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INTELLECTUAL PROPERTY Biotechnology Patents Christine R. Ethridge © 2008 Kirkpatrick & Lockhart Preston Gates Ellis LLP.

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Presentation on theme: "INTELLECTUAL PROPERTY Biotechnology Patents Christine R. Ethridge © 2008 Kirkpatrick & Lockhart Preston Gates Ellis LLP."— Presentation transcript:

1 INTELLECTUAL PROPERTY Biotechnology Patents Christine R. Ethridge © 2008 Kirkpatrick & Lockhart Preston Gates Ellis LLP

2 2 Introduction Patent: What is it?  A patent is a right granted by a government for a limited period of time to prohibit others, without authority, from making, using, offering for sale, selling, or importing into the granting country the subject matter claimed in a patent.  The right is granted in exchange for disclosing to the public the details of the invention.

3 3 Constitutional Authorization  The U.S. Constitution gives Congress the power: [to] promote the Progress of Science and useful Arts by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. (Article I, Sec. 8, clause 8)

4 4 Implementing Legislation  The first patent Act was passed in 1790.  The current Statute was enacted in 1952, but has been amended several times.  The U.S. Senate is considering Senate bill (S.1145), which if passed, would be the most significant changes to the patent law in more than 50 years. The patent reform legislation may be up for a vote in the next 2-3 weeks.

5 5 Patents: Background of Biotech Patents 1873 – U.S. Patent No. 141,072 issued to Louis Pasteur for “yeast, free from organic germs of disease, as an article of manufacture”. 1877 – U.S. Patent No. 197,612 issued to Cutler for vaccine prepared by pulverizing pustules and mixing with lymph. 1970’s - U.S. Patent Office adopted an administrative interpretation of the law excluding patents on living matter. 1980 – U.S. Supreme Court, in a 5-4 decision, in Diamond v. Chakrabarty, 447 U.S. 303 (1980) ruled that claims to a bacterium containing two stable energy generating plasmids, and an inoculation containing the bacterium and a carrier were a composition of matter and an article of manufacture under §101 of the Patent Act.

6 6 Diamond v. Chakrabarty  Diamond v. Chakrabarty, 447 U.S. 303 (1980)  Justice Burger, writing for the majority, quoted Thomas Jefferson’s philosophy that “ingenuity should receive liberal encouragement”, and the legislative history of the 1952 Patent Act that statutory subject matter should “include anything under the sun that is made by man.”  The inventor produced a new bacterium with markedly different characteristics from any found in nature. The discovery was not nature’s handiwork, but his own; therefore, it was patentable subject matter under §101.  On March 31, 1981, U.S. Patent No. 4,259,444 issued to Ananda Chakrabarty for a single cell life form.

7 7 Legal Framework  US Constitution  Federal Statute – United States Code, Title 35  Regulations – Code of federal Regulations, Title 37  Agency Procedures – U.S. Patent & Trademark Office Manual of Patent Examining Procedure (MPEP) and Agency decisions in appeals  Federal Court decisions and interpretations of statute  U.S. District Courts, Federal Circuit (CAFC), U.S. Supreme Court  International Treaties  Paris Convention  Patent Cooperation Treaty  Federal Statutes implementing US adherence to Treaties

8 8 Where to File: Jurisdictions  A patent is enforceable in the jurisdiction (country) in which it is acquired.  Each country has different laws, infringement statutes and enforceability issues.  Patents are available in countries world-wide.  Patents may be obtained by filing directly in a jurisdiction or by filing in a regional authority, and later entering individual nations or sub-regional authorities.

9 9 Where to File: Jurisdictions  National Patent Offices, e.g., the U.S. Patent & Trademark Office, see http://www.uspto.gov  The Paris Convention provides that a patent application can claim priority to an earlier application filed in a different member country so long as the second application is filed within one year of the first.  The Patent Cooperation Treaty provides a unified means to file an application in a single jurisdiction, obtain a preliminary patentability analysis and later enter into national (or regional) prosecution. see http://www.wipo.int  Regional authorities - European Patent Office (EPO), Eurasian and two African offices (OAPI and ARIPO).

