PATENTS Flashcards

Question

BIOTECHNOLOGY

Answer 1

- Applying NRDC, biological entities may be patentable if * a human technical intervention has resulted in * the creation of an artificial state of affairs * which does not occur in nature - Issue arises in context of isolating, sequencing, extracting or synthesising genes and genetic material - Rank Hovis McDougall Ltd’s Application (1976) 46 AOJP 3915 * Patenting something that it is a living thing. * any new variants claimed must have improved or altered useful properties and not merely have changed morphological characteristics which have no effect on the working of the organism  Similarly in US: Diamond v Chakrabarty, 447 US 303 (1980) US Supreme Court NOTE: s 18(3)

Answer 2

- Note: * s 18(3): For the purposes of an innovation patent, plants and animals, and the biological processes for the generation of plants and animals, are not patentable inventions.  (4) Subsection (3) does not apply if the invention is a microbiological process or a product of such a process.

Answer 3

18(2): Human beings, and the biological processes for their generation, are not patentable inventions. * Covers all biological processes for fertilisation of an ovum up to birth: Application by Luminis Pty Ltd and Fertilitescentrum - However, this is very specificly related to processes that result in the generation of a human being. What about other processes that involve treatment of a person and do not result in another human being? * Kirin-Amgen Inc v Board of Regents of University of Washington (1995) 33 IPR 557  a decision of a Deputy Commissioner of Patents  Held that a purified and isolated DNA sequence satisfies the NRDC requirement that there be an ‘artificially created state of affairs’  Cf naturally occurring DNA coding – discovery * ‘In my view, a claim directed to naturally occurring DNA characterised by specifying the DNA coding for a portion of that molecule would likely be claiming no more than a discovery per se and not be a manner of manufacture’

Answer 4

- Cancer Voices Australia v Myriad Genetics Inc (2013) 99 IPR 567, [104] * removal of the material from its natural environment and its separation from other cellular components - might reasonably be described as an artificial state of affairs.  Isolated  Different from its natural environment  DNA would now have a different chemical structure (science things). - D'Arcy v Myriad Genetics Inc [2014] FCAFC 115 * Analysis focusing on the differences in structure and function effected by the intervention of man (at [155]) - D'Arcy v Myriad Genetics Inc [2015] HCA 35; (2015) 325 ALR 100 * They found a specific marker on DNA that indicated higher risk for breast or ovarian cancer – screening test to determine if at higher risk.  Their claim was over the isolated DNA containing the sequence which indicated (application for substance, not the method – used a generic process to gain the sequence). * Distinction between discovery and invention not precise enough  e.g. [223] (Gordon J), [91] (French CJ et al) * What is the utility of the claimed sequence?  Utility = generic information in the sequence. * Didn’t care about the new state (the different chemical structure created because it was outside the body). – therefore cant focus on this have to focus on generic information in sequence.  The generic information in the sequence is the same outside as it is inside the human body. * The notion of manner of manufacture was therefore, not satisfied. * HCA overturned FFC decision.  Just seen it as matching up the genes, not manner of manufacture. - Note: * US Supreme Court in Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 12-398 (2013)  They interestingly noted that the fact they put in a lot of effort/money into the discovery wasn’t relevant.  They said if they had gone further to develop some sort of applications of the knowledge/ new ways to test they could’ve claimed a patent over that. * Myriad claims fall “squarely” within laws of nature exception  Note that claims similar, but not identical to Australian patent

Answer 5

* Distinguish Myriad from Ariosa Diagnostics v Sequenom [2021] FCAFC 101; Sequenom v Ariosa Diagnostics [2019] FCA 1011  The invention: non-invasive method to determine foetal traits and malformations by performing diagnosis of maternal serum or plasma sample  Not discovery of naturally occurring phenomena, but practical application of such phenomena * Distinguished because this is about the method not about the sample they were testing.

