood of success on the merits.
2. Whether BTG’s defenses (including alleged preclusion based on a prior ITC proceeding, laches, and validity/enforceability challenges) raised substantial questions sufficient to defeat likelihood of success.
3. Whether the district court abused its discretion in applying the preliminary-injunction factors (likelihood of success, irreparable harm, balance of hardships, and public interest).

## Decision

- The Federal Circuit affirmed the preliminary injunction.
- The court held the district court did not abuse its discretion in finding Genentech likely to succeed on infringement at this stage, including likely literal infringement of claims directed to leaderless hGH expression and related constructs.
- The court held BTG’s asserted defenses did not defeat Genentech’s likelihood of success, including:
  - No claim-preclusive effect from the cited ITC matter as to this dispute involving BTG’s products and conduct.
  - Laches did not bar preliminary injunctive relief on the record presented.
  - BTG failed to raise a substantial question of invalidity or unenforceability sufficient to overcome the patents’ presumptive validity at the preliminary stage.
- The court agreed Genentech was entitled to a presumption of irreparable harm given its strong merits showing and that BTG failed to rebut it, citing likely hard-to-quantify competitive injuries (market share, price erosion, goodwill, and harm to returns on investment).
- The court upheld the district court’s balancing of hardships and public-interest findings favoring protection of presumptively valid patent rights pending adjudication.

## Legal Principles

- A preliminary injunction in a patent case is reviewed for abuse of discretion; reversal requires an error of law, clearly erroneous fact-finding, or a clear error of judgment in weighing relevant factors.
- A movant must show: (1) likelihood of success on the merits, (2) irreparable harm absent an injunction, (3) balance of hardships favoring the movant, and (4) the injunction serves the public interest.
- At the preliminary-injunction stage, a patent owner may rely on the presumption of validity; the accused infringer must raise a substantial question of invalidity/enforceability to defeat likelihood of success.
- Strong proof of likely infringement and validity can support a presumption of irreparable harm; competitive harms that are difficult to measure can justify injunctive relief.
- Prior administrative determinations do not necessarily preclude later infringement litigation unless the requirements for preclusion (including identity of claims and parties or their equivalents) are satisfied.

## Conclusion

The Federal Circuit sustained a preliminary injunction preventing BTG from importing and marketing recombinant hGH in the United States because the district court reasonably found likely literal infringement of Genentech’s patents, no defense creating a substantial merits doubt, and irreparable competitive injury favoring interim patent enforcement.


Bio-Technology General Corp. v. Genentech, Inc., 80 F.3d 1553 (Fed. Cir. 1996)