USA Law and Practice Contributed by: Steven Lieberman, Joseph A Hynds and Jennifer P Nock, Rothwell, Figg, Ernst & Manbeck PC
present in the accused article. When more than one party infringes the patent, there can still be direct infringement if one party directs or con- trols the actions of another. A party induces infringement when it actively and knowingly aids and abets another’s direct infringement. The inducer must have knowl- edge of the patent and actively encourage the acts that result in direct infringement. Induced infringement can result in both parties being jointly and severally liable for the infringement. Contributory infringement involves supplying a component of a patented invention to another party that performs the direct infringement. The component must not be a staple article or com- modity of commerce suitable for non-infringing use, nor can it have substantial non-infringing uses. There are also rules primarily directed to the pharmaceutical industry. A party may engage in activities (such as testing) to support an Abbrevi- ated New Drug Application (ANDA) for a generic version of an FDA-approved drug or a Biolog- ics License Application (BLA) for a biosimilar of an FDA-approved biologic – even if that drug or biologic is patented – without incurring pat- ent infringement liability. However, filing an ANDA or BLA is considered an act of “artificial” infringement if the ANDA or BLA applicant seeks approval to engage in the commercial manufac- ture, use or sale before the patent expiration. The available remedies for patent infringement are discussed in 6. Remedies . 3.3 Process Patents An additional potential form of infringement applies to process patents. If a person makes, uses, offers to sell, sells or imports in the USA a
product made by a process patented in the USA during the term of the patent, the person com- mits infringement under 35 U.S.C. § 271(g). This includes instances where the patented process occurs outside of the USA. 3.4 Scope of Protection for an Intellectual Property Right The scope of protection of a patent is deter- mined by its claims, which describe the extent of the protection sought in a patent application. Often, significant dispute arises when determin- ing the precise meaning of terms or phrases in the patent claims. In 2018, the standard for claim interpretation became more uniform, whether in a district court, the ITC or in a post-grant proceeding at the USPTO. The “Phillips” standard seeks to interpret the claims from the perspective of a person having skill in the relevant art of the invention based on intrinsic and extrinsic evi- dence. Intrinsic evidence includes the patent’s description of the invention, including the claims themselves, and the patent prosecution history. This means arguments and statements made to the USPTO during patent prosecution may limit how claims are interpreted later. Extrinsic evidence includes dictionaries, treatises and expert testimony. Extrinsic evidence can aid the decision-maker’s understanding of how a skilled person would have understood the claims at the time of the invention. During patent prosecution, the USPTO uses a slightly different standard for analysing patent application claims. Generally, the USPTO uses the same types of information described above, but seeks to determine the “broadest reason- able interpretation” of the claims for purposes of issuing patents.
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