Answer 6

- Patents provide protection for software’s functionality and against independent creation: Powerflex Services Pty Ltd v Data Access Corporation [no 2] (1992) 75 FCR 108, 126 - Up to early 1990s, IP Australia rejected many applications for software patents * Patent stronger then copyright. * Cause it don’t matter if they don’t know about patent existing and can still infringe. - Turning point in Australia was IBM v Commissioner of Patents (1991) * FCA applied a broad test based on the principles established by the High Court in NRDC v Commissioner of Patents (1959) 102 CLR 252 - CCOM v Jiejing (1994) * Full Fed Court Confirmed approach adopted in IBM * Chinese language word processing was the relevant field of economic endeavour

Answer 7

- There is not business method exclusion: * Lack of technical implementation though is a problem. * Courts have said no exclusion in both US and Aus (see below) * But any case considered there has been a combination of business method and device. - What is a business method? * US: State Street Bank & Trust Co. v Signature Financial Group, Inc., 149 F. 3d 1368, 1373 (CA Fed. 1998)  Anything that produces a ‘useful, concrete, and tangible result,’ is patentable  No business method exclusion

Answer 8

 Claim 1 claimed: An asset protection method for protecting an asset owned by an owner, the method comprising the steps of: (a) Establishing a trust having a trustee (b) The owner making a gift of a sum of money to the trust (c) The trustee making a loan of said sum of money from the trust to the owner, and (d) The trustee securing the loan by taking a charge for said sum of money over the asset.  a method for structuring a financial transaction with the aim of protecting an individual’s assets  Held: not patentable (not because it was a business method but because:) * Considered a ‘legal discovery’: [33]-[34] * Lack of physicality: [32] o Not concrete effect, outcome or transformation.  Note US position - In re Bilski, 545 F 3d 943 (Fed. Cir., 2008); Bilski v Kappos, 561 US ___ (2010) - machine-or-transformation test

Answer 9

* Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150  Mere implementation of an abstract idea/scheme in a well-known machine (i.e. a computer) does not create an “artificial effect”  The invention is to be understood as a matter of substance, not form (at [106]) * Does inventive step lie in the computer implementation? (at [118])  Necessary to understand the nature of computer software * ‘…operates on data expressed in digits, solving a problem by doing arithmetic as a person would do it by head and hand’. o (at [104], quoting Bancorp Services v Sun Life 687 F.3d 1266 (2012), 1277) * However, calling it the ‘modern equivalent of writing the schemes on a piece of paper…ignores the utilisation of the power of a computer to generate information’. (at [111]) - CASES HAVE AFFIRMED RESEARCH AFFILIATES

Answer 10

* Contrary to law: s 50(1)(a)  e.g. Prohibition of Human Cloning Act 2002, s 20(2) makes it an offence to intentionally create a “hybrid embryo”, which is defined as “an animal egg into which the nucleus of a human cell has been introduced” * Woo-Suk Hwang [2004]  application claimed “a method for producing chimeric embryos derived by nuclear transfer using human cells as nucleus donors and enucleated bovine oocytes as recipients” - created an embryo where the nuclear DNA is human, and the mitochondrial DNA is bovine  Also held to be contrary to s 18(2) and refused under s 50(1)(a) * Generallie inconvenient? (s 6, Statute of Monopolies)

Answer 11

- Is it new? - Compare the invention with products or processes which have already been disclosed through prior publication or prior use * Includes publicly available documentary disclosures, public oral disclosures and information conveyed by public acts anywhere in the world - Novelty at priority date of claim * Novelty of each claim in a complete specification assessed against the prior art base (comprising publicly available prior art information) as it existed immediately before the priority date of the claim: s 18(1)(b)(i), (1A)(b)(i) * S 43 – priority date generally is the date of filing the specification - Claim lacks novelty = anticipated

Answer 12

- is information that is part of the prior art base which is relevant for deciding whether or not an invention is novel: sch 1 - Under s 7, invention assessed against the following prior art information: * a single document or single act: s 7(1)(a); * two or more related documents or two or more related acts,  IF the relationship between the documents or acts is such that a person skilled in the art would treat them as a single source of information: s 7(1)(b); and * General rule – can’t go pick out information that’s already out there and combine them and say that its novel, even though only reason found invention was information that already existed. (your invention would’ve been anticipated by the person skilled in the art reading the two sources together). * Exception: Skilled person would treat them as related or a single source of information under s 7(1)(b) * a single complete patent specification which was published after the priority date of the claim under consideration but has an earlier priority date: s 7(1)(c). - Therefore * Separate comparison under s 7(1)  not permissible to make a mosaic out of the prior art information: Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 * ‘two or more related’ documents or acts  Only permissible IF the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information: s 7(1)(b)

Answer 13

* Examples:  Info: * Non-confidential disclosure, with no restrictions on use o Re Bristol-Myers Co’s Application [1969] RPC 146 * Photos or articles in a magazine or journal o Van der Lely NV v Bamfords Ltd [1963] RPC 61 * foreign-language patent specifications o Dennison Manufacturing Co v Monarch Marketing Systems Inc (1983) 1 IPR 431  Use * applicant uses, sells or distributes the product o Fomento Industrial SA v Mentmore Manufacturing Co Ltd [1956] RPC 87 * Product is used by others who have created the same thing o Windsurfing Intl Inc v Petit (1983) 3 IPR 440.