10 10 Procurement: U.S. Application Types  Utility – protects the way in which an invention is made, how it is used or how it functions  Expires 20 years from the effective filing date, or, if filed before 6/8/95, the longer of 17 years from issue or 20 years from the effective filing date.  Design – protects new ornamental design for an article of manufacture.  Expires 14 years from date of grant.  Plant – protects distinct and new plant varieties  Expires 20 years from the effective filing date

11 11 Patent Process Stages: Procurement, Exploitation and Enforcement Conception of idea reduction to practice Prepare and file patent application Prosecute patent application in government Patent Office Patent Issues Market Enforce by litigation & defend against challenges to validity Assign or license to employer or other third party II III Third party Investment or Use as collateral I

12 12 US Utility Applications Non-Provisional Provisional Claims requiredNo Claims necessary (but recommended) Filing fee is currently $1,030*(large entity); $515*( small) plus extra claims fees (>3 indep., $210; >20 total, $50 (L)) Filing fee is much less $210 (large entity); $105 (small) Will be examined and can mature into patent *part of filing fee is for search ($510 (L)) and examination ($210 (L)) Will not be examined and expires one year from filing. Non-provisional claiming priority to the provisional must be filed within one year. Must satisfy invention disclosure requirements of §112, first paragraph of Patent Statute Must satisfy invention disclosure requirements of §112, first paragraph with respect to claims of the eventual non-provisional

13 13 Format of Utility Application  Specification  Background (optional)  Summary of the Invention  Brief description of the Drawings, if present  Detailed description of the invention, how to make and use it, and best mode of practice  Sequence Listing for amino acids and nucleotides  Claims – define the invention  Drawings, if necessary to understand the invention  Abstract

14 14 On what terms? In the United States, a patent will be granted on an application filed by (1) the first inventor of the claimed invention, (2) if the invention falls within the scope of the subject matter Congress has determined is deserving of patent protection, (3) if the invention is useful, novel and non obvious, and (4) if the invention is described in the manner required by statute.

15 15 Claim Utility and Subject Matter: 35 U.S.C. §101 Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor….

16 16 Patent Claims – Examples (Process) 1. A method of reconstituting a non-human mammalian embryo, comprising a. transferring the nucleus of a quiescent diploid donor cell into a suitable enucleated recipient cell of the same species, thereby obtaining a reconstituted cell; b. activating the recipient cell before, during or after nuclear transfer; c. incubating the reconstituted cell such that an embryo develops.

17 17 Patent Claims – Examples (Machine) 1. A sample retrieval apparatus comprising: a support platform; a support translation member for moving the support platform to designated coordinates on X and Y axes; a plurality of cutter members on the support platform; a cutter translation assembly for moving a selected one of the cutter members to designated positions on a Z axis, said Z axis lying in a plane perpendicular to the support platform; and, a controller for designating the X, Y axis coordinates of the support platform and the Z axis positions of the cutter members.

18 18 Patent Claims – Examples (Article of Manufacture) 1.A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage. 6. The mammal of claim 1 wherein said oncogene sequence comprises a coding sequence of a c-myc gene. 7. The mammal of claim 1 wherein transcription of said oncogene sequence is under the control of a viral promoter sequence. 8. The mammal of claim 7 wherein said viral promoter sequence comprises a sequence of an MMTV promoter. 9. The mammal of claim 7 wherein said viral promoter sequence comprises a sequence of an RSV promoter.

19 19 Patent Claims – Examples (Composition of matter) 1. A multichromophore complex comprising: i)a first fluorochrome having first absorption and emission spectra; ii)a second fluorochrome having second absorption and emission spectra, the wavelength of the emission maximum of said second fluorochrome being longer than the wavelength of the emission maximum of said first fluorochrome, and a portion of the absorption spectrum of said second fluorochrome overlapping a portion of the emission spectrum of said first fluorochrome; iii)at least one linker group of between 2 and 20 bond lengths for covalently attaching said first and second fluorochromes for transfer of resonance energy between said first and second fluorochromes; iv)at least one bonding group capable of forming a covalent bond with a target compound; wherein said first or second fluorochromes are selected from the group consisting of polymethine cyanine dyes, monomethine rigidized cyanine dyes, fluorescein, pyrene trisulphonate, rhodamine, and bispyrromethine boron difluoride dyes, wherein at least one of said first or second fluorochromes is a cyanine dye, and the combined molecular weight of said first or second fluorochromes and said linker group in each of said complexes is less than 20,000 Daltons.

20 20 Patent Claims – Examples (Composition of matter) A water soluble luminescent dye consisting of a cyanine having the structure: wherein: the dotted lines each represent carbon atoms necessary for the formation of one ring to three fused rings having 5 to 6 atoms in each ring and said R3, R 4 groups are attached to said rings X and Y are each CH3 --C--CH3 ; m is an integer selected from the grouping consisting of 1, 2 and 3; at least one of said R1, R2, R 3, R4 and R7 groups reacts with amino, hydroxy or sulfhydryl nucleophiles and is a reactive moiety selected from the group consisting of ….

