So we now know as scientists that we can patent microbes that are unlike any microbes found in nature, and cDNA and/or genetically modified DNA/RNA not found in nature. So, let’s say your invention is patentable under 35 USCS § 101. How do you protect the patent that you were awarded? What new or amended laws is the legislature proposing? How are courts interpreting patents in order to determine patent infringement? All of these questions will be answered in this post. First, patent infringement will be defined and broken down into its elements, Second, a bill that the Senate has proposed that modifies the patent infringement statute will be addressed, and third an example of the court interpreting language in the patent will be shown. Enjoy!
The infringement of a patent is a tort. A tort is a wrongdoing that the court offers compensation for if all the elements of the tort are met. These are the elements of patent infringement as provided in 35 USCS § 271:
(1) Whoever without authority
(2) makes, uses, offers to sell, or sells any patented invention,
(3) within the United States or imports into the United States any patented invention
(4) during the term of the patent
therefor, infringes the patent.
Each one of these elements must be met, in order for the inventor to be awarded damages against the patent infringer. If even one of these elements are not met, you will not receive compensation for the alleged infringement.
NEXT, the bill.
There is pending legislation regarding patent infringement. This is language from a bill (113 S. 504) that the Senate introduced March 7, 2013 and it is an amendment to this patent infringement statute:
d) No patent owner otherwise entitled to relief for infringement or contributory infringement of a patent shall be denied relief or deemed guilty of misuse or illegal extension of the patent right by reason of his having done one or more of the following: (1) derived revenue from acts which if performed by another without his consent would constitute contributory infringement of the patent; (2) licensed or authorized another to perform acts which if performed without his consent would constitute contributory infringement of the patent; (3) sought to enforce his patent rights against infringement or contributory infringement; (4) refused to license or use any rights to the patent; or (5) conditioned the license of any rights to the patent or the sale of the patented product on the acquisition of a license to rights in another patent or purchase of a separate product, unless, in view of the circumstances, the patent owner has market power in the relevant market for the patent or patented product on which the license or sale is conditioned.
- (1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
THE PROPOSED AMENDMENT BEING CONSIDERED BY THE SENATE:
(b) Infringement of Patent.– Section 271(e) of title 35, United States Code, is amended by adding at the end the following:
The exclusive remedy under this section for an infringement of a patent for which the Secretary of Health and Human Services has published information pursuant to subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act shall be an action brought under this subsection within the 45-day period described in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal Food, Drug, and Cosmetic Act.”
This means that redress for the patent infringement suit is brought under this statute, 35 USCS § 271 within 45 days.
Lastly, claim construction: the court’s interpretation of specific language found in patent 901.
“Determining whether accused device infringes patent requires two-step analysis: (1) claims of patent must be construed to determine proper scope; and (2) determination must be made as to whether properly construed claims read on accused device and first step of claim construction is question of law for court, only those terms in controversy need be construed, and only to extent necessary to resolve controversy.” Glaxo Group, Ltd. v Apotex, Inc. (2003, ND Ill) 268 F Supp 2d 1013
The following is the specific language in an actual patent, interpreted in Schering Corp. v. Amgen Inc., by the United States District Court for the District of Delaware in 1998:
“A recombinant DNA molecule consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells” is interpreted by the court in Schering:
- A ²recombinant DNA molecule² is a molecule consisting of segments of DNA from different genomes which have been joined end-to-end outside of living cells and they have the capacity to infect some host cell and being maintained therein.
- ²Consisting of² in Claim indicates the claim is closed and no elements not recited in the claim may be included.
- Segments of DNA from different genomes² refer to DNA segment or DNA sequences in genomes of cells or viruses which may be both naturally occurring and non-naturally occurring.
- ²Joined end-to-end outside of living cells² is a structural limitation which may encompass identical products made by different processes.
“Which have the capacity to infect some host and to be maintained therein, and the progeny thereof” interpreted by the court as requiring that the recombinant DNA segments infect the progeny of the host cells, but not necessarily maintained in the host cells.
“A substantially pure DNA sequence . . .said DNA sequences coding on expression for only a single polypeptide chain” is interpreted by the court as well:
Substantially pure DNA . . . coding on expression for only a single polypeptide chain² refers to “a naturally occurring or non-naturally occurring DNA sequence independent of any plasmid DNA in a host cell, which codes on expression for an immature, fused, and/or incomplete form of a naturally occurring, human leukocyte interferon protein, subsequently labeled IFN-a-1.”
18 F. Supp. 2d 372, *400; 1998 U.S. Dist. LEXIS 13421, **85
Thank you for reading my blog today. If I see that there a number of people interested in a particular topic regarding science and patents I will address it on subsequent posts. Happy Saturday!