Answer 14

* In order to impact on novelty it has to be an enabling disclosure. * Also have to consider whether a skilled person would have identified the element missing and added as a matter of course. – would still be an enabling disclosure.  If they had to use their own experimentation/ingenuity probably wouldn’t be an enabling disclosure. * Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517; Hill v Evans (1862) 45 ER 1195 at 1200

Answer 15

* If the skilled reader follows it, will result in the claimed invention  Reveals all essential features.  Alphapharm v Lundbeck A/S (2008) 76 IPR 618 at [160]

Answer 16

* Meyers Taylor Pty Ltd v Vicarr Industries Ltd, (1977) CLR 228 per Aickin J:  The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement.

Answer 17

following to be disregarded: s 24 (2) * Disclosure to public authorities * 12 month “grace period” in s 24 (1) (intro in 2002) – if you make a disclosure and then apply for patent within 12 months you may be fine/able to still apply.  Disclosure without consent: s 24(1)(b)  General disclosures S 24(1)(a) & Reg 2.2C  Aim to mitigate adverse consequences of inadvertent disclosures * But not uniform internationally (e.g. US, Japan, Canada, none in EU)

Answer 18

- When – before priority date? - How – public disclosure/use? - What – was the disclosure enabling? - Exemption – 12-month grace period

Answer 19

- Patent system rewards ingenuity that is inventive/innovative – not general expertise * e.g. Aktiebolagest Hassle v Alphapharm (2002) 212 CLR 411 - i.e. non-obviousness * Inventive step exists ‘unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed before the priority date’: s 7 * Cf Novelty – considering what has been disclosed before - “common general knowledge” * The body of knowledge known or used by all those in the relevant trade which forms the background knowledge and experience of those working in that field * Minnesota Mining & Manufacturing v Beiersdorf (Australia) (1980)

Answer 20

- Assessed before the priority date of the relevant claim: s 7(2) * Cf Novelty – compare with publicly available prior art information

Answer 21

- ‘Common general knowledge’ may be established from a ‘mosaic’ of information IF this combination would be obvious to the skilled person * Minnesota Mining & Manufacturing v Beiersdorf (Aus) (1980) - s 7(2) and (3). * Compared with the prior art base … in the light of the common general knowledge, whether that knowledge is considered separately or together with:  prior art information contained in any single piece of prior art information; or  a combination of any two or more pieces of prior art information, which is information that a person skilled in the relevant art could, before the priority date of the claim in question, be reasonably expected to have combined: - to the “person skilled in the relevant art” * Construct a hypothetical person - ‘skilled but non-inventive worker in the relevant field of technology’ * Australian Patent Office Manual of Practice and Procedure, Vol 2 * Depending on the field, could be:  Tradesman in some fields or highly qualified scientist in others: American Cyanamid v Ethicon [1979]  A cross-disciplinary team of technical specialists: Genentech v Wellcome Foundation (1989)

Answer 22

- Usual approach is the problem-solution approach * Wellcome Foundation Ltd v V R Laboratories (Aust) Pty Ltd (1981) 148 CLR 262:  “The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not” * If faced with same problem would have came up with same solution just as a matter of routine/daily skill being exercised. * HCA considered in a case that trying all methods, crossing them off etc. was inventive step.

Answer 23

- Does the simplicity of an idea prevent it from being inventive? * No - Leonardis v Sartas No 1 (1996) 35 IPR 23 * e.g. Providing practical solution to a problem that others have yet to overcome: see Martin Engineering vTrison 1989 14 IPR 330; 1989 FCA 64 at 63 - Solution “worth a try” via trial and error = obvious? * Not according to HCA in Aktiebolagest Hassle v Alphapharm (2002)

Answer 24

- the result claimed can be produced i.e. the invention works - Requirement for both standard or innovation patent: s 18(1)(c) and 18(1A)(c) - S 7A - Meaning of useful (1) For the purposes of this Act, an invention is taken not to be useful unless a specific, substantial and credible use for the invention (so far as claimed) is disclosed in the complete specification. (2) The disclosure in the complete specification must be sufficient for that specific, substantial and credible use to be appreciated by a person skilled in the relevant art.