21 21 On what terms? In the United States, a patent will be granted on an application filed by (1) the first inventor of the claimed invention, (2) if the invention falls within the scope of the subject matter Congress has determined is deserving of patent protection, (3) if the invention is useful, novel and non obvious, and (4) if the invention is described in the manner required by statute.

22 22 Who is an Inventor?  Inventorship Guidelines  An inventor is a person who conceives an invention claimed in a patent application or patent, not someone who only reduces an invention to practice.  A person is not an inventor simply because he or she is the boss, a friend, a deserving colleague or employee, or a project financier, or because he or she has toiled a complete lifetime developing an invention conceived by another in an instant.

23 23 Inventorship: Conception  Conception occurs when an inventor has a definite and permanent idea of an operative invention, including every feature of the subject matter sought to be patented.  Conception does not exist when the viability of the invention is uncertain. Often experimentation is needed to confirm the invention’s viability. In that case, conception occurs at the same time the invention is “reduced to practice.”  Conception does not include suggesting to another a problem and/or a desired result.

24 24 Inventorship: Collaboration Conception can be collaborative and does not require physical presence between collaborators, or even that they discuss the invention at the same time.

25 25 Inventorship  Proposed reforms would conform U.S. law to foreign law where patents go to the first to file the application rather than the first to invent.  Under the reforms, the correct inventors would still have to be named.

26 26 On what terms? In the United States, a patent will be granted on an application filed by (1) the first inventor of the claimed invention, (2) if the invention falls within the scope of the subject matter Congress has determined is deserving of patent protection, (3) if the invention is useful, novel and non obvious, and (4) if the invention is described in the manner required by statute.

27 27 Novelty of Claimed Invention: 35 U.S.C. §102 A person shall be entitled to a patent unless the invention -was known or used by others in this country, -patented or described in a printed publication in this or a foreign country either before the invention thereof by the applicant or more than one year prior to the date of the application -in public use or on sale in this country more than one year prior to the date of the application for patent in the United States

28 28 Novelty (continued) A person shall be entitled to a patent unless the invention - was first patented by the applicant in a foreign country prior to the date of application for patent in this country on an application for patent filed more than twelve months before the filing of the application in the United States - was described in a published application or patent by another filed in the United States before the invention by the applicant - was not invented by the applicant

29 29 Novelty (continued) US: One Year Grace Period Applications for patent in the United States must be filed within one year of any of:  the first offer for sale  the first sale  the first public disclosure  the first public use of the invention

30 30 Novelty (continued) Absolute Novelty Outside the United States If patent protection outside the United States is desired, then the US patent application has to be filed before any of the foregoing events.

31 31 Novelty (continued)  Known is interpreted to mean “publicly known”. Private or secret knowledge is not public.  To anticipate a claim, a single reference which is available to the public as prior art must contain, expressly or inherently, all of the elements of the claim.

32 32 On Sale and Public Use Bar Under § 102(b)  § 102(b) is intended to encourage prompt filing of patent applications. The term “on sale” includes offers to sell, presentations or promotions for the purpose of a sale or other activities intended to lead to a sale.  An offer for sale may trigger § 102(b) even though no details of the invention are disclosed and even though the invention has not been reduced to practice, or made.

33 33 On Sale and Public Use Bar Under § 102(b)  There is no exception even though the sale is made by another who is not the inventor and who is not authorized by the inventor to make the offer or sale.  A commercial use by the inventor, even if secret, constitutes a bar under §102(b). A secret use by the inventor of an invention for its intended purpose triggers the public use bar.  However, a secret commercial use by one other than the inventor is not a public use.

34 34  An experimental use is an exception to the public use bar.  Activities that are experimental, i.e., those intended to test the invention to see if it works for its intended purpose, are not public uses for purposes of §102(b). Experimental Use Exception to Public Use Bar

35 35 Things not to do before filing  Publish manuscript, paper or thesis – beware of early electronic publishing  Disclose invention in a presentation  Discuss with anyone without a confidentiality agreement  Offer for Sale or other commercial activity  Submit a non confidential grant application  All parties privy to invention (employees, research partners and sales force) must be advised adequately of, and be subject to, confidentiality requirements  Use Invention for its intended purpose.  Engage in Experimentation without meticulous record keeping of activities and results

36 36 Non-Obviousness of Claimed Invention 35 U.S.C. §103 A patent may not be obtained if the differences between the subject matter sought to be patented and the prior art would have been obvious at the time the invention was made to a person of ordinary skill in the art to which the subject matter pertains.

