Biotech & Pharmaceutical Patents: 2014 Year in Review

Transcription

1 February 26, 2015 Biotech & Pharmaceutical Patents: 2014 Year in Review Presented By: Ahmed Davis & Craig Countryman

2 2014 Developments 1. The Federal Circuit s Composition 2. Obviousness of Pharmaceutical Compounds and Formulations 3. Patent Eligible Subject Matter 4. Section 112 Issues 5. Potential Antitrust Liability for Hatch-Waxman Litigants

3 3 The Federal Circuit s Composition

4 A New Chief Judge Chief Judge Prost 4

5 Six New Judges Are Issuing Opinions Judge O Malley Judge Reyna Judge Chen Judge Taranto Judge Wallach Judge Hughes 5

6 6 Section 103 Obviousness

7 BMS v. Teva: Overview Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, reh g denied 769 F3d 1339 (Fed. Cir. 2014). BMS s patent to the Hepatitis B drug Baraclude (entecavir) is obvious. Several separate opinions on denial of rehearing: Concurrence by Judge Dyk, joined by Judge Wallach Concurrence by Judge O Malley Separate dissents by Judges Newman and Taranto, both joined by Judges Lourie and Reyna 7

8 BMS v. Teva: Prior Art vs. The Claims Entecavir (claimed compound) Most potent Hepatitis B treatment Very few patients become resistant 2 -CDG (prior art lead compound) Researchers were using it as a lead and viewed it as promising. Post-invention in vivo studies revealed it was toxic. 8

9 BMS v. Teva: The Panel s Rationale Obvious to select 2 -CDG as lead compound BMS s expert admissions about its use at the time of invention Obvious to modify 2 -CDG to arrive at entecavir Substitution of carbocyclic ring yielded greatest activity changes Prior art showed adding exocyclic methylene increased efficacy Any unexpected results were insufficient Unexpected properties did not upset the motivation to combine Superior efficacy a difference in degree, not difference in kind Difference in toxicity with 2 -CDG irrelevant because that was unknown at the time of invention 9

10 BMS v. Teva: Concurring Opinions Judge Dyk, joined by Judge Wallach: Post-invention evidence never relevant because 103 requires the inquiry to be conducted at the time of the invention (or, post- AIA, at the effective filing date ) Judge O Malley: Agrees with the dissenters view of the law But ultimately, a case is won or lost on the record. 10

11 BMS v. Teva: Judge Newman s Dissent Precedent says that data developed post-invention can be used to show non-obviousness The panel s rule creates conflicting incentives regarding when to file Rejects a bright-line rule regarding differences in degree and differences in kind 11

12 BMS v. Teva: Judge Taranto s Dissent Full court should analyze how to define reasonable expectation of success Serious question whether prior in vitro testing here was enough What is reasonable? KSR and policy suggest a higher bar What is success? Should be accomplishing what motivated the research Post-invention evidence Not prohibited by text of section 103 Seemingly allowed by precedent Can fit in depending on how you define reasonable expectation 12

13 Par v. TWI: Inherency in Obviousness Par Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186 (Fed. Cir. 2014): Claims to treatment method for anorexia Require specific dosage and particle size No substantial difference in blood level between fasted and fed states Prior art discloses everything except the blood level limitation Federal Circuit remands for reconsideration of whether blood level limitation is inherent 13

14 Par v. TWI: Inherency in Obviousness Reliance on inherency is permissible but must be carefully circumscribed. The limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art. The district court s finding that reducing particle size had some improvement on food effect was insufficient. No finding that the claimed particle size naturally results in no substantial difference in food effect, as claimed 14

15 Other Notable Obviousness Decisions Hoffman-LaRoche, Inc. v. Apotex, Inc., 748 F.3d 1326 (Fed. Cir. 2014) (invalidating claims to a method of treating osteoporosis with a once-monthly dose of a drug previously given daily in smaller doses) Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., USA, 748 F.3d 1354 (Fed. Cir. 2014) (upholding nonobviousness finding for claims to a combination therapy for hypertension that was unexpectedly longer lasting than either component alone) Allergan, Inc. v. Apotex, Inc., 754 F.3d 952 (Fed. Cir. 2014) (invalidating claims to compounds for treating hair loss where unexpected results weren t commensurate with the full claim scope) 15