Answer 25

- Invention must not have been secretly used in Australia before the priority date by, on behalf of or with the authority of the patentee: ss 18(1)(d) and 18(1A)(d) - Historical rationale * Prevent extension of monopoly: Azuko v Old Digger [2001] FCA Gyles J - Re Wheatley’s Patent Application [1984]: * Demonstration and order - Azuko v Old Digger [2001] FCA: * Manufacture with intent to sell and unsolicited order * Has patentee obtained a commercial benefit from the activity before the priority date? - Raising the Bar Act – for uses after 15 April 2013 * Removes distinction between secret use and public disclosures within ‘grace period’: see s 9(e) * Not invalidated provided complete specification made within 12 months

Answer 26

* Not invalidated provided complete specification made within 12 months - s 9 - not considered to be secret uses and do not preclude patent: (a) Use of invention by patentee for the purpose of reasonable trial and experiment only; (b) Use of invention by patentee solely in course of a confidential disclosure of the invention by or with authority of patentee; (c) Any other use by patentee for any purpose other than trade or commerce; (d) Use of invention by or on behalf of Cth or State (e) Any use of the invention by or on behalf of, or with the authority of, the patentee for any purpose, if a complete application is made for the invention within the prescribed period.

Answer 27

- Sufficiency of patent specification * Discloses best method for performing invention?  s 40(2)(a) , (aa) * Claims supported by matters disclosed in specification?  s 40(3)

Answer 28

- Complete spec (body + claims) needs to provide detailed info fully describing the invention, including the best method known to the applicant of performing it: s 40(2)(a) , (aa) * E.g. Novartis AG v Monsanto Co 2005 APO – “synergistic amount” not defined * There might be multiple ways but you need to suggest the best method (shouldn’t be making other people work to get to the invention). - Will the disclosure enable the skilled addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty? * Kimberley Clark v Arico [2001] HCA

Answer 29

- s 40(3): * Claims must be clear and succinct * Claim “must be supported by matter disclosed in the specification” (for applications made after 15 April 2013);  Cf pre-Raising the Bar terminology “fairly based” on matter in specification  In line with terminology in other jurisdictions e.g. UK, EU – see eg Biogen v Medeva [1996] UKHL 18; [1997] RPC 1, [80], see also [71] - Question is a narrow one: does the claim as expressed “travel beyond the matter disclosed in the specification?” * Stack v Brisbane City Council [1999] FCA 1279 per Cooper J - Provisional Specification – see: ss 40(1) & 43(2A) * are claims in the complete specification supported by matter disclosed in the provisional specification to claim the earlier priority date?

Answer 30

- Anyone can apply but patent can only be granted to certain persons – s 15(1) (a) Inventor (b) Someone entitled to have patent assigned upon grant (c) Someone deriving title from the inventor or the assignee (d) Legal representative of one of the above. * Non-entitlement a ground of revocation, but only if “just and equitable”: ss 138(3)(a), 138(4)

Answer 31

- No express provisions dealing with employee inventions * Duty to assign may be implied into contract of employment  assignment usually occurs where invention is produced by employee working under contract of service  employer entitled to ownership for inventions performed during usual course of employment duties: Sterling Engineering v Patchett (1955) * Is there a “duty to invent”?  if the employee didn’t have a duty to invent, then this duty to assign should not be implied.  See UWA v Gray [2008] FCA 498 – distinguish “duty to invent” and “duty to research”.  cf Royal Children’s Hospital v Alexander [2011] APO 94 * senior scientist was to identify areas of improvement in an area of the hospital. * One invention was considered sufficiently connected to this duty (other inventions were not considered sufficiently connected to the hospital work).