37 37 Non-Obviousness (continued)  In Graham v. John Deere & Co., 383 U.S. 1 (1966), the Supreme Court held that, under 35 U.S.C. §103,  “the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art are resolved. Against this background, the obviousness or non-obviousness of the subject matter is determined. Such secondary considerations as commercial success, long felt but unresolved needs, failure of others, etc. might be utilized to give light to the circumstances surrounding the original of the subject matter sought to be patented. As indicia of obviousness or non- obviousness, these inquiries may have relevancy.”

38 38 Non-Obviousness (continued)  The CAFC developed the “teaching, suggestion, or motivation” test to evaluate questions of obviousness.  The TSM tests asks:  whether the prior art provided some motivation or suggestion, expressly or by implication, to combine the prior art teachings to achieve the claimed invention; and  whether the claimed invention achieved more than a combination of any or all of the references suggested.

39 39 KSR International Co. v. Teleflex Inc. The U.S. Supreme Court, in April 2007, rejected the rigid application of the TSM test and reaffirmed the approach taken in Graham v. John Deere & Co.

40 40 What is obvious under KSR?  Combining prior art elements according to known methods to achieve predictable results  Simple substitution of one known element for another to obtain predictable results  Use of known techniques to improve similar devices (methods, or products) in the same way  Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results  “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success  Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or market forces if the variations would have been predictable to one of ordinary skill in the art.

41 41 Nonobviousness after KSR  How To Rebut A Showing Of Obviousness  Rebutting the Functional Test:  The invention is not merely a combination of known elements  The invention has an unexpected result  Rebutting Modified TSM  Rebutting “Obvious to Try”  At the time of the invention, there was not a small number of possible solutions, but a large number or broad range of them.  At the time, the solution chosen did not appear to have a reasonable likelihood of success.

42 42 Scope of Protection Relationship to Prior Art Claimed Invention Prior art

43 43 Duty of Disclosure  Current Law: everyone associated with the preparation and prosecution of a patent application must disclose in Information Disclosure Statements any prior art known to them that is material to patentability. No analysis is required. The failure to do so is inequitable conduct which can invalidate the patent.  Proposed Law: Under patent reform bill S. 1145, nearly every patent applicant will be required to (1) search the prior art and (2) submit a search report and analysis to the USPTO with its patent application.

44 44 On what terms? In the United States, a patent will be granted on an application filed by (1) the first inventor of the claimed invention, (2) if the invention falls within the scope of the subject matter Congress has determined is deserving of patent protection, (3) if the invention is useful, novel and non obvious, and (4) if the invention is described in the manner required by statute.

45 45 Description Requirements 35 U.S.C. §112, 1 st and 2d Paragraphs Disclosure and Claiming Requirements:  Description of the Invention.  Manner and Process of Making and Using the Invention Sufficient to Enable One Skilled in the Art to Make and Use the Claimed Invention  Best Mode  Claiming with Particularity and Distinctness

46 46 Written Description To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time the application was filed.

47 47 How do you show possession of the invention?  By describing the claimed invention with all of its limitations using: words, structures, figures, diagrams, and formulas.  An applicant is not required to disclose every detail of an invention.  The disclosure obligation varies with the maturity of the art to which the invention pertains.  It is better to err on the side of over-inclusiveness and over-description. The unacceptable alternative is non allowance or an unenforceable patent.

48 48 Examples of Showing Possession  Tests of the claimed composition to show its properties.  For biomolecules, by identifying characteristics, such as a sequence, structure, binding affinity, binding specificity, molecular weight and length, unique cleavage by particular enzymes, detailed restriction enzyme maps, isoelectric points, and antibody cross-reactivity.  For generic elements, by disclosure of a representative number of species where the common attributes are either known or identified in the specification.

49 49 Sequence Listings For purposes of uniformity in patent documents and to enable accurate classification and searching, information provided about nucleic acid and amino acid sequences must conform to internationally recognized standards and symbols.

50 50 Enablement “The specification shall contain a written description … of the manner and process of making [the invention], in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same,..”

51 51 Enablement (continued) The test for enablement is whether one reasonably skilled in the art could make and use the full scope of the claimed invention from the disclosures in the patent, at the time the application was filed, coupled with information known in the art without undue experimentation.

52 52 Enablement: What is undue experimentation? The test is not whether any experimentation is necessary or even complex, time consuming or expensive – it is whether the experimentation is undue.