16 16 Section 101 Eligible Subject Matter

17 The Supreme Court s Two-Part Test Alice Corp. Pty. Ltd. v. CLS Bank Int l, 134 S. Ct (2014): The two-step test for 101 eligibility from Mayo applies to all areas of technology. A court (or the PTO) must ask: 1. Are the claims directed to an abstract idea, law of nature, or natural phenomenon? 2. If so, do the claims contain an inventive concept to ensure they amount to significantly more than the abstract idea, law of nature, or natural phenomenon itself? Under that test, claims to a computer-implemented method of intermediated settlement were drawn to an unpatentable abstract idea. 17

18 Applying 101 to Genetic Tools and Testing In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014): Myriad sued several competitors who launched competing BRCA tests after the Supreme Court s 2013 decision Federal Circuit invalidates two sets of claims under 101: Single-stranded primers for sequencing BRCA gene via PCR Methods of comparing a patient s BRCA sequence and wild-type BRCA using a specific technique 18

19 The Prior Myriad Litigation Supreme Court 133 S. Ct (2013): Isolated genomic DNA is unpatentable cdna (i.e., just the protein-coding portions) is patentable Distinction is that isolated DNA appears in nature, while cdna does not Federal Circuit 689 F.3d 1303 (Fed. Cir. 2013): Claim to comparing patient s BRCA gene to wild-type BRCA is an unpatentable abstract idea Claim to growing a transformed host cell with an altered BRCA1 gene to screen potential cancer therapeutics is patentable 19

20 In re BRCA1 and BRCA2: Primers Primers are like the isolated DNA found previously found unpatentable: Structurally identical to the ends of DNA strands found in nature Doesn t matter that they were synthetically created copies of what is found in nature Doesn t matter that they are not found in the human body neither is isolated DNA Do not perform a significantly new function although primers start a polymerase chain reaction, they do so by binding to a complementary strand of DNA, which is a natural function 20

21 In re BRCA1 and BRCA2: Primers Detection method claims were an unpatentable abstract idea These were dependent claims of an independent claim previously held invalid by the Federal Circuit. They had two steps: 1. Comparing patient s BRCA gene to wild-type BRCA gene 2. Performing the comparison by using a particular technique (either hybridization or amplification, depending on the claim) The first step alone was unpatentable under the prior opinion Second step did not add enough to make the claim patent eligible Undisputed that these were routine, known comparison techniques Nothing new in using probes or primers, other than using with BRCA genes Claims not even limited to detecting particular BRCA mutations identified in the specification 21

22 Applying 101 to Cloned Animals In re Roslin Institute, 750 F.3d 1333 (Fed. Cir. 2014): Claims to Dolly the Sheep i.e., a live-born clone of a pre-existing non-embryonic donor mammal held unpatentable under 101 After Myriad, Dolly s generic material itself was unpatentable The innovation was preserving the same donor DNA to create an exact copy of the donor, but the copy still isn t patentable Unclaimed differences in phenotype and mitochondrial DNA between clone and donor are irrelevant to 101 inquiry Doesn t matter is the clone is a time-delayed version of the donor 22

23 23 Section 112 Issues

24 Promega: Enablement at the Point of Novelty Promega Corp. v. Life Techs. Corp., 773 F.3d 1338 (Fed. Cir. 2014) The patent related to a method of co-amplifying different places (loci) on DNA where a short tandem repeat (STR) sequence is found Claims cover any co-amplification reaction including 3 recited loci, even far more complicated reactions Federal Circuit holds the claims lack enablement as a matter of law 24

25 Promega: Enablement at the Point of Novelty The key limitation (the list of loci) was an open comprising set that included thousands of combinations Changing or adding even a single locus makes it difficult to predict whether the resulting set will co-amplify The patentee stressed that unpredictability to overcome prior art rejections during prosecution Yet the patentee chose broad claim language and relied on it to sweep in many additional infringing products Not every garden-variety comprising claim is at risk Here, the key limitation has its own comprising list that expands it to cover what are indisputably advances in this unpredictable art 25