Answer 32

- More than 1 person may be recognized as joint inventor * Collaborating parties having a material effect on the final concept of the invention as a whole: JVMB Ent v Camoflag (2005) 67 IPR 68; Polwood v Foxworth (2008) 75 IPR 1 * Held as tenants in common, subject to any agreement to the contrary: s 15(1), 63  each entitled to an equal, undivided share: s 16(1)(a)  Each entitled to work patent without accounting to others: s16(1)(b)  Consent of all needed to grant licence/assign interest: s16(1)(c) - Commissioner has power to issue directions on disputes between co-owners: s 17

Answer 33

- Patents do not extend to discoveries of what already exist in nature – think inventorship, novelty - “Bioprospecting” – Utilizing indigenous peoples' knowledge of these products and their properties, the industry may isolate and modify biological and genetic products, and registers patents for them

Answer 34

- a limited monopoly - lasts for 20 years from priority date - owner obtains exclusive right to “exploit” (defined in Sch 1) * for products: to make, hire, sell, dispose of; offer to make, hire, sell, dispose of; use or import; keep for the purpose of doing those things * for processes or methods: to use it, or do any of the above acts in relation to a product resulting from use of the method

Answer 35

* Can be assigned for a place in, or part of, Australia: s14(2) * must be in writing signed by or on behalf of the assignor and assignee: s14(1)

Answer 36

* may be oral or implied by conduct * May be exclusive, sole, non-exclusive * Exclusive licensee able to initiate infringement proceedings: s 120(1

Answer 37

* "exclusive licensee" means a licensee under a licence granted by the patentee and conferring on the licensee, or on the licensee and persons authorised by the licensee, the right to exploit the patented invention throughout the patent area to the exclusion of the patentee and all other persons. * exploit, in relation to an invention, includes: (a) where the invention is a product–make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or (b) where the invention is a method or process–use the method or process to do any act mentioned in paragraph (a) in respect of a product resulting from such use.  Single right to ‘exploit’ – therefore single exclusive licensee: Bristol-Myers Squibb Company v Apotex Pty Ltd [2015] FCAFC 2 * Cant grant multiple exclusive licences over different rights.

Answer 38

Section 133 * Federal Court may order that non-exclusive compulsory license be granted in 2 circumstances - Patentee: 1. fails to satisfy ‘the reasonable requirements of the public’ 2. is using patent to act in an anti-competitive manner

Answer 39

- “reasonable requirements of the public” * Trade/industry in Australia needs the article/process * After 3 years of sealing of patent, failure to manufacture it to an adequate extent, supply it on reasonable terms or grant licences on reasonable terms: s 135(1)(a),(b) - Must also show that * applicant has tried for a reasonable period, but without success, to obtain from the patentee an authorisation to work the invention on reasonable terms and conditions: s 133(2)(a)(i) * the patentee has given no satisfactory reason for failing to exploit the patent: s 133(2)(a)(iii)

Answer 40

- Occurs when the patentee’s exclusive right to exploit the patent is exercised within the patent area without the patentee’s authorisation * Strict liability standard  Infringer doesn’t need to know of existence of patents/that their act is infringing (lack of knowledge is only relevant to remedies). - Compared against the boundaries of the monopoly as claimed by patentee * Root Quality v Root Control [2000] FCA 980, [36] 1. The alleged infringer must have taken “each and every one of the essential integers" of that claim  Rodi and Wienenberger AG v Henry Showell Ltd, (1969) RPC 367 at 391 2. Final step must be taken to combine all integers  Sykes v Howarth (1879); Dunlop Pneumatic Tyre v David Moseley & Sons (1904)

Answer 41

- Catnic Components v Hill & Smith (1981)  Focus is on Patentees intention when drafting specification.  Relevant question with practical knowledge and experience would understand that strict compliance with particular descriptive word was intended by patentee to be an essential requirement.  Purposive approach may be explained through ‘the Improver questions’, though not conclusive

Answer 42

* Catnic had patent over steel lintel? It was used to provide structural support over door or window. o Was hollow, made from sheet steel, pressed into a rectangular shape, then anchored to a device. o Specification required a particular back plate which extended vertically.  Hill creates an identical invention but back plate extended on a upward slant (6 degrees) * Because it doesn’t extend vertical, could you say Hill not infringing. * Device still works exactly same way.  Court said: * For a builder vertical would just mean positioned near enough to vertical to allow it to be performed. * Purposive approach – slightly not vertical was an infringement.

Answer 43

* Notwithstanding that the “variant” is not within the literal meaning of the relevant claim(s) of the patent… 1. Does the variant have a material effect upon the way the invention works? If yes, the variant falls outside the claim. If no – 2. Would this fact (i.e., that the variant has no material effect) have been obvious to the skilled person at the date of publication of the patent? If no, the variant falls outside the claim. If yes – 3. Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim. If no, then the variant falls within the scope of the claim.