53 53 Enablement: Correlation of Animal Models  There must be correlation between in vivo or in vitro animal model assays or treatments with the claimed use.  If there is a known correlation of the disclosed animal model to a particular human condition, then an example using that animal model will constitute a working example.  Without a known correlation, the example alone does not correlate and therefore, is not enabling.

54 54 Enablement: Deposit of Biological Materials  A deposit made in a recognized depository (for example, the ATCC) of a viable biological material together with as much information as is possible to permit verification that the deposited material is in fact what is disclosed in the application and to aid in the resolution of infringement questions.  Includes bacteria, fungi, eukaryotic cells, plant tissue cells and cell lines, hybridomas, plasmids, viruses and seeds.  Replacements must be made if needed while application is pending and after patent issues. Deposit must be maintained for 30 years from the date of deposit and at least 5 years after the last request for a sample.

55 55 When Deposit Is Not Required  Biological Materials need not be deposited if they are known and readily available to the public.  If the material and its natural location can be adequately described so that one skilled in the art could obtain it using ordinary skill, §112 is satisfied.  Specification may adequately instruct on how to make the biological material. Proof of ease of manufacture of biological material is helpful. For instance, an example may be provided showing a particular cell line was made successfully on multiple occasions and/or multiple clones meeting the claim were made in one experiment.

56 56 Best Mode  Must disclose the best way known by the applicant of practicing the invention at the filing date of the application.  Cannot keep best way of practicing the invention as a trade secret and also obtain a patent.

57 57 Scope of Protection Relationship to Description Initial discovery or conception Description and additional work expands scope Claims commensurate with description and equivalents (enabled – valid) Claims broader than description (not enabled – invalid)

58 58 Enforcement: 35 U.S.C. §154  Every patent grants to the patentee, the right to exclude others from: - making, using, offering for sale, or selling the invention throughout the United States or - importing the invention into the United States.  If the invention is a process, the right to exclude others from - using, offering for sale or selling throughout the United States, or - importing into the United States, products made by that process.

59 59 Infringement : 35 U.S.C. §271 Direct Infringement whoever without authority - makes, - uses, - offers to sell, - sells - imports into the United States any patented invention during the term of the patent infringes the patent.

60 60 Infringement (continued) Inducement to Infringe Whoever actively induces infringement of a patent shall be liable as an infringer.

61 61 Infringement (continued) Contributory Infringement Whoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial non- infringing use, shall be liable as a contributory infringer.

62 62 The Methodology Of Determining Infringement Of A Properly Construed Claim  The claims of a patent are the operative language for purposes of determining infringement.  The claims, as properly construed in light of the specification and the prosecution history, must be compared to the accused device, process or composition.  To be a literal infringement, every limitation of the construed claim must be found in the accused device, process or composition.

63 63  A device that does not literally infringe the express terms of a patent claim limitation (or element) may nonetheless be found to infringe under the doctrine of equivalents if there is equivalence between the element of the accused device and the claimed element of the patented invention.  One test deemed suitable for analyzing equivalence is the "function-way-result" comparison between the accused device and each of the claimed elements.  The doctrine of equivalents analysis asks whether the accused device is substantially different from the claimed device. Infringement Under the Doctrine of Equivalents

64 64 Exceptions and Exemptions  Inequitable conduct during prosecution rendering the patent unenforceable (failure to disclose prior art, false or misleading arguments)  The Drug Price Competition and Patent Term Restoration Act for 1984 §271(e); and The Generic Animal Drug and Patent Term Restoration Act of 1988 --35 U.S.C. §271(e)(1)- (narrow exception relating to FDA submissions)  Medical Practitioners Exemption – 35 U.S.C. §287(c)  Experimental Use Defense, Madey v. Duke University, (Fed.Cir.2002), (limited to philosophical inquiry, does not immunize any conduct that is in keeping with the alleged infringer's legitimate business)  Research and experimentation in plant breeding (7 U.S.C § 2544)  Laches (Delay in enforcement)

65 65 Remedies: 35 U.S.C. §284  Damages must be adequate to compensate for the infringement,  no less than a reasonable royalty  lost profits plus  interest and costs as fixed by the court.  The court may treble the damages for willful infringement.  Attorneys’ Fees for Exceptional Cases  Injunction against further infringement under certain, increasingly rare circumstances

66 66 Contact information Christine R. Ethridge Kirkpatrick & Lockhart Preston Gates Ellis, LLP Henry W. Oliver Building 535 Smithfield Street Pittsburgh, PA 15222-2312 (412) 355-8619 (412) 355-6501 (fax) christine.ethridge@klgates.com


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