26 Alcon: Overview Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180 (Fed. Cir. 2014): Claims cover a method of enhancing the stability of an aqueous formulation for a prostaglandin drug with a chemically stabilizing amount of an additive The patent includes only 3 working examples and no data on chemical stability Federal Circuit reverses finding of invalidity for lack of written description and enablement 26

27 Alcon: Enablement Focus should be on the amount of experimentation, if any, that is required The patent disclosed exemplary compositions, listed drugs and additives that could be used, and gave concentration ranges No evidence that any claimed embodiment would be inoperable It did not matter if some embodiments were better than others because the claims didn t require a particular degree of stability Defendant had stressed predictability of the art when arguing obviousness Chemical stability data was unnecessary 27

28 Alcon: Written Description The patent conveyed the inventors had possession of their key idea that a particular class of additives could be used to stabilize prostaglandin drugs The patent detailed that idea step-by-step, including exemplary formulations, and lists of drugs and additives that could be used Written description is not about whether the patentee has proven to the skilled reader that the invention works, or how to make it work As a result, the absence of chemical stability data was irrelevant 28

29 Takeda: 112 and Multiple Measurement Methods Takeda Pharm. Co. v. Zydus Pharms. USA, Inc., 743 F.3d 1359 (Fed. Cir. 2014) Claims covered sustained release tablets with specific particle size Claims not indefinite, even though particle size could be measured in multiple, different ways Each measurement technique yielded substantially similar results, and any variation did not impact the infringement analysis Claims adequately described where the patent disclosed measuring particle size before tableting and nothing suggested the tableting process changed particle size Claims were enabled where the specification disclosed one way of testing particle size, regardless of whether the skilled artisan could do it the other way 29

30 30 Potential Antitrust Liability Associated with Hatch-Waxman Litigation

31 Tyco: New Potential Antitrust Liability Tyco Healthcare v. Mutual Pharm., 762 F.3d 1338 (Fed. Cir. 2014): Reverses SJ of no sham litigation because of fact issues on whether ANDA suit was objectively baseless Reverses SJ of no sham litigation for FDA Citizen s Petition 31

32 General Two-Part Test for Sham Litigation A litigant cannot face antitrust liability for bringing a lawsuit, unless: 1. The litigation is objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits, and 2. The litigation is motivated by a desire to interfere directly with the business relationships of a competitor. 32

33 Tyco: Sham Hatch-Waxman Litigation The patent required a drug formulation where the active ingredient had a given parameter ANDA reported non-infringing value for that parameter at one temperature The patentee relied on test data at a higher temperature The mere fact the ANDA suggested non-infringement was not itself enough for antitrust liability But the patentee s testing did not show infringement Higher temperature seemed to skew the ANDA product s composition Without decomposition, higher temperature would actually take the composition further outside the claim 33

34 Tyco: Sham FDA Citizen s Petition The same two-part test that applies to sham litigation claims applies to a sham FDA filing too Fact issues on whether CP was objectively baseless : FDA said CP provided no evidence from testing and relies entirely on uncorroborated generalities and theoretical speculation Generic s expert says patentee had no scientific basis Fact issues on whether CP was filed in bad faith: Timing of CP filed the day after district court found noninfringement Patentee s internal said it was possible to make a noninfringing but bioequivalent product 34

35 Thank You! Ahmed Davis Principal Fish & Richardson Craig Countryman Principal Fish & Richardson 35

36 Contact Fish & Richardson Download the presentation and access other valuable materials at Contact us with your questions and comments. Robin Chance Senior Marketing Manager Fish & Richardson Copyright 2015 Fish & Richardson P.C. These materials may be considered advertising for legal services under the laws and rules of professional conduct. The materials contained in this presentation has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only and is not intended to be legal advice. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. For more information about Fish & Richardson P.C. and our practices, please visit