Answer 44

- Caution: still not so broad as to protect “ideas” * Australian Mud Company Pty Ltd v Coretell Pty Ltd [2011] FCAFC 121  To give a purposive construction to a patent specification, and in particular its claims, is not to engage in a process of reasoning that extends the patentee’s monopoly to the “ideas” disclosed in the specification. Nor does it extend the patentee’s monopoly to products or processes that the patentee did not, by the claims, define as the invention, even if those products or processes can be seen to perform the same function as the invention or to be based on the patentee’s “ideas”.

Answer 45

- s 117 – if the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement by the supplier… [and reference to “use” is a reference to] (2)(a) if the product is capable of only one reasonable use, having regard to its nature or design--that use; or [“only use”] (b) if the product is not a staple commercial product--any use of the product, if the supplier had reason to believe that the person would put it to that use; or [“known use”] (c) in any case--the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier. [“instructed use”] * [ ] abbreviations from Hayne J in NT v Collins

Answer 46

* Northern Territory v Collins (2008) 235 CLR 619  Staple commercial product – whether the supply of the product is commercial and whether the product has various uses (at [145])  “In this setting “staple commercial product” should not be given a narrow meaning. To do so would expand the classes of supply which are reached by s 117, thus expanding the rights of the patentee where, by hypothesis, the act of supply is not otherwise an infringement of the patentee’s monopoly” [43] per Hayne J

Answer 47

 No evidence Apotex had reason to believe use for patented treatment * Crennan and Kiefel JJ, [303]; Hayne J [169]-[172]  (c) not relevant – product information did not instruct use in accordance with patented method

Answer 48

EXPERIMENTAL USE - 119C PRIOR USE - 119 ACTS FOR OBTAINING REGULATORY APPROVAL OF PHARMACEUTICALS - S 119 CROWN USE - S 163, 165 FOREIGN VESSELS TEMPORARILY IN PATENT AREA - S 118

Answer 49

s 119C) * Introduced by Raising the Bar Act * EM - if main purpose to commercialize e.g. carry out market research to test commercial demand – then not experimental * Experiment must focus on subject matter of invention, not using it as a tool in course of experiment  S 119C (2)(d) – e.g. determining the validity of the patent

Answer 50

s 119) * Applies to secret use by third parties * Aim to not deprive third party from what they have been legitimately doing before patent grant * Applies to continuous prior use (except if stopped temporarily)

Answer 51

s 119A * Aim to allow generic drug manufacturers time to seek regulatory approval (avoid de facto extension of patent monopoly) * Once term of patented drug expires, generic equivalent can enter the market

Answer 52

- Exhaustion of rights – only right to ‘make’ remains: Calidad Pty Ltd v Seiko Epson Corporation [2020] HCA 41(implied licence to use as a consumer) * Previously: An implied licence to use – Interstate Parcel Express v Time-Life International (1997) 138 CLR 534 - Notion of ‘make’ crucial – covers modification to all features of the invention as claimed

Answer 53

* On patentee (or exclusive licensee) to establish infringement * NB for patented process for obtaining a product - reversal under s 121A

Answer 54

* Standard patent may be infringed by conduct after the date of publication of the complete specification: s 57 * Proceedings cannot be commenced until the patent has been granted: s 57

Answer 55

* 3 years from the day on which the relevant patent is granted; or * 6 years from the day on which the infringing act was done; whichever period ends later: s 120(4)

Answer 56

(ss 125-127) - Aim to assist legitimate competitors where they are unable to obtain conclusive advice or assurances from the patentee that their activity will not infringe the patent - Applicant must: 1. Notify patentee in writing with full particulars of proposed use 2. Request admission that such use will not constitute infringement 3. Undertake to pay a reasonable amount for advice to the patentee as to whether the proposed use would be infringing 4. Patentee has refused or failed to make the admission

Answer 57

- Injunction (or interlocutory injunction) - Damages or account of profits: s 122(1) * Innocent infringement (i.e. no knowledge or reason to believe patent existed) - pecuniary remedy may be denied: s 123(1) - Basic measure – restoration of Pl to status quo * Lost manufacturing profits * Fair royalty

Answer 58

- s 128 – If unjustified threats of infringement proceedings are made, the person aggrieved may apply for: (a) a declaration that the threats are unjustifiable; and (b) an injunction against the continuance of the threats; and (c) the recovery of any damages sustained by the applicant as a result of the threats. - Distinguish notice of existing patent from threat of proceedings (s 131)